BurnsNCT00006129
Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury
A study testing testosterone in people with Burns, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Burns
- What is being tested?
- testosterone
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77550
Arny A. Ferrando, 409-770-6612
About this study
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.
Read more
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.
- 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.
Read the 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.
- Conditions
- Burns
- Being tested
- testosterone
- Keywords
- burns, dermatologic disorders, rare disease
- Medical subject headings
- Burns, Skin Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosteroneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2000 (estimated)
- Study startJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Texas
- Investigators
- Arny A. Ferrando, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006129
- Sponsor's protocol ID
- 199/15290
- Other IDs
- UTMB-97-284, UTMB-GCRC-474
- Status last verified
- Dec 2003
- First submitted
- 3 Aug 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury
- ClinicalTrials.gov ID
- NCT00006129
- Acronym / sponsor ID
- 199/15290
- Conditions
- Burns
- Keywords
- burns, dermatologic disorders, rare disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- University of Texas
- Study start
- Jun 2000
- First posted
- 4 Aug 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testosterone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arny A. Ferrando study chair
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing testosterone in people with Burns, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.