Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ethicon Endo-Surgery
LifeScan
Information provided by (Responsible Party):
Philip Schauer, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00432809
First received: February 6, 2007
Last updated: December 20, 2013
Last verified: December 2013
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type 2
Obesity
Interventions: Procedure: Gastric bypass
Procedure: Sleeve Gastrectomy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study recruitment began December 2006 and the last patient was enrolled January 2011. Patients were recruited from the Bariatric and Diabetes Outpatient clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
68 patients screened fail prior to randomization due to not meeting inclusion criteria.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Participant Flow for 2 periods

Period 1:   1 Year Follow-up
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
STARTED     50     50     50  
COMPLETED     41     50     49  
NOT COMPLETED     9     0     1  
Misses 9 and 12 month visit                 2                 0                 0  
Withdrawal by Subject                 7                 0                 1  

Period 2:   2 Year Sub-study
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
STARTED     20     20     20  
COMPLETED     17     18     19  
NOT COMPLETED     3     2     1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Total Total of all reporting groups

Baseline Measures
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy     Total  
Number of Participants  
[units: participants]
  50     50     50     150  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     50     50     50     150  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  49.7  ± 7.4     48.3  ± 8.4     47.9  ± 8.0     48.6  ± 7.9  
Gender  
[units: participants]
       
Female     31     29     39     99  
Male     19     21     11     51  
Race/Ethnicity, Customized [1]
[units: participants]
       
Caucasian     37     37     36     110  
Black/African American     12     13     14     39  
Asian     1     0     0     1  
Region of Enrollment  
[units: participants]
       
United States     50     50     50     150  
Duration of diabetes  
[units: Years]
Mean ± Standard Deviation
  8.9  ± 5.8     8.2  ± 5.5     8.5  ± 4.8     8.5  ± 5.4  
Use of insulin  
[units: participants]
       
Insulin dependent     22     22     22     66  
Non-insulin dependent     28     28     28     84  
body-mass index  
[units: kg/m2]
Mean ± Standard Deviation
  36.8  ± 3.0     37.0  ± 3.3     36.2  ± 3.9     36.7  ± 3.4  
Body-mass index < 35  
[units: participants]
       
BMI < 35     19     14     18     51  
BMI > / = 35     31     36     32     99  
Body weight  
[units: kg]
Mean ± Standard Deviation
  106.5  ± 14.7     106.7  ± 14.8     100.8  ± 16.4     104.6  ± 15.4  
Waist circumference  
[units: cm]
Mean ± Standard Deviation
  114.5  ± 9.4     116.4  ± 9.2     114.0  ± 10.4     115.0  ± 9.7  
Fasting glucose  
[units: mg/dL]
Mean ± Standard Deviation
  169.6  ± 59.1     188.9  ± 67.6     177.6  ± 70.3     178.7  ± 65.9  
Smoker  
[units: Participants]
       
Smoker     15     20     11     46  
Non-smoker     35     30     39     104  
Metabolic syndrome  
[units: participants]
       
Yes     46     45     47     138  
No     4     5     3     12  
History of dyslipidemia  
[units: participants]
       
Yes     36     44     40     120  
No     14     6     10     30  
History of hypertension  
[units: participants]
       
Yes     26     35     30     91  
No     24     15     20     59  
Systolic blood pressure  
[units: mmHg]
Mean ± Standard Deviation
  137.5  ± 17.4     134.6  ± 18.7     136.2  ± 18.8     136.1  ± 18.3  
Diastolic blood pressure  
[units: mmHg]
Mean ± Standard Deviation
  83.7  ± 11.5     81.8  ± 10.2     82.1  ± 11.5     82.5  ± 11.0  
High-density lipoprotein cholesterol  
[units: mg/dL]
Mean ± Standard Deviation
  46.3  ± 13.2     46.2  ± 13.4     44.5  ± 11.9     45.7  ± 12.8  
Triglycerides  
[units: mg/dL]
Median ( Inter-Quartile Range )
  169.0  
  ( 113 to 239 )  
  167.0  
  ( 125 to 257 )  
  157.0  
  ( 119 to 211 )  
  166.5  
  ( 118 to 236 )  
Diabetic medication - Biguanides  
[units: participants]
       
Taking Biguanides     46     42     42     130  
Not taking Biguanides     4     8     8     20  
Diabetes medication - Thiazolidinedione (TZD's)  
[units: participants]
       
