Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004419
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-06
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 Determine the efficacy and toxic effects of recombinant human insulin-like growth factor I rhIGF-I on carbohydrate tolerance insulin action insulin secretion hyperandrogenism and hyperlipidemia in patients with severe insulin resistance who have failed other therapies
II Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and secondary abnormalities in this patient population
III Determine the effect of rhIGF-I on insulin clearance the regulation of insulin-like growth factor binding protein 1 the regulation of sex hormone binding globulin and hypothalamic pituitary gonadal axis in this patient population
II Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and secondary abnormalities in this patient population
III Determine the effect of rhIGF-I on insulin clearance the regulation of insulin-like growth factor binding protein 1 the regulation of sex hormone binding globulin and hypothalamic pituitary gonadal axis in this patient population
Detailed Description:
PROTOCOL OUTLINE This is an open label study Patients receive the first dose of subcutaneous recombinant human insulin-like growth factor I rhIGF-I on day 7
Patients receive rhIGF-I twice daily 15-30 minutes before breakfast and dinner and are hospitalized for the first week of therapy Patients return for an outpatient exam on day 19 of rhIGF-I therapy Approximately 30 days into the therapy patients are readmitted to the clinical center for repeat screening tests Patients then receive maintenance therapy of rhIGF-I for up to 6-12 months A washout period follows the maintenance therapy phase
Patients are followed weekly biweekly or monthly depending on blood glucose response of patients off rhIGF-I therapy Weekly phone contact with study coordinator is mandatory during this time
Completion date provided represents the completion date of the grant per OOPD records
Patients receive rhIGF-I twice daily 15-30 minutes before breakfast and dinner and are hospitalized for the first week of therapy Patients return for an outpatient exam on day 19 of rhIGF-I therapy Approximately 30 days into the therapy patients are readmitted to the clinical center for repeat screening tests Patients then receive maintenance therapy of rhIGF-I for up to 6-12 months A washout period follows the maintenance therapy phase
Patients are followed weekly biweekly or monthly depending on blood glucose response of patients off rhIGF-I therapy Weekly phone contact with study coordinator is mandatory during this time
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| BIH-FDR001126 | None | None | None |
| BIH-98-1060 | None | None | None |
| BIH-E-147 | None | None | None |