Rochester, Minnesota 55905


Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

10-003435


NCT ID:

NCT01218633


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

20 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Adrian Vella, MD
Principal Investigator
Mayo Clinic

Study Dates

Start Date:May 2011
Completion Date:August 2012
Completion Type:Anticipated
Primary Completion Date:July 2012
Primary Completion Type:Anticipated
Verification Date:May 2012
Last Changed Date:May 24, 2012
First Received Date:October 8, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:glucagon secretion
Time Frame:over 360 minutes of study
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Insulin Secretion
Time Frame:over 360 minutes of study
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:saline infusion
Description:saline infused at 30ml/hour
Arm Name:Saline
Intervention Type:Drug
Name:GLP-1-9,36 infusion
Description:infused @ 1.2pmol/kg/min
Arm Name:GLP-1-(9,36)-amide
Intervention Type:Drug
Name:Exendin-9,39 at low dose
Description:infused at 30pmol/kg/min
Arm Name:Exendin-9,39 @30pmol/kg/min
Intervention Type:Drug
Name:Exendin-9,39 at high dose
Description:infused @ 300pmol/kg/min
Arm Name:Exendin-9,39 @300pmol/kg/min

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Saline
Study Arm Type:Active Comparator
Arm Name:GLP-1-(9,36)-amide
Study Arm Type:Active Comparator
Arm Name:Exendin-9,39 @30pmol/kg/min
Study Arm Type:Active Comparator
Arm Name:Exendin-9,39 @300pmol/kg/min

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Adrian Vella

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.