Status:
COMPLETED
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
Lead Sponsor:
Diva De Leon
Conditions:
Congenital Hyperinsulinism
Eligibility:
All Genders
6-18 years
Phase:
PHASE1
PHASE2
Brief 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...
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, ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of hyperinsulinism
- Mutation analysis results demonstrating KATP channel defect
- Age 6 months to 18 years with
- Persistent hypoglycemia
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00897676
Start Date
May 1 2009
End Date
January 1 2017
Last Update
March 13 2020
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104