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

NCT ID: NCT01843855

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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Gastric Bypass bariatric surgery glucose metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Exendin 9,39

Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes.

Group Type EXPERIMENTAL

Exendin 9,39

Intervention Type DRUG

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

Placebo

Subjects randomized to this arm will receive a saline infusion for 360 minutes.

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 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

11-000161

Identifier Type: -

Identifier Source: org_study_id