Investigating the Relationship Between Circadian Phase and Insulin Resistance in Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Dim Light Melatonin Onset and Offset
研究概览
简要总结
This study examines the relationship between sleep timing and insulin resistance in adolescents with obesity. The investigators also aim to develop a physiologically-based mathematical model of adolescent sleep/wake and circadian interactions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 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 ages of 15-19
- •BMI > 90th percentile
- •Tanner stage 2 or greater
排除标准
- •Any medications that affect insulin resistance or sleep (e.g., metformin, hormonal contraception, stimulants, atypical antipsychotics)
- •Regular use of melatonin or sleep aids
- •A prior diagnosis of obstructive sleep apnea, diabetes (HbA1c > 6.5), liver disease other than non-alcoholic fatty liver disease, pregnancy or breastfeeding
- •IQ < 70 or severe mental illness that may impact sleep (e.g., schizophrenia, psychotic episodes)
- •Not enrolled in a traditional high school academic program (e.g., home school students)
- •Night shift employment
- •Travel across more than 2 time zones in the month prior to the study
结局指标
主要结局
Dim Light Melatonin Onset and Offset
时间窗: 1 day
\~1mL saliva was collected at 30- to 60- minute intervals in dim light (\<5 lux in the angle of gaze, approximately the light level of candlelight or civil twilight) from approximately 5pm until noon the next day. Dim light melatonin onset (DLMOn) was defined as the linear interpolated clock time at which evening salivary melatonin concentrations increased and remained above a threshold of 3pg/mL. Melatonin offset (DLMOff) was the linear interpolated clock time at which salivary melatonin concentrations fell below this threshold. Later DLMOn and DLMOff are indicative of a later circadian rhythm.
Insulin Sensitivity
时间窗: 3 hours
After an overnight fast, participants completed an oral glucose tolerance test (OGTT) in the morning. Participants consumed a 75g dextrose drink and serum for glucose and insulin concentrations were collected at baseline and every 30 minutes for 3 hours. The homeostatic model assessment for insulin resistance (HOMA-IR) was calculated as \[fasting insulin (μU/ml) x fasting glucose (mmol/l)\] / 22.5); lower HOMA-IR indicates better insulin sensitivity. The Matsuda Index was calculated as √10,000 / \[\[fasting insulin (μU/ml) x fasting glucose (mmol/l)\] x \[mean OSTT insulin (μU/ml) x mean OSTT glucose (mmol/l)\]\]; high Matsuda Index indicates better insulin sensitivity.
次要结局
未报告次要终点