Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004825
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
PROTOCOL OUTLINE Octreotide andor 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHP-FDR001181-ST | None | None | None |