Hyperinsulinism Clinical Trial
Verified date | July 1998 |
Source | FDA Office of Orphan Products Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 1998 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 18 Years |
Eligibility |
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) No suspected insulinoma Must be currently managed on a regimen of diazoxide, octreotide and/or frequent feedings to control hypoglycemia --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Hematopoietic: No anemia or other concerns of blood volume depletion Renal: No renal dysfunction Other: - No known malignancy - No other major medical conditions |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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FDA Office of Orphan Products Development | Children's Hospital of Philadelphia |
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