Shift Work, Heredity, Insulin, and Food Timing Study

Completed

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

• Registration Number: NCT02997319
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-20
• Study Start: 2017-02-24
• Status Verified: 2021-05
• Primary Completion: 2021-05-08
• Study Completion: 2021-05-08
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) glucose	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	Between 0-120 minutes, Visit 2 and 3	Disposition index will be determined by frequently sampled oral glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States