Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Total Plasma Ceramides
研究概览
简要总结
The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
详细描述
A randomized controlled trial with real-world sleep extension in adults with overweight and obesity who habitually obtain short sleep duration will be conducted. Group allocation will be 1:1 and research staff and participants will be blinded until the conclusion of the baseline segment. The sleep extension group will receive counseling and instruction to increase nightly time in bed by 2 hours per night. Participants randomized to control will maintain their habitual sleep habits in their home environment. The intervention segment will last 8 weeks regardless of group assignment. Both groups will have equal contact time with the study team.
Prior to enrollment participants will complete a clinical overnight sleep disorders screening. Baseline consists of an ~1-week ambulatory real-world monitoring segment. Following baseline, participants will be randomized 1:1 to either the sleep extension or control group for 8 weeks at home (intervention segment). Throughout the study, sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. Following the baseline and intervention segments participants will complete rigorous overnight laboratory visits to assess plasma ceramides (targeted metabolomics assay) and insulin sensitivity (hyperinsulinemic-euglycemic clamp).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-45 years old; equal numbers of men and women
- •Body mass index (BMI): 27.5-34.9 kg/m2
- •Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months
排除标准
- •Clinically diagnosed sleep disorder or major psychiatric illness
- •Evidence of significant organ dysfunction or disease (e.g., heart disease, kidney disease)
- •Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
- •Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications.
- •Cancer that has been in remission less than 5 years
- •Pregnant/nursing, experiencing menopause or post-menopausal
- •Shift-work: current or history of within last year
- •Weight change: >10% of body weight over prior six months
- •Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
- •Currently smoking
- •Alcohol intake>14 drinks per week or >3 drinks per day
研究组 & 干预措施
Control Group
Provided with general health information on diet and physical activity.
Intervention Group
Sleep extension-based intervention focused on increasing time in bed by 2 hours per night.
干预措施: Sleep Extension Intervention (Behavioral)
结局指标
主要结局
Total Plasma Ceramides
时间窗: Immediately after the intervention
Total plasma ceramides will be measured by assessing plasma ceramides by targeted metabolomics.
Insulin Sensitivity
时间窗: Immediately after the intervention
Insulin sensitivity will be measured by the glucose infusion rate per kg body weight during the hyperinsulinemic-euglycemic clamp.
次要结局
- Circadian Phase (change from baseline)(Immediately after the intervention)
- Body Mass Index(Immediately after the intervention)
- Average (per week) nightly total sleep time (change from baseline)(Analyzed as change from baseline for each week of the ~8 week experimental segment)
- Average (per week) sleep satisfaction change from baseline(Analyzed as change from baseline for each week of the ~8 week experimental segment)
- Average (per week) timing of food intake change from baseline(During the baseline ambulatory assessment and weeks 2, 4, 6, and 8 of the intervention ambulatory assessment.)
- Average (per week) daytime alertness change from baseline(Time Frame: Analyzed as change from baseline for each week of the ~8 week experimental segment)
- Individual C16, C18, C20, C22, C24, and C24:1 Plasma Ceramides, Dihydroceramides, Glucosylceramides, and fourteen Sphingolipids.(Immediately after the intervention)
- Cardiac Event Risk Test 1 (CERT 1)(Immediately after the intervention)
研究者
Christopher Depner
Assistant Professor
University of Utah