Taking TZD's     20     25     17     62  
Not taking TZD's     30     25     33     88  
Diabetes medication - Incretin Mimetics  
[units: participants]
       
Taking Incretin Mimetics     24     19     21     64  
Not taking Incretin Mimetics     26     31     29     86  
Diabetes medication - Secretagogues  
[units: participants]
       
Taking Secretagogues     18     17     19     54  
Not taking Secretagogues     32     33     31     96  
Number of Diabetic Medications  
[units: participants]
       
0     1     1     1     3  
1     8     10     11     29  
2     11     13     14     38  
3     16     12     13     41  
> / = 4     14     14     11     39  
Cardiovascular medication - Lipid Lowering Agents  
[units: participants]
       
Taking Lipid Lowering Agent     41     43     39     123  
Not taking Lipid Lowering Agent     9     7     11     27  
Cardiovascular medication - Beta blocker  
[units: participant]
       
Taking Beta Blocker     9     9     6     24  
Not taking Beta Blocker     41     41     44     126  
Cardiovascular medications - ACE Inhibitors or ARB  
[units: participant]
       
Taking ACE Inhibitor or ARB     30     32     25     87  
Not taking ACE Inhibitor or ARB     20     18     25     63  
Cardiovascular medication - Anticoagulant  
[units: participant]
       
Taking Anticoagulants     26     21     16     63  
Not taking Anticoagulants     24     29     34     87  
[1] Participants self reported race/ethnicity according to Caucasian, Black/African American, Asian, Hispanic/Latino, American Indian/Alaska Native, Pacific Islander, or Other.



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.   [ Time Frame: 1 year ]

Measure Type Primary
Measure Title Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
Measure Description The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat (ITT) population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.  
[units: participants]
  5     21     18  


Statistical Analysis 1 for Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] 0.002
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.008
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.59
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Not adjusted for multiple comparisons



2.  Primary:   Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications   [ Time Frame: 1 year ]

Measure Type Primary
Measure Title Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
Measure Description The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications  
[units: participants]
  0     21     13  


Statistical Analysis 1 for Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Medical Therapy vs. Gastric Bypass
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.10
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   Change in Glycated Hemoglobin (HbA1c)   [ Time Frame: 1 year - baseline ]

Measure Type Secondary
Measure Title Change in Glycated Hemoglobin (HbA1c)
Measure Description Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change
Time Frame 1 year - baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Change in Glycated Hemoglobin (HbA1c)  
[units: percentage points of glycated hemoglobin]
Mean ± Standard Deviation
  -1.4  ± 1.5     -2.9  ± 1.6     -2.9  ± 1.8  


Statistical Analysis 1 for Change in Glycated Hemoglobin (HbA1c)
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Change in Glycated Hemoglobin (HbA1c)
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Change in Glycated Hemoglobin (HbA1c)
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.85
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Secondary:   Fasting Plasma Glucose   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Fasting Plasma Glucose
Measure Description Fasting Plasma Glucose measured in mg/dL.
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Fasting Plasma Glucose  
[units: mg/dL]
Median ( Inter-Quartile Range )
  120  
  ( 97 to 154 )  
  99  
  ( 83 to 121 )  
  97  
  ( 84 to 114 )  


Statistical Analysis 1 for Fasting Plasma Glucose
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.004
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Fasting Plasma Glucose
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.003
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Fasting Plasma Glucose
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.86
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   Glycated Hemoglobin (HbA1c)   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Glycated Hemoglobin (HbA1c)
Measure Description Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Glycated Hemoglobin (HbA1c)  
[units: percentage points of glycated hemoglobin]
Mean ± Standard Deviation
  7.5  ± 1.8     6.4  ± 0.9     6.6  ± 1.0  


Statistical Analysis 1 for Glycated Hemoglobin (HbA1c)
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Glycated Hemoglobin (HbA1c)
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.003
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Glycated Hemoglobin (HbA1c)
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.23
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



6.  Secondary:   Body Weight   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Body Weight
Measure Description Body weight in kilograms (kg) measured at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Body Weight  
[units: kg]
Mean ± Standard Deviation
  99.0  ± 16.4     77.3  ± 13.0     75.5  ± 12.9  


Statistical Analysis 1 for Body Weight
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Body Weight
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Body Weight
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.02
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



