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

Congenital Hyperinsulinism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897676
• Other study ID #: 2008-10-6255
• Secondary ID: R01FD004905
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2009
• Est. completion date: January 2017

Study information

• Verified date: March 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2017
• Est. primary completion date: August 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Hyperinsulinism
• Hyperinsulinism

Intervention

Drug:
• Exendin-(9-39)
100-500pmol/kg/min
• placebo
placebo (0.9% NaCl)

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Diva De Leon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC) Plasma Glucose	Area under the curve plasma glucose from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion	Time 0 min - time 360 min
Secondary	Area Under the Curve (AUC) Plasma Insulin	Area under the curve plasma insulin from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion	time 0 min to time 360 min
Secondary	Area Under the Curve (AUC) Plasma C-peptide	Area under the curve plasma C-peptide from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion	time 0 min to time 360 min
Secondary	Area Under the Curve (AUC) Plasma Glucagon	Area under the curve plasma glucagon from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion	time 0 min to time 360 min
Secondary	Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1)	Area under the curve plasma total GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion	time 0 to time 360 min
Secondary	Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1)	Area under the curve plasma active GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion	time 0 min to time 360 min