Determinants of Diabetes Remission After Gastric Bypass Surgery
Completed · Early Phase 1
Conditions studied: Type 2 Diabetes Mellitus
In brief
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).
Key facts
- Study ID
- NCT02287285
- Run by
- Blandine Laferrere
- People needed
- 25
- Starts
- 2014-10-01
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2020-04-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- New York Obesity Research Center, Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
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