Non-Diabetic Disorder of Endocrine Pancreas Clinical Trial
Official title:
MTNR1B SNP*Food Timing Interaction on Glucose Control in a Late Eater Mediterranean Population
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.
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).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03003936 -
Glucose Tolerance, Meal Timing and MTNR1B
|
N/A |