The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass

Adrian Vella

Status and phase: Completed; Early Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Exendin 9,39; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01843855

11-000161

UL1RR024150 (U.S. NIH Grant/Contract)

R01DK082396 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.

Enrollment: 12 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of > 110 mg/dL
• Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB).

Exclusion criteria

• Subjects taking thiazolidinediones
• Subjects with active systemic illness
• Subjects with active microvascular or macrovascular complications of their diabetes
• For female subject: positive pregnancy test at the time of enrollment in study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups, including a placebo group

Exendin 9,39

Experimental group

Description:

Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes.

Treatment:

Drug: Exendin 9,39

Placebo

Placebo Comparator group

Description:

Subjects randomized to this arm will receive a saline infusion for 360 minutes.

Treatment:

Drug: Placebo