Hyperinsulinism
Conditions
Keywords
endocrine disorders, hyperinsulinism, rare disease
Brief summary
OBJECTIVES: Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.
Detailed description
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. Completion date provided represents the completion date of the grant per OOPD records
Interventions
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
Inclusion 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
Outcome results
None listed