Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Disposition Index
研究概览
简要总结
This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.
详细描述
The investigators' recent GWAS discovery of MTNR1B as a novel type 2 diabetes gene has sparked great interest into the role of melatonin in glycemic control, for which the mechanism is largely unknown. This research will determine the effect of melatonin and MTNR1B on glycemic control under highly-controlled, in-laboratory protocols while manipulating circulating melatonin concentrations (both up and down) and assessing glycemic control by frequently-sampled intravenous glucose tolerance tests, as well as in ex vivo human pancreatic islets. This research will provide mechanistic insights into the metabolic effects of melatonin and the MTNR1B risk variant and may help in evidence-based approaches and personalized recommendations to improve glycemic control in night shift workers and late-night eaters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index: 20 and 35 kg/m2
- •Age: 21-55 years of age
- •Caucasian
- •Non-smoking
- •With regular sleep-wake cycle
- •Passed medical and psychological screening tests
排除标准
- •Acute, chronic or debilitating medical conditions
- •History of neurological or psychiatric disorder
- •History of sleep disorder or regular use of sleep-promoting medication
- •Current prescription, herbal, or over-the-counter medication use
- •Traveling across 2 or more time zones within past 3 months
- •Worked night or rotating shift work within past 1 year
- •Drug or alcohol dependency
研究组 & 干预措施
melatonin-placebo
subjects will receive melatonin first and placebo second
干预措施: melatonin (Dietary Supplement)
melatonin-placebo
subjects will receive melatonin first and placebo second
干预措施: placebo (Drug)
placebo-melatonin
subjects will receive placebo first and melatonin second
干预措施: melatonin (Dietary Supplement)
placebo-melatonin
subjects will receive placebo first and melatonin second
干预措施: placebo (Drug)
结局指标
主要结局
Disposition Index
时间窗: During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visit
Disposition index is determined by frequently sampled intravenous glucose tolerance test. It is a composite measure of β-cell function adjusted for insulin sensitivity-was calculated as the product of insulin sensitivity and insulin secretion indices. High value means stronger β-cell function. Theoretical minimum is 0, no theoretical maximum.
次要结局
- First-phase Beta-cell Responsivity(During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visit)
- Insulin Sensitivity(During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visit)
- Glucose Tolerance(During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visit)
研究者
Frank AJL Scheer, PhD
Professor of Medicine
Brigham and Women's Hospital