<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02990533</url>
  </required_header>
  <id_info>
    <org_study_id>16-0146</org_study_id>
    <nct_id>NCT02990533</nct_id>
  </id_info>
  <brief_title>Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients</brief_title>
  <acronym>GRAMS</acronym>
  <official_title>Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this pilot study is to collect preliminary data on the feasibility and effect&#xD;
      size of interventions to modify the physiological recovery trajectory from hospitalization in&#xD;
      community dwelling older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this pilot study is to test the feasibility and effect size of interventions&#xD;
      to modify the physiological recovery trajectory from hospitalization in community dwelling&#xD;
      older adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Actual">November 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Performance</measure>
    <time_frame>Change from Baseline to 30-day Followup</time_frame>
    <description>Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Handgrip Strength</measure>
    <time_frame>Change from Baseline to 30-day Followup</time_frame>
    <description>strength by handheld dynamometer, kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Level</measure>
    <time_frame>Change from Baseline to 30-day Followup</time_frame>
    <description>Number of daily steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 day re-admission</measure>
    <time_frame>30 days post-discharge</time_frame>
    <description>Readmission within 30 days of hospital discharge</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Supplement Placebo Injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testosterone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo Supplement Testosterone Injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protein Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protein Supplement Placebo Injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protein Supplement + Testosterone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protein Supplement Testosterone Injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone</intervention_name>
    <arm_group_label>Protein Supplement + Testosterone</arm_group_label>
    <arm_group_label>Testosterone</arm_group_label>
    <other_name>testosterone enanthate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Protein Supplement</intervention_name>
    <arm_group_label>Protein Supplement</arm_group_label>
    <arm_group_label>Protein Supplement + Testosterone</arm_group_label>
    <other_name>whey protein</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Injection</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Protein Supplement</arm_group_label>
    <other_name>saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo supplement</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Testosterone</arm_group_label>
    <other_name>maltodextrin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to the UTMB hospital&#xD;
&#xD;
          -  Aged 65 years or older&#xD;
&#xD;
          -  Self-reported ability (with or without the aid of an assistive device) to walk across&#xD;
             a small room two weeks prior to hospitalization&#xD;
&#xD;
          -  Alert and oriented x3 by a physician on H&amp;P.&#xD;
&#xD;
          -  Discharged &quot;to home&quot; at hospital discharge. Participation in the study will be&#xD;
             terminated in those subjects not discharged to home after hospital stay.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A Nursing home resident or hospice care patient&#xD;
&#xD;
          -  Uncontrolled blood pressure (systolic &gt;170, or diastolic &gt; 100)&#xD;
&#xD;
          -  New onset motor disability that prevents walking at the time of baseline testing&#xD;
             (stroke with motor disability, lower limb orthopedic dx)&#xD;
&#xD;
          -  End stage renal disease&#xD;
&#xD;
          -  AST/ALT 2.5 times above the normal limit&#xD;
&#xD;
          -  Recent (within 3 months) or current treatment with anabolic steroids.&#xD;
&#xD;
          -  History of breast or prostate cancer&#xD;
&#xD;
          -  Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml&#xD;
             (PSA ≥ 3 ng/ml in men at high risk of prostate cancer)&#xD;
&#xD;
          -  Hematocrit ≥ 50%&#xD;
&#xD;
          -  Any other condition or event considered exclusionary by the PI and faculty physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Volpi, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>UTMB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jennie Sealy Hospital</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02990533
org study id: 16-0146
nct id: NCT02990533
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Physical Performance
time frame: Change from Baseline to 30-day Followup
description: Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance
measure: Handgrip Strength
time frame: Change from Baseline to 30-day Followup
description: strength by handheld dynamometer, kg
measure: Physical Activity Level
time frame: Change from Baseline to 30-day Followup
description: Number of daily steps
measure: 30 day re-admission
time frame: 30 days post-discharge
description: Readmission within 30 days of hospital discharge
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Supplement Placebo Injection
arm group label: Testosterone
arm group type: Experimental
description: Placebo Supplement Testosterone Injection
arm group label: Protein Supplement
arm group type: Experimental
description: Protein Supplement Placebo Injection
arm group label: Protein Supplement + Testosterone
arm group type: Experimental
description: Protein Supplement Testosterone Injection
intervention type: Drug
intervention name: Testosterone
arm group label: Protein Supplement + Testosterone
arm group label: Testosterone
other name: testosterone enanthate
intervention type: Dietary Supplement
intervention name: Protein Supplement
arm group label: Protein Supplement
arm group label: Protein Supplement + Testosterone
other name: whey protein
intervention type: Other
intervention name: Placebo Injection
arm group label: Placebo
arm group label: Protein Supplement
other name: saline
intervention type: Other
intervention name: Placebo supplement
arm group label: Placebo
arm group label: Testosterone
other name: maltodextrin
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Elena Volpi, MD, PhD
role: Study Chair
affiliation: UTMB
facility: 
country: United States
responsible party type: Sponsor
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: No