<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/NCT02997319</url>
  </required_header>
  <id_info>
    <org_study_id>2016P000651</org_study_id>
    <secondary_id>R01DK105072</secondary_id>
    <nct_id>NCT02997319</nct_id>
  </id_info>
  <brief_title>Shift Work, Heredity, Insulin, and Food Timing Study</brief_title>
  <acronym>SHIFT</acronym>
  <official_title>Shift Work, Heredity, Insulin, and Food Timing (SHIFT) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Broad Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether night time eating that coincides with&#xD;
      elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the&#xD;
      MTNR1B risk allele.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preliminary observations suggest that food intake coincident with high melatonin levels leads&#xD;
      to impaired glucose tolerance-particularly in MTNR1B risk allele carriers. Our objectives are&#xD;
      to determine the effect of concurrent food intake and melatonin on glucose tolerance; and to&#xD;
      assess the role of MTNR1B single nucleotide polymorphism (SNP)*melatonin interaction in this&#xD;
      deleterious effect. Our central hypothesis is that concurrent high melatonin levels and food&#xD;
      intake, commonly experienced in night shift workers, cause long-term impairment of glucose&#xD;
      tolerance and that this effect is worse in carriers of the MTNR1B type 2 diabetes (T2D) risk&#xD;
      SNP than in non-carriers. The results of this proposal will help to clarify an ongoing&#xD;
      controversy about the role of melatonin in glucose tolerance, and will help to develop novel&#xD;
      strategies in the prevention and treatment of T2D, especially in shift workers, night eaters,&#xD;
      and MTNR1B risk allele carriers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2017</start_date>
  <completion_date type="Actual">May 8, 2021</completion_date>
  <primary_completion_date type="Actual">May 8, 2021</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>Area Under the Curve (AUC) glucose</measure>
    <time_frame>Between 0-120 minutes, Visit 2 and 3</time_frame>
    <description>Investigators will measure insulin and glucose levels for 120 minutes at day time and night time visits, and compare them by genotype at selected loci.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disposition index</measure>
    <time_frame>Between 0-120 minutes, Visit 2 and 3</time_frame>
    <description>Disposition index will be determined by frequently sampled oral glucose tolerance test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Corrected Insulin Response</measure>
    <time_frame>Between 0-120 minutes, Visit 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin Sensitivity Index</measure>
    <time_frame>Between 0-120 minutes, Visit 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Glucose</measure>
    <time_frame>Between 0-120 minutes, Visit 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Insulin</measure>
    <time_frame>Between 0-120 minutes, Visit 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Melatonin</measure>
    <time_frame>Between 0-120 minutes, Visit 2 and 3</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Sleep Duration</measure>
    <time_frame>Total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Sleep duration will be computed from self-reported bed and wake up times using sleep logs and measured using an Actiwatch.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Sleep quality will be assessed using the Pittsburgh Sleep Quality Index and Insomnia Severity Index</description>
  </other_outcome>
  <other_outcome>
    <measure>Light Exposure</measure>
    <time_frame>Total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Measured using Actiwatch</description>
  </other_outcome>
  <other_outcome>
    <measure>Total Energy Intake</measure>
    <time_frame>Total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Total energy intake in kcal/day will be computed from 14-day 24-hr dietary recalls</description>
  </other_outcome>
  <other_outcome>
    <measure>Dietary Composition</measure>
    <time_frame>Total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary recalls</description>
  </other_outcome>
  <other_outcome>
    <measure>Dietary Intake Timing</measure>
    <time_frame>Total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Food timing will be self-reported and averaged across 14-days of 24-hr dietary recalls</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessed using the International Physical Activity Questionnaire (IPAQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Chronotype</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessed using the Morningness-Eveningness Questionnaire (MEQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Emotional Eating Behavior</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessed using the Emotional Eating Questionnaire (EEQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessed using the Patient Health Questionnaire (PHQ-8)</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">365</enrollment>
  <condition>Shift Work Type Circadian Rhythm Sleep Disorder</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Circadian Rhythm Sleep Disorder, Shift Work Type</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Night Shift-Workers</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Day Workers</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA, serum insulin, serum glucose, plasma melatonin, blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects residing in New England (USA) region&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non-pregnant female&#xD;
&#xD;
          -  18-60 years&#xD;
&#xD;
          -  Currently employed (night shift workers and day workers), graduate students, part-time&#xD;
             workers, or unemployed&#xD;
&#xD;
          -  Able and willing to give consent relevant to genetic investigation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently taking any medications for the treatment of diabetes&#xD;
&#xD;
          -  Currently taking medications known to affect glycemic parameters, such as&#xD;
             glucocorticoids, growth hormone or fluoroquinolones&#xD;
&#xD;
          -  Pregnant, nursing or at risk of becoming pregnant&#xD;
&#xD;
          -  Chronic renal failure, hepatic diseases, or cancer diagnoses&#xD;
&#xD;
          -  Bulimia diagnosis, prone to binge eating&#xD;
&#xD;
          -  Eating disorder diagnosis such as anorexia, binge eating, or bulimia&#xD;
&#xD;
          -  With psychiatric illness, such as schizophrenia or bipolar affective disorder&#xD;
&#xD;
          -  Blind&#xD;
&#xD;
          -  History of bariatric surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richa Saxena, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Frank AJL Scheer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.partners.org/study/shiftstudy</url>
    <description>Recruitment Website</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Richa Saxena</investigator_full_name>
    <investigator_title>Assistant Professor of Anaesthesia</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus, Type 2</keyword>
  <keyword>Insulin Resistance</keyword>
  <keyword>Shift Work</keyword>
  <keyword>Circadian Rhythms</keyword>
  <keyword>MTNR1B</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Sleep Disorders, Circadian Rhythm</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Insulin Resistance</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/NCT02997319
org study id: 2016P000651
secondary id: R01DK105072
nct id: NCT02997319
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether night time eating that coincides with
      elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the
      MTNR1B risk allele.