7.  Secondary:   Change in Body Weight From Baseline   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Change in Body Weight From Baseline
Measure Description Mean change in body weight from baseline measured in kilograms (kg)
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Change in Body Weight From Baseline  
[units: kg]
Mean ± Standard Deviation
  -5.4  ± 8.0     -29.4  ± 8.9     -25.1  ± 8.5  


Statistical Analysis 1 for Change in Body Weight From Baseline
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Change in Body Weight From Baseline
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Change in Body Weight From Baseline
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.02
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Secondary:   Body Mass Index (BMI)   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Body Mass Index (BMI)
Measure Description Body Mass Index (BMI) at 12 months measured as kg/m2
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Body Mass Index (BMI)  
[units: kg/m2]
Mean ± Standard Deviation
  34.4  ± 3.7     26.8  ± 3.2     27.2  ± 3.5  


Statistical Analysis 1 for Body Mass Index (BMI)
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Body Mass Index (BMI)
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Body Mass Index (BMI)
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.61
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Secondary:   Change in Body Mass Index (BMI)   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Change in Body Mass Index (BMI)
Measure Description Change in Body Mass Index (BMI) at 12 months, measured in kg/m2
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Change in Body Mass Index (BMI)  
[units: kg/m2]
Mean ± Standard Deviation
  -1.9  ± 2.9     -10.2  ± 3.1     -9.0  ± 2.7  


Statistical Analysis 1 for Change in Body Mass Index (BMI)
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Change in Body Mass Index (BMI)
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Change in Body Mass Index (BMI)
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.03
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



10.  Secondary:   Change in Systolic Blood Pressure (SBP)   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Change in Systolic Blood Pressure (SBP)
Measure Description Change in Systolic Blood Pressure (SBP) at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Change in Systolic Blood Pressure (SBP)  
[units: mm Hg]
Mean ± Standard Deviation
  -3.9  ± 14.7     -2.4  ± 18.7     -5.1  ± 17.0  


Statistical Analysis 1 for Change in Systolic Blood Pressure (SBP)
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] ANOVA
P Value [3] 0.87
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Change in Systolic Blood Pressure (SBP)
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.67
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Change in Systolic Blood Pressure (SBP)
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.46
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



11.  Secondary:   Change in High-density Lipoprotein (HDL)   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Change in High-density Lipoprotein (HDL)
Measure Description Percent change in high-density lipoprotein (HDL) at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Change in High-density Lipoprotein (HDL)  
[units: mg/dL]
Mean ± Standard Deviation
  11.3  ± 25.7     28.5  ± 22.7     28.4  ± 21.9  


Statistical Analysis 1 for Change in High-density Lipoprotein (HDL)
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] ANOVA
P Value [3] 0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Change in High-density Lipoprotein (HDL)
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Change in High-density Lipoprotein (HDL)
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] ANOVA
P Value [3] 0.98
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



12.  Secondary:   Change in Triglycerides   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Change in Triglycerides
Measure Description Median percent change in triglycerides at 12 months from baseline measure
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Change in Triglycerides  
[units: mg/dL]
Median ( Inter-Quartile Range )
  -14  
  ( -40 to 3 )  
  -44  
  ( -65 to -16 )  
  -42  
  ( -56 to 0 )  


Statistical Analysis 1 for Change in Triglycerides
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.002
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Change in Triglycerides
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.08
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Change in Triglycerides
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.17
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



13.  Secondary:   Change in High-sensitivity C-reactive Protein (Hs-CRP)   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Change in High-sensitivity C-reactive Protein (Hs-CRP)
Measure Description Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Change in High-sensitivity C-reactive Protein (Hs-CRP)  
[units: mg/L]
Median ( Inter-Quartile Range )
  -33.2  
  ( -71 to 0 )  
  -84  
  ( -91 to -59 )  
  -80  
  ( -90 to -63 )  


Statistical Analysis 1 for Change in High-sensitivity C-reactive Protein (Hs-CRP)
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Change in High-sensitivity C-reactive Protein (Hs-CRP)
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Change in High-sensitivity C-reactive Protein (Hs-CRP)
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.59
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



14.  Secondary:   Diabetes Medication - Use of Insulin   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Diabetes Medication - Use of Insulin
Measure Description Number of participants taking insulin at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Diabetes Medication - Use of Insulin  
[units: participants]
  15     2     4  


Statistical Analysis 1 for Diabetes Medication - Use of Insulin
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Diabetes Medication - Use of Insulin
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 1.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Diabetes Medication - Use of Insulin
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.68
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



