Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study.
Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study.
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DOI：
10.2147/dmso.s23904
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发表时间：
2011
期刊：
影响因子：
--
通讯作者：
Zisapel N
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文献类型：
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作者：
Garfinkel D;Zorin M;Wainstein J;Matas Z;Laudon M;Zisapel N
糖尿病是失眠患者的主要合并症。在36例2型糖尿病伴失眠患者（11例男性，25例女性，年龄46-77岁）中研究了缓释褪黑素2 mg治疗血糖、脂代谢和睡眠的有效性和安全性。在一项随机、双盲、交叉研究中，受试者接受3周（第1阶段）的长效褪黑激素或安慰剂治疗，随后是1周的洗脱期，然后再交叉接受另一种制剂治疗3周（第2阶段）。所有片剂均在睡前2小时服用，持续3周。在5个月的延长期内，在开放标签设计中，每晚给予所有患者缓释褪黑激素。使用腕动记录仪对22例患者的睡眠进行客观监测。在基线和研究结束时测量了空腹血糖、果糖胺、胰岛素、C肽、甘油三酯、总胆固醇、高密度和低密度脂蛋白胆固醇和一些抗氧化剂以及糖基化血红蛋白（HbA 1c）水平。在整个研究期间继续使用所有合并用药。在3周的缓释褪黑激素治疗后，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没有显著变化。与安慰剂相比，使用缓释褪黑激素后，睡眠效率、入睡后的清醒时间和清醒次数显著改善。在5个月的褪黑素缓释治疗后，平均HbA 1c（±标准差）显著低于基线水平（分别为9.13% ± 1.55%和8.47% ± 1.67%，P = 0.005）。短期使用缓释褪黑激素改善2型糖尿病失眠患者的睡眠维持，而不影响糖和脂质代谢。长期缓释褪黑激素给药对HbA 1c具有有益作用，表明血糖控制得到改善。
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). 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. 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). 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.