<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/NCT03299205</url>
  </required_header>
  <id_info>
    <org_study_id>9767</org_study_id>
    <nct_id>NCT03299205</nct_id>
  </id_info>
  <brief_title>Alcohol &amp; Metabolic Comorbidities in PLWHA: Evidence Driven Interventions</brief_title>
  <acronym>ALIVE-Ex</acronym>
  <official_title>Alcohol &amp; Metabolic Comorbidities in PLWHA: Evidence Driven Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Louisiana State University Health Sciences Center in New Orleans</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cross-sectional and prospective studies are proposed to test the prediction that a higher&#xD;
      proportion of HIV+ individuals with hazardous alcohol drinking with subclinical fasting&#xD;
      dysglycemia will present with impaired oral glucose tolerance and dysfunctional metabolic&#xD;
      skeletal muscle phenotype. Prospective studies will test the efficacy of an exercise&#xD;
      intervention in improving glycemic control. Results will inform larger scale interventions to&#xD;
      ameliorate metabolic comorbidities, improve health, quality of life, and possibly decrease&#xD;
      hazardous alcohol drinking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult male and female in care PLWHA with fasting plasma glucose (FPG) &gt;94 mg/dL and &lt;125&#xD;
      mg/dL will be recruited. Measures of FPG and HbA1c obtained from overnight fasted subjects.&#xD;
      Alcohol use disorder (AUD) will be assessed by AUDIT and time-line follow back&#xD;
      questionnaires, coupled with Phosphatidylethanol (PEth) measures. Glucose tolerance will be&#xD;
      assessed by oral glucose tolerance test (OGTT). Blood sample collected at the time of the&#xD;
      OGTT will be used for determination of circulating levels of adipokines (adiponectin and&#xD;
      resistin).&#xD;
&#xD;
      A subset of adult male and female PLWHA +/- AUD with impaired OGTT will be recruited to&#xD;
      undergo skeletal muscle (SKM) biopsy (vastus lateralis), 90 min after a defined (calorie and&#xD;
      nutrient composition) meal (i.e.,Ensure, Carnation Instant Breakfast). Muscle samples will be&#xD;
      used for phenotype characterization (markers of inflammation, insulin signaling,&#xD;
      mitochondrial homeostasis) and for myoblast isolation.&#xD;
&#xD;
      Adult male and female PLWHA +/- AUD with impaired OGTT will undergo a moderate intensity&#xD;
      aerobic exercise intervention that will include the wearing of an accelerometer (i.e. Fitbit&#xD;
      Zip) to monitor daily activity and steps. A SKM biopsy will be performed after completion of&#xD;
      the exercise protocol in a subset of subjects to examine the changes in gene expression and&#xD;
      myoblast mitochondrial oxidative capacity. We will expand recruitment by enrolling PLWHA +/-&#xD;
      AUD based on a FPG between 94-120 mg/dL to participate in the exercise intervention.&#xD;
      Clearance for participation in this study will require EKG, completion of a physical activity&#xD;
      readiness questionnaire, and medical clearance from a staff clinician. Individuals with&#xD;
      significant peripheral neuropathies or the prevalence of significant cardiovascular&#xD;
      impairments (i.e. resting cardiac abnormalities or arrhythmias, severe hypertension, etc.)&#xD;
      will be excluded from exercise testing or intervention. The 10-week exercise intervention&#xD;
      program will consist of aerobic exercise 3 days per week of moderate intensity for 30-45&#xD;
      minutes each session with the goal of achieving 135 minutes per week. The program will begin&#xD;
      at low-moderate intensity (40 to 50% of heart rate reserve; HRR) and progress to a higher&#xD;
      intensity (50 to 60% HRR) exercise after week 4 of the program. The frequency and duration of&#xD;
      exercise sessions will remain constant after week 4 so the absolute dose of exercise will be&#xD;
      altered through increasing intensity, i.e. from low-moderate to more vigorous. All exercise&#xD;
      will be completed on a treadmill at the Louisiana State University Health Sciences Center&#xD;
      (LSUHSC) Wellness Center. Additionally, each participant will be provided with a Fitbit Zip&#xD;
      to monitor daily activity and steps. Data from the Fitbit Zip will be downloaded weekly&#xD;
      basis. Participants will be given a healthy step goal of 7000 steps per day. Based on initial&#xD;
      step counts after the first week of wearing the accelerometer, individual goals will be&#xD;
      discussed with the participants. Personal limitations that develop during the study period&#xD;
      (i.e. peripheral neuropathy, orthopedic limitation, etc.) will be monitored and will be&#xD;
      reason for exclusion from the exercise program. All sessions will be supervised and adherence&#xD;
      to the exercise prescription will be fully monitored under the supervision and care of Dr.&#xD;
      Stefany Primeaux in consultation with Dr. Neil Johannsen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting plasma glucose and OGTT values (subclinical dysglycemia)</measure>