15.  Secondary:   Diabetes Medication - Use of Biguanides   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Diabetes Medication - Use of Biguanides
Measure Description Number of participants taking Biguanides at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Diabetes Medication - Use of Biguanides  
[units: participants]
  38     10     19  


Statistical Analysis 1 for Diabetes Medication - Use of Biguanides
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Diabetes Medication - Use of Biguanides
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Diabetes Medication - Use of Biguanides
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



16.  Secondary:   Diabetes Medication - Use of Thiazolidinedione   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Diabetes Medication - Use of Thiazolidinedione
Measure Description Number of participants using thiazolidinedione at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Diabetes Medication - Use of Thiazolidinedione  
[units: participants]
  20     0     5  


Statistical Analysis 1 for Diabetes Medication - Use of Thiazolidinedione
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Diabetes Medication - Use of Thiazolidinedione
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Diabetes Medication - Use of Thiazolidinedione
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.06
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



17.  Secondary:   Diabetes Medication - Use of Incretin Mimetics   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Diabetes Medication - Use of Incretin Mimetics
Measure Description Number of participants taking Incretin Mimetics
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Diabetes Medication - Use of Incretin Mimetics  
[units: participants]
  34     1     10  


Statistical Analysis 1 for Diabetes Medication - Use of Incretin Mimetics
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Diabetes Medication - Use of Incretin Mimetics
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.005
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Diabetes Medication - Use of Incretin Mimetics
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.004
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



18.  Secondary:   Diabetes Medication - Use of Secretagogue   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Diabetes Medication - Use of Secretagogue
Measure Description Number of participants taking Secretagogues at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Diabetes Medication - Use of Secretagogue  
[units: participants]
  10     1     5  


Statistical Analysis 1 for Diabetes Medication - Use of Secretagogue
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Diabetes Medication - Use of Secretagogue
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.06
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Diabetes Medication - Use of Secretagogue
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.20
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



19.  Secondary:   Cardiovascular Medications - Lipid Lowering Agents   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Cardiovascular Medications - Lipid Lowering Agents
Measure Description Number of participants taking Lipid lowering agents at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Cardiovascular Medications - Lipid Lowering Agents  
[units: participants]
  36     13     19  


Statistical Analysis 1 for Cardiovascular Medications - Lipid Lowering Agents
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Cardiovascular Medications - Lipid Lowering Agents
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Cardiovascular Medications - Lipid Lowering Agents
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.20
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



20.  Secondary:   Cardiovascular Medications - Beta Blocker   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Cardiovascular Medications - Beta Blocker
Measure Description Number of participants taking Beta Blockers at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Cardiovascular Medications - Beta Blocker  
[units: participants]
  5     9     3  


Statistical Analysis 1 for Cardiovascular Medications - Beta Blocker
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] 0.48
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Cardiovascular Medications - Beta Blocker
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.46
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Cardiovascular Medications - Beta Blocker
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.06
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



21.  Secondary:   Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
Measure Description Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)  
[units: participants]
  26     9     11  


Statistical Analysis 1 for Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.62
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



22.  Secondary:   Cardiovascular Medications - Anticoagulants   [ Time Frame: 1 year ]

Measure Type Secondary
Measure Title Cardiovascular Medications - Anticoagulants
Measure Description Number of participants taking anticoagulants at 12 months
Time Frame 1 year  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Measured Values
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
Number of Participants Analyzed  
[units: participants]
  41     50     49  
Cardiovascular Medications - Anticoagulants  
[units: participants]
  24     1     8  


Statistical Analysis 1 for Cardiovascular Medications - Anticoagulants
Groups [1] Medical Therapy vs. Gastric Bypass
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Cardiovascular Medications - Anticoagulants
Groups [1] Medical Therapy vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Cardiovascular Medications - Anticoagulants
Groups [1] Gastric Bypass vs. Sleeve Gastrectomy
Method [2] Chi-squared
P Value [3] 0.03
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



23.  Secondary:   Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).   [ Time Frame: 1, 2, and 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

24.  Secondary:   Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.   [ Time Frame: 1, 2, and 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

25.  Secondary:   The Cost-effectiveness of Each Program and the Side Effects and /or Complications.   [ Time Frame: 1, 2, and 5 years. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Important limitations in the primary endpoint and 1 year outcomes are the short duration of follow-up (12 months), the study occurred at a single-center and the open-label nature of the study (subjects were not blinded to treatment).


  More Information