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

Mass General Brigham

Status: Completed

Conditions: Insulin Resistance; Diabetes Mellitus, Type 2; Circadian Rhythm Sleep Disorder, Shift Work Type; Shift Work Type Circadian Rhythm Sleep Disorder

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02997319

2016P000651

R01DK105072 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 365 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

365 participants in 2 patient groups

Night Shift-Workers

Day Workers