Shift Work, Heredity, Insulin, and Food Timing Study

NCT ID: NCT02997319

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-24

Study Completion Date

2021-05-08

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Night Shift-Workers

No interventions assigned to this group

Day Workers

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Broad Institute of MIT and Harvard

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Richa Saxena

Assistant Professor of Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richa Saxena, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Frank AJL Scheer, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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R01DK105072

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016P000651

Identifier Type: -

Identifier Source: org_study_id

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