Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents: The REM Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Total Sleep Time
研究概览
简要总结
The investigators propose to deliver a 4-week sleep extension intervention to adolescents to evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes in metabolic parameters induced by sleep extension.
详细描述
The specific aims of this feasibility study are to 1) examine the feasibility of recruitment and retention of adolescents with overweight/obesity, pre-diabetes, and inadequate sleep into a sleep extension intervention; 2) assess adherence of a sleep extension intervention to increase total sleep time in adolescents with overweight/obesity, pre-diabetes, and inadequate sleep; 3) determine estimates of mean and variability of potential intervention outcomes including metabolomic, body composition, and substrate oxidation. The investigators propose to deliver a 4-week sleep extension intervention to adolescents to evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes in metabolic parameters induced by sleep extension.
This proposal is the first step to demonstrate feasibility in delivering the intervention in a research setting, measure the effect of the intervention on changing sleep duration, and examine changes in obesity-related IR metabolites that would lead to improved IR in an adolescent population with pre-diabetes. The long-term goal is to disseminate an effective and feasible T2D prevention program that can be sustainably implemented in clinical weight management settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High school students between the age of 13-19 years
- •BMI >85th percentile for age and sex
- •Prediabetes defined as a HbA1c 5.7-6.4%
- •Tanner Stage 4-5 (based on breast development for girls and testicular size for boys)
排除标准
- •Any medications that affect insulin resistance or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
- •Regular use of melatonin or other sleep aids
- •A prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea) or abnormal scores on sleep disorders screening measures
- •Type 2 diabetes (HbA1c ≥ 6.5%)
- •IQ<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes), verified through chart review
- •Teens not enrolled in a traditional high school academic program (e.g., home school students)
- •Schedules that would preclude participants from adhering to the sleep extension protocol (e.g. night shift employment)
- •Travel across more than two time zones in the 2 weeks prior to the study
结局指标
主要结局
Change in Total Sleep Time
时间窗: up to 12 weeks
The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention
次要结局
未报告次要终点
