MTNR1B SNP*Food Timing Interaction on Glucose Control

Non-Diabetic Disorder of Endocrine Pancreas Clinical Trial

— ONTIME-MT  

Official title:

MTNR1B SNP*Food Timing Interaction on Glucose Control in a Late Eater Mediterranean Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03036592
• Other study ID #: 2017ES00001
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2020
• Source: Universidad de Murcia
• Contact: Marta Garaulet, PHD
• Phone: 678996368
• Email: garaulet[@]um.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this investigation is to assess the role of melatonin receptor 1B (MTNR1B) single nucleotide polymorphism (SNP)*food timing interaction on glucose control in the deleterious effect in a vulnerable population with regular exposure to concurrent high melatonin and food intake as late night eaters (those having dinner within 2.5 h before their usual bed time). With the results from this study, we expect to advance our 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 glucose oral tolerance test (OGTT) conditions: a) delayed OGTT or Late Eating (LE): starting1 hour before their usual bed time, b) advanced OGTT 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 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 in obese women (n=1000).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2021
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

IInclusion Criteria:

• Body Mass Index: > 18.5 o < 40 kg/m2

• Age: between 18 and 65 year of age

• Caucasian

• Day workers

Exclusion Criteria:

• Receiving treatment with thermogenic, lipogenic, or drugs

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

• Bulimia diagnosis, prone to binge eating

• Undergoing treatment with Type 2 diabetes mellitus (high blood sugar) medications such as Metformin or other non-Metformin oral anti-diabetic drugs such as sulfonylureas, meglitinides, or glitazones

• Undergoing treatment with Corticosteroids/steroids, Growth hormone, Anticoagulant medicines, or blood thinners, Beta blockers for hypertension, Medications for sleep, Fluvoxamine, Opioids or Amphetamines, Tranquilizers, nonsteroidal anti-inflammatory drugs.

• Pregnant

Related Conditions & MeSH terms

• Non-Diabetic Disorder of Endocrine Pancreas

Intervention

Behavioral:
• Early OGTT
Test glucose tolerance using identical mixed 75 gr of glucose under early condition (4 hours before habitual bedtime)
• Late OGTT
Test glucose tolerance using identical mixed 75 gr of glucose under late condition (1 hour before habitual bedtime)

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	Temperature record	Measured using temperature sensor	total of 1 week between Visit 1 and 2
Other	Activity record	Measured using Acceleration Data Logger	total of 1 week between Visit 1 and 2
Other	Light Exposure	Measured using a light sensor	total of 1 week between Visit 1 and 2
Other	Sleep Duration	Sleep duration will be computed from self-reported	total of 1 week between Visit 1 and 2
Other	Total Energy Intake	Total energy intake in kcal/day will be computed from 7-day 24-hr dietary recalls	total of 1 week between Visit 1 and 2
Other	Dietary Composition	Macronutrient and micronutrient intake will be computed from 7-days of self-reported 24-hr dietary recalls	total of 1 week between Visit 1 and 2
Other	Dietary Intake Timing	Food timing will be self-reported and averaged across 7-days of 24-hr dietary recalls	total of 1 week between Visit 1 and 2
Other	Physical activity	Assessed using the International Physical Activity Questionnaire (IPAQ)	at baseline
Other	Chronotype	Assessed using the Morningness-Eveningness Questionnaire (MEQ).	at baseline
Other	Emotional eating	Assessed using the Emotional Eating Questionnaire (EEQ)	at baseline
Other	Sleep quality	Assessed using the Pittsburgh Sleep Quality Index (PSQI)	at baseline
Other	Insomnia	Assessed using the Insomnia Severity Index (ISI)	at baseline
Other	Depression	Assessed using the Patient Health Questionnaire (PHQ-9)	at 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	Corrected Insulin Response	between 0-120 minutes, Visit 2 and 3
Secondary	Insulin Sensitivity Index	Insulin Sensitivity Index	between 0-120 minutes, Visit 2 and 3
Secondary	Fasting glucose	Fasting glucose	between 0-120 minutes, Visit 2 and 3
Secondary	Fasting insulin	Fasting insulin	0-120 minutes, Visit 2 and 3
Secondary	Serum Melatonin	Serum Melatonin	at baseline and 120 minutes, Visit 2 and 3
Secondary	DLMO	Dim Light Melatonin Onset	between 0-5 hours, Visit 3