Amsterdam UMC location Vrije Universiteit Amsterdam, Epidemiology and Data Science, Meibergdreef 9, Amsterdam, The Netherlands.
Amsterdam Public Health, Health Behaviors & Chronic Diseases, Amsterdam, The Netherlands.
Trials. 2024 Jul 12;25(1):474. doi: 10.1186/s13063-024-08329-w.
Social jetlag is a chronic disruption of sleep timing that is characterized by different sleep timing during workdays and free days. Social jetlag has been associated with disturbed glucose metabolism, insulin resistance, and increased risk of metabolic syndrome and type 2 diabetes. In this study, we aim to investigate whether a combination of bright light therapy in the morning, bright light reduction in the evening and sleep advance instructions for 3 weeks reduces social jetlag and if this results in improvement of glycemic and metabolic control, sleep, mood and quality of life after 3 and 12 weeks in people with prediabetes and type 2 diabetes and to assess possible mediators, compared to regular sleep habits.
In this randomized controlled trial, 60 people with prediabetes or type 2 diabetes with > 1 h social jetlag will be recruited. The intervention consists of bright light therapy (5000 lx) emitted by Vitamine-L (Lumie, UK) for 30 min each morning, combined with the advice to follow sleep advance instructions and to wear bright light-dimming goggles every evening for a period of 3 weeks. The control group adheres to their regular sleep habits and conditions. The primary outcome is glycated hemoglobin (HbA1c) after 12 weeks comparing the intervention and control in an intention-to-treat analysis. Secondary outcomes at 3 and 12 weeks are (1) social jetlag; (2) insulin sensitivity, fasting blood glucose, glucose-lowering medication use, and frequency of perceived hypoglycemia; (3) metabolic outcomes, including body mass index (BMI), waist circumference, body fat percentage, and blood pressure; (4) mood, including depression, fatigue and anxiety (measured with questionnaires); and (5) quality of life measured using EQ5D questionnaire. To assess other factors that might play a role as possible mediators, we will measure (para)sympathetic nervous system activity assessed with ECGs and electrochemical skin conductance tests, sleep quality and sleep phase distribution assessed with a sleep measuring headband (ZMax), the Dim Light Melatonin Onset in saliva samples (in a subgroup) at 3 and 12 weeks, the feeling of satiety and satiation with a 10-cm visual analog scale (VAS), diet using a food frequency questionnaire, and physical activity using an accelerometer (ActiGraph).
Social jetlag can contribute to poorer glycemic control and metabolic control in those with type 2 diabetes. With this intervention, we aim to reduce social jetlag and thereby improve glycemic and metabolic control. This could offer a way to improve overall population health and to reduce the disease burden of type 2 diabetes.
ISRCTN registry ISRCTN11967109 . Registered on 9 May 2024.
社会时差是一种慢性睡眠时间紊乱，其特征是工作日和休息日的睡眠时间不同。社会时差与葡萄糖代谢紊乱、胰岛素抵抗以及代谢综合征和 2 型糖尿病风险增加有关。在这项研究中，我们旨在研究为期 3 周的早晨进行强光治疗、晚上减少强光照射和提前睡眠指导的组合是否可以减少社会时差，如果这可以改善血糖和代谢控制，在有前驱糖尿病和 2 型糖尿病的人群中，3 周和 12 周后的睡眠、情绪和生活质量，并评估可能的介导因素，与常规睡眠习惯相比。
在这项随机对照试验中，将招募 60 名有前驱糖尿病或 2 型糖尿病且社会时差超过 1 小时的人。干预措施包括每天早晨使用 Vitamine-L（Lumie，英国）进行 30 分钟的 5000 lx 强光治疗，同时建议遵循提前睡眠指导，并在晚上佩戴明亮光暗化护目镜，持续 3 周。对照组遵循他们的常规睡眠习惯和条件。主要结局是在 12 周时进行意向治疗分析，比较干预组和对照组的糖化血红蛋白（HbA1c）。次要结局在 3 周和 12 周时评估为：（1）社会时差；（2）胰岛素敏感性、空腹血糖、降糖药物使用和感知低血糖的频率；（3）代谢结果，包括体重指数（BMI）、腰围、体脂百分比和血压；（4）使用 EQ5D 问卷评估情绪，包括抑郁、疲劳和焦虑；（5）使用睡眠测量头带（ZMax）评估睡眠质量和睡眠阶段分布，在唾液样本中测量（副）交感神经系统活动，使用心电图和电化学皮肤电导率测试（在亚组中）在 3 周和 12 周时测量（在亚组中），使用 10 厘米视觉模拟量表（VAS）评估饱腹感和饱腹感，使用食物频率问卷评估饮食，使用加速度计（ActiGraph）评估体力活动。
社会时差会导致 2 型糖尿病患者血糖控制和代谢控制更差。通过这种干预，我们旨在减少社会时差，从而改善血糖和代谢控制。这可能为改善整体人群健康和减少 2 型糖尿病的疾病负担提供一种方法。
ISRCTN 注册表 ISRCTN84346567 。于 2024 年 5 月 9 日注册。
