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

This study is currently recruiting participants.
Verified by Children's Hospital of Philadelphia, July 2008

Sponsors and Collaborators: Children's Hospital of Philadelphia
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

MedlinePlus related topics:   Hypoglycemia   

ChemIDplus related topics:   Glucagon-like peptide 1    Glucagon    Exendin (9-39)   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, 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

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 2008
Estimated Primary Completion Date:   December 2008 (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 O'Rourke     267-426-7251     orourkes@email.chop.edu    
Contact: Jaclyn Sharman     267-426-9205     sharman@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

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
First Received:   December 10, 2007
Last Updated:   July 11, 2008
ClinicalTrials.gov Identifier:   NCT00571324
Health Authority:   United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
hyperinsulinism  
hypoglycemia  
KATP channel  
SUR-1  
Kir6.2  

Study placed in the following topic categories:
Hyperinsulinism
Metabolic Diseases
Nesidioblastosis of pancreas
Hyperinsulinemic hypoglycemia, familial, 1
Glucagon
Infant, Newborn, Diseases
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Persistent Hyperinsulinemia Hypoglycemia of Infancy
Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on August 28, 2008




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