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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

Study Description
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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.

Condition or disease
Shift Work Type Circadian Rhythm Sleep Disorder Diabetes Mellitus, Type 2 Circadian Rhythm Sleep Disorder, Shift Work Type Insulin Resistance

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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Shift Work, Heredity, Insulin, and Food Timing (SHIFT) Study
Study Start Date : January 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Groups and Cohorts
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Group/Cohort
Night Shift-Workers
Day Workers


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Disposition index [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
    Disposition index will be determined by frequently sampled oral glucose tolerance test


Secondary Outcome Measures :
  1. Corrected Insulin Response [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
  2. Insulin Sensitivity Index [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
  3. Fasting Glucose [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
  4. Fasting Insulin [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]
  5. Plasma Melatonin [ Time Frame: Between 0-120 minutes, Visit 2 and 3 ]

Other Outcome Measures:
  1. 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.

  2. 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

  3. Light Exposure [ Time Frame: Total of 2 weeks between Visit 1 and 3 ]
    Measured using Actiwatch

  4. 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

  5. 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

  6. 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

  7. Physical Activity [ Time Frame: Baseline ]
    Assessed using the International Physical Activity Questionnaire (IPAQ)

  8. Chronotype [ Time Frame: Baseline ]
    Assessed using the Morningness-Eveningness Questionnaire (MEQ)

  9. Emotional Eating Behavior [ Time Frame: Baseline ]
    Assessed using the Emotional Eating Questionnaire (EEQ)

  10. Depression [ Time Frame: Baseline ]
    Assessed using the Patient Health Questionnaire (PHQ-8)


Biospecimen Retention:   Samples With DNA
DNA, serum insulin, serum glucose, plasma melatonin, blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects residing in New England (USA) region
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997319


Contacts
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Contact: Hassan S Dashti, PhD, RD 617-643-7167 SHIFTStudy@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Hassan S Dashti, PhD, RD    617-643-7167    SHIFTStudy@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Broad Institute
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Richa Saxena, PhD Massachusetts General Hospital
Principal Investigator: Frank AJL Scheer, PhD Brigham and Women's Hospital
More Information
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Additional Information:
Recruitment Website  This link exits the ClinicalTrials.gov site Study Website  This link exits the ClinicalTrials.gov site

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Responsible Party: Richa Saxena, Assistant Professor of Anaesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02997319     History of Changes
Other Study ID Numbers: 2016P000651
R01DK105072 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Richa Saxena, Massachusetts General Hospital:
Diabetes Mellitus, Type 2
Insulin Resistance
Shift Work
Circadian Rhythms
MTNR1B
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Disease
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperinsulinism
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs