Shift Work, Heredity, Insulin, and Food Timing Study

Diabetes Mellitus, Type 2 Clinical Trial

— SHIFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997319
• Other study ID #: 2016P000651
• Secondary ID: R01DK105072
• Status: Completed
• Start date: February 24, 2017
• Est. completion date: May 8, 2021

Study information

• Verified date: May 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: May 8, 2021
• Est. primary completion date: May 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Circadian Rhythm Sleep Disorder, Shift Work Type
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Disease
• Insulin Resistance
• Parasomnias
• Shift Work Type Circadian Rhythm Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Broad Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep Duration	Sleep duration will be computed from self-reported bed and wake up times using sleep logs and measured using an Actiwatch.	Total of 2 weeks between Visit 1 and 3
Other	Sleep Quality	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index and Insomnia Severity Index	Total of 2 weeks between Visit 1 and 3
Other	Light Exposure	Measured using Actiwatch	Total of 2 weeks between Visit 1 and 3
Other	Total Energy Intake	Total energy intake in kcal/day will be computed from 14-day 24-hr dietary recalls	Total of 2 weeks between Visit 1 and 3
Other	Dietary Composition	Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary recalls	Total of 2 weeks between Visit 1 and 3
Other	Dietary Intake Timing	Food timing will be self-reported and averaged across 14-days of 24-hr dietary recalls	Total of 2 weeks between Visit 1 and 3
Other	Physical Activity	Assessed using the International Physical Activity Questionnaire (IPAQ)	Baseline
Other	Chronotype	Assessed using the Morningness-Eveningness Questionnaire (MEQ)	Baseline
Other	Emotional Eating Behavior	Assessed using the Emotional Eating Questionnaire (EEQ)	Baseline
Other	Depression	Assessed using the Patient Health Questionnaire (PHQ-8)	Baseline
Primary	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
Primary	Disposition index	Disposition index will be determined by frequently sampled oral glucose tolerance test	Between 0-120 minutes, Visit 2 and 3
Secondary	Corrected Insulin Response		Between 0-120 minutes, Visit 2 and 3
Secondary	Insulin Sensitivity Index		Between 0-120 minutes, Visit 2 and 3
Secondary	Fasting Glucose		Between 0-120 minutes, Visit 2 and 3
Secondary	Fasting Insulin		Between 0-120 minutes, Visit 2 and 3
Secondary	Plasma Melatonin		Between 0-120 minutes, Visit 2 and 3

External Links

•   Recruitment Website