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

February 24, 2000
June 23, 2005
May 1998
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00004825 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Short Term Study of Recombinant Human Insulin-Like Growth Factor I in Children With Hyperinsulinism
Not Provided

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.

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.

Interventional
Not Provided
Primary Purpose: Treatment
Hyperinsulinism
Drug: recombinant human insulin-like growth factor I
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
May 1998
Not Provided

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
Both
1 Month to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00004825
199/13283, CHP-FDR001181-ST
Not Provided
Not Provided
FDA Office of Orphan Products Development
Children's Hospital of Philadelphia
Study Chair: Pinchas Cohen Children's Hospital of Philadelphia
FDA Office of Orphan Products Development
July 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP