<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/NCT03829982</url>
  </required_header>
  <id_info>
    <org_study_id>NL63655.068.17</org_study_id>
    <nct_id>NCT03829982</nct_id>
  </id_info>
  <brief_title>The Effects of Light on Glucose Metabolism</brief_title>
  <official_title>The Effects of Light on Glucose Metabolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of bright light on postprandial blood glucose metabolism in&#xD;
      obese subjects with impaired fasting glucose and/or impaired glucose tolerance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Light has a major influence on the biological clock and several studies suggest that bright&#xD;
      light during the day and dim light in the evening are beneficial for the circadian timing&#xD;
      system. Nowadays, large parts of the population spend 90% of their time indoors and are&#xD;
      thereby exposed to artificial lighting instead of daylight. The artificial light levels are&#xD;
      relatively low during the day and continue relatively late in the evening. The lack of a&#xD;
      clear natural light-dark cycle could results in delayed timing of the biological clock&#xD;
      relative to the behaviour. Optimizing the lighting conditions under controlled laboratory&#xD;
      settings might lead to better alignment of the biological clock, which in turn could improve&#xD;
      metabolic parameters such as glucose control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2018</start_date>
  <completion_date type="Actual">February 7, 2020</completion_date>
  <primary_completion_date type="Actual">February 7, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Crossover Assignment</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial glucose (mg/dL)</measure>
    <time_frame>Study Day 1-3</time_frame>
    <description>Assessed with a continuous glucose monitor (CGM)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose levels (mmol/L) in the postprandial state</measure>
    <time_frame>Study Day 2-3</time_frame>
    <description>venous blood draw every 30 min for 4 hours after breakfast and after dinner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free fatty acid levels (µmol/L) in the postprandial state</measure>
    <time_frame>Study Day 2-3</time_frame>
    <description>venous blood draw every 30 min for 4 hours after breakfast and after dinner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides levels (mmol/L) in the postprandial state</measure>
    <time_frame>Study Day 2-3</time_frame>
    <description>venous blood draw every 30 min for 4 hours after breakfast and after dinner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin levels (µU/mL) in the postprandial state</measure>
    <time_frame>Study Day 2-3</time_frame>
    <description>venous blood draw every 30 min for 4 hours after breakfast and after dinner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous interstitial glucose (mg/dL)</measure>
    <time_frame>Study Day 1-3</time_frame>
    <description>Assessed with continuous glucose monitor (CGM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy expenditure</measure>
    <time_frame>Study Day 1-3</time_frame>
    <description>continuous measurement with whole room indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core body temperature (CBT) and skin temperature</measure>
    <time_frame>Study Day 1-3</time_frame>
    <description>Measured with a telemetric pill (CBT) and 14 temperature sensors (iButtons) in degrees celsius</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Glucose Intolerance</condition>
  <condition>Prediabetic State</condition>
  <arm_group>
    <arm_group_label>bright light during the day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dim light during the day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure to bright light during the day</intervention_name>
    <description>Participants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00.</description>
    <arm_group_label>bright light during the day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure to dim light during the day</intervention_name>
    <description>Participants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00.</description>
    <arm_group_label>dim light during the day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  BMI 25-35 kg/m2&#xD;
&#xD;
          -  Stable weight (+/- 3 kg in the last 3 months)&#xD;
&#xD;
          -  One of the four criteria for prediabetes:&#xD;
&#xD;
               -  Impaired fasting glucose (6.1 mM to 6.9 mM)&#xD;
&#xD;
               -  Blood glucose values 7.8 - 11.1 mM 2h after glucose drink consumption during the&#xD;
                  oral glucose tolerance test (OGTT) in screening&#xD;
&#xD;
               -  Insulin Resistance: glucose clearance rate ≤ 360 ml/kg/min, as determined using&#xD;
                  the oral glucose insulin sensitivity (OGIS120) index&#xD;
&#xD;
               -  HbA1c of 5.7 - 6.4%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fasting plasma glucose ≥7.0 mM&#xD;
&#xD;
          -  Blood donation one month prior to study and three months after finishing study.&#xD;
&#xD;
          -  Participants with extreme chronotypes (going to bed extremely late/early).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wouter van Marken Lichtenbelt, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229 ER</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>September 23, 2020</last_update_submitted>
  <last_update_submitted_qc>September 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Circadian Rhythm</keyword>
  <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>


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/NCT03829982
org study id: NL63655.068.17
nct id: NCT03829982
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of bright light on postprandial blood glucose metabolism in
      obese subjects with impaired fasting glucose and/or impaired glucose tolerance.
Light has a major influence on the biological clock and several studies suggest that bright
      light during the day and dim light in the evening are beneficial for the circadian timing
      system. Nowadays, large parts of the population spend 90% of their time indoors and are
      thereby exposed to artificial lighting instead of daylight. The artificial light levels are
      relatively low during the day and continue relatively late in the evening. The lack of a
      clear natural light-dark cycle could results in delayed timing of the biological clock
      relative to the behaviour. Optimizing the lighting conditions under controlled laboratory
      settings might lead to better alignment of the biological clock, which in turn could improve
      metabolic parameters such as glucose control.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Postprandial glucose (mg/dL)
time frame: Study Day 1-3
description: Assessed with a continuous glucose monitor (CGM)
measure: Glucose levels (mmol/L) in the postprandial state
time frame: Study Day 2-3
description: venous blood draw every 30 min for 4 hours after breakfast and after dinner
measure: Free fatty acid levels (µmol/L) in the postprandial state
time frame: Study Day 2-3
description: venous blood draw every 30 min for 4 hours after breakfast and after dinner
measure: Triglycerides levels (mmol/L) in the postprandial state
time frame: Study Day 2-3
description: venous blood draw every 30 min for 4 hours after breakfast and after dinner
measure: Insulin levels (µU/mL) in the postprandial state
time frame: Study Day 2-3
description: venous blood draw every 30 min for 4 hours after breakfast and after dinner
measure: Continuous interstitial glucose (mg/dL)
time frame: Study Day 1-3
description: Assessed with continuous glucose monitor (CGM)
measure: Energy expenditure
time frame: Study Day 1-3
description: continuous measurement with whole room indirect calorimetry
measure: Core body temperature (CBT) and skin temperature
time frame: Study Day 1-3
description: Measured with a telemetric pill (CBT) and 14 temperature sensors (iButtons) in degrees celsius
arm group label: bright light during the day
arm group type: Experimental
description: Participants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00.
arm group label: dim light during the day
arm group type: Experimental
description: Participants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00.
intervention type: Behavioral
intervention name: Exposure to bright light during the day
description: Participants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00.
arm group label: bright light during the day
intervention type: Behavioral
intervention name: Exposure to dim light during the day
description: Participants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00.
arm group label: dim light during the day
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wouter van Marken Lichtenbelt, Prof. Dr.
role: Principal Investigator
affiliation: Maastricht University
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: Undecided