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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Role of GLP-1 in Congenital Hyperinsulinism:Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity

Brief Summary: 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 Office of Orphan Products Development (OODP).

Detailed Summary: 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.
Sponsor: Diva De Leon

Current Primary Outcome: Blood Glucose Levels [ Time Frame: -60, 0, and every 30 minutes for 6 hours ]

Original Primary Outcome: Blood Glucose Levels [ Time Frame: 6 hours ]

Current Secondary Outcome: Plasma Insulin, C-Peptide, glucagon and intact GLP-1 levels [ Time Frame: -60, 0, and every 30 minutes for 6 hours ]

Original Secondary Outcome: Plasma Insulin, C-Peptide, glucagon and intact GLP-1 levels [ Time Frame: 6 hours ]

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: May 8, 2009
Date Started: May 2009
Date Completion:
Last Updated: April 26, 2017
Last Verified: April 2017