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

Early Phase 1CompletedNCT01843855

Adrian Vella12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Exendin 9,39DRUG

Exendin 9,39 is a competitive antagonist of endogenous GLP-1.

PlaceboDRUG

A saline infusion will be given to match the study drug infusion.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB)

The total disposition index equals the product of insulin secretion and insulin sensitivity.

Time frame: baseline, 4 weeks post-operative intervention

Data from ClinicalTrials.gov

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