Clinical trial NCT02997319: Shift Work, Heredity, Insulin, and Food Timing Study
Official title: Shift Work, Heredity, Insulin, and Food Timing (SHIFT) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Broad Institute of MIT and Harvard
name: Brigham and Women's Hospital
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-12-20
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects residing in New England (USA) region

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Curve (AUC) glucose
timeFrame: Between 0-120 minutes, Visit 2 and 3
measure: Disposition index
timeFrame: Between 0-120 minutes, Visit 2 and 3
Secondary outcomes:
measure: Corrected Insulin Response
timeFrame: Between 0-120 minutes, Visit 2 and 3
measure: Insulin Sensitivity Index
timeFrame: Between 0-120 minutes, Visit 2 and 3
measure: Fasting Glucose
timeFrame: Between 0-120 minutes, Visit 2 and 3
measure: Fasting Insulin
timeFrame: Between 0-120 minutes, Visit 2 and 3
measure: Plasma Melatonin
timeFrame: Between 0-120 minutes, Visit 2 and 3
Other outcomes:
measure: Sleep Duration
timeFrame: Total of 2 weeks between Visit 1 and 3
measure: Sleep Quality
timeFrame: Total of 2 weeks between Visit 1 and 3
measure: Light Exposure
timeFrame: Total of 2 weeks between Visit 1 and 3
measure: Total Energy Intake
timeFrame: Total of 2 weeks between Visit 1 and 3
measure: Dietary Composition
timeFrame: Total of 2 weeks between Visit 1 and 3
measure: Dietary Intake Timing
timeFrame: Total of 2 weeks between Visit 1 and 3
measure: Physical Activity
timeFrame: Baseline
measure: Chronotype
timeFrame: Baseline
measure: Emotional Eating Behavior
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Richa Saxena, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Frank AJL Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
References: