Skip to main content
OpenTrials
Completed

NCT Number: NCT02997319

Shift Work, Heredity, Insulin, and Food Timing 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Disposition index

    Time frame: Between 0-120 minutes, Visit 2 and 3

    Disposition index will be determined by frequently sampled oral glucose tolerance test

Secondary outcomes

  1. Corrected Insulin Response

    Time frame: Between 0-120 minutes, Visit 2 and 3

  2. Insulin Sensitivity Index

    Time frame: Between 0-120 minutes, Visit 2 and 3

  3. Fasting Glucose

    Time frame: Between 0-120 minutes, Visit 2 and 3

  4. Fasting Insulin

    Time frame: Between 0-120 minutes, Visit 2 and 3

  5. Plasma Melatonin

    Time frame: Between 0-120 minutes, Visit 2 and 3

Other outcomes

  1. 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.

  2. 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

  3. Light Exposure

    Time frame: Total of 2 weeks between Visit 1 and 3

    Measured using Actiwatch

  4. 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

  5. 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

  6. 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

  7. Physical Activity

    Time frame: Baseline

    Assessed using the International Physical Activity Questionnaire (IPAQ)

  8. Chronotype

    Time frame: Baseline

    Assessed using the Morningness-Eveningness Questionnaire (MEQ)

  9. Emotional Eating Behavior

    Time frame: Baseline

    Assessed using the Emotional Eating Questionnaire (EEQ)

  10. Depression

    Time frame: Baseline

    Assessed using the Patient Health Questionnaire (PHQ-8)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brigham and Women's Hospital
  • Broad Institute of MIT and Harvard
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: SHIFT

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2016
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.