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/NCT06000735</url>
    </required_header>
    <id_info>
      <org_study_id>21-000975</org_study_id>
      <nct_id>NCT06000735</nct_id>
    </id_info>
    <brief_title>Daily Blood Glucose Trends in Patients at Risk for Diabetes</brief_title>
    <official_title>Daily Blood Glucose Trends in Patients at Risk for Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karol E. Watson, MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of California, Los Angeles</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, Los Angeles</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to learn about the relationship between blood sugar, diet, stress,&#xD;
        and metabolic parameters including waist circumference, body mass index (BMI), cholesterol&#xD;
        levels and blood pressure in patients at risk for diabetes. The main questions it aims to&#xD;
        answer are 1) are there trends in blood sugar responses after meals for patients at risk of&#xD;
        developing diabetes? And 2) are there correlations between stress and fluctuations in blood&#xD;
        sugar? During the first visit, participant's waist circumference, body composition,&#xD;
        cholesterol, and resting blood pressure will be measured, and a continuous glucose monitor&#xD;
        sensor will be placed on the participant's non-dominant arm. This sensor will be worn for&#xD;
        seven days, and the participant will be asked to complete a daily food log during that time.&#xD;
        Each participant will be asked to return to clinic after one week to return the continuous&#xD;
        glucose monitor and daily food log.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The relevance of diet, sleep, and stress and their metabolic consequences in cardiovascular&#xD;
        risk is principal. Current improvements and developments in food labeling and personal&#xD;
        self-tracking devices and applications (e.g. continuous glucose monitors [CGMs] and food&#xD;
        logging apps), signal potential for better quantification of personal traits that could&#xD;
        assist in defining personalized approaches for glycemic control. The objective of the&#xD;
        proposed study is to evaluate daily glucose fluctuations and blood glucose time-in-range in&#xD;
        relation to dietary intake and correlate excursions with metabolic risk factors in&#xD;
        non-diabetic adults with one risk factor for diabetes mellitus. With the use of CGM&#xD;
        technology to explore daily blood glucose trends in patients at risk for diabetes, the goal&#xD;
        is to investigate relationships between blood glucose and metabolic parameters as well as&#xD;
        sleep and stress factors.&#xD;
  &#xD;
        The study will include two visits. During the first visit, the patient is explained the study&#xD;
        details, their consent is obtained, their metabolic parameters measured, perceived stress&#xD;
        scale questionnaire administered, and finally, the CGM is placed on them. The patient will be&#xD;
        asked to return after one week to return the CGM reader, so the study team may collect the&#xD;
        data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2024</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>
      <intervention_model_description>Pilot Study (uncontrolled)</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood glucose time-in-range (TIR)</measure>
      <time_frame>7 days</time_frame>
      <description>The relationship between participants' TIR and cholesterol level, blood pressure, waist circumference, and perceived stress levels will be analyzed for any correlations.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Stress</condition>
    <condition>Blood Sugar; High</condition>
    <condition>Cholesterol, Elevated</condition>
    <condition>Diet Habit</condition>
    <arm_group>
      <arm_group_label>7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will go through the same intervention described above.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2</intervention_name>
      <description>All participants will go through the same intervention described above</description>
      <arm_group_label>7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria (Must meet at least one of the following):&#xD;
  &#xD;
            -  Overweight and/or obese BMI classification, 25 to 35 kg/m2&#xD;
  &#xD;
            -  Fasting serum glucose ≥100 mg/dL and &lt;126 mg/dL or HbA1c &gt;5.7% and &lt; 6.5%&#xD;
  &#xD;
            -  Family history of Type 2 DM&#xD;
  &#xD;
            -  History of hypertension, hypertriglyceridemia, heart disease, and/or stroke&#xD;
  &#xD;
            -  History of gestational diabetes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any subject currently taking blood thinning medications such as Warfarin or Coumadin&#xD;
  &#xD;
            -  Any history of gastrointestinal disease or surgery except for appendectomy or&#xD;
               cholecystectomy.&#xD;
  &#xD;
            -  History of gastrointestinal surgery, diabetes mellitus, or other serious medical&#xD;
               condition, such as chronic hepatic or renal disease, bleeding disorder, congestive&#xD;
               heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery&#xD;
               bypass graft, angioplasty within 6 months prior to screening, current diagnosis of&#xD;
               uncontrolled hypertension (defined as systolic BP &gt;160mmHg, diastolic BP &gt;95mmHg),&#xD;
               active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or&#xD;
