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The Contribution of Incretin Hormones to the Amelioration of 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, glucose metabolism

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01843855

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

NCT01843855

Brief Title

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

Official Title

The Contribution of Incretin Hormones to the Amelioration of 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

June 2011 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

September 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 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.

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, glucose metabolism

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exendin 9,39

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

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 (pre-RYGB) to Study 2 (post-RYGB)

Description

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

Time Frame

baseline, 4 weeks post-operative intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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

55905-0001

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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