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

This study has been completed.
Sponsor:
Collaborators:
Ethicon Endo-Surgery
LifeScan
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00432809
First received: February 6, 2007
Last updated: April 25, 2016
Last verified: February 2016
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
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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
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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 
Overall Participants Analyzed 
[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 
[1] Participants self reported race/ethnicity according to Caucasian, Black/African American, Asian, Hispanic/Latino, American Indian/Alaska Native, Pacific Islander, or Other.
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]
       
 1   1   1   3 
 8   10   11   29 
 11   13   14   38 
 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 


  Outcome Measures
  Show All Outcome Measures

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

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 ]

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

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

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

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

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

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

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 
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 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

23.  Secondary:   Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).   [ Time Frame: 1, 2, and 5 years ]
Results not yet reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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