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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01218633
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : January 23, 2013
Information provided by (Responsible Party):
Adrian Vella, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1 Drug: saline infusion Drug: GLP-1-9,36 infusion Drug: Exendin-9,39 at low dose Drug: Exendin-9,39 at high dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Dose-response Study of the Effects of Exendin-9,39 on Glucose Metabolism, Glucagon and Insulin Secretion and on Insulin Action.
Study Start Date : May 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012

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

Primary Outcome Measures :
  1. Insulin Secretion [ Time Frame: over 360 minutes of study ]

Secondary Outcome Measures :
  1. glucagon secretion [ Time Frame: over 360 minutes of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01218633

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Adrian Vella
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Principal Investigator: Adrian Vella, MD Mayo Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Adrian Vella, Professor of Medicine, Mayo Clinic Identifier: NCT01218633    
Other Study ID Numbers: 10-003435
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013