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Shift Work, Heredity, Insulin, and Food Timing Study (SHIFT)

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ClinicalTrials.gov Identifier: NCT02997319
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : October 24, 2019
Sponsor:
Collaborators:
Broad Institute
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Richa Saxena, Massachusetts General Hospital

Tracking Information
First Submitted Date December 13, 2016
First Posted Date December 20, 2016
Last Update Posted Date October 24, 2019
Study Start Date January 2017
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 15, 2016)
  • Area Under the Curve (AUC) glucose [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
    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.
  • Disposition index [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
    Disposition index will be determined by frequently sampled oral glucose tolerance test
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02997319 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 15, 2016)
  • Corrected Insulin Response [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
  • Insulin Sensitivity Index [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
  • Fasting Glucose [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
  • Fasting Insulin [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
  • Plasma Melatonin [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 12, 2017)
  • Sleep Duration [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Sleep duration will be computed from self-reported bed and wake up times using sleep logs and measured using an Actiwatch.
  • Sleep Quality [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index and Insomnia Severity Index
  • Light Exposure [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Measured using Actiwatch
  • Total Energy Intake [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Total energy intake in kcal/day will be computed from 14-day 24-hr dietary recalls
  • Dietary Composition [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary recalls
  • Dietary Intake Timing [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Food timing will be self-reported and averaged across 14-days of 24-hr dietary recalls
  • Physical Activity [ Time Frame: Baseline ]
    Assessed using the International Physical Activity Questionnaire (IPAQ)
  • Chronotype [ Time Frame: Baseline ]
    Assessed using the Morningness-Eveningness Questionnaire (MEQ)
  • Emotional Eating Behavior [ Time Frame: Baseline ]
    Assessed using the Emotional Eating Questionnaire (EEQ)
  • Depression [ Time Frame: Baseline ]
    Assessed using the Patient Health Questionnaire (PHQ-8)
Original Other Pre-specified Outcome Measures
 (submitted: December 15, 2016)
  • Sleep Duration [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Sleep duration will be computed from self-reported bed and wake up times using sleep logs and measured using an Actiwatch.
  • Sleep Quality [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
  • Light Exposure [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Measured using Actiwatch
  • Total Energy Intake [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Total energy intake in kcal/day will be computed from 14-day 24-hr dietary recalls
  • Dietary Composition [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary recalls
  • Dietary Intake Timing [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Food timing will be self-reported and averaged across 14-days of 24-hr dietary recalls
  • Physical Activity [ Time Frame: Baseline ]
    Assessed using the International Physical Activity Questionnaire (IPAQ)
  • Chronotype [ Time Frame: Baseline ]
    Assessed using the Morningness-Eveningness Questionnaire (MEQ)
  • Emotional Eating Behavior [ Time Frame: Baseline ]
    Assessed using the Emotional Eating Questionnaire (EEQ)
  • Depression [ Time Frame: Baseline ]
    Assessed using the Patient Health Questionnaire (PHQ-9)
 
Descriptive Information
Brief Title Shift Work, Heredity, Insulin, and Food Timing Study
Official Title Shift Work, Heredity, Insulin, and Food Timing (SHIFT) Study
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, serum insulin, serum glucose, plasma melatonin, blood
Sampling Method Probability Sample
Study Population Subjects residing in New England (USA) region
Condition
  • Shift Work Type Circadian Rhythm Sleep Disorder
  • Diabetes Mellitus, Type 2
  • Circadian Rhythm Sleep Disorder, Shift Work Type
  • Insulin Resistance
Intervention Not Provided
Study Groups/Cohorts
  • Night Shift-Workers
  • Day Workers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 15, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or non-pregnant female
  • 18-60 years
  • Currently employed (night shift workers and day workers), graduate students, part-time workers, or unemployed
  • Able and willing to give consent relevant to genetic investigation

Exclusion Criteria:

  • Currently taking any medications for the treatment of diabetes
  • Currently taking medications known to affect glycemic parameters, such as glucocorticoids, growth hormone or fluoroquinolones
  • Pregnant, nursing or at risk of becoming pregnant
  • Chronic renal failure, hepatic diseases, or cancer diagnoses
  • Bulimia diagnosis, prone to binge eating
  • Eating disorder diagnosis such as anorexia, binge eating, or bulimia
  • With psychiatric illness, such as schizophrenia or bipolar affective disorder
  • Blind
  • History of bariatric surgery
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Hassan S Dashti, PhD, RD 617-643-7167 SHIFTStudy@partners.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02997319
Other Study ID Numbers 2016P000651
R01DK105072 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Richa Saxena, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators
  • Broad Institute
  • Brigham and Women's Hospital
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Richa Saxena, PhD Massachusetts General Hospital
Principal Investigator: Frank AJL Scheer, PhD Brigham and Women's Hospital
PRS Account Massachusetts General Hospital
Verification Date January 2019