Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients
NCT ID: NCT02990533
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2016-09-30
2020-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo Supplement Placebo Injection
Placebo Injection
Placebo supplement
Testosterone
Placebo Supplement Testosterone Injection
Testosterone
Placebo supplement
Protein Supplement
Protein Supplement Placebo Injection
Protein Supplement
Placebo Injection
Protein Supplement + Testosterone
Protein Supplement Testosterone Injection
Testosterone
Protein Supplement
Interventions
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Testosterone
Protein Supplement
Placebo Injection
Placebo supplement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 65 years or older
* Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization
* Alert and oriented x3 by a physician on H\&P.
* Discharged "to home" at hospital discharge. Participation in the study will be terminated in those subjects not discharged to home after hospital stay.
Exclusion Criteria
* Uncontrolled blood pressure (systolic \>170, or diastolic \> 100)
* New onset motor disability that prevents walking at the time of baseline testing (stroke with motor disability, lower limb orthopedic dx)
* End stage renal disease
* AST/ALT 2.5 times above the normal limit
* Recent (within 3 months) or current treatment with anabolic steroids.
* History of breast or prostate cancer
* Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml (PSA ≥ 3 ng/ml in men at high risk of prostate cancer)
* Hematocrit ≥ 50%
* Any other condition or event considered exclusionary by the PI and faculty physician
65 Years
ALL
No
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Elena Volpi, MD, PhD
Role: STUDY_CHAIR
UTMB
Locations
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Jennie Sealy Hospital
Galveston, Texas, United States
Countries
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Other Identifiers
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16-0146
Identifier Type: -
Identifier Source: org_study_id