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

Sponsor
The University of Texas Medical Branch, Galveston (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02990533
Collaborator
(none)
80
Enrollment
1
Location
4
Arms
86
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Testosterone
  • Dietary Supplement: Protein Supplement
  • Other: Placebo Injection
  • Other: Placebo supplement
 Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Nov 1, 2020
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo Supplement Placebo Injection

Other: Placebo Injection
Other Names:
  • saline

    • Other: Placebo supplement
    Other Names:
  • maltodextrin

    		•
    Experimental: Testosterone

    Placebo Supplement Testosterone Injection

    Drug: Testosterone
    Other Names:
  • testosterone enanthate

    • Other: Placebo supplement
    Other Names:
  • maltodextrin

    		•
    Experimental: Protein Supplement

    Protein Supplement Placebo Injection

    Dietary Supplement: Protein Supplement
    Other Names:
  • whey protein

    • Other: Placebo Injection
    Other Names:
  • saline

    		•
    Experimental: Protein Supplement + Testosterone

    Protein Supplement Testosterone Injection

    Drug: Testosterone
    Other Names:
  • testosterone enanthate

    • Dietary Supplement: Protein Supplement
    Other Names:
  • whey protein

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Physical Performance [Change from Baseline to 30-day Followup]

      Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance

    Secondary Outcome Measures

    1. Handgrip Strength [Change from Baseline to 30-day Followup]

      strength by handheld dynamometer, kg

    2. Physical Activity Level [Change from Baseline to 30-day Followup]

      Number of daily steps

    3. 30 day re-admission [30 days post-discharge]

      Readmission within 30 days of hospital discharge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jennie Sealy Hospital Galveston Texas United States 77555

    Sponsors and Collaborators

    • The University of Texas Medical Branch, Galveston

    Investigators

    • Study Chair: Elena Volpi, MD, PhD, UTMB

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Medical Branch, Galveston
    ClinicalTrials.gov Identifier:
    NCT02990533
    Other Study ID Numbers:
    • 16-0146
    First Posted:
    Dec 13, 2016
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Methyltestosterone
    Testosterone
    Testosterone undecanoate
    Testosterone enanthate
    Testosterone 17 beta-cypionate

    Study Results

    No Results Posted as of Apr 14, 2022