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/NCT06005051</url>
    </required_header>
    <id_info>
      <org_study_id>68475</org_study_id>
      <nct_id>NCT06005051</nct_id>
    </id_info>
    <brief_title>Prediabetes Stratification by Multi-omics Profile After Food Intake</brief_title>
    <official_title>Prediabetes Stratification by Multi-omics Profile After Food Intake</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</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>
        1 in 3 adults have prediabetes in the United States, and many of them will eventually develop&#xD;
        diabetes, which has significant public health and economic costs. However, type 2 diabetes&#xD;
        (T2D) and prediabetes are heterogeneous groups with different pathological mechanisms,&#xD;
        dysfunctions in different processes, and varied disease trajectories. Patient stratifications&#xD;
        into subtypes and personalized nutrition interventions are highly needed but not yet&#xD;
        available. Metabolic responses (e.g., glucose excursion) after food intake provide a direct&#xD;
        observation of personal metabolic control and its association with T2D.&#xD;
  &#xD;
        The investigators hope to learn how prediabetes and type 2 diabetes evolve, and specifically&#xD;
        what food or exercise can do to mitigate blood sugar response.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Screening: The investigators will check fasting blood sugars, HbA1C to determine status&#xD;
        (healthy, prediabetes or diabetes).&#xD;
  &#xD;
        Enrolled participants will be provided with a Continuous Glucose Monitor (CGM) to measure&#xD;
        blood sugars for 10 days and a Fitbit fitness tracker. They will then follow the instructions&#xD;
        for each of the 10 days on the monitors:&#xD;
  &#xD;
        Day 0: participants will start using the devices and start recording food intake in a food&#xD;
        logging app (Cronometer) Day 1-6: Participants will eat a provided portion of white rice (50g&#xD;
        of carbohydrates) within 1.5 hrs of waking up). Day 1,3, 5 consume one of the mitigator foods&#xD;
        provided (fat (cream), protein (egg whites), or fiber (powdered pea fiber)). Days 2 and 4 no&#xD;
        mitigators will be consumed. Day 6 the investigators will ask participants to exercise before&#xD;
        eating the rice. Exercise will be moderate for 20 min with constant heart rate level about&#xD;
        (220-age)*0.7. During these 6 days participants will be asked to collect microsamples of&#xD;
        blood using the Tasso device on the following time points: right after waking up; right&#xD;
        before eating their rice; 30 minutes, 1, 2 and 3 hours after the start of the rice meal;&#xD;
        right before going to bed&#xD;
  &#xD;
        Days 7-9 no intervention, just continue to use devices and log food intake.&#xD;
  &#xD;
        Optional- 5 participants who volunteer to repeat this 10 day cycle 3 times.&#xD;
  &#xD;
        Optional metabolic tests:&#xD;
  &#xD;
          1. Oral Glucose Tolerance Test (OGTT) to measure glucose tolerance and beta cell function:&#xD;
             participants will be provided with a 75g glucose solution to drink and collect samples&#xD;
             at 10-30min intervals for 180 minutes.&#xD;
  &#xD;
          2. Undergo an insulin sensitivity test (Steady State Plasma Glucose, SSPG)- glucose,&#xD;
             insulin and ocreotide infusions will be provided and blood samples taken at 10-30min&#xD;
             intervals for 240 min.&#xD;
  &#xD;
          3. Undergo an Isoglycemic Intravenous Glucose Infusion test (IIGI) to test for incretin&#xD;
             hormone function- a glucose infusion will be given and blood samples collected at 10-30&#xD;
             min intervals for 180 min.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</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>All participants will consume the meals using the cgm and fitbit devices and log their meal intake.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comparison of blood glucose levels after the different dietary and exercise mitigators</measure>
      <time_frame>10 days</time_frame>
      <description>Blood glucose value is derived from continuous glucose monitor (CGM) data, expressed in milligrams/deciliter, and measured for 10 days. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in postprandial metabolites response as measured by micro-sampling</measure>
      <time_frame>10 days</time_frame>
      <description>Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals at 5 time points. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic interaction LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in postprandial proteomic responses as measured in micro-sampling by Olink</measure>
      <time_frame>10 days</time_frame>
