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
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||Phase|
|Hyperinsulinism||Drug: recombinant human insulin-like growth factor I||Not Applicable|
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)|
|Enrollment :||10 participants|
|Study Start Date :||May 1998|
|Study Completion Date :||May 1998|
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
|Study Chair:||Pinchas Cohen||Children's Hospital of Philadelphia|