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临床试验/NCT04759755
NCT04759755已完成不适用

Circadian and Sleep Pathways to Cardiometabolic Disease Risk: Role of Neurobehavioral Processes

University of Utah1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2019年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
1
主要终点
Insulin resistance

研究概览

简要总结

This study design will test biological and behavioral mechanisms in the cross-sectional analyses and determine the prospective effects of circadian alignment and sleep on changes in cardiometabolic risk factors.

详细描述

The goal of this study is to determine how sleep and circadian rhythm alignment contribute to neurobehavioral and behavioral mechanisms of cardiometabolic risk. The investigators propose that circadian misalignment, which is more common among individuals with late sleep timing, leads to increased consumption of energy dense/prepared foods and to decreased insulin sensitivity. Short sleep duration and neurobehavioral measures (i.e. delay discounting) may moderate these associations, thus exacerbating cardiometabolic risk factors. There is evidence for a direct biological link between circadian misalignment and insulin resistance, and for a relationship that is mediated through changes in eating behaviors. Insulin resistance and increased caloric intake over time lead to increased BMI and body fat.

In this study, the investigators will conduct cross-sectional and longitudinal analyses to determine biological and behavioral mechanisms that link circadian alignment and sleep duration to changes in cardiometabolic risk over 1 year. This study will identify individual differences that predict risk for cardiometabolic disorders and suggest potential for sleep, circadian and neurobehavioral interventions to reduce cardiometabolic risk.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Demonstrate habitual sleep onset time between 10:00 pm-3:00 am on actigraphy;
  • able to read and write in English;
  • BMI 25-39.9 (overweight, class one obesity, or class two obesity)

排除标准

  • High risk or presence of sleep disorders (obstructive sleep apnea (OSA), restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight OSA screening;
  • Diagnosed with diabetes or HbA1c>7 at screening or taking medications known to affect glucose;
  • History of cognitive or neurological disorders;
  • Presence of major psychiatric disorders, current alcohol or substance abuse as determined by screening questionnaires or self-report;
  • Unstable or serious medical illness;
  • Overnight shift work or travel over 2 time zones in the past 2 months;
  • Use of hypnotic, stimulant or medications know to affect melatonin concentrations such as beta blockers, daily NSAIDs;
  • Current smoking;
  • Daily caffeine intake >300 mg;
  • Pregnant or lactating;
  • Currently on a restrictive of special diet.

结局指标

主要结局

Insulin resistance

时间窗: Baseline

Measured by a frequently sampled IV glucose tolerance test

次要结局

  • Delay discounting(Baseline)
  • Eating behaviors(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelly Glazer Baron

Associate Professor

University of Utah

研究点 (1)

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