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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Insulin Resistance; Circadian Rhythm Sleep Disorder, Shift Work Type; Shift Work Type Circadian Rhythm Sleep Disorder

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
• Enrollment (Actual): 365

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects residing in New England (USA) region

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Night Shift-Workers
Day Workers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) glucose	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.	Between 0-120 minutes, Visit 2 and 3
Disposition index	Disposition index will be determined by frequently sampled oral glucose tolerance test	Between 0-120 minutes, Visit 2 and 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Corrected Insulin Response	Between 0-120 minutes, Visit 2 and 3
Insulin Sensitivity Index	Between 0-120 minutes, Visit 2 and 3
Fasting Glucose	Between 0-120 minutes, Visit 2 and 3
Fasting Insulin	Between 0-120 minutes, Visit 2 and 3
Plasma Melatonin	Between 0-120 minutes, Visit 2 and 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Duration	Sleep duration will be computed from self-reported bed and wake up times using sleep logs and measured using an Actiwatch.	Total of 2 weeks between Visit 1 and 3
Sleep Quality	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index and Insomnia Severity Index	Total of 2 weeks between Visit 1 and 3
Light Exposure	Measured using Actiwatch	Total of 2 weeks between Visit 1 and 3
Total Energy Intake	Total energy intake in kcal/day will be computed from 14-day 24-hr dietary recalls	Total of 2 weeks between Visit 1 and 3
Dietary Composition	Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary recalls	Total of 2 weeks between Visit 1 and 3
Dietary Intake Timing	Food timing will be self-reported and averaged across 14-days of 24-hr dietary recalls	Total of 2 weeks between Visit 1 and 3
Physical Activity	Assessed using the International Physical Activity Questionnaire (IPAQ)	Baseline
Chronotype	Assessed using the Morningness-Eveningness Questionnaire (MEQ)	Baseline
Emotional Eating Behavior	Assessed using the Emotional Eating Questionnaire (EEQ)	Baseline
Depression	Assessed using the Patient Health Questionnaire (PHQ-8)	Baseline

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Brigham and Women's Hospital; Broad Institute
• Investigators: Principal Investigator: Richa Saxena, PhD, Massachusetts General Hospital; Principal Investigator: Frank AJL Scheer, PhD, Brigham and Women's Hospital

Publications and helpful links

Helpful Links

• Recruitment Website

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2017
• Primary Completion (Actual): May 8, 2021
• Study Completion (Actual): May 8, 2021

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Insulin Resistance; Diabetes Mellitus, Type 2; Circadian Rhythms; Shift Work; MTNR1B
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Endocrine System Diseases; Occupational Diseases; Hyperinsulinism; Chronobiology Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Disease; Sleep Wake Disorders; Parasomnias; Insulin Resistance; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 2016P000651; R01DK105072 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED