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首页> 外文期刊>Diabetes, metabolic syndrome and obesity: targets and therapy >Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study
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Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study

机译：褪黑素缓释剂在糖尿病失眠患者中的疗效和安全性：一项随机，双盲，交叉研究

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Background: Diabetes is a major comorbidity in insomnia patients. The efficacy and safety of prolonged-release melatonin 2 mg in the treatment of glucose, lipid metabolism, and sleep was studied in 36 type 2 diabetic patients with insomnia (11 men, 25 women, age 46–77 years).Methods: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks (period 1) with prolonged-release melatonin or placebo, followed by a one-week washout period, and then crossed over for another 3 weeks (period 2) of treatment with the other preparation. All tablets were taken 2 hours before bedtime for a period of 3 weeks. In an extension period of 5 months, prolonged-release melatonin was given nightly to all patients in an open-label design. Sleep was objectively monitored in a subgroup of 22 patients using wrist actigraphy. Fasting glucose, fructosamine, insulin, C-peptide, triglycerides, total cholesterol, high-density and low-density lipoprotein cholesterol, and some antioxidants, as well as glycosylated hemoglobin (HbA1c) levels were measured at baseline and at the end of the study. All concomitant medications were continued throughout the study.Results: No significant changes in serum glucose, fructosamine, insulin, C-peptide, antioxidant levels or blood chemistry were observed after 3 weeks of prolonged-release melatonin treatment. Sleep efficiency, wake time after sleep onset, and number of awakenings improved significantly with prolonged-release melatonin as compared with placebo. Following 5 months of prolonged-release melatonin treatment, mean HbA1c (±standard deviation) was significantly lower than at baseline (9.13% ± 1.55% versus 8.47% ± 1.67%, respectively, P = 0.005).Conclusion: Short-term use of prolonged-release melatonin improves sleep maintenance in type 2 diabetic patients with insomnia without affecting glucose and lipid metabolism. Long-term prolonged-release melatonin administration has a beneficial effect on HbA1c, suggesting improved glycemic control.
机译：背景：糖尿病是失眠患者的主要合并症。在36名2型糖尿病失眠患者（11名男性，25名女性，年龄46-77岁）中研究了2 mg褪黑素缓释剂治疗葡萄糖，脂质代谢和睡眠的有效性和安全性。一项随机，双盲，交叉研究，用褪黑素或安慰剂延长释放时间治疗受试者3周（期间1），然后进行1周的洗脱期，然后再进行3周（期间2）的交叉治疗用其他制剂治疗。睡前2小时服用所有片剂，持续3周。在5个月的延长期中，以开放标签设计向所有患者每晚服用延长释放的褪黑激素。使用腕部活动记录仪对22名患者的亚组的睡眠进行了客观监测。在基线和研究结束时测量空腹血糖，果糖胺，胰岛素，C肽，甘油三酸酯，总胆固醇，高密度和低密度脂蛋白胆固醇以及一些抗氧化剂以及糖基化血红蛋白（HbA1c）的水平。在整个研究过程中，所有伴随用药均继续进行。结果：长期释放褪黑激素治疗3周后，未观察到血清葡萄糖，果糖胺，胰岛素，C肽，抗氧化剂水平或血液化学的显着变化。与安慰剂相比，长期释放褪黑激素可显着改善睡眠效率，入睡后的唤醒时间和清醒次数。褪黑激素延长释放治疗5个月后，平均HbA1c（±标准偏差）显着低于基线水平（分别为9.13％±1.55％和8.47％±1.67％，P = 0.005）。褪黑素的延长释放可改善2型糖尿病失眠患者的睡眠，而不会影响葡萄糖和脂质的代谢。长期长期释放褪黑激素对HbA1c有有益作用，提示改善了血糖控制。

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