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/NCT06007404</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00208301</org_study_id>
      <secondary_id>R01DK130864</secondary_id>
      <nct_id>NCT06007404</nct_id>
    </id_info>
    <brief_title>Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents</brief_title>
    <official_title>The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Michigan</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>
        This research study collects health-related information and blood samples to better&#xD;
        understand how body composition, lifestyle habits, and diet influence meta-inflammatory&#xD;
        monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk&#xD;
        for metabolic disease have enhanced MiMo related activities leading to insulin resistance.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 6, 2023</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2027</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>Glucose (OGTT)</measure>
      <time_frame>120 minutes</time_frame>
      <description>Plasma Glucose (mg/dL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Insulin (OGTT)</measure>
      <time_frame>120 minutes</time_frame>
      <description>Plasma Insulin (µU/mL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glucose (MMTT)</measure>
      <time_frame>180 minutes</time_frame>
      <description>Plasma Glucose (mg/dL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Insulin (MMTT)</measure>
      <time_frame>180 minutes</time_frame>
      <description>Plasma Insulin (µU/mL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Monocyte /macrophage populations by flow cytometry</measure>
      <time_frame>180 minutes</time_frame>
      <description>Frequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Free fatty acids (MMTT)</measure>
      <time_frame>180 minutes</time_frame>
      <description>Serum Free fatty acids (mmol/L) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Triglycerides (MMTT)</measure>
      <time_frame>180 minutes</time_frame>
      <description>Serum Triglycerides (mg/dL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">175</enrollment>
    <condition>Type 2 Diabetes</condition>
    <condition>Insulin Resistance</condition>
    <condition>Obesity</condition>
    <condition>Metabolic Disease</condition>
    <condition>PreDiabetes</condition>
    <arm_group>
      <arm_group_label>Normal weight</arm_group_label>
      <description>BMI ≥ 5th percentile &amp; &lt; 85th percentile</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Obese weight</arm_group_label>
      <description>BMI ≥ 95th percentile</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PreDiabetes</arm_group_label>
      <description>HbA1c &gt; 5.7%</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Participants may be recruited from a variety of sites including University of Michigan&#xD;
          clinical sites, non-University of Michigan clinical sites, local communities and schools&#xD;
          throughout Southeast Michigan, and the University of Michigan campus.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between 14 and 18 years of age&#xD;
  &#xD;
            -  Tanner stage 5 (mature adult stage of puberty)&#xD;
  &#xD;
            -  Normal weight (BMI ≥ 5th percentile &amp; &lt; 85th percentile), obese weight (BMI percentile&#xD;
               ≥ 95th percentile), and/or pre-diabetes (HbA1c &gt; 5.7%)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently pregnant&#xD;
  &#xD;
            -  Use medications known to affect glucose metabolism (immunosuppressive medications,&#xD;
               cancer medications, or high dose steroids)&#xD;
  &#xD;
            -  Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability&#xD;
  &#xD;
            -  Allergies or intolerance to milk, soy, or palm oil&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kanakadurga Singer, MA, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>The Singer Lab Team</last_name>
      <phone>(734) 615-4938</phone>
      <email>MiMoStudy@med.umich.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Kanakadurga Singer</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Insulin Resistance</mesh_term>
      <mesh_term>Metabolic Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Genomic and associated phenotypic data will be shared through NIH-designated data repositories.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Genotype/sequencing and phenotype data will be submitted after the genotyping/sequencing data have been cleaned. Following submission, data will be released within six months.</ipd_time_frame>
      <ipd_access_criteria>In regards to genomic data, individual-level data will be deidentified and made available through controlled-access.</ipd_access_criteria>
    </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/NCT06007404
  org study id: HUM00208301
  secondary id: R01DK130864
  nct id: NCT06007404
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This research study collects health-related information and blood samples to better
        understand how body composition, lifestyle habits, and diet influence meta-inflammatory
        monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk
        for metabolic disease have enhanced MiMo related activities leading to insulin resistance.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Glucose (OGTT)
  time frame: 120 minutes
  description: Plasma Glucose (mg/dL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose
  measure: Insulin (OGTT)
  time frame: 120 minutes
  description: Plasma Insulin (µU/mL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose
  measure: Glucose (MMTT)
  time frame: 180 minutes
  description: Plasma Glucose (mg/dL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake.
  measure: Insulin (MMTT)
  time frame: 180 minutes
  description: Plasma Insulin (µU/mL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake.
  measure: Monocyte /macrophage populations by flow cytometry
  time frame: 180 minutes
  description: Frequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake
  measure: Free fatty acids (MMTT)
  time frame: 180 minutes
  description: Serum Free fatty acids (mmol/L) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake
  measure: Triglycerides (MMTT)
  time frame: 180 minutes
  description: Serum Triglycerides (mg/dL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake
  arm group label: Normal weight
  description: BMI ≥ 5th percentile & < 85th percentile
  arm group label: Obese weight
  description: BMI ≥ 95th percentile
  arm group label: PreDiabetes
  description: HbA1c > 5.7%
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kanakadurga Singer, MA, MD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: The Singer Lab Team
  phone: (734) 615-4938
  email: MiMoStudy@med.umich.edu
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Kanakadurga Singer
  investigator title: Associate Professor
  mesh term: Insulin Resistance
  mesh term: Metabolic Diseases
  sharing ipd: Yes
  ipd description: Genomic and associated phenotypic data will be shared through NIH-designated data repositories.
  ipd info type: Study Protocol
  ipd time frame: Genotype/sequencing and phenotype data will be submitted after the genotyping/sequencing data have been cleaned. Following submission, data will be released within six months.
  ipd access criteria: In regards to genomic data, individual-level data will be deidentified and made available through controlled-access.