Status:
COMPLETED
Mechanisms of Diabetes Relapse After Bariatric Surgery
Lead Sponsor:
Blandine Laferrere
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 glucos...
Detailed Description
The mechanisms of type 2 diabetes (T2DM) remission after gastric bypass surgery (GBP) are unclear. The levels of the gut hormones incretins and their effect on insulin secretion, which is impaired in ...
Eligibility Criteria
Inclusion
- Post GBP, LAGB or VSG Subjects
- Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
- History of Type 2 Diabetes before surgery
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
May 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01516320
Start Date
May 13 2009
End Date
September 1 2014
Last Update
February 1 2017
Active Locations (1)
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1
New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025