Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004699

Enrollment

Registered

2000-02-25

Start date

1995-08-31

Completion date

1999-01-31

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperinsulinism

Keywords

endocrine disorders, hyperinsulinism, rare disease

Brief summary

OBJECTIVES: I. Determine the dose of recombinant human insulin-like growth factor I that minimizes or decreases the need for exogenous glucose support without causing hypoglycemia.

Detailed description

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

Interventions

DRUGinsulin-like growth factor I

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

3 Weeks to 3 Months

Healthy volunteers

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) * 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026