Shift Work, Heredity, Insulin, and Food Timing Study
SHIFT
2 other identifiers
observational
365
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedStudy Start
First participant enrolled
February 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2021
CompletedMay 19, 2021
May 1, 2021
4.2 years
December 13, 2016
May 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area Under the Curve (AUC) glucose
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
Disposition index will be determined by frequently sampled oral glucose tolerance test
Between 0-120 minutes, Visit 2 and 3
Secondary Outcomes (5)
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 Outcomes (10)
Sleep Duration
Total of 2 weeks between Visit 1 and 3
Sleep Quality
Total of 2 weeks between Visit 1 and 3
Light Exposure
Total of 2 weeks between Visit 1 and 3
- +7 more other outcomes
Study Arms (2)
Night Shift-Workers
Day Workers
Eligibility Criteria
Subjects residing in New England (USA) region
You may qualify if:
- Male or non-pregnant female
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Links
Biospecimen
DNA, serum insulin, serum glucose, plasma melatonin, blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richa Saxena, PhD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Frank AJL Scheer, PhD
Brigham and Women's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Anaesthesia
Study Record Dates
First Submitted
December 13, 2016
First Posted
December 20, 2016
Study Start
February 24, 2017
Primary Completion
May 8, 2021
Study Completion
May 8, 2021
Last Updated
May 19, 2021
Record last verified: 2021-05