Ignite Creation Date:
2024-05-06 @ 9:31 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT03003936
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2016-12-16
Brief Title:
Glucose Tolerance Meal Timing and MTNR1B
Sponsor:
Universidad de Murcia
Organization:
Universidad de Murcia
Study Overview
Official Title:
Glucose Tolerance Meal Timing and MTNR1B in a Mediterranean Population
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONTIME-DINE
Brief 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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None