Effect of Exendin-(9-39) On Glucose Requirements To Maintain Euglycemia

This study is not yet open for participant recruitment.

Verified by Children's Hospital of Philadelphia, February 2009

First Received: February 2, 2009 No Changes Posted

Sponsored by:	Children's Hospital of Philadelphia
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00835328

Purpose

The purpose of this study is to examine the effect of exendin-(9-39)on glucose requirements to maintain euglycemia in infants with congenital hyperinsulinism unresponsive to medical therapy

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

MedlinePlus related topics: Hypoglycemia

Drug Information available for: Exendin (9-39)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Role of GLP-1 In Congenital Hyperinsulinism: Effect Of Exendin-(9-39)On Glucose Requirements To Maintain Euglycemia

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

Primary Outcome Measures:

Glucose infusion rate over a period of 12 hours [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma glucagon levels [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Plasma Insulin Level [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Plasma levels of exendin-(9-39) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Intervention Details:

100-200 pmol/kg/min as an intravenous infusion over 12 hours

Detailed Description:

This is an open label sudy to examine the effect of exendin-(9-39)on glucose requirements to maintain euglycemia in infants with congenital hyperinsulinism unresponsive to medical therapy and to determine therapeutic plasma levels,plasma half life and pharmacokinetics of exendin-(9-39)

Eligibility

Ages Eligible for Study:	up to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of congenital hyperinsulinism (based on insulin, beta hydroxybutyrate, and free fatty acid plasma levels at the time of hypoglycemia, and glycemic response to glucagon at the time of hypoglycemia)
Age: from birth to 12 months
Failure to respond to diazoxide and octreotide (defined as the failure to maintain blood glucose > 70 mg/dL without supraphysiologic rates of glucose infusion:> 4-5 mg/Kg/min)
Schedule for pancreatectomy

Exclusion Criteria:

Evidence of a medical condition that might alter results, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
Current therapy with medications that affect glucose metabolism, such as glucocorticoids, ß-agonists, glucagon, diazoxide and octreotide. Subjects will be eligible to participate 48 hrs after the last dose of octreotide and 72 hours after last dose of diazoxide

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835328

Contacts

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

Locations

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

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 De Leon )
Study ID Numbers:	2008-10-6256, 08-006256
Study First Received:	February 2, 2009
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00835328 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:

hyperinsulinism
hypoglycemia
KATP channel

Study placed in the following topic categories:

Hyperinsulinism
Hyperinsulinemic Hypoglycemia, Familial, 1
Metabolic Diseases
Benzocaine
Infant, Newborn, Diseases
Nesidioblastosis of Pancreas

Glucose Metabolism Disorders
Hypoglycemia
Persistent Hyperinsulinemia Hypoglycemia of Infancy
Metabolic Disorder
Glucagon-Like Peptide 1

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 May 07, 2009