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Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity

This study is currently recruiting participants.
Verified September 2012 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Diva De Leon, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00897676
First received: May 8, 2009
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism.


Condition Intervention Phase
Congenital Hyperinsulinism
 Drug: Exendin-(9-39)
Drug: placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of GLP-1 in Congenital Hyperinsulinism:Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Blood Glucose Levels [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Insulin, C-Peptide, glucagon and intact GLP-1 levels [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: placebo
placebo normal saline
Experimental: Exendin-(9-39) Drug: Exendin-(9-39)
100-500pmol/kg/min
Other Name: Exendin-(9-39)

Detailed Description:

This is a placebo controlled study with randomized crossover design to evaluate the effect of the GLP-1 receptor antagonist, exendin-(9-39), on fasting blood glucose levels, protein-induced hypoglycemia, and fasting tolerance of subjects with congenital hyperinsulinism due to mutations in the KATP channel.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of hyperinsulinism
  • Age 6 months to 18 years with
  • Persistent hypoglycemia

Exclusion Criteria:

  • Current therapy with medications that may affect glucose metabolism such as octreotide, diazoxide, high dose glucocorticoids, adrenergic agents, etc. Subjects will be eligible to participate 48 hrs after the last dose of octreotide and 72 hours after last dose of diazoxide
  • Evidence of a medical condition that might alter results or compromised the elimination of the peptide, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
  • Pregnancy
  • Subjects with milk protein allergy will be excluded for participating in studies involving protein tolerance test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897676

Contacts
Contact: Stephanie Givler, BS, CCRC 267-426-7622 givler@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Stephanie Givler, BS     267-426-7622     givler@email.chop.edu    
Principal Investigator: Diva D De Leon, MD            
Sub-Investigator: Charles A Stanley, MD            
Sponsors and Collaborators
Diva De Leon
Investigators
Principal Investigator: Diva D DeLeon, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Diva De Leon, M.D. Assistant Professor of Pediatrics, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00897676     History of Changes
Other Study ID Numbers: 2008-10-6255
Study First Received: May 8, 2009
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Hyperinsulinism
Hypoglycemia
KATP channel

Additional relevant MeSH terms:
Hyperinsulinism
Persistent Hyperinsulinemia Hypoglycemia of Infancy
Glucose Metabolism Disorders
 Metabolic Diseases
Infant, Newborn, Diseases
Hypoglycemia

ClinicalTrials.gov processed this record on May 16, 2013