Determinants of Diabetes Remission After Gastric Bypass Surgery

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Blandine Laferrere
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)