Back to resultsDose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Primary Purpose
Hyperinsulinism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
insulin-like growth factor I
Sponsored by
About this trial
This is an interventional treatment trial for Hyperinsulinism focused on measuring endocrine disorders, hyperinsulinism, rare disease
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004699
First Posted
February 24, 2000
Last Updated
March 24, 2015
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT00004699
Brief Title
Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Study Type
Interventional
2. Study Status
Record Verification Date
March 1999
Overall Recruitment Status
Completed
Study Start Date
August 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperinsulinism
Keywords
endocrine disorders, hyperinsulinism, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
8 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
insulin-like growth factor I
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinchas Cohen
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
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