Overview

This trial is active, not recruiting.

Conditions obesity, type 2 diabetes
Treatments laparoscopic roux en y gastric bypass operation, medical management
Sponsor The Cleveland Clinic
Start date January 2011
End date December 2014
Trial size 60 participants
Trial identifier NCT01278823, 1R01DK089547

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
laparoscopic roux en y gastric bypass
laparoscopic roux en y gastric bypass operation bariatric surgery
roux en y gastric bypass operation
(Active Comparator)
Comprehensive medical management of diabetes including medications, diet intervention, lifestyle modification, exercise regimen
medical management meal replacement
latest type 2 diabetes medications, lifestyle/behavior modification and dietary regimen

Primary Outcomes

Measure
Test the effect of gastric bypass surgery on glycemic control in obese type 2 DM patients
time frame: 12 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes
Principal investigator John Kirwan, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.