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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03003936
Other study ID # 15123/PI/10
Secondary ID
Status Completed
Phase N/A
First received December 16, 2016
Last updated October 26, 2017
Start date December 2014
Est. completion date June 2017

Study information

Verified date October 2017
Source Universidad de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this investigation is to assess in a community-based cohort of late-night eaters the effect of coincident food intake and endogenous melatonin on glycemic control, and the putative interaction effect of melatonin receptor 1B (MTNR1B) genetic variation on this relationship. With the results from this study, the investigators expect to advance in the understanding of the role of endogenous melatonin on glucose metabolism in late night eaters and carriers of the MTNR1B risk allele, with potential implications on the guidelines to mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.


Description:

Late-night dinner eating is associated with increased risk for type-2-diabetes. The underlying mechanism is unclear. One explanatory hypothesis is that the concurrence of elevated circulating melatonin and high glucose concentrations (characterizing late-eating) leads to impaired glucose-tolerance. However, to date, no study has tested the influence of physiological melatonin concentrations on glucose tolerance. The discovery of melatonin receptor MTNR1B as a diabetes risk gene provides evidence for a role of physiological levels of melatonin in glucose control.

The aim of the current study is to test the hypothesis that the concurrence of meal timing with elevated endogenous melatonin concentrations results in impaired glucose control and that this effect is stronger in homozygous MTNR1B risk carriers than in non-carriers. To do so we will test glucose tolerance using identical mixed meals under two dinner conditions: a) delayed dinner or Late Eating (LE): starting1 hour before usual bed time, b) advanced dinner or Early Eating (EE): starting 4 hours before habitual bed time, in a randomized, cross-over study design.

These findings could support a clinical application for the screening of this single nucleotide polymorphism (SNP) and the possibility of implementing tailored and cost-effective behavioral interventions to prevent type 2 diabetes in vulnerable populations.

These goals will be achieved through a specific approach:

• Interventional (randomized, cross-over controlled trials) (Aim 1): To study the potential interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance.


Recruitment information / eligibility

Status Completed
Enrollment 280
Est. completion date June 2017
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Body Mass Index: >19 kg/m2

- Age: >18 years of age

- Caucasian

Exclusion Criteria:

- Receiving treatment with thermogenic, lipogenic, or contraceptive drugs

- Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis

- Bulimia diagnosis, prone to binge eating

- Undergoing treatment with anxiolytic or antidepressant drugs

Study Design


Related Conditions & MeSH terms

  • Non-Diabetic Disorder of Endocrine Pancreas

Intervention

Behavioral:
Dinner timing
Glucose tolerance after a late diner (1 hour before habitual bedtime) differs from early dinner (4 hours before habitual bedtime) due to the concurrence of meal timing with different levels of endogenous melatonin. This effect can be different among risk allele carriers (G) or non-rick allele carriers (C) of the MTNR1B.

Locations

Country Name City State
Spain University of Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Sleep Duration Sleep duration will be computed from self-reported. total of 2 weeks between Visit 1 and 3
Other Light Exposure Measured using Pendant G Acceleration Data Logger. 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 record. 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 record. 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 record. total of 2 weeks between Visit 1 and 3
Other Chronotype Assessed using the Morningness-Eveningness Questionnaire (MEQ). at baseline
Primary Area Under the Curve (AUC) glucose Investigators will measure glucose levels for 120 minutes at day time and night time visits, and compare the results by genotype at selected loci. between 0-120 minutes, Visit 2 and 3
Secondary Fasting glucose between 0-120 minutes, Visit 2 and 3
Secondary Saliva Melatonin between 0-120 minutes, Visit 2 and 3
See also
  Status Clinical Trial Phase
Recruiting NCT03036592 - MTNR1B SNP*Food Timing Interaction on Glucose Control N/A