Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

• Status: Completed
• Trial end date: 1999-01-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES:

I. Determine the dose of recombinant human insulin-like growth factor I that minimizes or decreases the need for exogenous glucose support without causing hypoglycemia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Treatments: Complement Factor I; Insulin; Mitogens

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action)

• Intractable hypoglycemia (i.e., persistent IV glucose requirement for maintaining glucose levels greater than 60 mg/dL)

• Failed standard treatment regimen of diazoxide, octreotide, and frequent feedings to control hypoglycemia

• No other major medical problems