Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130286
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2005-08-12
Brief Title:
Growth Hormone andor Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Study of the Safety and Efficacy of Recombinant Human Growth Hormone andor Rosiglitazone in the Treatment of Human Immunodeficiency Virus-Associated Visceral Adiposity and Insulin Resistance
Status:
COMPLETED
Status Verified Date:
2014-02
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:
The purpose of the study is to determine if the combination of recombinant human growth hormone plus rosiglitazone an insulin-sensitizing drug is safe and more effective than either drug alone or no active therapy for the treatment of fat accumulation in people with HIV infection and insulin resistance
Detailed Description:
A number of people with HIV infection who gain weight in the abdomen sometimes called lipodystrophy also have a high level of the sugar-controlling hormone called insulin These people need to produce this extra insulin to help keep their blood sugar normal This is called insulin resistance
Studies have shown that growth hormone also called Serostim can decrease abdominal fat but it can also worsen the insulin resistance Rosiglitazone also called Avandia is used to treat insulin resistance in people who have diabetes so we want to see if taking growth hormone and rosiglitazone together will be better for treating the fat accumulation part of lipodystrophy than either drug alone or no active therapy
The study is 24 weeks long divided into two 12-week parts
The first part of the study is double-blind meaning that neither participants nor the study staff will know which drugs participants are on Participants will be assigned randomly like flipping a coin to one of four groups
1 Growth hormone one injection daily PLUS rosiglitazone one tablet twice daily
2 Growth hormone PLUS rosiglitazone placebo sugar pill
3 Growth hormone placebo plain water injection PLUS rosiglitazone
4 Growth hormone placebo PLUS rosiglitazone placebo
Everyone in the study will need to be hospitalized overnight for special tests at the beginning of the study and at week 12
The second part of the study is open-label meaning that participants and the study staff will know which drugs participants are receiving All volunteers will receive both active drugs
Growth hormone one 2 mg injection every other day PLUS rosiglitazone one 4 mg tablet twice daily
Studies have shown that growth hormone also called Serostim can decrease abdominal fat but it can also worsen the insulin resistance Rosiglitazone also called Avandia is used to treat insulin resistance in people who have diabetes so we want to see if taking growth hormone and rosiglitazone together will be better for treating the fat accumulation part of lipodystrophy than either drug alone or no active therapy
The study is 24 weeks long divided into two 12-week parts
The first part of the study is double-blind meaning that neither participants nor the study staff will know which drugs participants are on Participants will be assigned randomly like flipping a coin to one of four groups
1 Growth hormone one injection daily PLUS rosiglitazone one tablet twice daily
2 Growth hormone PLUS rosiglitazone placebo sugar pill
3 Growth hormone placebo plain water injection PLUS rosiglitazone
4 Growth hormone placebo PLUS rosiglitazone placebo
Everyone in the study will need to be hospitalized overnight for special tests at the beginning of the study and at week 12
The second part of the study is open-label meaning that participants and the study staff will know which drugs participants are receiving All volunteers will receive both active drugs
Growth hormone one 2 mg injection every other day PLUS rosiglitazone one 4 mg tablet twice daily
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK065515 | NIH | None | httpsreporternihgovquickSearchR01DK065515 |