               endocrine diseases (except thyroid disease requiring medication) as indicated by&#xD;
               medical history.&#xD;
  &#xD;
            -  Pregnant or breastfeeding&#xD;
  &#xD;
            -  Currently uses tobacco products.&#xD;
  &#xD;
            -  Currently has an alcohol intake &gt; 20 g ⁄ day;&#xD;
  &#xD;
            -  Currently has a coffee intake &gt; 3 cups ⁄ day;&#xD;
  &#xD;
            -  Is unable or unwilling to comply with the study protocol.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Karol Watson, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, Los Angeles</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Karol Watson, MD, PhD</last_name>
      <phone>310-825-9011</phone>
      <email>kwatson@mednet.ucla.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Vijaya Surampudi, MD</last_name>
      <phone>310-825-7921</phone>
      <email>vsurampudi@mednet.ucla.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UCLA Clinical Nutrition Clinic, 200 UCLA Medical Plaza, Suite 365-C</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90095</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Vijaya Surampudi, MD</last_name>
        <phone>310-825-7921</phone>
        <email>vsurampudi@mednet.ucla.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
      <investigator_full_name>Karol E. Watson, MD</investigator_full_name>
      <investigator_title>Professor of Medicine, Cardiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperglycemia</mesh_term>
      <mesh_term>Hypercholesterolemia</mesh_term>
    </condition_browse>
    <!-- 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/NCT06000735
  org study id: 21-000975
  nct id: NCT06000735
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The goal of this study is to learn about the relationship between blood sugar, diet, stress,
        and metabolic parameters including waist circumference, body mass index (BMI), cholesterol
        levels and blood pressure in patients at risk for diabetes. The main questions it aims to
        answer are 1) are there trends in blood sugar responses after meals for patients at risk of
        developing diabetes? And 2) are there correlations between stress and fluctuations in blood
        sugar? During the first visit, participant's waist circumference, body composition,
        cholesterol, and resting blood pressure will be measured, and a continuous glucose monitor
        sensor will be placed on the participant's non-dominant arm. This sensor will be worn for
        seven days, and the participant will be asked to complete a daily food log during that time.
        Each participant will be asked to return to clinic after one week to return the continuous
        glucose monitor and daily food log.
  The relevance of diet, sleep, and stress and their metabolic consequences in cardiovascular
        risk is principal. Current improvements and developments in food labeling and personal
        self-tracking devices and applications (e.g. continuous glucose monitors [CGMs] and food
        logging apps), signal potential for better quantification of personal traits that could
        assist in defining personalized approaches for glycemic control. The objective of the
        proposed study is to evaluate daily glucose fluctuations and blood glucose time-in-range in
        relation to dietary intake and correlate excursions with metabolic risk factors in
        non-diabetic adults with one risk factor for diabetes mellitus. With the use of CGM
        technology to explore daily blood glucose trends in patients at risk for diabetes, the goal
        is to investigate relationships between blood glucose and metabolic parameters as well as
        sleep and stress factors.
  
        The study will include two visits. During the first visit, the patient is explained the study
        details, their consent is obtained, their metabolic parameters measured, perceived stress
        scale questionnaire administered, and finally, the CGM is placed on them. The patient will be
        asked to return after one week to return the CGM reader, so the study team may collect the
        data.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Pilot Study (uncontrolled)
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Blood glucose time-in-range (TIR)
  time frame: 7 days
  description: The relationship between participants' TIR and cholesterol level, blood pressure, waist circumference, and perceived stress levels will be analyzed for any correlations.
  arm group label: 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2
  arm group type: Experimental
  description: All participants will go through the same intervention described above.
  intervention type: Device
  intervention name: 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2
  description: All participants will go through the same intervention described above
  arm group label: 7-Day Continuous Glucose Monitoring with Abbott Freestyle Libre 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Karol Watson, MD, PhD
  role: Principal Investigator
  affiliation: University of California, Los Angeles
  last name: Karol Watson, MD, PhD
  phone: 310-825-9011
  email: kwatson@mednet.ucla.edu
  last name: Vijaya Surampudi, MD
  phone: 310-825-7921
  email: vsurampudi@mednet.ucla.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of California, Los Angeles
  investigator full name: Karol E. Watson, MD
  investigator title: Professor of Medicine, Cardiology
  mesh term: Hyperglycemia
  mesh term: Hypercholesterolemia