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

NCT ID: NCT01843881

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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Gastric Bypass bariatric surgery carbohydrate metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Exendin 9, 39

Exendin 9, 39 will be infused at 300pmol/kg/min in either first intervention period or second intervention period.

Group Type EXPERIMENTAL

Exendin 9, 39

Intervention Type DRUG

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

Placebo

A saline infusion will be administered in either first intervention period or second intervention period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Exendin 9, 39

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who have undergone RYGB


* Must match RYGB subjects in age, weight, and gender
* Subjects will be without active systemic illness

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

Adrian Vella

OTHER

Sponsor Role lead

Responsible Party

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Adrian Vella

Consultant, Endocrinology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Adrian Vella, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK082396

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UL1RR024150

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-007667

Identifier Type: -

Identifier Source: org_study_id