<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/NCT03256292</url>
  </required_header>
  <id_info>
    <org_study_id>H-40598</org_study_id>
    <nct_id>NCT03256292</nct_id>
  </id_info>
  <brief_title>Long-term Lifestyle Change and Testosterone Replacement</brief_title>
  <acronym>LITE</acronym>
  <official_title>Long-term Lifestyle Change in Obese Older Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Older hypogonadal obese veterans previously participated in a 6 month lifestyle change&#xD;
      (diet-induced weight loss and exercise) study with or without testosterone replacement&#xD;
      therapy before being followed for the following year at the clinic while receiving standard&#xD;
      of care consisting of diet and exercise counseling (for healthy lifestyle change) and&#xD;
      testosterone replacement therapy. This study will determine if long-term lifestyle change and&#xD;
      testosterone replacement therapy with associated improvement in physical and metabolic health&#xD;
      can be maintained in obese older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: There are studies on long-term testosterone replacement in older adults with&#xD;
      hypogonadism showing benefits on body composition, sexual function and mood but not on&#xD;
      testosterone replacement therapy in combination with lifestyle change (diet-induced weight&#xD;
      loss and exercise) in the specific population of older adults with both obesity and&#xD;
      hypogonadism.&#xD;
&#xD;
      Purpose: To determine if long-term lifestyle change and testosterone replacement therapy with&#xD;
      associated improvement in physical and metabolic health can be maintained in obese older&#xD;
      adults .&#xD;
&#xD;
      Design: Overweight/obese older veteran patients with obesity and hypogonadism who are being&#xD;
      followed at the endocrine clinic while receiving standard of care consisting of diet and&#xD;
      exercise counseling (for healthy lifestyle change) and testosterone replacement therapy will&#xD;
      be recruited for testing of physical, metabolic, cognitive/mood, quality of life, and body&#xD;
      composition testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Physical Performance Test score</measure>
    <time_frame>18 month</time_frame>
    <description>The primary functional outcome is the modified physical performance test, which includes seven standardized tasks (walking 50 ft, putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg tests) plus two additional tasks (climbing up and down four flights of stairs and performing a 360-degree turn). The score for each task ranges form 0 to 4; a perfect score is 36.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>18 month</time_frame>
    <description>Measured after an overnight fast using calibrated scales</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body composition (lean mass, fat mass and bone mineral density)</measure>
    <time_frame>18 month</time_frame>
    <description>Assessed by using dual-energy x-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volumetric BMD</measure>
    <time_frame>18 month</time_frame>
    <description>Assessed by using peripheral quantitative computed tomography (pQCT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical Markers of Bone Turnover (Serum C-terminal telopeptide (CTX)</measure>
    <time_frame>18 month</time_frame>
    <description>measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in prostate specific antigen</measure>
    <time_frame>18 month</time_frame>
    <description>measured in the blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate Symptom Assessment</measure>
    <time_frame>18 month</time_frame>
    <description>Using the International Prostate Symptom Scoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>18 month</time_frame>
    <description>Using the Geriatric Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>18 month</time_frame>
    <description>Using SF-36 and impact of weight on quality of life short form (IWQOL-lite)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual function</measure>
    <time_frame>18 month</time_frame>
    <description>Using the International Index of Erectile Function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in trabecular bone score</measure>
    <time_frame>18 month</time_frame>
    <description>Using DXA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in muscle strength and quality</measure>
    <time_frame>18 month</time_frame>
    <description>Using biodex dynamometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in balance</measure>
    <time_frame>18 month</time_frame>
    <description>as measured by leg stance and obstacle course</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Status</measure>
    <time_frame>18 month</time_frame>
    <description>Using functional status questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in gait</measure>
    <time_frame>18 month</time_frame>
    <description>as measured by completing the time to walk a certain distance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bone quality</measure>
    <time_frame>18 month</time_frame>
    <description>Using HrpQCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in testosterone level</measure>
    <time_frame>18 month</time_frame>
    <description>as measured in the blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sex hormone globulin</measure>
    <time_frame>18 month</time_frame>
    <description>as measured in the blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in metabolic hormones</measure>
    <time_frame>18 month</time_frame>
    <description>Leptin, adiponectin, and similar metabolic hormones as measured in the blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Composite cognitive z-score</measure>
    <time_frame>18 month</time_frame>
    <description>using cognitive instrument testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Modified mini-mental exam</measure>
    <time_frame>18 month</time_frame>
    <description>using cognitive instrument testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stroop color naming</measure>
    <time_frame>18 month</time_frame>
    <description>using cognitive instrument testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Word list fluency</measure>
    <time_frame>18 month</time_frame>
    <description>using cognitive instrument testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Ray auditory verbal learning test</measure>
    <time_frame>18 month</time_frame>
    <description>using cognitive instrument testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Trail A/B</measure>
    <time_frame>18 month</time_frame>
    <description>using cognitive instrument testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>18 month</time_frame>
