Status:
COMPLETED
Determinants of Diabetes Remission After Gastric Bypass Surgery
Lead Sponsor:
Blandine Laferrere
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
Longitudinal study of beta cell function up to 2 years after GBP surgery. Evaluation of the role of endogenous glucagon-like peptide-1 (GLP-1).
Detailed Description
The increased prevalence of obesity and type 2 diabetes (T2DM) has resulted in a surge in the number of patients seeking surgical weight loss. Gastric bypass surgery (GBP) results in 30-40% body weigh...
Eligibility Criteria
Inclusion
- Patients with a wide range of T2DM (duration, treatment modalities and control, in or not in remission) and scheduled for GBP surgery
- Blood pressure is under at least moderate control \<160/100 mmHg
- Patients can be on dyslipidemia medications but need fasting triglyceride \< 600 mg/dl
- Patients without recent (last 6 months) history of cardiovascular disease (CVD)
- BMI \> 35 and \< 55 kg/m2 prior to GBP surgery
Exclusion
- Active cancer
- Unstable angina
- Recent stroke
- Current therapy that may affect glucose metabolism such as glucocorticoids, HIV medications, etc
- Active infection
- Kidney failure
- Severe liver dysfunction
- Severe respiratory or cardiac failure
- History of allergic reaction to exendin 9-39
- History of pancreatitis, history of cholelithiasis, history of alcoholism
- Presence of high triglyceride levels (\>600 ng/dl)
- Pregnancy (a pregnancy test will be done prior to enrollment and prior to each procedure in all premenopausal women)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02287285
Start Date
October 1 2014
End Date
July 1 2019
Last Update
April 24 2020
Active Locations (1)
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1
New York Obesity Research Center, Columbia University
New York, New York, United States, 10032