Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes (STAMPEDEII)
|ClinicalTrials.gov Identifier: NCT01278823|
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : March 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Type 2 Diabetes||Procedure: laparoscopic roux en y gastric bypass operation Other: medical management||Not Applicable|
Obesity and type 2 diabetes mellitus (T2DM) are two of the greatest public health problems of the 21st century. Lifestyle changes and pharmacotherapy, which are mainstay treatments for T2DM have had limited success. More intensive lifestyle weight management such as in the Look AHEAD trial reported an 8.6% weight loss after 1 year, while the Diabetes Prevention Program reported a 7% weight loss after 2 years, and a 58% decrease in the risk of developing T2DM. In contrast,we have observed a 31% weight loss together with 83% remission of T2DM in severely obese patients after Roux-en-Y gastric bypass (RYGB) surgery. However, direct evidence of the glycemic benefits of bariatric surgery from randomized control trials is lacking; there is no clear consensus that RYGB surgery is a good treatment option for moderately obese T2DM patients; and the mechanisms responsible for reversing T2DM after surgery remain unclear but may involve pancreatic insulin secretion and skeletal muscle and hepatic insulin resistance.
The objective of this application is to evaluate the effects of RYGB surgery on glycemic control and underlying mechanisms that contribute to T2DM in obese subjects (BMI: 30-40 kg/m2). Our central hypothesis is that RYGB surgery will reduce hyperglycemia via reversal of beta-cell dysfunction and decrease hepatic and peripheral insulin resistance. The approach requires a 12-month randomized controlled trial. The rationale is based on data showing that RYGB lowers fasting and postprandial glucose, and increases the GLP-1 response to a meal. However, the therapeutic efficacy of RYGB surgery in obesity-related T2DM needs to be demonstrated in a randomized trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||February 15, 2017|
|Actual Study Completion Date :||February 15, 2017|
Surgery: laparoscopic roux en y gastric bypass operation
Procedure: laparoscopic roux en y gastric bypass operation
roux en y gastric bypass operation
Other Name: bariatric surgery
Active Comparator: Medical treatment
Medical Treatment: Comprehensive medical management of diabetes including medications, diet intervention, lifestyle modification, exercise regimen
Other: medical management
latest type 2 diabetes medications, lifestyle/behavior modification and dietary regimen
- Test the effect of gastric bypass surgery on glycemic control in obese type 2 DM patients [ Time Frame: 12 months ]The working hypothesis for this aim is that significantly more obese T2DM patients who undergo RYGB surgery will achieve glycemic control based on a primary endpoint of an HbA1c ≤ 6.5% at 12 months, than patients managed by intensive medical therapy.
- Determine the effects of gastric bypass surgery on pancreatic beta cell function and incretin hormone secretion in obese type 2 dm patients [ Time Frame: 12 months ]The working hypothesis for this aim is that a primary physiological link between obesity and T2DM is specific to beta-cell dysfunction; RYGB will reverse beta-cell dysfunction by increasing postprandial incretin secretion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278823
|United States, Ohio|
|Cleveland Clinic Bariatric and Metabolic Institute, Department of Pathobiology|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||John Kirwan, PhD||The Cleveland Clinic|