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/NCT05962099</url>
    </required_header>
    <id_info>
      <org_study_id>15296</org_study_id>
      <nct_id>NCT05962099</nct_id>
    </id_info>
    <brief_title>Defining Circadian Metabolism in Non-alcoholic Fatty Liver Disease</brief_title>
    <acronym>DECIMAL</acronym>
    <official_title>Defining Circadian Metabolism in Non-alcoholic Fatty Liver Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oxford</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Oxford</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators will conduct an open label, experimental medicine study exploring the&#xD;
        diurnal patterns of hepatic lipid metabolism in NAFLD and non-NAFLD participants (determined&#xD;
        by Transient elastography (TE) with controlled attenuation parameter (CAP)). We will also&#xD;
        determine whether the diurnal patterns of lipid metabolism in NAFLD participants can be&#xD;
        modified using lifestyle and weight loss intervention. Fourteen participants without NAFLD&#xD;
        will have morning and evening metabolic investigations (visit 1M &amp; 1E) to assess for changes&#xD;
        in lipid flux pathways across the course of the day. After morning and evening investigations&#xD;
        their involvement in the clinical study will then end. Seventeen NAFLD participants will also&#xD;
        have identical baseline morning and evening investigation after which they will be enrolled&#xD;
        into a 12-week lifestyle and weight loss programme. After 12-weeks, all 17 participants with&#xD;
        NAFLD will have a follow up CAP, and morning and evening metabolic investigations (visit 2M &amp;&#xD;
        2E).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2021</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in hepatic fatty acid synthesis as measured by incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) between morning and evening</measure>
      <time_frame>12 hours</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference in morning and evening glucose production and disposal (of a labelled stable isotope tracer) during a two-step hyperinsulinaemic-euglycaemic clamp</measure>
      <time_frame>12 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in morning and evening glucose oxidation measured by incorporation of 13C in breath CO2 across a 2-step hyperinsulinemia euglycaemic clamp</measure>
      <time_frame>12 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in diurnal patterns of hepatic fatty acid synthesis after weight loss programme (measured by incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG)</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">31</enrollment>
    <condition>NAFLD</condition>
    <arm_group>
      <arm_group_label>NAFLD</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Controls (non-NAFLD)</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Lifestyle and weight loss advice</intervention_name>
      <description>Commercially available lifestyle and weight loss intervention</description>
      <arm_group_label>NAFLD</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Adipose and skeletal muscle tissue, urine, serum/plasma&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          NAFLD participants Confirmed by transient elastography (TE) with controlled attenuation&#xD;
          parameter (CAP) ≥306 dB/m&#xD;
  &#xD;
          Non-NAFLD Confirmed by transient elastography (TE) with controlled attenuation parameter&#xD;
          (CAP) ≤215 dB/m&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  BMI 25-50 kg/m2&#xD;
  &#xD;
            -  Age 18-75 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A diagnosis of type 1 diabetes&#xD;
  &#xD;
            -  Type 2 diabetes controlled with medications other than metformin (within last 3&#xD;
               months)&#xD;
  &#xD;
            -  Shift working patterns in last 3-months or if likely to work shifts during study&#xD;
               period.&#xD;
  &#xD;
            -  Current or recent (&lt;3-months) use of weight loss medications&#xD;
  &#xD;
            -  Current or recent use of oral contraceptive pill or hormone replacement therapy&#xD;
               (within last 3-months)&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  A blood haemoglobin &lt;120mg/dL&#xD;
  &#xD;
            -  History of alcoholism or a greater than recommended alcohol intake (Recommendations &gt;&#xD;
               21 units on average per week for men and &gt; 14 units on average per week for women)&#xD;
  &#xD;
            -  Haemorrhagic disorders&#xD;
  &#xD;
            -  Treatment with anticoagulant agents&#xD;
  &#xD;
            -  Other co-morbidities that in the eyes of the investigators may affect data collection&#xD;
  &#xD;
            -  Any medical condition in the opinion of the investigator that might impact upon safety&#xD;
               or validity of the results&#xD;
  &#xD;
            -  Transient elastography (TE) controlled attenuation parameter (CAP) of between 216-305&#xD;
               dB/m&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Jeremy Tomlinson</last_name>
      <phone>01865 857359</phone>
      <email>jeremy.tomlinson@ocdem.ox.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Oxford</name>
        <address>
          <city>Oxford</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jeremy W Tomlinson, MD PhD</last_name>
        <phone>44(0)1865 857359</phone>
        <email>jeremy.tomlinson@ocdem.ox.ac.uk</email>
      </contact>
      <contact_backup>
        <last_name>Leanne Hodson, PhD</last_name>
        <email>leanne.hodson@ocdem.ox.ac.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Thomas Marjot, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Leanne Hodson, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>David Ray, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 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>Liver Diseases</mesh_term>
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Non-alcoholic Fatty Liver Disease</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/NCT05962099
  org study id: 15296
  nct id: NCT05962099
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators will conduct an open label, experimental medicine study exploring the
        diurnal patterns of hepatic lipid metabolism in NAFLD and non-NAFLD participants (determined
        by Transient elastography (TE) with controlled attenuation parameter (CAP)). We will also
        determine whether the diurnal patterns of lipid metabolism in NAFLD participants can be
        modified using lifestyle and weight loss intervention. Fourteen participants without NAFLD
        will have morning and evening metabolic investigations (visit 1M & 1E) to assess for changes
        in lipid flux pathways across the course of the day. After morning and evening investigations
        their involvement in the clinical study will then end. Seventeen NAFLD participants will also
        have identical baseline morning and evening investigation after which they will be enrolled
        into a 12-week lifestyle and weight loss programme. After 12-weeks, all 17 participants with
        NAFLD will have a follow up CAP, and morning and evening metabolic investigations (visit 2M &
        2E).
  observational model: Case-Control
  time perspective: Prospective
  measure: Change in hepatic fatty acid synthesis as measured by incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) between morning and evening
  time frame: 12 hours
  measure: Difference in morning and evening glucose production and disposal (of a labelled stable isotope tracer) during a two-step hyperinsulinaemic-euglycaemic clamp
  time frame: 12 hours
  measure: Difference in morning and evening glucose oxidation measured by incorporation of 13C in breath CO2 across a 2-step hyperinsulinemia euglycaemic clamp
  time frame: 12 hours
  measure: Changes in diurnal patterns of hepatic fatty acid synthesis after weight loss programme (measured by incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG)
  time frame: 12 weeks
  arm group label: NAFLD
  arm group label: Controls (non-NAFLD)
  intervention type: Behavioral
  intervention name: Lifestyle and weight loss advice
  description: Commercially available lifestyle and weight loss intervention
  arm group label: NAFLD
  Adipose and skeletal muscle tissue, urine, serum/plasma
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  last name: Jeremy Tomlinson
  phone: 01865 857359
  email: jeremy.tomlinson@ocdem.ox.ac.uk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  sharing ipd: No