Non-Diabetic Disorder of Endocrine Pancreas Clinical Trial
— ONTIME-DINEOfficial title:
Glucose Tolerance, Meal Timing and MTNR1B in a Mediterranean Population
Verified date | October 2017 |
Source | Universidad de Murcia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | University of Murcia | Murcia |
Lead Sponsor | Collaborator |
---|---|
Universidad de Murcia |
Spain,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03036592 -
MTNR1B SNP*Food Timing Interaction on Glucose Control
|
N/A |