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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Texas
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006129
First received: August 3, 2000
Last updated: June 23, 2005
Last verified: December 2003
History of Changes
  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: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 60
Study Start Date: June 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006129

Locations
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77550
Contact: Arny A. Ferrando     409-770-6612        
Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Texas
Investigators
Study Chair: Arny A. Ferrando University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006129     History of Changes
Other Study ID Numbers: 199/15290, UTMB-97-284, UTMB-GCRC-474
Study First Received: August 3, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
burns
dermatologic disorders
rare disease

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 16, 2013