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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 30, 2014
Last verified: July 2014
  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. Funding Source - FDA OOPD.


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:


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: 18
Study Start Date: May 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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 glucagon-like peptide-1 (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 ATP- sensitive potassium channel (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
  • Mutation analysis results demonstrating KATP channel defect
  • 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 if the last dose of octreotide is given 48 hrs before study day 1 and the last dose of diazoxide is given 72 hours before study day 1
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 2008-10-6255,1R01FD004905-01
Study First Received: May 8, 2009
Last Updated: July 30, 2014
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
Congenital Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia

ClinicalTrials.gov processed this record on August 28, 2014