    <time_frame>Baseline</time_frame>
    <description>Risk for subclinical dysglycemia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skeletal muscle phenotype</measure>
    <time_frame>Baseline</time_frame>
    <description>Subclinical dysglycemia associated with dysfunctional skeletal muscle measured by myomiRs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting plasma glucose</measure>
    <time_frame>Change from baseline in fasting plasma glucose after 10 weeks</time_frame>
    <description>Glycemic control measured by fasting plasma glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myomiRs</measure>
    <time_frame>Change from baseline in myomiRs after 10 weeks</time_frame>
    <description>Dysfunctional SKM measured by myomiRs</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Dysglycemia</condition>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic exercise program using treadmill.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>The exercise intervention consists of moderate intensity aerobic exercise intervention that will include the wearing of an accelerometer (i.e. Fitbit Zip) to monitor daily activity and steps. Aerobic exercise will be conducted over 10-weeks in PLWHA +/- AUD. The programs will consist of aerobic exercise 3 days per week of moderate intensity for 30-45 minutes each session with the goal of achieving 135 minutes per week. The program will begin at low-moderate intensity and progress to higher intensity exercise after week 4 of the program. All exercise will be completed on a treadmill and supervised by study staff. Each participant will be provided with a Fitbit Zip to monitor daily activity and steps with a goal of 7000 steps per day.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. HIV positive&#xD;
&#xD;
          2. Fasting glucose above 94 mg/dL and below 125 mg/dl&#xD;
&#xD;
          3. Without diagnosis of diabetes mellitus&#xD;
&#xD;
          4. &quot;No&quot; response to six questions in Physical Activity Readiness Questionnaire (PAR-Q),&#xD;
             given at time of screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lack of informed consent&#xD;
&#xD;
          2. Decisionally impaired individuals&#xD;
&#xD;
          3. Non-English speaking&#xD;
&#xD;
          4. Acute illness within the preceding six weeks (defined as fever, new antibiotic use or&#xD;
             unscheduled healthcare visit (for illness))&#xD;
&#xD;
          5. Acute alcohol intoxication&#xD;
&#xD;
          6. Pregnancy&#xD;
&#xD;
          7. Currently prescribed blood thinners (if undergoing muscle biopsy)&#xD;
&#xD;
          8. Allergy to Lidocaine (if undergoing muscle biopsy)&#xD;
&#xD;
          9. Significant peripheral neuropathies (if undergoing exercise)&#xD;
&#xD;
         10. Significant cardiovascular impairments (if undergoing exercise)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Molina, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Louisiana State University Health Sciences Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stefany Primeaux, PhD</last_name>
    <phone>504-568-2633</phone>
    <email>sprime@lsuhsc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Louisiana State University Health Sciences Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefany Primeaux, PhD</last_name>
      <phone>504-568-2633</phone>
      <email>sprime@lsuhsc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University Health Sciences Center in New Orleans</investigator_affiliation>
    <investigator_full_name>Patricia Molina</investigator_full_name>
    <investigator_title>Professor and Head Department of Physiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Requests for access to biological samples or existing clinical data obtained from our subjects will be evaluated by Dr. Molina.</ipd_description>
  </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/NCT03299205
org study id: 9767
nct id: NCT03299205
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cross-sectional and prospective studies are proposed to test the prediction that a higher
      proportion of HIV+ individuals with hazardous alcohol drinking with subclinical fasting
      dysglycemia will present with impaired oral glucose tolerance and dysfunctional metabolic
      skeletal muscle phenotype. Prospective studies will test the efficacy of an exercise
      intervention in improving glycemic control. Results will inform larger scale interventions to
      ameliorate metabolic comorbidities, improve health, quality of life, and possibly decrease
      hazardous alcohol drinking.
Adult male and female in care PLWHA with fasting plasma glucose (FPG) >94 mg/dL and <125
      mg/dL will be recruited. Measures of FPG and HbA1c obtained from overnight fasted subjects.
      Alcohol use disorder (AUD) will be assessed by AUDIT and time-line follow back
      questionnaires, coupled with Phosphatidylethanol (PEth) measures. Glucose tolerance will be
      assessed by oral glucose tolerance test (OGTT). Blood sample collected at the time of the
      OGTT will be used for determination of circulating levels of adipokines (adiponectin and
      resistin).

