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Completed

NCT Number: NCT00897676

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

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).

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Key information

Conditions

Congenital Hyperinsulinism Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Infant, Newborn, Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exendin-(9-39)

Drug

100-500pmol/kg/min

Placebo

Drug

placebo (0.9% NaCl)

Other names: (0.9% NaCl)

Primary outcomes

  1. Area Under the Curve (AUC) Plasma Glucose

    Time frame: Time 0 min - time 360 min

    Area under the curve plasma glucose from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion

Secondary outcomes

  1. Area Under the Curve (AUC) Plasma Insulin

    Time frame: time 0 min to time 360 min

    Area under the curve plasma insulin from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion

  2. Area Under the Curve (AUC) Plasma C-peptide

    Time frame: time 0 min to time 360 min

    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

  3. Area Under the Curve (AUC) Plasma Glucagon

    Time frame: time 0 min to time 360 min

    Area under the curve plasma glucagon from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion

  4. Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1)

    Time frame: time 0 to time 360 min

    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

  5. Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1)

    Time frame: time 0 min to time 360 min

    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

Sponsors and collaborators

Lead sponsor

Diva De Leon

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2017
First posted
May 12, 2009
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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