|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Texas |
|---|---|
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00006129 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Burns |
Drug: testosterone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Second degree or worse burn injury Percent of total body surface area burned and degree of burn(s) must be carefully quantified
--Patient Characteristics--
Cardiovascular: No limiting or unstable angina No myocardial infarction within the past 6 months No horizontal or downsloping ST segment depression greater than 0.2 mV and/or frequent or repetitive arrhythmias (defined as more than 10 premature ventricular contractions per minute) No hypertension that is uncontrolled by one blood pressure medication No prior arrhythmia or valvular disease requiring treatment
Other: No history of prostate cancer or indication of an occult carcinoma, defined by PSA greater than 4.0 micrograms/L
Contacts and Locations| United States, Texas | |
| University of Texas Medical Branch | Recruiting |
| Galveston, Texas, United States, 77550 | |
| Contact: Arny A. Ferrando 409-770-6612 | |
| Study Chair: | Arny A. Ferrando | University of Texas |
More Information
| Study ID Numbers: | 199/15290, UTMB-97-284, UTMB-GCRC-474 |
| Study First Received: | August 3, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006129 History of Changes |
| Health Authority: | United States: Federal Government |
|
burns dermatologic disorders rare disease |
|
Burns Anabolic Agents Testosterone Antineoplastic Agents, Hormonal Skin Diseases Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Rare Diseases Methyltestosterone Hormones Androgens Testosterone 17 beta-cypionate |
|
Anabolic Agents Testosterone Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Methyltestosterone Hormones Pharmacologic Actions Androgens Testosterone 17 beta-cypionate |
