NCT04202731终止不适用
Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
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
- 是
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
研究点 (2)
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