Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT02997319
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.
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Notify Me18 year–60 year
All sexes
Observational
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Between 0-120 minutes, Visit 2 and 3
Disposition index will be determined by frequently sampled oral glucose tolerance test
Time frame: Between 0-120 minutes, Visit 2 and 3
Time frame: Between 0-120 minutes, Visit 2 and 3
Time frame: Between 0-120 minutes, Visit 2 and 3
Time frame: Between 0-120 minutes, Visit 2 and 3
Time frame: Between 0-120 minutes, Visit 2 and 3
Time frame: Total of 2 weeks between Visit 1 and 3
Sleep duration will be computed from self-reported bed and wake up times using sleep logs and measured using an Actiwatch.
Time frame: Total of 2 weeks between Visit 1 and 3
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index and Insomnia Severity Index
Time frame: Total of 2 weeks between Visit 1 and 3
Measured using Actiwatch
Time frame: Total of 2 weeks between Visit 1 and 3
Total energy intake in kcal/day will be computed from 14-day 24-hr dietary recalls
Time frame: Total of 2 weeks between Visit 1 and 3
Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary recalls
Time frame: Total of 2 weeks between Visit 1 and 3
Food timing will be self-reported and averaged across 14-days of 24-hr dietary recalls
Time frame: Baseline
Assessed using the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline
Assessed using the Morningness-Eveningness Questionnaire (MEQ)
Time frame: Baseline
Assessed using the Emotional Eating Questionnaire (EEQ)
Time frame: Baseline
Assessed using the Patient Health Questionnaire (PHQ-8)
Massachusetts General Hospital
Other
Shift Work, Heredity, Insulin, and Food Timing (SHIFT) Study
Acronym: SHIFT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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