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Shift Work, Heredity, Insulin, and Food Timing Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02997319
Acronym
SHIFT
Enrollment
365
Registered
2016-12-20
Start date
2017-02-24
Completion date
2021-05-08
Last updated
2021-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Diabetes Mellitus, Type 2, Insulin Resistance, Shift Work, Circadian Rhythms, MTNR1B

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.

Interventions

None listed

Sponsors

Broad Institute of MIT and Harvard
CollaboratorOTHER
Brigham and Women's Hospital
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Area Under the Curve (AUC) glucoseBetween 0-120 minutes, Visit 2 and 3Investigators 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 indexBetween 0-120 minutes, Visit 2 and 3Disposition index will be determined by frequently sampled oral glucose tolerance test

Secondary

MeasureTime frame
Fasting GlucoseBetween 0-120 minutes, Visit 2 and 3
Corrected Insulin ResponseBetween 0-120 minutes, Visit 2 and 3
Plasma MelatoninBetween 0-120 minutes, Visit 2 and 3
Fasting InsulinBetween 0-120 minutes, Visit 2 and 3
Insulin Sensitivity IndexBetween 0-120 minutes, Visit 2 and 3

Other

MeasureTime frameDescription
ChronotypeBaselineAssessed using the Morningness-Eveningness Questionnaire (MEQ)
Sleep DurationTotal of 2 weeks between Visit 1 and 3Sleep duration will be computed from self-reported bed and wake up times using sleep logs and measured using an Actiwatch.
DepressionBaselineAssessed using the Patient Health Questionnaire (PHQ-8)
Emotional Eating BehaviorBaselineAssessed using the Emotional Eating Questionnaire (EEQ)
Sleep QualityTotal of 2 weeks between Visit 1 and 3Sleep quality will be assessed using the Pittsburgh Sleep Quality Index and Insomnia Severity Index
Light ExposureTotal of 2 weeks between Visit 1 and 3Measured using Actiwatch
Total Energy IntakeTotal of 2 weeks between Visit 1 and 3Total energy intake in kcal/day will be computed from 14-day 24-hr dietary recalls
Dietary CompositionTotal of 2 weeks between Visit 1 and 3Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary recalls
Dietary Intake TimingTotal of 2 weeks between Visit 1 and 3Food timing will be self-reported and averaged across 14-days of 24-hr dietary recalls
Physical ActivityBaselineAssessed using the International Physical Activity Questionnaire (IPAQ)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026