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Completed

NCT Number: NCT01843881

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

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.

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

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 (Exendin 9,39) to Study 2 (saline)

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

    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
2012
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.

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