      <description>Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals at 5 time points. Based on those samples, proteomics will be quantified by proximity extension assay for the cardiometabolic panel. 96 proteins will be measured in the unit of normalized protein expression. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in personal metabolic states through the day as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)</measure>
      <time_frame>10 days</time_frame>
      <description>Dry blood samples will be collected by micro-sampling after getup, after the standardized meals, and before sleep. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites. Comparisons will be made for the different time points during the day.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in personal metabolic states through the day as measured in micro-sampling by Olink proteomics</measure>
      <time_frame>10 days</time_frame>
      <description>Dry blood samples will be collected by micro-sampling after getup, after the standardized meals, and before sleep. Based on those samples, proteomics will be quantified by proximity extension assay for the cardiometabolic panel. 96 proteins will be measured in the unit of normalized protein expression. Comparisons will be made for the different time points during the day.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>PreDiabetes</condition>
    <arm_group>
      <arm_group_label>mitigator</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Test different foods to see their mitigating effect on blood sugars after a rice meal.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dietary intervention</intervention_name>
      <description>Using different combination of foods to see if the glucose response to a load of carbohydrates can be mitigated.</description>
      <arm_group_label>mitigator</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be 18 years of age or older;&#xD;
  &#xD;
            -  Not be pregnant;&#xD;
  &#xD;
            -  Live close to Stanford Campus&#xD;
  &#xD;
            -  Be generally healthy (with no apparent symptoms at the time of enrollment)&#xD;
  &#xD;
            -  Patients with prediabetes or diet-controlled or type 2 diabetes or controlled with&#xD;
               metformin, will also be allowed to participate.&#xD;
  &#xD;
            -  Be willing to provide written informed consent for all study procedures.-&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Major organ diseases,&#xD;
  &#xD;
            -  Pregnant or lactating. If a participant will become pregnant while in the study, she&#xD;
               will be removed from the study.&#xD;
  &#xD;
            -  are on diabetogenic medications (with the exclusion of metformin),&#xD;
  &#xD;
            -  have malabsorptive disorders like celiac sprue or similar&#xD;
  &#xD;
            -  report heavy alcohol use,&#xD;
  &#xD;
            -  use of weight loss medications or specific diets,&#xD;
  &#xD;
            -  weight change &gt; 2 kg in the last three weeks,&#xD;
  &#xD;
            -  history of bariatric surgery&#xD;
  &#xD;
            -  Any medical condition that our physician believes would interfere with study&#xD;
               participation or evaluation of results.&#xD;
  &#xD;
            -  Mental incapacity and/or cognitive impairment on the part of the patient that would&#xD;
               preclude the adequate understanding of, or cooperation 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>Yue Wu, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Caroline Study Coordinator</last_name>
      <phone>(650)723-9160</phone>
      <email>bejikian@stanford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dalia Study Dietitian</last_name>
      <phone>(650)723-9160</phone>
      <email>daliap@stanford.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Stanford University</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94304</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Yue Wu</investigator_full_name>
      <investigator_title>Postdoctoral Scholar</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
      <mesh_term>Prediabetic State</mesh_term>
      <mesh_term>Glucose Intolerance</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06005051
  org study id: 68475
  nct id: NCT06005051
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  1 in 3 adults have prediabetes in the United States, and many of them will eventually develop
        diabetes, which has significant public health and economic costs. However, type 2 diabetes
        (T2D) and prediabetes are heterogeneous groups with different pathological mechanisms,
        dysfunctions in different processes, and varied disease trajectories. Patient stratifications
        into subtypes and personalized nutrition interventions are highly needed but not yet
        available. Metabolic responses (e.g., glucose excursion) after food intake provide a direct
        observation of personal metabolic control and its association with T2D.
  
