MTNR1B SNP*Food Timing Interaction on Glucose Control in a Late Eater Mediterranean Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 889
- 试验地点
- 2
- 主要终点
- Area Under the Curve (AUC) Glucose
研究概览
简要总结
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.
详细描述
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 (n=1000).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index: > 18.5 o < 40 kg/m2
- •Age: between 18 and 65 year of age
- •European ancestry
- •Day workers
排除标准
- •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.
结局指标
主要结局
Area Under the Curve (AUC) Glucose
时间窗: Along 120 minutes in visits 1 and 2
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.
Disposition Index (DI)
时间窗: Along 120 minutes in visits 1 and 2
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.
次要结局
- Fasting Glucose(At minute 0 in visit 1 and 2.)
- Serum Melatonin(At baseline and 120 minutes in visit 1 and 2)
- Corrected Insulin Response (CIR)(At minute 30 during the visit 1 and 2.)
- Fasting Insulin(At minute 0 in visit 1 and 2)
- Dim Light Melatonin Onset (DLMO) at Early Condition Only(Melatonin measured every half hour for 5 hours at Early condition in all participants)
- Insulin Sensitivity Index (ISI)(Along 120min in visits 1 and 2)
研究者
PROF. MARTA GARAULET AZA
Full Professor
Universidad de Murcia