Sleep and Obesity in Teenagers: Impact of Sleep Length and Quality on Obesity and Diabetes Risks in Teenagers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- The influence of sleep extension on leptin level for the obese teens group.
研究概览
简要总结
This study aims to investigate
- whether sleep extension results in improvements of endocrine and metabolic markers of obesity and diabetes in obese teenagers,
- the relationship between habitual sleep quality and duration and markers of obesity and diabetes in lean and obese teenagers.
详细描述
Inclusion of 13 obese teens. Duration : 1 week of screening period + 1 week of intervention: habitual/extended sleep length + 1 week of intervention: extended/habitual sleep length. A wash out period of at least 3 months will be required between the two interventions.
Inclusion of 13 non obese healthy teen controls for measuring reference sleep duration and physiology level. Duration for these group: 1 week of screening period + 1 week of habitual sleep length
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female over 15 and under 18 year-old.
- •Teenager with normal weight or stage 2 obesity, according to international standards (WHO)
- •Post-pubescent teenagers (menstruation for girls and stage 4-5 of Tanner scale for boys)
- •Teens with an social security
- •Girl with negative urine pregnancy test
排除标准
- •Active smoker (interview)
- •Refuse consent (parents or teen)
- •Addiction such as coffee, drug...(interview)
- •Medicinal treatment that may influence sleep and measured variables (interview)
- •Obesity diagnosis : less than 1 year (interview)
- •Concomitant diseases : renal or hepatic failure, iron deficit, diabetes, endocrinal pathology, hypertension
- •Anxiety (Spielberg>56), , depression (CDI>19).
- •Mild or sever insomnia (ISI>15), poor sleep quality (PSQI >10), excessive sleepiness (Epworth>10, sleep) length>9 hour), extreme circadian typology (Horne et Ostberg from 70 to 86 or 16 to 30)
- •Blood sample taken within the last two months before inclusion
- •Mild or severe sleep apnoea or excessive leg movements according to EEG analysis
研究组 & 干预措施
1
Study of habitual sleep length on non obese teen group
2
Study of habitual sleep length period followed by extended sleep length period on obese teen group
干预措施: habitual sleep length period + extended sleep length period (Behavioral)
3
Study of extended sleep length period followed by habitual sleep length period on obese teen group
干预措施: extended sleep length period + habitual sleep length period (Behavioral)
结局指标
主要结局
The influence of sleep extension on leptin level for the obese teens group.
时间窗: at the end of each sleep experimental period
次要结局
- Difference between the two groups (obese vs non-obese) regarding sleep length and delta waves activity.(during each sleep experimental period (habitual or extended))
- Study the correlation between delta waves activity and habitual sleep length(During each sleep experimental period)
- Study the correlation between delta waves activity and psychological, behavioural, anthropometric and physiological markers of obesity and its co morbidities(During each sleep experimental period)