SHIFT: Shift Work, Heredity, Insulin, and Food Timing Study

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02997319

Collaborator

Broad Institute (Other), Brigham and Women's Hospital (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

365

Enrollment

Location

50.4

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational

Actual Enrollment :

365 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 24, 2017

Actual Primary Completion Date :

May 8, 2021

Actual Study Completion Date :

May 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Night Shift-Workers
Day Workers

Outcome Measures

Primary Outcome Measures

Area Under the Curve (AUC) glucose [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 [Between 0-120 minutes, Visit 2 and 3]
Disposition index will be determined by frequently sampled oral glucose tolerance test

Secondary Outcome Measures

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

Sleep Duration [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 [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 [Total of 2 weeks between Visit 1 and 3]
Measured using Actiwatch
Total Energy Intake [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 [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 [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 [Baseline]
Assessed using the International Physical Activity Questionnaire (IPAQ)
Chronotype [Baseline]
Assessed using the Morningness-Eveningness Questionnaire (MEQ)
Emotional Eating Behavior [Baseline]
Assessed using the Emotional Eating Questionnaire (EEQ)
Depression [Baseline]
Assessed using the Patient Health Questionnaire (PHQ-8)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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