Dose-response Study of Exendin-9,39 on Glucose Metabolism

January 18, 2013 updated by: Adrian Vella

A Dose-response Study of the Effects of Exendin-9,39 on Glucose Metabolism, Glucagon and Insulin Secretion and on Insulin Action.

Multiple studies have examined the effect of endogenous GLP-1 secretions by using a competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However, the presence of an effect does not necessarily imply that this effect is due to the blockade of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic concentrations of Exendin may have effects of its own. To examine the effect of Exendin on glucose metabolism the investigators propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Drug: saline infusion
saline infused at 30ml/hour
Active Comparator: GLP-1-(9,36)-amide
Drug: GLP-1-9,36 infusion
infused @ 1.2pmol/kg/min
Active Comparator: Exendin-9,39 @30pmol/kg/min
Drug: Exendin-9,39 at low dose
infused at 30pmol/kg/min
Active Comparator: Exendin-9,39 @300pmol/kg/min
Drug: Exendin-9,39 at high dose
infused @ 300pmol/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin Secretion
Time Frame: over 360 minutes of study
over 360 minutes of study

Secondary Outcome Measures

Outcome Measure
Time Frame
glucagon secretion
Time Frame: over 360 minutes of study
over 360 minutes of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adrian Vella

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 10-003435

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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