        The investigators hope to learn how prediabetes and type 2 diabetes evolve, and specifically
        what food or exercise can do to mitigate blood sugar response.
  Screening: The investigators will check fasting blood sugars, HbA1C to determine status
        (healthy, prediabetes or diabetes).
  
        Enrolled participants will be provided with a Continuous Glucose Monitor (CGM) to measure
        blood sugars for 10 days and a Fitbit fitness tracker. They will then follow the instructions
        for each of the 10 days on the monitors:
  
        Day 0: participants will start using the devices and start recording food intake in a food
        logging app (Cronometer) Day 1-6: Participants will eat a provided portion of white rice (50g
        of carbohydrates) within 1.5 hrs of waking up). Day 1,3, 5 consume one of the mitigator foods
        provided (fat (cream), protein (egg whites), or fiber (powdered pea fiber)). Days 2 and 4 no
        mitigators will be consumed. Day 6 the investigators will ask participants to exercise before
        eating the rice. Exercise will be moderate for 20 min with constant heart rate level about
        (220-age)*0.7. During these 6 days participants will be asked to collect microsamples of
        blood using the Tasso device on the following time points: right after waking up; right
        before eating their rice; 30 minutes, 1, 2 and 3 hours after the start of the rice meal;
        right before going to bed
  
        Days 7-9 no intervention, just continue to use devices and log food intake.
  
        Optional- 5 participants who volunteer to repeat this 10 day cycle 3 times.
  
        Optional metabolic tests:
  
          1. Oral Glucose Tolerance Test (OGTT) to measure glucose tolerance and beta cell function:
             participants will be provided with a 75g glucose solution to drink and collect samples
             at 10-30min intervals for 180 minutes.
  
          2. Undergo an insulin sensitivity test (Steady State Plasma Glucose, SSPG)- glucose,
             insulin and ocreotide infusions will be provided and blood samples taken at 10-30min
             intervals for 240 min.
  
          3. Undergo an Isoglycemic Intravenous Glucose Infusion test (IIGI) to test for incretin
             hormone function- a glucose infusion will be given and blood samples collected at 10-30
             min intervals for 180 min.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All participants will consume the meals using the cgm and fitbit devices and log their meal intake.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Comparison of blood glucose levels after the different dietary and exercise mitigators
  time frame: 10 days
  description: Blood glucose value is derived from continuous glucose monitor (CGM) data, expressed in milligrams/deciliter, and measured for 10 days. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.
  measure: Changes in postprandial metabolites response as measured by micro-sampling
  time frame: 10 days
  description: Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals at 5 time points. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic interaction LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.
  measure: Changes in postprandial proteomic responses as measured in micro-sampling by Olink
  time frame: 10 days
  description: Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals at 5 time points. Based on those samples, proteomics will be quantified by proximity extension assay for the cardiometabolic panel. 96 proteins will be measured in the unit of normalized protein expression. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.
  measure: Changes in personal metabolic states through the day as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)
  time frame: 10 days
  description: Dry blood samples will be collected by micro-sampling after getup, after the standardized meals, and before sleep. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites. Comparisons will be made for the different time points during the day.
  measure: Changes in personal metabolic states through the day as measured in micro-sampling by Olink proteomics
  time frame: 10 days
  description: Dry blood samples will be collected by micro-sampling after getup, after the standardized meals, and before sleep. Based on those samples, proteomics will be quantified by proximity extension assay for the cardiometabolic panel. 96 proteins will be measured in the unit of normalized protein expression. Comparisons will be made for the different time points during the day.
  arm group label: mitigator
  arm group type: Experimental
  description: Test different foods to see their mitigating effect on blood sugars after a rice meal.
  intervention type: Other
  intervention name: Dietary intervention
  description: Using different combination of foods to see if the glucose response to a load of carbohydrates can be mitigated.
  arm group label: mitigator
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yue Wu, PhD
  role: Study Director
  affiliation: Stanford University
  last name: Caroline Study Coordinator
  phone: (650)723-9160
  email: bejikian@stanford.edu
  last name: Dalia Study Dietitian
  phone: (650)723-9160
  email: daliap@stanford.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Yue Wu
  investigator title: Postdoctoral Scholar
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Prediabetic State
  mesh term: Glucose Intolerance
  sharing ipd: Undecided