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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990533
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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
Aging 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo Supplement Placebo Injection
Other: Placebo Injection
Other Name: saline

Other: Placebo supplement
Other Name: maltodextrin

Experimental: Testosterone
Placebo Supplement Testosterone Injection
Drug: Testosterone
Other Name: testosterone enanthate

Other: Placebo supplement
Other Name: maltodextrin

Experimental: Protein Supplement
Protein Supplement Placebo Injection
Dietary Supplement: Protein Supplement
Other Name: whey protein

Other: Placebo Injection
Other Name: saline

Experimental: Protein Supplement + Testosterone
Protein Supplement Testosterone Injection
Drug: Testosterone
Other Name: testosterone enanthate

Dietary Supplement: Protein Supplement
Other Name: whey protein




Primary Outcome Measures :
  1. Physical Performance [ Time Frame: 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 [ Time Frame: Change from Baseline to 30-day Followup ]
    strength by handheld dynamometer, kg

  2. Physical Activity Level [ Time Frame: Change from Baseline to 30-day Followup ]
    Number of daily steps

  3. 30 day re-admission [ Time Frame: 30 days post-discharge ]
    Readmission within 30 days of hospital discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990533


Contacts
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Contact: Rachel R Deer, PhD 4092669640 rrdeer@utmb.edu

Locations
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United States, Texas
Jennie Sealy Hospital Recruiting
Galveston, Texas, United States, 77555
Contact: Rachel R Deer, PhD    409-266-9640    rrdeer@utmb.edu   
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Study Chair: Elena Volpi, MD, PhD UTMB
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02990533    
Other Study ID Numbers: 16-0146
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents