Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

MTNR1B SNP*Food Timing Interaction on Glucose Control (ONTIME-MT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03036592
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
PROF. MARTA GARAULET AZA, Universidad de Murcia

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Diabetic Disorder of Endocrine Pancreas Behavioral: Early OGTT Behavioral: Late OGTT Not Applicable

Detailed 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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: MTNR1B SNP*Food Timing Interaction on Glucose Control in a Late Eater Mediterranean Population
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: MTNR1B CC
Test glucose tolerance in homozygous non-carriers (CC) for MTNR1B rs10830963 in Early OGTT and Late OGTT
Behavioral: Early OGTT
Test glucose tolerance using identical mixed 75 gr of glucose under early condition (4 hours before habitual bedtime)

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

Experimental: MTNR1B GG
Test glucose tolerance in homozygous (GG) risk allele carriers for MTNR1B rs10830963 in Early OGTT and Late OGTT
Behavioral: Early OGTT
Test glucose tolerance using identical mixed 75 gr of glucose under early condition (4 hours before habitual bedtime)

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

Experimental: MTNR1B CG
Test glucose tolerance in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early OGTT and Late OGTT
Behavioral: Early OGTT
Test glucose tolerance using identical mixed 75 gr of glucose under early condition (4 hours before habitual bedtime)

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




Primary Outcome Measures :
  1. Area Under the Curve (AUC) glucose [ 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.

  2. Disposition index [ Time Frame: between 0-120 minutes, Visit 2 and 3 ]
    Disposition index will be determined by frequently sampled oral glucose tolerance test


Secondary Outcome Measures :
  1. Corrected Insulin Response [ Time Frame: between 0-120 minutes, Visit 2 and 3 ]
    Corrected Insulin Response

  2. Insulin Sensitivity Index [ Time Frame: between 0-120 minutes, Visit 2 and 3 ]
    Insulin Sensitivity Index

  3. Fasting glucose [ Time Frame: between 0-120 minutes, Visit 2 and 3 ]
    Fasting glucose

  4. Fasting insulin [ Time Frame: 0-120 minutes, Visit 2 and 3 ]
    Fasting insulin

  5. Serum Melatonin [ Time Frame: at baseline and 120 minutes, Visit 2 and 3 ]
    Serum Melatonin

  6. DLMO [ Time Frame: between 0-5 hours, Visit 3 ]
    Dim Light Melatonin Onset


Other Outcome Measures:
  1. Temperature record [ Time Frame: total of 1 week between Visit 1 and 2 ]
    Measured using temperature sensor

  2. Activity record [ Time Frame: total of 1 week between Visit 1 and 2 ]
    Measured using Acceleration Data Logger

  3. Light Exposure [ Time Frame: total of 1 week between Visit 1 and 2 ]
    Measured using a light sensor

  4. Sleep Duration [ Time Frame: total of 1 week between Visit 1 and 2 ]
    Sleep duration will be computed from self-reported

  5. Total Energy Intake [ Time Frame: total of 1 week between Visit 1 and 2 ]
    Total energy intake in kcal/day will be computed from 7-day 24-hr dietary recalls

  6. Dietary Composition [ Time Frame: total of 1 week between Visit 1 and 2 ]
    Macronutrient and micronutrient intake will be computed from 7-days of self-reported 24-hr dietary recalls

  7. Dietary Intake Timing [ Time Frame: total of 1 week between Visit 1 and 2 ]
    Food timing will be self-reported and averaged across 7-days of 24-hr dietary recalls

  8. Physical activity [ Time Frame: at baseline ]
    Assessed using the International Physical Activity Questionnaire (IPAQ)

  9. Chronotype [ Time Frame: at baseline ]
    Assessed using the Morningness-Eveningness Questionnaire (MEQ).

  10. Emotional eating [ Time Frame: at baseline ]
    Assessed using the Emotional Eating Questionnaire (EEQ)

  11. Sleep quality [ Time Frame: at baseline ]
    Assessed using the Pittsburgh Sleep Quality Index (PSQI)

  12. Insomnia [ Time Frame: at baseline ]
    Assessed using the Insomnia Severity Index (ISI)

  13. Depression [ Time Frame: at baseline ]
    Assessed using the Patient Health Questionnaire (PHQ-9)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036592


Contacts
Layout table for location contacts
Contact: Marta Garaulet, PHD 678996368 ext +34 garaulet@um.es
Contact: Jesus Lopez-Minguez 660672851 ext +34 jesus.lopez5@um.es

Locations
Layout table for location information
Spain
University of Murcia Recruiting
Murcia, Spain, 30100
Contact: Marta Garaulet, PHD    678996368 ext +34    garaulet@um.es   
Contact: Jesus Lopez-Minguez    660672851 ext +34    jesus.lopez5@um.es   
Sponsors and Collaborators
Universidad de Murcia
Investigators
Layout table for investigator information
Study Chair: Purificación Gomez Abellan, PHD Universidad de Murcia
  Study Documents (Full-Text)

Documents provided by PROF. MARTA GARAULET AZA, Universidad de Murcia:
Study Protocol  [PDF] September 1, 2016
Informed Consent Form  [PDF] September 1, 2016


Layout table for additonal information
Responsible Party: PROF. MARTA GARAULET AZA, Full Proffesor, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT03036592     History of Changes
Other Study ID Numbers: 2017ES00001
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PROF. MARTA GARAULET AZA, Universidad de Murcia:
Glucose tolerance test, MTNR1B, nutrigenomics, food timing