Determinants of Diabetes Remission After Gastric Bypass Surgery

Blandine Laferrere

Status and phase

Completed

Early Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Exendin9

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02287285

1F32DK113747-01A1 (U.S. NIH Grant/Contract)

1R01DK098056-01A1 (U.S. NIH Grant/Contract)

AAAO1360

Details and patient eligibility

About

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).

Full 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 weight loss with resolution of T2DM in 40-80% of cases. The mechanisms by which T2DM improves after GBP are unclear. Glycemic control occurs long before significant weight loss, suggesting that the nature of the procedure, rather than the weight loss, is responsible for the T2DM improvement. Recent data have singled out the role of the gut hormones known as incretins in diabetes improvement after GBP. The current proposal will study 1) whether the short and long term change in the gut hormone incretins after GBP results in improved insulin secretion in response to the administration of oral and IV glucose, in patients with diabetes undergoing GBP surgery; 2) the factors responsible for diabetes remission - or lack of - after GBP. The investigators wish to apply our finding to define better surgical outcome on diabetes.

Enrollment

25 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)