Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes

Obesity Clinical Trial

— STAMPEDEII  

Official title:

Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278823
• Other study ID #: 1R01DK089547
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: February 15, 2017

Study information

• Verified date: July 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of bariatric surgery on blood sugar control and underlying mechanisms that contribute to type 2 diabetes in men and women with a BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y gastric bypass operation or intensive medical, dietary and exercise management.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• candidate for general surgery

• 18 to 60 years old

• BMI 27-43

• type 2 diabetes

• willing to participate in either study arm

• understand and comply with requirements of each arm

• not pregnant

• willing to use reliable birth control for duration of study

Exclusion Criteria:

• prior bariatric surgery of any type

• prior complex abdominal surgery

• abdominal, thoracic, pelvic, obstetrical surgery within last 6 months

• significant cardiovascular disease

• kidney disease with a creatinine greater than or equal to 1.8 mg/dl

• chronic liver disease except for NAFLD/NASH

• celiac, malabsorptive, inflammatory bowel disorders

• psychiatric disorders requiring 3 or more medications

• pregnancy

• cancer except squamous or basal cell skin cancer or cancer in remission

• anticoagulation therapy that can't be stopped for surgery

• clotting disorders

• severe pulmonary disease

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Procedure:
• laparoscopic roux en y gastric bypass operation
roux en y gastric bypass operation

Other:
• medical management
latest type 2 diabetes medications, lifestyle/behavior modification and dietary regimen

Locations

Country	Name	City	State
United States	Cleveland Clinic Bariatric and Metabolic Institute, Department of Pathobiology	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test the effect of gastric bypass surgery on glycemic control in obese type 2 DM patients	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.	12 months
Secondary	Determine the effects of gastric bypass surgery on pancreatic beta cell function and incretin hormone secretion in obese type 2 dm patients	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.	12 months

External Links

•   Cleveland Clinic Bariatric and Metabolic Institute web site