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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Exendin 9, 39

Placebo

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Gastric Bypass, bariatric surgery, carbohydrate metabolism

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exendin 9, 39

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Total Disposition Index from Study 1 (Exendin 9,39) to Study 2 (saline)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01843881

First Posted

April 26, 2013

Last Updated

December 3, 2013

Sponsor

Adrian Vella

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01843881

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Adrian Vella

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Gastric Bypass, bariatric surgery, carbohydrate metabolism

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exendin 9, 39

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Exendin 9, 39

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Total Disposition Index from Study 1 (Exendin 9,39) to Study 2 (saline)

Description

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

Time Frame

Day 1, Day 2 (approximately 2 weeks after day 1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian Vella, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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