Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

• Status: Completed
• Trial end date: 1998-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Collaborator: Children's Hospital of Philadelphia
• Treatments: Complement Factor I; Insulin; Insulin, Globin Zinc; Mecasermin; 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)

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