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
  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 ]

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 ]
  Hide Outcome Measure 13

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 ]

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 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


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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).  


Results Point of Contact:  
Name/Title: Dr. Philip Schauer
Organization: Cleveland Clinic
phone: 216-444-4794
e-mail: schauep@ccf.org


Publications:
Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic cost of diabetes mellitus in the US in 2002. Diabetes Care 26:917-932, 2003.

Publications automatically indexed to this study:

Responsible Party: Philip Schauer, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00432809     History of Changes
Other Study ID Numbers: EES IIS 19900
Study First Received: February 6, 2007
Results First Received: November 9, 2012
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board