Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism - Full Text View

Sponsor:	Children's Hospital of Philadelphia
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00571324

Purpose

The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.

Condition	Intervention	Phase
Congenital Hyperinsulinism	Drug: exendin-(9-39)	Phase I Phase II

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
Official Title:	An Open Label Pilot Study of the Effects of the Glucagon-like Peptide-1 Receptor Antagonist, Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism

Resource links provided by NLM:

MedlinePlus related topics: Hypoglycemia

Drug Information available for: Exendin (9-39)

U.S. FDA Resources

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:

Fasting blood glucose level [ Time Frame: 7 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Insulin, glucagon-like peptide-1 and insulin levels [ Time Frame: 7 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: exendin-(9-39) A short term intravenous infusion of exendin-(9-39) over 6 hours.

Detailed Description:

This is an open-label, pilot study , to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cells, increases fasting blood glucose levels in subjects with congenital hyperinsulinism. Our overall hypothesis is that abnormal GLP-1 secretion resulting from dysfunctional nutrient sensing in intestinal L-cells plays a role in the dysregulated insulin secretion characteristic of this disorder, and that antagonism of the GLP-1 receptor will increase fasting blood glucose levels.

Aim 1. To evaluate the dose of exendin-(9-39) required to elevate fasting blood glucose levels in subjects with congenital hyperinsulinism due to KATP channel mutations.

Aim 2. To determine therapeutic plasma levels, plasma half-life and pharmacokinetics of exendin-(9-39) during an intravenous short-term infusion in subjects with congenital hyperinsulinism due to KATP channel mutations.

Eligibility

Ages Eligible for Study:	7 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with congenital hyperinsulinism

Exclusion Criteria:

Acute medical illness
History of other systemic chronic disease such as cardiac failure, renal insufficiency, hepatic insufficiency, chronic obstructive pulmonary disease, anemia, or uncontrolled hypertension
Pregnancy
Diabetes mellitus
Use of medications that affect glucose metabolism, such as glucocorticoids, beta agonists, diazoxide and octreotide.
Subjects will be eligible to participate 48 hrs after the last dose of octreotide and 72 hrs after last dose of diazoxide

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571324

Contacts

Contact: Susan Becker	267-426-7251	beckers@email.chop.edu
Contact: Stephanie Givler	267-426-7622	givler@email.chop.edu

Locations

United States, Pennsylvania
The Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Diva D De Leon, MD
Sub-Investigator: Charles A Stanley, MD

Sponsors and Collaborators

Children's Hospital of Philadelphia

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Diva D De Leon, MD

Children's Hospital of Philadelphia

More Information

No publications provided

Responsible Party:	The Children's Hospital of Philadelphia ( Diva D De Leon, MD/ Assistant Professor of Pediatrics )
Study ID Numbers:	2007-1-5131, R03DK078535-01
Study First Received:	December 10, 2007
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00571324 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:

hyperinsulinism
hypoglycemia
KATP channel
SUR-1
Kir6.2

Additional relevant MeSH terms:

Hyperinsulinism
Metabolic Diseases
Infant, Newborn, Diseases

Hypoglycemia
Glucose Metabolism Disorders
Persistent Hyperinsulinemia Hypoglycemia of Infancy

ClinicalTrials.gov processed this record on November 27, 2009