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

May 18, 2021 updated by: Richa Saxena, Massachusetts General Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
365

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Night Shift-Workers
Day Workers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Between 0-120 minutes, Visit 2 and 3
Disposition index
Time Frame: Between 0-120 minutes, Visit 2 and 3
Disposition index will be determined by frequently sampled oral glucose tolerance test
Between 0-120 minutes, Visit 2 and 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Corrected Insulin Response
Time Frame: Between 0-120 minutes, Visit 2 and 3
Between 0-120 minutes, Visit 2 and 3
Insulin Sensitivity Index
Time Frame: Between 0-120 minutes, Visit 2 and 3
Between 0-120 minutes, Visit 2 and 3
Fasting Glucose
Time Frame: Between 0-120 minutes, Visit 2 and 3
Between 0-120 minutes, Visit 2 and 3
Fasting Insulin
Time Frame: Between 0-120 minutes, Visit 2 and 3
Between 0-120 minutes, Visit 2 and 3
Plasma Melatonin
Time Frame: Between 0-120 minutes, Visit 2 and 3
Between 0-120 minutes, Visit 2 and 3

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Total of 2 weeks between Visit 1 and 3
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
Total of 2 weeks between Visit 1 and 3
Light Exposure
Time Frame: Total of 2 weeks between Visit 1 and 3
Measured using Actiwatch
Total of 2 weeks between Visit 1 and 3
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
Total of 2 weeks between Visit 1 and 3
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
Total of 2 weeks between Visit 1 and 3
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
Total of 2 weeks between Visit 1 and 3
Physical Activity
Time Frame: Baseline
Assessed using the International Physical Activity Questionnaire (IPAQ)
Baseline
Chronotype
Time Frame: Baseline
Assessed using the Morningness-Eveningness Questionnaire (MEQ)
Baseline
Emotional Eating Behavior
Time Frame: Baseline
Assessed using the Emotional Eating Questionnaire (EEQ)
Baseline
Depression
Time Frame: Baseline
Assessed using the Patient Health Questionnaire (PHQ-8)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brigham and Women's Hospital
Broad Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richa Saxena, PhD, Massachusetts General Hospital
  • Principal Investigator: Frank AJL Scheer, PhD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016P000651
  • R01DK105072 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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