Skip to main content
OpenTrials
Completed

NCT Number: NCT01843855

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905-0001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exendin 9,39

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: baseline, 4 weeks post-operative intervention

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

Sponsors and collaborators

Lead sponsor

Adrian Vella

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 1, 2013
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.