METHODS: 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).
CONCLUSIONS: 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.
BACKGROUND: ISRCTN registry ISRCTN11967109 . Registered on 9 May 2024.
方法:在这项随机对照试验中,将招募60名患有前驱糖尿病或2型糖尿病且社交时差>1小时的人。干预包括Vitamine-L(Lumie,英国)每天早上30分钟,结合建议,遵循睡眠提前指示,每天晚上佩戴明亮的调光护目镜,为期3周。对照组坚持他们的正常睡眠习惯和条件。主要结果是在12周后在意向治疗分析中比较干预和对照的糖化血红蛋白(HbA1c)。3周和12周时的次要结果是(1)社会时差;(2)胰岛素敏感性,空腹血糖,使用降糖药物,和感知到的低血糖的频率;(3)代谢结果,包括体重指数(BMI),腰围,身体脂肪百分比,和血压;(4)情绪,包括抑郁症,疲劳和焦虑(用问卷测量);和(5)使用EQ5D问卷测量的生活质量。为了评估可能起到调解作用的其他因素,我们将测量(对)交感神经系统活动评估与心电图和电化学皮肤电导测试,使用睡眠测量头带(ZMax)评估睡眠质量和睡眠相位分布,在第3周和第12周的唾液样本中(在一个亚组中)出现弱光褪黑素,用10厘米的视觉模拟量表(VAS)来感受饱腹感和饱腹感,使用食物频率问卷的饮食,和使用加速度计(ActiGraph)的身体活动。
结论:社会时差可能导致2型糖尿病患者血糖控制和代谢控制较差。通过这种干预,我们的目标是减少社会时差,从而改善血糖和代谢控制.这可以提供改善总体人群健康和减少2型糖尿病疾病负担的方法。
背景:ISRCTN注册表ISRCTN11967109。2024年5月9日注册。