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临床试验/NCT04202731
NCT04202731终止不适用

Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
Sleep duration

研究概览

简要总结

Assessing sleep and circadian health in severely obese adolescents undergoing bariatric surgery and examine relation to health outcomes including insulin sensitivity and percent weight loss to date at 1-year and evaluate the impact of sleep extension on health outcomes in this population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ages 12-21 years
  • attending high school or middle school (peak period for insufficient and delayed sleep)
  • completion of bariatric surgery procedure (i.e., vertical sleeve gastrectomy) within the past 2 years but not less than 6 months prior to study participation
  • All must also be Tanner Stage 5

排除标准

  • regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids) or insulin resistance (systemic steroids, other oral diabetes medications)
  • HbA1c ≥6.5%
  • intelligence quotient (IQ) <70 or severe mental illness

结局指标

主要结局

Sleep duration

时间窗: 1 week

Total sleep time at night in hours

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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