Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
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Purpose
The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Hyperinsulinism |
Drug: exendin-(9-39) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: exendin-(9-39)
A short term intravenous infusion of exendin-(9-39) over 6 hours.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 7 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects with congenital hyperinsulinism
Exclusion Criteria:
- Acute medical illness
- History of other systemic chronic disease such as cardiac failure, renal insufficiency, hepatic insufficiency, chronic obstructive pulmonary disease, anemia, or uncontrolled hypertension
- Pregnancy
- Diabetes mellitus
- Use of medications that affect glucose metabolism, such as glucocorticoids, beta agonists, diazoxide and octreotide.
- Subjects will be eligible to participate 48 hrs after the last dose of octreotide and 72 hrs after last dose of diazoxide
Contacts and Locations| 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 |
More Information
No publications provided by Children's Hospital of Philadelphia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Diva De Leon, M.D. Assistant Professor of Pediatrics, Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00571324 History of Changes |
| Other Study ID Numbers: | 2007-1-5131, R03DK078535-01 |
| Study First Received: | December 10, 2007 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital of Philadelphia:
|
hyperinsulinism hypoglycemia KATP channel SUR-1 Kir6.2 |
Additional relevant MeSH terms:
|
Hyperinsulinism Persistent Hyperinsulinemia Hypoglycemia of Infancy Glucose Metabolism Disorders Metabolic Diseases Infant, Newborn, Diseases Hypoglycemia |
Glucagon-Like Peptide 1 Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013