Preliminary observations suggest that food intake coincident with high melatonin levels leads
      to impaired glucose tolerance-particularly in MTNR1B risk allele carriers. Our objectives are
      to determine the effect of concurrent food intake and melatonin on glucose tolerance; and to
      assess the role of MTNR1B single nucleotide polymorphism (SNP)*melatonin interaction in this
      deleterious effect. Our central hypothesis is that concurrent high melatonin levels and food
      intake, commonly experienced in night shift workers, cause long-term impairment of glucose
      tolerance and that this effect is worse in carriers of the MTNR1B type 2 diabetes (T2D) risk
      SNP than in non-carriers. The results of this proposal will help to clarify an ongoing
      controversy about the role of melatonin in glucose tolerance, and will help to develop novel
      strategies in the prevention and treatment of T2D, especially in shift workers, night eaters,
      and MTNR1B risk allele carriers.
observational model: Cohort
time perspective: Cross-Sectional
measure: Area Under the Curve (AUC) glucose
time frame: Between 0-120 minutes, Visit 2 and 3
description: Investigators will measure insulin and glucose levels for 120 minutes at day time and night time visits, and compare them by genotype at selected loci.
measure: Disposition index
time frame: Between 0-120 minutes, Visit 2 and 3
description: Disposition index will be determined by frequently sampled oral glucose tolerance test
measure: Corrected Insulin Response
time frame: Between 0-120 minutes, Visit 2 and 3
measure: Insulin Sensitivity Index
time frame: Between 0-120 minutes, Visit 2 and 3
measure: Fasting Glucose
time frame: Between 0-120 minutes, Visit 2 and 3
measure: Fasting Insulin
time frame: Between 0-120 minutes, Visit 2 and 3
measure: Plasma Melatonin
time frame: Between 0-120 minutes, Visit 2 and 3
measure: Sleep Duration
time frame: Total of 2 weeks between Visit 1 and 3
description: Sleep duration will be computed from self-reported bed and wake up times using sleep logs and measured using an Actiwatch.
measure: Sleep Quality
time frame: Total of 2 weeks between Visit 1 and 3
description: Sleep quality will be assessed using the Pittsburgh Sleep Quality Index and Insomnia Severity Index
measure: Light Exposure
time frame: Total of 2 weeks between Visit 1 and 3
description: Measured using Actiwatch
measure: Total Energy Intake
time frame: Total of 2 weeks between Visit 1 and 3
description: Total energy intake in kcal/day will be computed from 14-day 24-hr dietary recalls
measure: Dietary Composition
time frame: Total of 2 weeks between Visit 1 and 3
description: Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary recalls
measure: Dietary Intake Timing
time frame: Total of 2 weeks between Visit 1 and 3
description: Food timing will be self-reported and averaged across 14-days of 24-hr dietary recalls
measure: Physical Activity
time frame: Baseline
description: Assessed using the International Physical Activity Questionnaire (IPAQ)
measure: Chronotype
time frame: Baseline
description: Assessed using the Morningness-Eveningness Questionnaire (MEQ)
measure: Emotional Eating Behavior
time frame: Baseline
description: Assessed using the Emotional Eating Questionnaire (EEQ)
measure: Depression
time frame: Baseline
description: Assessed using the Patient Health Questionnaire (PHQ-8)
arm group label: Night Shift-Workers
arm group label: Day Workers
DNA, serum insulin, serum glucose, plasma melatonin, blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richa Saxena, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Frank AJL Scheer, PhD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
url: https://clinicaltrials.partners.org/study/shiftstudy
description: Recruitment Website
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Richa Saxena
investigator title: Assistant Professor of Anaesthesia
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Sleep Disorders, Circadian Rhythm
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Resistance
sharing ipd: Undecided