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/NCT05984979</url>
    </required_header>
    <id_info>
      <org_study_id>VOCircle</org_study_id>
      <nct_id>NCT05984979</nct_id>
    </id_info>
    <brief_title>The Daytime Circadian Rhythm in Exhaled Volatile Organic Compounds in People Living Without and Diabetes</brief_title>
    <acronym>VOCircle</acronym>
    <official_title>The Daytime Circadian Rhythm in Exhaled Volatile Organic Compounds in People Living Without and With Type 1 and 2 Diabetes: an Exploratory Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Bern</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Insel Gruppe AG, University Hospital Bern</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>DCB Research AG</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Bern</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>
        Exhaled volatile organic compounds will be measured during daytime with the goal to&#xD;
        identifying circadian variability. The study incudes three subgroups: people without&#xD;
        diabetes, people with type 1 diabetes, and people with type 2 diabetes. A total of 60 people&#xD;
        will be recruited for the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>VOC Patterns over time as gallery plots</measure>
      <time_frame>During the study procedure (approximately 8 hours)</time_frame>
      <description>Gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>VOC Patterns over time as boxplots</measure>
      <time_frame>During the study procedure (approximately 8 hours)</time_frame>
      <description>Box plots from selected VOC peaks over time.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Capillary blood glucose</measure>
      <time_frame>During the study procedure (approximately 8 hours)</time_frame>
      <description>Correlation between capillary blood glucose and VOCs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between VOCs in breath intestinal microbiota</measure>
      <time_frame>day 1</time_frame>
      <description>Correlation between VOCs in breath and intestinal microbiota species abundance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between VOCs in breath oral microbiota</measure>
      <time_frame>day 1</time_frame>
      <description>Correlation between VOCs in breath and oral microbiota species abundance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between VOCs and subgroups</measure>
      <time_frame>day 1 or 8 hours</time_frame>
      <description>Wilcoxon signed-rank test will be used to explore if the patterns in VOCs differ between subgroup: people without diabetes, people living with T1D, and people living with T2D</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Diabetes Mellitus</condition>
    <arm_group>
      <arm_group_label>People without diabetes</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>People with type 1 diabetes</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>People with type 2 diabetes</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standardized meal</intervention_name>
      <description>The participants will receive a standardized meal for breakfast</description>
      <arm_group_label>People with type 1 diabetes</arm_group_label>
      <arm_group_label>People with type 2 diabetes</arm_group_label>
      <arm_group_label>People without diabetes</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        The spare aliquots used for the study research will be destroyed after the completion of the&#xD;
        study. Purified oral and gut microbiota DNA will be stored up to 10 years.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          60 participants with the following subgroups: Subgroup 1: People without diabetes Subgroup&#xD;
          2: People diagnosed with T1D Subgroup 3: People diagnosed with T2D&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
          Subgroup 1:&#xD;
  &#xD;
            -  Age 18 or older&#xD;
  &#xD;
            -  HbA1c below 6.5%&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Subgroup 2:&#xD;
  &#xD;
            -  Age 18 or older&#xD;
  &#xD;
            -  T1D (Type 1 diabetes) with MDI (multiple daily injection) or CSII (Continuous&#xD;
               subcutaneous insulin infusion therapy) therapy &gt;1 year&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Subgroup 3&#xD;
  &#xD;
            -  Age 18 or older&#xD;
  &#xD;
            -  T2D (Type 2 diabetes) with oral antidiabetic medication or insulin therapy&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Smoking (last cigarette less than 6 months ago)&#xD;
  &#xD;
            -  Any chronical lung and intestinal disease diagnosis (such as intestinal bowel disease&#xD;
               (IBD); asthma; COPD (chronic obstructive pulmonary disease); lung cancer, …)&#xD;
  &#xD;
            -  Coeliac disease&#xD;
  &#xD;
            -  Lactose and fructose intolerance&#xD;
  &#xD;
            -  Any acute disease diagnosis (such as viral or bacterial infection)&#xD;
  &#xD;
            -  Drinking habit of more than four units of alcohol per day&#xD;
  &#xD;
            -  Current inhaled medicines treatments&#xD;
  &#xD;
            -  Antibiotic treatment in the previous 4 months&#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>Lilian Witthauer, Prof.Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Bern</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cléo Nicolier</last_name>
      <phone>+41 31 664 22 77</phone>
      <email>cleo.nicolier@unibe.ch</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Bern</name>
        <address>
          <city>Bern</city>
          <zip>3010</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Witthauer Lilian, Prof.Dr.</last_name>
        <phone>+41 31 664 22 77</phone>
        <email>lilian.witthauer@unibe.ch</email>
      </contact>
      <investigator>
        <last_name>Witthauer Lilian, Prof.Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Balmer Maria Luisa, Prof.Dr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nicolier Cléo</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 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>Diabetes Mellitus</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/NCT05984979
  org study id: VOCircle
  nct id: NCT05984979
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Exhaled volatile organic compounds will be measured during daytime with the goal to
        identifying circadian variability. The study incudes three subgroups: people without
        diabetes, people with type 1 diabetes, and people with type 2 diabetes. A total of 60 people
        will be recruited for the study.
  observational model: Other
  time perspective: Other
  measure: VOC Patterns over time as gallery plots
  time frame: During the study procedure (approximately 8 hours)
  description: Gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.
  measure: VOC Patterns over time as boxplots
  time frame: During the study procedure (approximately 8 hours)
  description: Box plots from selected VOC peaks over time.
  measure: Capillary blood glucose
  time frame: During the study procedure (approximately 8 hours)
  description: Correlation between capillary blood glucose and VOCs
  measure: Correlation between VOCs in breath intestinal microbiota
  time frame: day 1
  description: Correlation between VOCs in breath and intestinal microbiota species abundance
  measure: Correlation between VOCs in breath oral microbiota
  time frame: day 1
  description: Correlation between VOCs in breath and oral microbiota species abundance
  measure: Correlation between VOCs and subgroups
  time frame: day 1 or 8 hours
  description: Wilcoxon signed-rank test will be used to explore if the patterns in VOCs differ between subgroup: people without diabetes, people living with T1D, and people living with T2D
  arm group label: People without diabetes
  arm group label: People with type 1 diabetes
  arm group label: People with type 2 diabetes
  intervention type: Other
  intervention name: Standardized meal
  description: The participants will receive a standardized meal for breakfast
  arm group label: People with type 1 diabetes
  arm group label: People with type 2 diabetes
  arm group label: People without diabetes
  The spare aliquots used for the study research will be destroyed after the completion of the
        study. Purified oral and gut microbiota DNA will be stored up to 10 years.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lilian Witthauer, Prof.Dr.
  role: Principal Investigator
  affiliation: University of Bern
  last name: Cléo Nicolier
  phone: +41 31 664 22 77
  email: cleo.nicolier@unibe.ch
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  sharing ipd: No