      A subset of adult male and female PLWHA +/- AUD with impaired OGTT will be recruited to
      undergo skeletal muscle (SKM) biopsy (vastus lateralis), 90 min after a defined (calorie and
      nutrient composition) meal (i.e.,Ensure, Carnation Instant Breakfast). Muscle samples will be
      used for phenotype characterization (markers of inflammation, insulin signaling,
      mitochondrial homeostasis) and for myoblast isolation.

      Adult male and female PLWHA +/- AUD with impaired OGTT will undergo a moderate intensity
      aerobic exercise intervention that will include the wearing of an accelerometer (i.e. Fitbit
      Zip) to monitor daily activity and steps. A SKM biopsy will be performed after completion of
      the exercise protocol in a subset of subjects to examine the changes in gene expression and
      myoblast mitochondrial oxidative capacity. We will expand recruitment by enrolling PLWHA +/-
      AUD based on a FPG between 94-120 mg/dL to participate in the exercise intervention.
      Clearance for participation in this study will require EKG, completion of a physical activity
      readiness questionnaire, and medical clearance from a staff clinician. Individuals with
      significant peripheral neuropathies or the prevalence of significant cardiovascular
      impairments (i.e. resting cardiac abnormalities or arrhythmias, severe hypertension, etc.)
      will be excluded from exercise testing or intervention. The 10-week exercise intervention
      program will consist of aerobic exercise 3 days per week of moderate intensity for 30-45
      minutes each session with the goal of achieving 135 minutes per week. The program will begin
      at low-moderate intensity (40 to 50% of heart rate reserve; HRR) and progress to a higher
      intensity (50 to 60% HRR) exercise after week 4 of the program. The frequency and duration of
      exercise sessions will remain constant after week 4 so the absolute dose of exercise will be
      altered through increasing intensity, i.e. from low-moderate to more vigorous. All exercise
      will be completed on a treadmill at the Louisiana State University Health Sciences Center
      (LSUHSC) Wellness Center. Additionally, each participant will be provided with a Fitbit Zip
      to monitor daily activity and steps. Data from the Fitbit Zip will be downloaded weekly
      basis. Participants will be given a healthy step goal of 7000 steps per day. Based on initial
      step counts after the first week of wearing the accelerometer, individual goals will be
      discussed with the participants. Personal limitations that develop during the study period
      (i.e. peripheral neuropathy, orthopedic limitation, etc.) will be monitored and will be
      reason for exclusion from the exercise program. All sessions will be supervised and adherence
      to the exercise prescription will be fully monitored under the supervision and care of Dr.
      Stefany Primeaux in consultation with Dr. Neil Johannsen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Fasting plasma glucose and OGTT values (subclinical dysglycemia)
time frame: Baseline
description: Risk for subclinical dysglycemia
measure: Skeletal muscle phenotype
time frame: Baseline
description: Subclinical dysglycemia associated with dysfunctional skeletal muscle measured by myomiRs
measure: Fasting plasma glucose
time frame: Change from baseline in fasting plasma glucose after 10 weeks
description: Glycemic control measured by fasting plasma glucose
measure: myomiRs
time frame: Change from baseline in myomiRs after 10 weeks
description: Dysfunctional SKM measured by myomiRs
arm group label: Exercise
arm group type: Experimental
description: Aerobic exercise program using treadmill.
intervention type: Behavioral
intervention name: Exercise
description: The exercise intervention consists of moderate intensity aerobic exercise intervention that will include the wearing of an accelerometer (i.e. Fitbit Zip) to monitor daily activity and steps. Aerobic exercise will be conducted over 10-weeks in PLWHA +/- AUD. The programs will consist of aerobic exercise 3 days per week of moderate intensity for 30-45 minutes each session with the goal of achieving 135 minutes per week. The program will begin at low-moderate intensity and progress to higher intensity exercise after week 4 of the program. All exercise will be completed on a treadmill and supervised by study staff. Each participant will be provided with a Fitbit Zip to monitor daily activity and steps with a goal of 7000 steps per day.
arm group label: Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patricia Molina, MD, PhD
role: Principal Investigator
affiliation: Louisiana State University Health Sciences Center
last name: Stefany Primeaux, PhD
phone: 504-568-2633
email: sprime@lsuhsc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University Health Sciences Center in New Orleans
investigator full name: Patricia Molina
investigator title: Professor and Head Department of Physiology
mesh term: Alcoholism
sharing ipd: No
ipd description: Requests for access to biological samples or existing clinical data obtained from our subjects will be evaluated by Dr. Molina.