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

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004825
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: July 1998
History of Changes
  Purpose

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.


Condition Intervention
Hyperinsulinism
 Drug: recombinant human insulin-like growth factor I

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 10
Study Start Date: May 1998
Estimated Study Completion Date: May 1998
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.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004825

Sponsors and Collaborators
FDA Office of Orphan Products Development
Children's Hospital of Philadelphia
Investigators
Study Chair: Pinchas Cohen Children's Hospital of Philadelphia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004825     History of Changes
Other Study ID Numbers: 199/13283, CHP-FDR001181-ST
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
endocrine disorders
hyperinsulinism
rare disease

Additional relevant MeSH terms:
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Complement Factor I
Mitogens
Insulin
Complement Inactivating Agents
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 16, 2013