褪黑素补充对慢性肾脏病合并糖尿病患者代谢参数、氧化应激和炎症生物标志物的影响：一项双盲、随机对照试验的研究方案。

Effects of melatonin supplementation on metabolic parameters, oxidative stress, and inflammatory biomarkers in diabetic patients with chronic kidney disease: study protocol for a double-blind, randomized controlled trial.

机构信息

Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.

Department of Nephrology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Trials. 2024 Nov 13;25(1):757. doi: 10.1186/s13063-024-08584-x.

DOI:10.1186/s13063-024-08584-x

PMID:39533376

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11559127/

Abstract

INTRODUCTION

Chronic kidney disease (CKD) is a pervasive disease of the current century that usually affects the adult population, especially people with diabetes and hypertension. According to the recent studies, inflammation, oxidative stress, apoptosis, and mitochondrial dysfunction are determining risk factors in the pathogenesis of CKD. Melatonin as a strong antioxidant is produced in various tissues including the kidneys. The present clinical trial aims to examine the efficacy of melatonin supplementation on metabolic parameters, oxidative stress, and inflammatory biomarkers in diabetic patients with CKD.

METHODS

This is a double-blind, randomized, placebo-controlled clinical study that will be investigated the impacts of melatonin supplementation in diabetic patients with CKD. Laboratory findings will be applied to diagnose diabetic CKD. Forty-eight eligible diabetic subjects with CKD will be selected and randomly assigned to receive 5 mg melatonin tablets or identical placebo twice daily for 10 weeks. Participants will be asked to remain on their usual diet and physical activity. The primary outcome of this study is changes in oxidative stress and inflammatory biomarkers. The secondary outcomes include changes in lipid profile, renal function indicators, fasting blood sugar and serum insulin, systolic and diastolic blood pressure (SBP and DBP), serum phosphorous concentration, sleep quality, body weight, body mass index (BMI), and waist circumference (WC). Statistical analysis will be conducted using the SPSS software (version 25).

DISCUSSION

We hypothesize that melatonin administration may be useful for treating diabetic CKD by modulating oxidative stress, inflammation, regulating lipid metabolism, and increasing insulin sensitivity through different mechanisms. The current trial will exhibit the effects of melatonin, whether negative or positive, on diabetic CKD status.

ETHICAL ASPECTS

The current trial received approval from Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.SHARIATI.REC.1402.072).

TRIAL REGISTRATION

This study had been registered in Iranian Registry of Clinical Trials.

REGISTRATION NUMBER

IRCT20170202032367N9 on 11 August 2023. https://www.irct.ir/trial/70709 .

摘要

简介

慢性肾脏病（CKD）是本世纪普遍存在的疾病，通常影响成年人群，尤其是患有糖尿病和高血压的人群。根据最近的研究，炎症、氧化应激、细胞凋亡和线粒体功能障碍是 CKD 发病机制中的决定风险因素。褪黑素作为一种强大的抗氧化剂，存在于包括肾脏在内的各种组织中。本临床研究旨在检验褪黑素补充剂对 CKD 糖尿病患者代谢参数、氧化应激和炎症生物标志物的疗效。

方法

这是一项双盲、随机、安慰剂对照的临床研究，旨在研究褪黑素补充剂对 CKD 糖尿病患者的影响。实验室结果将用于诊断糖尿病 CKD。将选择 48 名符合条件的 CKD 糖尿病患者，并将其随机分为两组，分别每天两次服用 5mg 褪黑素片或相同的安慰剂，持续 10 周。参与者将被要求保持其常规饮食和体育活动。本研究的主要结果是氧化应激和炎症生物标志物的变化。次要结果包括血脂谱、肾功能指标、空腹血糖和血清胰岛素、收缩压和舒张压（SBP 和 DBP）、血清磷浓度、睡眠质量、体重、体重指数（BMI）和腰围（WC）的变化。统计分析将使用 SPSS 软件（版本 25）进行。