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临床试验/NCT03814512
NCT03814512已完成不适用

Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents: The REM Study

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年3月21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
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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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