xml: <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/NCT06023407</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00147285</org_study_id>
      <nct_id>NCT06023407</nct_id>
    </id_info>
    <brief_title>Feasibility of Improving Glycemia With Heat Therapy to Prevent AD</brief_title>
    <acronym>FIGHT-AD</acronym>
    <official_title>Feasibility of Improving Glycemia With Heat Therapy to Prevent AD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Kansas Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Kansas Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        We will determine if heat therapy can improve blood (Aim 1) and brain (Aim 2) glucose&#xD;
        metabolism in cognitively healthy older adults (65+) who are at risk for AD. We will also&#xD;
        examine the degree to which changes in blood and brain glucose metabolism track together and&#xD;
        explore several additional potential mechanisms that are critical to understanding the brain&#xD;
        benefits of heat therapy (Aim 3). These aims will provide a comprehensive understanding of&#xD;
        the impact of heat therapy on whole body metabolic function and brain health.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim 1. Examine the effects of heat therapy on blood glucose regulation in older adults at&#xD;
        risk for AD. We will determine the ability of 10 weeks of heat therapy (3 days/week) to&#xD;
        improve blood glucose regulation in older adults at risk for AD. Our primary outcome measures&#xD;
        will be change in glycated hemoglobin (HbA1c), and change in insulin sensitivity index (ISI)&#xD;
        assessed pre- vs post-intervention. We will also perform continuous glucose monitoring for 7&#xD;
        days prior to and following the intervention, as well as monitor dietary patterns during the&#xD;
        intervention. We hypothesize that 10 weeks of heat therapy will lower HbA1c values and&#xD;
        improve ISI outcomes.&#xD;
  &#xD;
        Aim 2. Test the effect of heat therapy on brain glucose metabolism. To date, no studies have&#xD;
        examined the impact of heat therapy on brain glucose metabolism. Here we will determine the&#xD;
        effect of 10 weeks of heat therapy on brain glucose metabolism in older adults at risk for&#xD;
        AD. Our primary outcome measure will be change in [18F] fluorodeoxyglucose (FDG) global&#xD;
        standardized uptake value ratio (SUVR) pre- vs post- heat therapy. We hypothesize that&#xD;
        individuals will improve (increase) global cerebral glucose metabolism following 10 weeks of&#xD;
        heat therapy. We further hypothesize that the degree of change in blood glucose metabolism&#xD;
        will track with change in brain glucose metabolism.&#xD;
  &#xD;
        Aim 3. Explore the effect of heat therapy on fluid biomarkers (proteostasis, inflammation,&#xD;
        neuropathology) and neuroimaging markers of brain health. We will explore the effect of heat&#xD;
        therapy on plasma markers of proteostasis (HSP's), inflammation (CRP, TNF, IL-6, JNK and IKK)&#xD;
        and AD-related neuropathology (Amyloid/Tau/Neurodegeneration; A/T/N measures) markers in&#xD;
        plasma at baseline and following 10 weeks of heat treatment. We will also obtain MRI measures&#xD;
        of resting state metabolism, brain blood flow, and oxygen uptake for preliminary&#xD;
        characterization of intervention-related changes. We hypothesize that proteostasis,&#xD;
        inflammation, and AD neuropathology will be beneficially affected by heat treatment. We&#xD;
        further hypothesize that we will observe benefits in MRI-related brain outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">January 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2026</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>1:1 allocation to either heat therapy intervention or thermoneutral control group</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Primary Investigators will be blinded to participants group. Due to the type of intervention we are unable to blind participant or certain members of the study team</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>HbA1C</measure>
      <time_frame>10 weeks</time_frame>
      <description>hemoglobin A1C (HbA1C) test is a blood test that shows what your average blood sugar (glucose) level was over the past two to three months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Insulin sensitivity index</measure>
      <time_frame>10 weeks</time_frame>
      <description>Using glucose and insulin from a the OGTT, an indices will be calculated for insulin sensitivity</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fluorodeoxyglucose (FDG) positron emission tomography (PET) Metabolism (Standard Uptake Value Ratio)</measure>
      <time_frame>10 weeks</time_frame>
      <description>FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) will be calculated from native-space region of interest (ROI).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Healthy Aging</condition>
    <condition>Alzheimer Disease</condition>
    <condition>Metabolic Disease</condition>
    <arm_group>
      <arm_group_label>Heat therapy Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>40.5°C water</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Thermoneutral Control Group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>36°C water</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Water Immersion Heat Therapy</intervention_name>
      <description>10-weeks of 3 days per week in 1 of the 2 arms</description>
      <arm_group_label>Heat therapy Group</arm_group_label>
      <arm_group_label>Thermoneutral Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 65 and older&#xD;
  &#xD;
            -  Stable medication doses (&gt;1 month)&#xD;
  &#xD;
            -  Post-menopausal&#xD;
  &#xD;
            -  Clinical Dementia Rating (CDR) of 0&#xD;
  &#xD;
            -  History of or current metabolic impairment (i.e. metabolic syndrome, pre-diabetes,&#xD;
               Type 2 Diabetes, etc)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Excluded from or unable to complete an MRI scan. MRI compatible pacemakers will&#xD;
               require cardiologist clearance prior to enrolling.&#xD;
  &#xD;
            -  ACSM Risk score stratification of &quot;High&quot; unless cleared by a physician prior to&#xD;
               participation.&#xD;
  &#xD;
            -  Myocardial infarction or symptoms of coronary artery disease in the last 2 years.&#xD;
  &#xD;
            -  History of or current diagnosis of disorders with the potential to impair cognition&#xD;
