Ignite Creation Date:
2024-05-06 @ 9:38 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03036592
Status:
UNKNOWN
Last Update Posted:
2020-02-06
First Post:
2017-01-26
Brief Title:
MTNR1B SNPFood Timing Interaction on Glucose Control
Sponsor:
Universidad de Murcia
Organization:
Universidad de Murcia
Study Overview
Official Title:
MTNR1B SNPFood Timing Interaction on Glucose Control in a Late Eater Mediterranean Population
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
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-MT
Brief Summary:
The purpose of this investigation is to assess the role of melatonin receptor 1B MTNR1B single nucleotide polymorphism SNPfood 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 25 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
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 n1000
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 n1000
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None