NCT00897676

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Diva De Leon · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Congenital Hyperinsulinism

Interventions

Type	Name	Description
DRUG	Exendin-(9-39)	100-500pmol/kg/min
DRUG	placebo	placebo (0.9% NaCl)

Timeline

• Start date: 2009-05-01
• Primary completion: 2016-08-26
• Completion: 2017-01-01
• First posted: 2009-05-12
• Last updated: 2020-03-13
• Results posted: 2018-01-18

Locations

1 site across 1 country: United States