OBJECTIVES: Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.

Condition	Treatment or Intervention	Phase
Hyperinsulinism	Drug: insulin-like growth factor I	Phase II

Further Study Details: 

Expected Total Enrollment:  16

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross-over study. Patients are randomized to receive recombinant human insulin-like growth factor I (IGF-I) or placebo subcutaneously twice daily for 4 weeks. After a 2 week washout period, patients are crossed over to the other regimen for an additional 4 weeks.

Ages Eligible for Study:  3 Months   -   18 Years,  Genders Eligible for Study:  Both

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) Suboptimal control of blood sugar (i.e., inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other major medical conditions No known adverse reaction to recombinant human insulin-like growth factor I

Study chairs or principal investigators

Pinchas Cohen,  Study Chair,  Children's Hospital of Philadelphia   

Study ID Numbers:  199/13382; CHP-FDR001181-DBPC
Record last reviewed:  March 1999
Last Updated:  October 13, 2004
Record first received:  February 24, 2000
ClinicalTrials.gov Identifier:  NCT00004700
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08