Mechanisms of Diabetes Relapse After Bariatric Surgery
Completed · Not applicable
Conditions studied: Type 2 Diabetes
In brief
The objective of this study is to investigate the different mechanisms by which Gastric Bypass (GBP), laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in gut peptides in the short and long term in morbidly obese patients with Type 2 Diabetes Mellitus after GBP, LAGB or VSG. The 2 surgical groups will be compared at 10% equivalent weight loss and at after surgery in terms of gut hormones levels, insulin secretion and glucose control.
Key facts
- Study ID
- NCT01516320
- Run by
- Blandine Laferrere
- People needed
- 56
- Starts
- 2009-05-13
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2017-02-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 35 < BMI < 50
- Non-Smoker
- Total Body Weight < 300 LBS
- 30<Age<60
- HbA1c < 9%
- Resting Blood Pressure < 160/100 mmHg
- Beta Blockers discontinued 2 weeks prior
- Fasting Triglyceride Concentration < 600 mg/dl (patient can be on dyslipidemia medications)
- Without recent (within last 6 months) CHD history (prior history of angioplasty or coronary artery bypass surgery with normal stress test ok)
You may not qualify if…
- Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
- Patients should not have significant secondary complications from diabetes that would preclude undergoing gastric by-pass surgery. This would include significant psychiatric, renal or neurological, or known active coronary artery disease.
- Any abnormality during the maximum exercise stress test that indicates it would be unsafe to undergo bariatric surgery.
- Currently pregnant or nursing.
- Known cardiovascular disease
- Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
- HbA1c >9% and diabetes diagnosed more than 6 years prior to enrollment, or patients taking insulin or TZD (Avandia, Actos, Exenatide, DPP-IV inhibitors etc.) at the time of enrollment.
- Patients diagnosed with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome. These clinical conditions would interfere with the collection and interpretation of the H2 breath test.
- Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.
Where it is running
- New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center — New York, New York, United States
Full record on ClinicalTrials.gov
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