Recruiting

Testosterone & Exercise

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00006129

Conditions

Burns

Eligibility Criteria

Sex: Male

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

testosterone

Study Details

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.

Conditions

Burns

Study ID

NCT00006129

Start date

Jun, 2000

Status verified date

Dec, 2003

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Allocation

Randomized

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

testosterone

Central Contacts and Locations

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77550

Contacts

Arny A. Ferrando

409-770-6612

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Jun 24, 2005

Last verified

Dec, 2003

Keywords

  • burns
  • dermatologic disorders
  • rare disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2005-06-24.