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

March 24, 2015 updated by: FDA Office of Orphan Products Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FDA Office of Orphan Products Development

Collaborators

Children's Hospital of Philadelphia

Investigators

  • Study Chair: Pinchas Cohen, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Study Completion

May 1, 1998

Study Registration Dates

First Submitted

February 24, 2000

First Submitted That Met QC Criteria

February 24, 2000

First Posted (Estimate)

February 25, 2000

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

July 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/13283
  • CHP-FDR001181-ST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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