Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
insulin-like growth factor I
Metabolic Diseases+6
+ Nutritional and Metabolic Diseases
+ Pathologic Processes
Treatment Study
Summary
Study start date: August 1, 1995
Actual date on which the first participant was enrolled.PROTOCOL OUTLINE: This is a dose escalation study. Patients receive an escalating dose of recombinant human insulin-like growth factor I (IGF-I). IGF-I is given subcutaneously twice a day. The dose of IGF-I is increased each day for 4 days. Glucose is administered intravenously, when necessary, to prevent hypoglycemia. Following the study treatment patients resume prior medication and may undergo surgery. Completion date provided represents the completion date of the grant per OOPD records
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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