Overview

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

Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Diva De Leon
Criteria
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