    <description>as measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum PTH</measure>
    <time_frame>18 month</time_frame>
    <description>as measured in the blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid profile</measure>
    <time_frame>18 month</time_frame>
    <description>as measured in the blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>18 month</time_frame>
    <description>as measured by sphygmomanometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in metabolic syndrome</measure>
    <time_frame>18 month</time_frame>
    <description>using harmonized metabolic syndrome criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bone strength index</measure>
    <time_frame>18 months</time_frame>
    <description>assessed by pQCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortical to total area</measure>
    <time_frame>18 months</time_frame>
    <description>assessed by pQCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in density weighted polar section modulus</measure>
    <time_frame>18 months</time_frame>
    <description>assessed by pQCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cortical density</measure>
    <time_frame>18 months</time_frame>
    <description>assessed by pQCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cortical area</measure>
    <time_frame>18 months</time_frame>
    <description>assessed by pQCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Biochemical Markers of Bone Turnover (PINP)</measure>
    <time_frame>18 months</time_frame>
    <description>measured by RIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid profile</measure>
    <time_frame>18 months</time_frame>
    <description>measured in the blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in vitamin D level</measure>
    <time_frame>18 months</time_frame>
    <description>measured in the blood</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">38</enrollment>
  <condition>Hypogonadism</condition>
  <condition>Aging</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>testosterone, diet, and increased physical activity</arm_group_label>
    <description>Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone replacement</intervention_name>
    <description>Testosterone replacement therapy</description>
    <arm_group_label>testosterone, diet, and increased physical activity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>lifestyle</intervention_name>
    <description>lifestyle intervention consisting of diet and increased physical activity</description>
    <arm_group_label>testosterone, diet, and increased physical activity</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Older adults with hypogonadism following lifestyle change (diet and exercise on their own&#xD;
        for at least one year) with testosterone replacement therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight/obese (BMI = or &gt; 27 kg/m2)&#xD;
&#xD;
          -  Older (65-85 yr)&#xD;
&#xD;
          -  Male veteran patients being seen at the PI's endocrine clinic and receiving standard&#xD;
             of care consisting of diet and regular exercise counseling&#xD;
&#xD;
          -  Diagnosed with hypogonadism on current or previous testosterone replacement at the&#xD;
             PI's endocrine clinic&#xD;
&#xD;
          -  Willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to provide informed consent&#xD;
&#xD;
          -  Unstable cardiopulmonary disease (e.g. recent MI, unstable angina, stroke) or unstable&#xD;
             disease (Class III or IV congestive heart failure).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis T Villareal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michael E DeBakey VA Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>March 8, 2021</last_update_submitted>
  <last_update_submitted_qc>March 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Dennis T. Villareal</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Hypogonadism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Testosterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A De-identified, Anonymized Dataset will be created and shared. NOTE: ORO recommends that such sharing take place under a written agreement that adheres to any applicable Informed Consent provisions and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Controlled access requests will be provided to the greatest extent possible under specific DUAs or other written agreements and open access will be provided to the final datasets underlying peer-reviewed publications in accordance with the research disposition policy which states that research records will be destroyed 6 years after cutoff (at the end of the fiscal year) after completion of the research project, but may be retained longer if required by other federal regulations or sponsor archive requirements.</ipd_time_frame>
    <ipd_access_criteria>Controlled access requests will be provided to the greatest extent possible under specific DUAs or other written agreements and open access will be provided to the final datasets underlying peer-reviewed publications in accordance with the research disposition policy which states that research records will be destroyed 6 years after cutoff (at the end of the fiscal year) after completion of the research project, but may be retained longer if required by other federal regulations or sponsor archive requirements.</ipd_access_criteria>
  </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/NCT03256292
org study id: H-40598
nct id: NCT03256292
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Older hypogonadal obese veterans previously participated in a 6 month lifestyle change
      (diet-induced weight loss and exercise) study with or without testosterone replacement
      therapy before being followed for the following year at the clinic while receiving standard
      of care consisting of diet and exercise counseling (for healthy lifestyle change) and
      testosterone replacement therapy. This study will determine if long-term lifestyle change and
      testosterone replacement therapy with associated improvement in physical and metabolic health
      can be maintained in obese older adults.
Background: There are studies on long-term testosterone replacement in older adults with
      hypogonadism showing benefits on body composition, sexual function and mood but not on
      testosterone replacement therapy in combination with lifestyle change (diet-induced weight
      loss and exercise) in the specific population of older adults with both obesity and
      hypogonadism.

      Purpose: To determine if long-term lifestyle change and testosterone replacement therapy with
      associated improvement in physical and metabolic health can be maintained in obese older
      adults .

