Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients (GRAMS)

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Aging

Treatments: Other: Placebo Injection; Drug: Testosterone; Other: Placebo supplement; Dietary Supplement: Protein Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02990533

16-0146

Details and patient eligibility

About

The goal of this pilot study is to collect preliminary data on the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Full description

The purpose of this pilot study is to test the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Enrollment: 80 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted to the UTMB hospital
• 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

• A Nursing home resident or hospice care patient
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Supplement Placebo Injection

Treatment:

Other: Placebo supplement

Other: Placebo Injection

Testosterone

Experimental group

Description:

Placebo Supplement Testosterone Injection

Treatment:

Other: Placebo supplement

Drug: Testosterone

Protein Supplement

Experimental group

Description:

Protein Supplement Placebo Injection

Treatment:

Dietary Supplement: Protein Supplement

Other: Placebo Injection

Protein Supplement + Testosterone

Experimental group

Description:

Protein Supplement Testosterone Injection

Treatment:

Dietary Supplement: Protein Supplement

Drug: Testosterone