MTNR1B SNP*Food Timing Interaction on Glucose Control

NCT03036592 | Completed Results DMC

• 1 other identifier: 2017ES00001
• Study Type: interventional
• Target: 889
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Diabetic Disorder of Endocrine Pancreas

Keywords

Glucose tolerance test, MTNR1B, nutrigenomics, food timing

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve (AUC) Glucose

  Glucose levels are measured along 120 minutes corresponding to at early and late condition in each visit. The Area Under the Curve was calculated as the sum of the area of several trapezoids. This trapezoids was obtained at times 0-30 min, 30-60 min, 60-90 min, 90-120 min. The values are the difference between the late and the early condition.

  Along 120 minutes in visits 1 and 2

• Disposition Index (DI)

  Disposition Index (DI) is the product of insulin sensitivity times by the amount of insulin secreted in response to blood glucose levels. Disposition index is used as a measure of beta cell function and the ability of the body to dispose of a glucose load. This index was determined by this formula: DI= CIR × ISI, where CIR is the measure Corrected Insulin Response, and ISI is Insulin Sensitivity Index. The values are the difference between the late and the early condition. Higher DI indicates an increased beta cell function and increased ability of the body to dispose of a glucose load.

  Along 120 minutes in visits 1 and 2

Secondary Outcomes (6)

• Corrected Insulin Response (CIR)

  At minute 30 during the visit 1 and 2.

• Insulin Sensitivity Index (ISI)

  Along 120min in visits 1 and 2

• Fasting Glucose

  At minute 0 in visit 1 and 2.

• Fasting Insulin

  At minute 0 in visit 1 and 2

• Serum Melatonin

  At baseline and 120 minutes in visit 1 and 2

Other Outcomes (13)

• Temperature Record (Mean Value 10hours Daytime)

  For 1 week between visit 1 and 2

• Activity Record (Mean Value 10hours Daytime)

  For 1 week between visit 1 and 2

• Light Exposure (Mean Value 10hours Daytime)

  For 1 week between the visits 1 and 2

Study Arms (6)

Early OGTT, then late OGTT in MTNR1B CC

EXPERIMENTAL

Oral glucose tolerance test (OGTT) in homozygous non-carriers (CC) for MTNR1B rs10830963 in Early and Late conditions

Behavioral: Early OGTT; Behavioral: Late OGTT

Early OGTT, then late OGTT in MTNR1B CG

EXPERIMENTAL

Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions

Behavioral: Early OGTT; Behavioral: Late OGTT

Early OGTT, then late OGTT in MTNR1B GG

EXPERIMENTAL

Oral glucose tolerance test (OGTT) in homozygous (GG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions

Behavioral: Early OGTT; Behavioral: Late OGTT

Late OGTT, then Early OGTT in MTNR1B CC

EXPERIMENTAL

Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions

Behavioral: Early OGTT; Behavioral: Late OGTT

Late OGTT, then Early OGTT in MTNR1B CG

EXPERIMENTAL

Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions

Behavioral: Early OGTT; Behavioral: Late OGTT

Late OGTT, then Early OGTT in MTNR1B GG

EXPERIMENTAL

Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions

Behavioral: Early OGTT; Behavioral: Late OGTT

Interventions

Early OGTT BEHAVIORAL

Oral glucose tolerance test using identical mixed 75 gr of glucose under early condition (4 hours before habitual bedtime)

Early OGTT, then late OGTT in MTNR1B CC; Early OGTT, then late OGTT in MTNR1B CG; Early OGTT, then late OGTT in MTNR1B GG; Late OGTT, then Early OGTT in MTNR1B CC; Late OGTT, then Early OGTT in MTNR1B CG; Late OGTT, then Early OGTT in MTNR1B GG

Late OGTT BEHAVIORAL

Oral glucose tolerance test using identical mixed 75 gr of glucose under late condition (1 hour before habitual bedtime)

Early OGTT, then late OGTT in MTNR1B CC; Early OGTT, then late OGTT in MTNR1B CG; Early OGTT, then late OGTT in MTNR1B GG; Late OGTT, then Early OGTT in MTNR1B CC; Late OGTT, then Early OGTT in MTNR1B CG; Late OGTT, then Early OGTT in MTNR1B GG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index: \> 18.5 o \< 40 kg/m2
• Age: between 18 and 65 year of age
• European ancestry
• Day workers

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

University of Murcia

Murcia, 30100, Spain

Location

Related Publications (1)

• Garaulet M, Lopez-Minguez J, Dashti HS, Vetter C, Hernandez-Martinez AM, Perez-Ayala M, Baraza JC, Wang W, Florez JC, Scheer FAJL, Saxena R. Interplay of Dinner Timing and MTNR1B Type 2 Diabetes Risk Variant on Glucose Tolerance and Insulin Secretion: A Randomized Crossover Trial. Diabetes Care. 2022 Mar 1;45(3):512-519. doi: 10.2337/dc21-1314.

  PMID: 35015083 DERIVED

Limitations and Caveats

* Typically, the Participant Flow list Arms/Groups "per sequence" (i.e., "MTNR1B CC Early OGTT first, then Late OGTT", MTNR1B CC Late OGTT first, then Early OGTT", etc.). However, as shown (Diabetes Care, PUBMED: 35015083), the study was conducted to compare the conditions of "early" and "late", within each genotyping-group without considering the order. * The individual's genotypes were not known until the end of the study, then we could not assign the groups until we finished the study.

Results Point of Contact

• Title: Prof. Marta Garaulet Aza
• Organization: University of Murcia

garaulet@um.es

868884030

Study Officials

• Purificación Gomez Abellan, PHD

  Universidad de Murcia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 30, 2017
• Study Start: January 1, 2017
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)