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/NCT05962112</url>
    </required_header>
    <id_info>
      <org_study_id>306915</org_study_id>
      <nct_id>NCT05962112</nct_id>
    </id_info>
    <brief_title>Metabolic Implications of Day and Night-shift Working on NHS Healthcare Staff</brief_title>
    <acronym>MIDNIGHT</acronym>
    <official_title>Metabolic Implications of Day and Night-shift Working on NHS Healthcare Staff</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 acute&#xD;
        metabolic impact of night-shift compared to day-shift work in NHS healthcare workers.&#xD;
        Employees who are scheduled to work both day and night shifts will be recruited and identical&#xD;
        metabolic investigations will be performed in the same participant following at least 3&#xD;
        consecutive day and night-shifts respectively. These investigations will take place at the&#xD;
        Clinical Research Unit (CRU) in Oxford Centre for Diabetes, Endocrinology and Metabolism&#xD;
        (OCDEM) at Churchill Hospital. The order of post-day and post-night shift investigations will&#xD;
        be randomly determined and there will be a 2-week minimum interval between both sets of&#xD;
        investigations. Participants will complete a self-reported food diary before and during each&#xD;
        set of shifts (both day and night) and will have wrist-watch actigraphy performed throughout&#xD;
        the entire study period in order to measure sleep and activity parameters. All study visits&#xD;
        and investigations will commence at the CRU at 8am and will include a 2-step&#xD;
        hyperinsulinaemic euglycaemic clamp with stable isotope infusions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in percentage incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) after night shifts compared to day-shifts</measure>
      <time_frame>Through study completion (average of 2 weeks)</time_frame>
      <description>Incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) represents a marker of hepatic de novo lipogenesis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in hepatic and peripheral insulin sensitivity (measured by glucose metabolism during hyperinsulinaemic euglycaemic clamp procedure) after night shifts compared to day shifts</measure>
      <time_frame>Through study completion (average of 2 weeks)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean daily sleep onset, wake time, midpoint of sleep, and sleep efficiency</measure>
      <time_frame>Through study completion (average of 2 weeks)</time_frame>
      <description>Measured by continuous actigraphy during night- compared to day-shifts night-shifts</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean daily activity counts</measure>
      <time_frame>Through study completion (average of 2 weeks)</time_frame>
      <description>Measured by continuous wrist watch accelerometry during night- compared to day-shifts night-shifts</description>
    </secondary_outcome>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Shift-work Disorder</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Metabolic investigations after night-shifts</intervention_name>
      <description>Metabolic investigations after night-shifts</description>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          • NHS worker with rotating night and day shift working patterns&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  National Health Service (NHS) worker with rotating night and day shift working&#xD;
               patterns&#xD;
  &#xD;
            -  Age 18-75 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A diagnosis of type 1 or type 2 diabetes&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  A blood haemoglobin &lt;120mg/dL&#xD;
  &#xD;
            -  History of alcohol use disorder or a greater than recommended alcohol intake&#xD;
               (Recommendations &gt; 21 units on average per week for men and &gt; 14 units on average per&#xD;
               week for women)&#xD;
  &#xD;
            -  Other conditions or co-morbidities that in the eyes of the investigators may affect&#xD;
               data collection&#xD;
  &#xD;
            -  Any condition in the opinion of the investigator that might impact upon safety or&#xD;
               validity of the results&#xD;
  &#xD;
            -  Primary sleep disorder&#xD;
  &#xD;
            -  Current glucocorticoid use&#xD;
  &#xD;
            -  Current melatonin use&#xD;
  &#xD;
            -  Patients with known non-alcoholic steatohepatitis or advanced hepatic&#xD;
               fibrosis/cirrhosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Thomas Marjot</last_name>
      <phone>07816566933</phone>
      <email>thomas.marjot@ndm.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 23, 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 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05962112
  org study id: 306915
  nct id: NCT05962112
  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 acute
        metabolic impact of night-shift compared to day-shift work in NHS healthcare workers.
        Employees who are scheduled to work both day and night shifts will be recruited and identical
        metabolic investigations will be performed in the same participant following at least 3
        consecutive day and night-shifts respectively. These investigations will take place at the
        Clinical Research Unit (CRU) in Oxford Centre for Diabetes, Endocrinology and Metabolism
        (OCDEM) at Churchill Hospital. The order of post-day and post-night shift investigations will
        be randomly determined and there will be a 2-week minimum interval between both sets of
        investigations. Participants will complete a self-reported food diary before and during each
        set of shifts (both day and night) and will have wrist-watch actigraphy performed throughout
        the entire study period in order to measure sleep and activity parameters. All study visits
        and investigations will commence at the CRU at 8am and will include a 2-step
        hyperinsulinaemic euglycaemic clamp with stable isotope infusions.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in percentage incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) after night shifts compared to day-shifts
  time frame: Through study completion (average of 2 weeks)
  description: Incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) represents a marker of hepatic de novo lipogenesis
  measure: Change in hepatic and peripheral insulin sensitivity (measured by glucose metabolism during hyperinsulinaemic euglycaemic clamp procedure) after night shifts compared to day shifts
  time frame: Through study completion (average of 2 weeks)
  measure: Mean daily sleep onset, wake time, midpoint of sleep, and sleep efficiency
  time frame: Through study completion (average of 2 weeks)
  description: Measured by continuous actigraphy during night- compared to day-shifts night-shifts
  measure: Mean daily activity counts
  time frame: Through study completion (average of 2 weeks)
  description: Measured by continuous wrist watch accelerometry during night- compared to day-shifts night-shifts
  intervention type: Other
  intervention name: Metabolic investigations after night-shifts
  description: Metabolic investigations after night-shifts
  Plasma
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  last name: Thomas Marjot
  phone: 07816566933
  email: thomas.marjot@ndm.ox.ac.uk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: No