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

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ClinicalTrials.gov Identifier: NCT00004825
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
Children's Hospital of Philadelphia
Information provided by:
FDA Office of Orphan Products Development

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.

Condition or disease Intervention/treatment
Hyperinsulinism Drug: recombinant human insulin-like growth factor I

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Primary Purpose: Treatment
Study Start Date : May 1998
Estimated Study Completion Date : May 1998

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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


  • No known malignancy
  • No other major medical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004825

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

ClinicalTrials.gov Identifier: NCT00004825     History of Changes
Other Study ID Numbers: 199/13283
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: July 1998

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

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Complement Factor I
Hypoglycemic Agents
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Growth Substances