NCT00004825

Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Confirm the inhibitory effect of recombinant human insulin-like growth factor I (IGF-I) on insulin secretion in children with hyperinsulinism. II. Define the effects of short term IGF-I therapy on postprandial blood sugar levels in this patient population. III. Characterize the effects of short term IGF-I therapy on fasting behavior, and other insulin dependent parameters, in this patient population.

Detailed description

PROTOCOL OUTLINE: Octreotide and/or diazoxide are discontinued on day 1, and fasting blood glucose is monitored. Patients receive test meals of Sustacal on days 3 and 4 and are assessed for insulin response. Beginning on day 5, patients are given recombinant human insulin-like growth factor I subcutaneously every 12 hours for a total of 3 doses. The first dose (on day 5) is given 30 minutes before a Sustacal challenge, the second dose is followed by a bedtime snack, and the third dose (on day 6) is followed by a supervised fast.

Conditions

• Hyperinsulinism

Interventions

Type	Name	Description
DRUG	recombinant human insulin-like growth factor I

Timeline

• Start date: 1998-05-01
• Completion: 1998-05-01
• First posted: 2000-02-25
• Last updated: 2015-03-25