Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury

NCT00006129 | Unknown

• 3 other identifiers: 199/15290UTMB-97-284UTMB-GCRC-474
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

burns; dermatologic disorders; rare disease

Interventions

testosterone DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• University of Texas: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77550, United States

RECRUITING

MeSH Terms

Conditions

Burns; Skin Diseases; Rare Diseases

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Arny A. Ferrando

  University of Texas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: August 4, 2000
• Study Start: June 1, 2000
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)