Impact of Sleep Education Program on Glycemic Control in Hong Kong Chinese Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 264
- 试验地点
- 4
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
This is a randomized controlled trial with 12 month sleep education as intervention, followed by a 12 month observational period, to study whether sleep education would improve glycemic control and cardiometabolic profile of sleep deprived type 2 diabetic patients and evaluate the neurohormonal changes associated with sleep education.
详细描述
Patients will be identified from the Diabetes Mellitus and Endocrine Centre of Prince of Wales Hospital and Yao Chung Kit Diabetes Assessment Centre, The Chinese University of Hong Kong. All participants will have diabetes complications screening and comphrensive evaluations for glycemic control and cardiometabolic risk factors.Eligible subjects will be randomized to 2 groups (usual or conventional care versus intervention with sleep education program) for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years
- •Type 2 diabetes mellitus
- •Chinese ethnicity
- •Able and willing to give informed written consent
- •Sleep deprived, defined as subjective sleeping time <6 hours per day
排除标准
- •Type 1 diabetes mellitus
- •Known history of psychiatric disorders (e.g. depression, anxiety, dementia)
- •Sleep disorders secondary to another medical condition (e.g. obstructive sleep apnoea (OSA), circadian rhythm sleep disorder)
- •Concomitant chronic medical condition that was likely to be the cause of sleep problem (e.g. benign prostatic hypertrophy, chronic pain)
- •Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep.
- •Any condition, as judged by the investigators, as ineligible to participate in this study
结局指标
主要结局
Change in HbA1c from baseline
时间窗: 12 months
次要结局
- fasting plasma glucose(12 months)
- insulin resistance(12 months)
- body weight(12 months)
- blood pressure(12 months)
- lipid profile(12 months)
- sleep duration(12 months)
研究者
Alice Pik Shan KONG
Associate Professor
Chinese University of Hong Kong