Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
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 Design:||Primary Purpose: Treatment|
|Study Start Date:||May 1998|
|Estimated Study Completion Date:||May 1998|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004825
|Study Chair:||Pinchas Cohen||Children's Hospital of Philadelphia|