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Short Term 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
recombinant human insulin-like growth factor I
Sponsored by
FDA Office of Orphan Products Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperinsulinism focused on measuring endocrine disorders, hyperinsulinism, rare disease

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    March 24, 2015
    Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    Children's Hospital of Philadelphia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004825
    Brief Title
    Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 1998
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1998 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 1998 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    Children's Hospital of Philadelphia

    4. Oversight

    5. Study Description

    Brief 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.
    Detailed Description
    PROTOCOL OUTLINE: Octreotide and/or diazoxide are discontinued on day 1, and fasting blood glucose is monitored. Patients receive test meals of Sustacal on days 3 and 4 and are assessed for insulin response. Beginning on day 5, patients are given recombinant human insulin-like growth factor I subcutaneously every 12 hours for a total of 3 doses. The first dose (on day 5) is given 30 minutes before a Sustacal challenge, the second dose is followed by a bedtime snack, and the third dose (on day 6) is followed by a supervised fast.

    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
    10 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    recombinant human insulin-like growth factor I

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    18 Years
    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) 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
    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

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

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