Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Trials. 2021 Mar 25;22(1):231. doi: 10.1186/s13063-021-05174-z.
Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM).
In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for 8 weeks. Systolic blood pressure (SBP), mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), a body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHtR) were evaluated in all the patients pre- and post-intervention.
Melatonin supplementation for 8 weeks significantly decreased the mean levels of SBP, MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHtR post-intervention (p < 0.05). Also, the median changes of SBP, MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p < 0.05). A significant increase (p < 0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p < 0.001).
Consumption of melatonin supplement may be effective in controlling arterial pressure including SBP, MAP, and PP and anthropometric indices (as predictors of obesity) in T2DM patients.
Iranian Registry of Clinical Trials IRCT20190303042905N1 . Registered on 17 May 2019.
糖尿病是一种常见的慢性疾病。如果不能控制高血糖、胰岛素抵抗和体重增加，糖尿病患者可能会出现血脂异常和高血压等并发症。本研究旨在探讨褪黑素补充剂对 2 型糖尿病（T2DM）患者一些心血管疾病危险因素和人体测量指标的影响。
在这项双盲、随机、安慰剂对照试验中，50 名 T2DM 患者被随机分配到干预组和对照组，每天分别服用两片褪黑素或安慰剂（250mg），持续 8 周。所有患者在干预前后评估收缩压（SBP）、平均动脉压（MAP）、脉压（PP）、血浆致动脉粥样硬化指数（AIP）、体重、体重指数（BMI）、腰围和臀围（WC、HC）、体形成指数（ABSI）、腹部体积指数（AVI）、体脂指数（BAI）、脂质蓄积产物（LAP）、锥度指数和腰高比（WHtR）。
褪黑素补充 8 周后，SBP、MAP、PP、体重、BMI、WC、HC、BAI、AVI、锥度指数和 WHtR 的平均水平显著降低（p<0.05）。此外，与对照组相比，干预组 SBP、MAP、PP、体重、BMI、WC、HC、BAI、AVI 和锥度指数的中位变化明显更低（p<0.05）。干预组 ABSI 的平均水平显著升高（p<0.001）。与对照组相比，干预组 ABSI 的中位变化明显更大（p<0.001）。
褪黑素补充剂的摄入可能有助于控制 T2DM 患者的动脉压（包括 SBP、MAP 和 PP）和人体测量指标（肥胖的预测指标）。
伊朗临床试验注册处 IRCT20190303042905N1。注册于 2019 年 5 月 17 日。
