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

Diva De Leon17 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Hyperinsulinism

Interventions

Exendin-(9-39)DRUG

100-500pmol/kg/min

placeboDRUG

placebo (0.9% NaCl)

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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 frame: Time 0 min - time 360 min

Secondary Outcomes

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 frame: time 0 min to time 360 min

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 frame: time 0 min to time 360 min

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 frame: time 0 min to time 360 min

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 frame: time 0 to time 360 min

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 frame: time 0 min to time 360 min

Data from ClinicalTrials.gov

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