               (i.e. AD, Parkinson's disease, stroke (defined as clinical episode w/ neuroimaging&#xD;
               evidence in appropriate area to explain symptoms)).&#xD;
  &#xD;
            -  Insulin-dependent (Type 1) Diabetes Mellitus.&#xD;
  &#xD;
            -  Clinically significant chronic disease such as cancer, HIV, or acquired&#xD;
               immunodeficiency syndrome.&#xD;
  &#xD;
            -  Clinically significant depressive symptoms that may impair cognition, use of&#xD;
               psychoactive and investigational medications, and significant visual or auditory&#xD;
               impairment.&#xD;
  &#xD;
            -  Orthopedic complications that would preclude individuals from safely entering a hot&#xD;
               tub.&#xD;
  &#xD;
            -  Untreated hypothyroidism or diseases associated with heat intolerance (i.e. Graves&#xD;
               disease, etc).&#xD;
  &#xD;
            -  Contraindication for temperature pill ingestion (i.e. inflammatory bowel disease,&#xD;
               diverticulitis or related).&#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_contact>
      <last_name>Jill Morris</last_name>
      <phone>913-945-7675</phone>
      <email>jmorris2@kumc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Paige Geiger</last_name>
      <phone>913-588-7408</phone>
      <email>pgeiger@kumc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Univeristy of Kansas Medical Center</name>
        <address>
          <city>Kansas City</city>
          <state>Kansas</state>
          <zip>66160</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jill Morris 913-945-7675</last_name>
        <email>morrisj2@kumc.edu</email>
      </contact>
      <investigator>
        <last_name>Jill Morris, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Metabolic Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023407
  org study id: STUDY00147285
  nct id: NCT06023407
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  We will determine if heat therapy can improve blood (Aim 1) and brain (Aim 2) glucose
        metabolism in cognitively healthy older adults (65+) who are at risk for AD. We will also
        examine the degree to which changes in blood and brain glucose metabolism track together and
        explore several additional potential mechanisms that are critical to understanding the brain
        benefits of heat therapy (Aim 3). These aims will provide a comprehensive understanding of
        the impact of heat therapy on whole body metabolic function and brain health.
  Aim 1. Examine the effects of heat therapy on blood glucose regulation in older adults at
        risk for AD. We will determine the ability of 10 weeks of heat therapy (3 days/week) to
        improve blood glucose regulation in older adults at risk for AD. Our primary outcome measures
        will be change in glycated hemoglobin (HbA1c), and change in insulin sensitivity index (ISI)
        assessed pre- vs post-intervention. We will also perform continuous glucose monitoring for 7
        days prior to and following the intervention, as well as monitor dietary patterns during the
        intervention. We hypothesize that 10 weeks of heat therapy will lower HbA1c values and
        improve ISI outcomes.
  
        Aim 2. Test the effect of heat therapy on brain glucose metabolism. To date, no studies have
        examined the impact of heat therapy on brain glucose metabolism. Here we will determine the
        effect of 10 weeks of heat therapy on brain glucose metabolism in older adults at risk for
        AD. Our primary outcome measure will be change in [18F] fluorodeoxyglucose (FDG) global
        standardized uptake value ratio (SUVR) pre- vs post- heat therapy. We hypothesize that
        individuals will improve (increase) global cerebral glucose metabolism following 10 weeks of
        heat therapy. We further hypothesize that the degree of change in blood glucose metabolism
        will track with change in brain glucose metabolism.
  
        Aim 3. Explore the effect of heat therapy on fluid biomarkers (proteostasis, inflammation,
        neuropathology) and neuroimaging markers of brain health. We will explore the effect of heat
        therapy on plasma markers of proteostasis (HSP's), inflammation (CRP, TNF, IL-6, JNK and IKK)
        and AD-related neuropathology (Amyloid/Tau/Neurodegeneration; A/T/N measures) markers in
        plasma at baseline and following 10 weeks of heat treatment. We will also obtain MRI measures
        of resting state metabolism, brain blood flow, and oxygen uptake for preliminary
        characterization of intervention-related changes. We hypothesize that proteostasis,
        inflammation, and AD neuropathology will be beneficially affected by heat treatment. We
        further hypothesize that we will observe benefits in MRI-related brain outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 1:1 allocation to either heat therapy intervention or thermoneutral control group
  primary purpose: Other
  masking: Single (Investigator)
  masking description: Primary Investigators will be blinded to participants group. Due to the type of intervention we are unable to blind participant or certain members of the study team
  measure: HbA1C
  time frame: 10 weeks
  description: hemoglobin A1C (HbA1C) test is a blood test that shows what your average blood sugar (glucose) level was over the past two to three months
  measure: Insulin sensitivity index
  time frame: 10 weeks
  description: Using glucose and insulin from a the OGTT, an indices will be calculated for insulin sensitivity
  measure: Fluorodeoxyglucose (FDG) positron emission tomography (PET) Metabolism (Standard Uptake Value Ratio)
  time frame: 10 weeks
  description: FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) will be calculated from native-space region of interest (ROI).
  arm group label: Heat therapy Group
  arm group type: Experimental
  description: 40.5°C water
  arm group label: Thermoneutral Control Group
  arm group type: Sham Comparator
  description: 36°C water
  intervention type: Other
  intervention name: Water Immersion Heat Therapy
  description: 10-weeks of 3 days per week in 1 of the 2 arms
  arm group label: Heat therapy Group
  arm group label: Thermoneutral Control Group
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jill Morris
  phone: 913-945-7675
  email: jmorris2@kumc.edu
  last name: Paige Geiger
  phone: 913-588-7408
  email: pgeiger@kumc.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  mesh term: Metabolic Diseases
  sharing ipd: No