Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
|Study Design:||Intervention Model: Crossover Assignment
Masking: Open Label
|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|
- Fasting blood glucose level [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
- Insulin, glucagon-like peptide-1 and insulin levels [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
A short term intravenous infusion of exendin-(9-39) over 6 hours.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571324
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Diva D De Leon, MD||Children's Hospital of Philadelphia|