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

Early Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Exendin 9, 39

• Registration Number: NCT01843881
• Lead Sponsor: Adrian Vella

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-05-01
• Primary Completion: 2013-09
• Status Verified: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	A saline infusion will be administered in either first intervention period or second intervention period.
Exendin 9, 39	Exendin 9, 39	Exendin 9, 39 will be infused at 300pmol/kg/min in either first intervention period or second intervention period.

Primary Outcome Measures

Name	Time	Method
Change in Total Disposition Index from Study 1 (Exendin 9,39) to Study 2 (saline)	Day 1, Day 2 (approximately 2 weeks after day 1)	The total disposition index equals the product of insulin secretion and insulin sensitivity.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States