The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass

Early Phase 1CompletedNCT01843881

Adrian Vella20 enrolled

Overview

The study is being undertaken to understand how the Roux-en-Y Gastric Bypass procedure can affect insulin secretion after meals. The hypothesis of this study is the Disposition Index is decreased in subjects who had previously undergone Roux-en-Y Gastric Bypass by glucagon-like peptide-1 (GLP-1) receptor blockade.

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: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria Roux-en-Y Gastric Bypass (RYGB)Subjects: * Subjects who have undergone RYGB Inclusion Criteria Healthy Subjects: * Must match RYGB subjects in age, weight, and gender * Subjects will be without active systemic illness Exclusion Criteria all Subjects: * Subjects \<20 years old and \>70 years old * For Female Subjects: positive pregnancy text at the time of enrollment or study * Subjects with functional or organic bowel symptoms.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in Total Disposition Index from Study 1 (Exendin 9,39) to Study 2 (saline)

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

Time frame: Day 1, Day 2 (approximately 2 weeks after day 1)

Data from ClinicalTrials.gov

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