Melatonin supplementation to treat the metabolic syndrome: a randomized controlled trial.

Melatonin supplementation to treat the metabolic syndrome: a randomized controlled trial.
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DOI:
10.1186/1758-5996-6-124
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发表时间:
2014
影响因子:
4.8
通讯作者:
Kutner MH
Kutner MH
中科院分区:
医学2区
文献类型:
--
作者:
Goyal A;Terry PD;Superak HM;Nell-Dybdahl CL;Chowdhury R;Phillips LS;Kutner MH

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补充褪黑素可能改善代谢综合征(MetS)成分,但缺乏安慰剂对照试验的数据。我们进行了一项双盲、安慰剂对照、交叉、II期随机临床试验,以评估褪黑素补充对MetS成分和MetS总体患病率的影响。我们随机分配了39名met患者,每晚接受8.0 mg口服褪黑素或匹配的安慰剂,持续10周。在6周的洗脱期后,受试者接受另外10周的治疗。在两个10周的治疗期开始和结束时,我们测量了每个受试者的腰围、甘油三酯、高密度脂蛋白胆固醇、空腹血糖和血压(BP)。主要结果是每个代谢产物成分在10周内的平均变化,次要结果是褪黑激素与安慰剂对比后无代谢产物的受试者比例。大多数MetS成分的平均10周变化倾向于褪黑激素而不是安慰剂(空腹血糖除外):腰围-0.9 vs +1.0 cm (p = 0.15);甘油三酯-66.3 vs -4.2 mg/dL (p = 0.17);高密度脂蛋白胆固醇-0.2 vs -1.1 mg/dL (p = 0.59);空腹血糖+0.3 vs. -3.1 mg/dL (p = 0.29);收缩压-2.7 vs. +4.7 mmHg (p = 0.013);舒张压-1.1 vs. +1.1 mmHg (p = 0.24)。与安慰剂治疗相比,褪黑激素治疗后,MetS的自由更常见(前10周后,35.3%对15.0%,p = 0.25;后10周,45.0%对23.5%,p = 0.30)。褪黑素耐受性良好。与安慰剂相比,补充褪黑激素适度改善了大多数个体MetS成分,并且倾向于增加治疗后无MetS的受试者比例。NCT01038921, clinicaltrials.gov
Supplemental melatonin may ameliorate metabolic syndrome (MetS) components, but data from placebo-controlled trials are lacking. We conducted a double-blind, placebo-controlled, crossover, Phase II randomized pilot clinical trial to estimate the effects of melatonin supplementation on MetS components and the overall prevalence of MetS. We randomized 39 subjects with MetS to receive 8.0 mg oral melatonin or matching placebo nightly for 10 weeks. After a 6-week washout, subjects received the other treatment for 10 more weeks. We measured waist circumference, triglycerides, HDL cholesterol, fasting glucose, and blood pressure (BP) in each subject at the beginning and end of both 10-week treatment periods. The primary outcome was the mean 10-week change in each MetS component, and a secondary outcome was the proportion of subjects free from MetS, after melatonin versus placebo. The mean 10-week change for most MetS components favored melatonin over placebo (except fasting glucose): waist circumference -0.9 vs. +1.0 cm (p = 0.15); triglycerides -66.3 vs. -4.2 mg/dL (p = 0.17); HDL cholesterol -0.2 vs. -1.1 mg/dL (p = 0.59); fasting glucose +0.3 vs. -3.1 mg/dL (p = 0.29); systolic BP -2.7 vs. +4.7 mmHg (p = 0.013); and diastolic BP -1.1 vs. +1.1 mmHg (p = 0.24). Freedom from MetS tended to be more common following melatonin versus placebo treatment (after the first 10 weeks, 35.3% vs. 15.0%, p = 0.25; after the second 10 weeks, 45.0% vs. 23.5%, p = 0.30). Melatonin was well-tolerated. Melatonin supplementation modestly improved most individual MetS components compared with placebo, and tended to increase the proportion of subjects free from MetS after treatment. NCT01038921, clinicaltrials.gov
DOI: 10.2337/diacare.28.7.1769
发表时间: 2005-07-01
期刊: DIABETES CARE
影响因子: 16.2
作者:
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发表时间: 2011-01-01
影响因子: 2.9
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DOI: 10.1111/j.1600-079x.2005.00297.x
发表时间: 2006-03-01
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DOI: 10.1038/ng.1053
发表时间: 2012-01-29
期刊: NATURE GENETICS
影响因子: 30.8
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DOI: 10.1136/bmj.38731.532766.f6
发表时间: 2006-02-18
影响因子: 105.7
作者:
Buscemi, N;Vandermeer, B;Baker, G
通讯作者: Baker, G