      Design: Overweight/obese older veteran patients with obesity and hypogonadism who are being
      followed at the endocrine clinic while receiving standard of care consisting of diet and
      exercise counseling (for healthy lifestyle change) and testosterone replacement therapy will
      be recruited for testing of physical, metabolic, cognitive/mood, quality of life, and body
      composition testing.
observational model: Cohort
time perspective: Cross-Sectional
measure: Change in Physical Performance Test score
time frame: 18 month
description: The primary functional outcome is the modified physical performance test, which includes seven standardized tasks (walking 50 ft, putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg tests) plus two additional tasks (climbing up and down four flights of stairs and performing a 360-degree turn). The score for each task ranges form 0 to 4; a perfect score is 36.
measure: Change in body weight
time frame: 18 month
description: Measured after an overnight fast using calibrated scales
measure: Change in body composition (lean mass, fat mass and bone mineral density)
time frame: 18 month
description: Assessed by using dual-energy x-ray absorptiometry
measure: Volumetric BMD
time frame: 18 month
description: Assessed by using peripheral quantitative computed tomography (pQCT)
measure: Biochemical Markers of Bone Turnover (Serum C-terminal telopeptide (CTX)
time frame: 18 month
description: measured by ELISA
measure: Change in prostate specific antigen
time frame: 18 month
description: measured in the blood
measure: Prostate Symptom Assessment
time frame: 18 month
description: Using the International Prostate Symptom Scoring
measure: Mood
time frame: 18 month
description: Using the Geriatric Depression Scale
measure: Quality of Life
time frame: 18 month
description: Using SF-36 and impact of weight on quality of life short form (IWQOL-lite)
measure: Sexual function
time frame: 18 month
description: Using the International Index of Erectile Function
measure: Change in trabecular bone score
time frame: 18 month
description: Using DXA
measure: Change in muscle strength and quality
time frame: 18 month
description: Using biodex dynamometry
measure: Change in balance
time frame: 18 month
description: as measured by leg stance and obstacle course
measure: Change in Functional Status
time frame: 18 month
description: Using functional status questionnaire
measure: Change in gait
time frame: 18 month
description: as measured by completing the time to walk a certain distance
measure: Change in bone quality
time frame: 18 month
description: Using HrpQCT
measure: Change in testosterone level
time frame: 18 month
description: as measured in the blood
measure: Change in sex hormone globulin
time frame: 18 month
description: as measured in the blood
measure: Change in metabolic hormones
time frame: 18 month
description: Leptin, adiponectin, and similar metabolic hormones as measured in the blood
measure: Change in Composite cognitive z-score
time frame: 18 month
description: using cognitive instrument testing
measure: Change in Modified mini-mental exam
time frame: 18 month
description: using cognitive instrument testing
measure: Change in Stroop color naming
time frame: 18 month
description: using cognitive instrument testing
measure: Change in Word list fluency
time frame: 18 month
description: using cognitive instrument testing
measure: Change in Ray auditory verbal learning test
time frame: 18 month
description: using cognitive instrument testing
measure: Change in Trail A/B
time frame: 18 month
description: using cognitive instrument testing
measure: Change in waist circumference
time frame: 18 month
description: as measured
measure: Change in serum PTH
time frame: 18 month
description: as measured in the blood
measure: Change in lipid profile
time frame: 18 month
description: as measured in the blood
measure: Change in blood pressure
time frame: 18 month
description: as measured by sphygmomanometry
measure: Change in metabolic syndrome
time frame: 18 month
description: using harmonized metabolic syndrome criteria
measure: bone strength index
time frame: 18 months
description: assessed by pQCT
measure: Cortical to total area
time frame: 18 months
description: assessed by pQCT
measure: Change in density weighted polar section modulus
time frame: 18 months
description: assessed by pQCT
measure: Change in cortical density
time frame: 18 months
description: assessed by pQCT
measure: Change in cortical area
time frame: 18 months
description: assessed by pQCT
measure: Change in Biochemical Markers of Bone Turnover (PINP)
time frame: 18 months
description: measured by RIA
measure: Change in lipid profile
time frame: 18 months
description: measured in the blood
measure: Change in vitamin D level
time frame: 18 months
description: measured in the blood
arm group label: testosterone, diet, and increased physical activity
description: Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy
intervention type: Drug
intervention name: Testosterone replacement
description: Testosterone replacement therapy
arm group label: testosterone, diet, and increased physical activity
intervention type: Behavioral
intervention name: lifestyle
description: lifestyle intervention consisting of diet and increased physical activity
arm group label: testosterone, diet, and increased physical activity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: No
last name: Dennis T Villareal, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Dennis T. Villareal
investigator title: Professor
mesh term: Overweight
mesh term: Hypogonadism
mesh term: Testosterone
sharing ipd: Yes
ipd description: A De-identified, Anonymized Dataset will be created and shared. NOTE: ORO recommends that such sharing take place under a written agreement that adheres to any applicable Informed Consent provisions and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.
ipd info type: Study Protocol
ipd time frame: Controlled access requests will be provided to the greatest extent possible under specific DUAs or other written agreements and open access will be provided to the final datasets underlying peer-reviewed publications in accordance with the research disposition policy which states that research records will be destroyed 6 years after cutoff (at the end of the fiscal year) after completion of the research project, but may be retained longer if required by other federal regulations or sponsor archive requirements.
ipd access criteria: Controlled access requests will be provided to the greatest extent possible under specific DUAs or other written agreements and open access will be provided to the final datasets underlying peer-reviewed publications in accordance with the research disposition policy which states that research records will be destroyed 6 years after cutoff (at the end of the fiscal year) after completion of the research project, but may be retained longer if required by other federal regulations or sponsor archive requirements.