NCT01786564已完成不适用
Home Sleep and Circadian Phase: Mediators of Diabetes Risk
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Oral Disposition Index
研究概览
简要总结
The purpose of this study is to determine if deficient sleep and/or disruption with the body's internal clock ("circadian rhythms") are associated with diabetes risk. This study is being done to look at the possible relationships between sleep and risk of diabetes by examining sleep in the home and diabetes risk in the laboratory.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 21-50 years
- •BMI <40 kg/m
- •No major illness.
- •No history of psychiatric, endocrine, cardiac or sleep disorders,
- •Premenopausal, non-pregnant women.
- •Those with dyslipidemia and hypertension will be included if these conditions are controlled by a stable treatment, such as lipid-lowering or antihypertensive medications (except beta blockers).
- •Exclusion criteria include:
- •Persons with diabetes.
- •Persons with diagnosed sleep disorders or apnea-hypopnea index>
- •History of cardiovascular event or disease (excluding controlled hypertension).
- •Major psychiatric disorder or other major illness.
- •Persons taking medications, including but not limited to antidepressants and hypnotics (but excluding lipid-lowering drugs and anti-hypertensive medications as mentioned above).
- •Persons regularly taking medication that affects melatonin such as beta blockers and exogenous melatonin.
- •Anyone who tests positive for common drugs of abuse.
- •People with color blindness.
- •People who have had Lasik eye surgery.
- •People who work night shifts.
- •Participants who travel across multiple time zones will be studied only after they have remained in the Central Time Zone (or Indiana) for one month prior to the study.
排除标准
- 未提供
结局指标
主要结局
Oral Disposition Index
时间窗: baseline
The oral disposition index is based on the glucose and insulin levels during the first 30 minutes of a frequently sampled 5-hour oral glucose tolerance test. It reflects the combination of insulin sensitivity and insulin release in response to the glucose challenge. Higher values suggest a greater response.
次要结局
未报告次要终点
研究者
Kristen Knutson
Associate Professor
Northwestern University
研究点 (1)
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