Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006129
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-08-03
Brief Title:
Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
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 whether testosterone normalization ameliorates muscle protein hypercatabolism by increasing net protein synthesis in men with burn injury
II Determine whether the effectiveness of testosterone is enhanced by stimulation of inward amino acid transport as a consequence of hyperaminoacidemia in these men
III Determine whether testosterone normalization during hospitalization minimizes the need for rehabilitation by increasing net protein synthesis and preserving skeletal muscle in these men
IV Determine whether testosterone normalization after hospital discharge and throughout convalescence increases muscle strength and lean body mass after burn injury by increasing net protein synthesis
V Determine whether testosterone combined with progressive resistance exercise during convalescence confers added benefits on muscle protein synthesis and in turn lean body mass and muscle strength in these patients
II Determine whether the effectiveness of testosterone is enhanced by stimulation of inward amino acid transport as a consequence of hyperaminoacidemia in these men
III Determine whether testosterone normalization during hospitalization minimizes the need for rehabilitation by increasing net protein synthesis and preserving skeletal muscle in these men
IV Determine whether testosterone normalization after hospital discharge and throughout convalescence increases muscle strength and lean body mass after burn injury by increasing net protein synthesis
V Determine whether testosterone combined with progressive resistance exercise during convalescence confers added benefits on muscle protein synthesis and in turn lean body mass and muscle strength in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized study Patients are stratified according to percent of total body surface area TBSA burned no more than 40 vs more than 40
Patients receive standard inpatient burn care During hospitalization patients are randomized to one of two treatment arms
Arm I Patients receive testosterone intramuscularly IM weekly for 2-3 weeks during hospitalization
Arm II Patients receive standard care only during hospitalization
After hospital discharge patients with burns covering no more than 40 of TBSA are randomized to arm III IV or V whereas patients with burns covering more than 40 of TBSA are randomized to arm III or V
Arm III Patients receive testosterone IM every 2 weeks for 2 months
Arm IV Patients receive testosterone as in arm III Patients perform progressive resistance weight lifting exercises 3 times a week for 2 months concurrently with testosterone therapy
Arm V Patients receive standard convalescence care only
Patients receive standard inpatient burn care During hospitalization patients are randomized to one of two treatment arms
Arm I Patients receive testosterone intramuscularly IM weekly for 2-3 weeks during hospitalization
Arm II Patients receive standard care only during hospitalization
After hospital discharge patients with burns covering no more than 40 of TBSA are randomized to arm III IV or V whereas patients with burns covering more than 40 of TBSA are randomized to arm III or V
Arm III Patients receive testosterone IM every 2 weeks for 2 months
Arm IV Patients receive testosterone as in arm III Patients perform progressive resistance weight lifting exercises 3 times a week for 2 months concurrently with testosterone therapy
Arm V Patients receive standard convalescence care only
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 |
|---|---|---|---|
| UTMB-GCRC-474 | None | None | None |
| UTMB-97-284 | None | None | None |