Shift Work Type Circadian Rhythm Sleep DisorderSHIFTNCT02997319
Shift Work, Heredity, Insulin, and Food Timing Study
An observational study of Shift Work Type Circadian Rhythm Sleep Disorder and Diabetes Mellitus, Type 2, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift Work Type Circadian Rhythm Sleep Disorder, Diabetes Mellitus, Type 2, Circadian Rhythm Sleep Disorder, Shift Work Type
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2017to 8 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects residing in New England (USA) region
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- With psychiatric illness, such as schizophrenia or bipolar affective disorder
- Blind
- History of bariatric surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Shift Work Type Circadian Rhythm Sleep Disorder, Diabetes Mellitus, Type 2, Circadian Rhythm Sleep Disorder, Shift Work Type, Insulin Resistance
- Keywords
- Diabetes Mellitus, Type 2, Insulin Resistance, Shift Work, Circadian Rhythms, MTNR1B
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Disorders, Circadian Rhythm, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Night Shift-Workers | Not described | |
| Day Workers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between 0-120 minutes, Visit 2 and 3
Disposition index
Disposition index will be determined by frequently sampled oral glucose tolerance test
Measured: Between 0-120 minutes, Visit 2 and 3
Secondary outcomes (5)
Corrected Insulin Response
Measured: Between 0-120 minutes, Visit 2 and 3
Insulin Sensitivity Index
Measured: Between 0-120 minutes, Visit 2 and 3
Fasting Glucose
Measured: Between 0-120 minutes, Visit 2 and 3
Fasting Insulin
Measured: Between 0-120 minutes, Visit 2 and 3
Plasma Melatonin
Measured: Between 0-120 minutes, Visit 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start24 Feb 2017
- Primary completion8 May 2021
- Study completion8 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift Work Type Circadian Rhythm Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Broad Institute of MIT and Harvard, Brigham and Women's Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Richa Saxena, Massachusetts General Hospital
- Investigators
- Richa Saxena, PhD, Principal investigator, Massachusetts General HospitalFrank AJL Scheer, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997319
- Sponsor's protocol ID
- 2016P000651
- Other IDs
- R01DK105072
- Acronym
- SHIFT
- Status last verified
- May 2021
- First submitted
- 13 Dec 2016
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shift Work, Heredity, Insulin, and Food Timing (SHIFT) Study
- ClinicalTrials.gov ID
- NCT02997319
- Acronym / sponsor ID
- SHIFT / 2016P000651
- Conditions
- Shift Work Type Circadian Rhythm Sleep Disorder, Diabetes Mellitus, Type 2, Circadian Rhythm Sleep Disorder, Shift Work Type, Insulin Resistance
- Keywords
- Diabetes Mellitus, Type 2, Insulin Resistance, Shift Work, Circadian Rhythms, MTNR1B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Broad Institute of MIT and Harvard, Brigham and Women's Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 8 May 2021 (actual)
- Study completion
- 8 May 2021 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Night Shift-Workers | – | – |
| Day Workers | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects residing in New England (USA) region
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Disposition index
Time frame: Between 0-120 minutes, Visit 2 and 3
Disposition index will be determined by frequently sampled oral glucose tolerance test
5 secondary outcomes
Corrected Insulin Response
Time frame: Between 0-120 minutes, Visit 2 and 3
Insulin Sensitivity Index
Time frame: Between 0-120 minutes, Visit 2 and 3
Fasting Glucose
Time frame: Between 0-120 minutes, Visit 2 and 3
Fasting Insulin
Time frame: Between 0-120 minutes, Visit 2 and 3
Plasma Melatonin
Time frame: Between 0-120 minutes, Visit 2 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Recruitment WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Shift Work Type Circadian Rhythm Sleep Disorder
Enrolling by invitation
Recovery and Early Sleep Tracking Using the SuperPatch REM Patch
Shift Work Sleep Disorder, Shift Work Type Circadian Rhythm Sleep Disorder
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Active, not recruiting
Eating Behaviors in Shift Workers
Shift Work Type Circadian Rhythm Sleep Disorder, Eating Behavior
Recruiting
Impact of Circulating and Tissue-specific Lipids on Vascular Function and Insulin Sensitivity in Chronic Night Shift Workers
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Recruiting
Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers
Cardiovascular Diseases, Circadian Rhythm Sleep Disorder, Shift Work Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richa Saxena, PhD principal investigator
Massachusetts General Hospital
Frank AJL Scheer, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shift Work Type Circadian Rhythm Sleep Disorder and Diabetes Mellitus, Type 2, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) glucose (time frame: Between 0-120 minutes, Visit 2 and 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021; AzTrials last refreshed its copy on 27 Oct 2026.