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Resveratrol for Endothelial Dysfunction and Metabolic Control in Type 2 Diabetes (RESENDO-DM2)

2026年6月14日 更新者:Universitas Sriwijaya

Effectiveness of Resveratrol Addition in Improving Endothelial Dysfunction and Metabolic Control in Type 2 Diabetes Mellitus Patients: A Randomized Controlled Trial

Type 2 diabetes mellitus is associated with endothelial dysfunction, which contributes to increased cardiovascular risk. Chronic hyperglycemia induces oxidative stress and reduces nitric oxide bioavailability, leading to impaired endothelial function. Resveratrol, a natural polyphenol with antioxidant and anti-inflammatory properties, has been shown to improve endothelial function in experimental studies.

This randomized controlled trial aims to evaluate the effectiveness of resveratrol supplementation in improving endothelial dysfunction and metabolic control in patients with type 2 diabetes mellitus. Endothelial function will be assessed using flow-mediated dilatation (FMD) of the brachial artery and serum endothelial nitric oxide synthase (eNOS) levels. Metabolic parameters including fasting blood glucose, postprandial glucose, HbA1c, and lipid profile will also be evaluated.

研究概览

详细说明

Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular disease, in which endothelial dysfunction plays a central role. Chronic hyperglycemia leads to oxidative stress and increased production of reactive oxygen species, resulting in decreased nitric oxide bioavailability and impaired endothelial function.

Resveratrol (3,5,4-trihydroxystilbene) is a natural polyphenol with antioxidant, anti-inflammatory, and endothelial-protective effects. Previous experimental and clinical studies have suggested that resveratrol may improve endothelial function through enhancement of endothelial nitric oxide synthase (eNOS) activity and reduction of oxidative stress.

This study is a randomized controlled trial involving patients with type 2 diabetes mellitus and endothelial dysfunction. Participants will be randomized to receive either resveratrol 50 mg or placebo for 12 weeks. Endothelial function will be evaluated using flow-mediated dilatation (FMD) of the brachial artery and serum eNOS levels before and after intervention.

Metabolic control will be assessed by measuring fasting blood glucose, postprandial glucose, HbA1c, and lipid profile including LDL, HDL, and triglycerides. The primary objective is to determine whether resveratrol supplementation improves endothelial function, while secondary outcomes include changes in metabolic parameters and safety evaluation.

This study aims to provide evidence regarding the role of resveratrol as an adjunct therapy in improving endothelial function and metabolic control in patients with type 2 diabetes mellitus.

研究类型

介入性

注册 (实际的)

48

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • South Sumatera
      • Palembang、South Sumatera、印度尼西亚、30126
        • Universitas Sriwijaya

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 18-65 years
  • Diagnosed with type 2 diabetes mellitus
  • Evidence of endothelial dysfunction
  • Stable antidiabetic therapy for at least 3 months prior to enrollment
  • Willing to participate and provide informed consent

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Acute or chronic infection
  • History of cardiovascular events (e.g., myocardial infarction, stroke)
  • Severe renal impairment or hepatic dysfunction
  • Pregnancy or breastfeeding
  • Use of antioxidant supplements or investigational drugs within the last 3 months
  • Known allergy or contraindication to resveratrol

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Resveratrol Group
Participants receive resveratrol 50 mg orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
Resveratrol 50 mg administered orally once daily for 12 weeks.
其他名称:
  • Lecitrol
安慰剂比较:Placebo Group
Participants receive placebo orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
Matching placebo administered orally once daily for 12 weeks.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Flow-Mediated Dilatation (FMD) of the Brachial Artery
大体时间:Baseline and 12 weeks
Flow-mediated dilatation (FMD) will be measured as the percentage change in brachial artery diameter using ultrasound before and after intervention.
Baseline and 12 weeks
Change in Serum Endothelial Nitric Oxide Synthase (eNOS) Levels
大体时间:Baseline and 12 weeks
Serum endothelial nitric oxide synthase (eNOS) levels will be measured to assess endothelial function before and after intervention.
Baseline and 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in Fasting Blood Glucose
大体时间:Baseline and 12 weeks
Fasting blood glucose levels will be measured to assess glycemic control before and after intervention.
Baseline and 12 weeks
Change in Postprandial Blood Glucose
大体时间:Baseline and 12 weeks
Postprandial blood glucose levels will be measured to assess glycemic control before and after intervention.
Baseline and 12 weeks
Change in Hemoglobin A1c (HbA1c)
大体时间:Baseline and 12 weeks
HbA1c levels will be measured to evaluate long-term glycemic control before and after intervention.
Baseline and 12 weeks
Change in LDL Cholesterol
大体时间:Baseline and 12 weeks
LDL cholesterol levels will be measured before and after intervention.
Baseline and 12 weeks
Change in HDL Cholesterol
大体时间:Baseline and 12 weeks
HDL cholesterol levels will be measured before and after intervention.
Baseline and 12 weeks
Change in Triglyceride Levels
大体时间:Baseline and 12 weeks
Triglyceride levels will be measured before and after intervention.
Baseline and 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Yulianto Kusnadi, MD, DR、Faculty of Medicine Universitas Sriwijaya / RSUP Dr. Mohammad Hoesin Palembang
  • 研究主任:Rita Sriwulandari, MD、Division of Endocrinology, FK UNSRI / RSMH Palembang

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月1日

初级完成 (实际的)

2026年6月1日

研究完成 (实际的)

2026年6月10日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月14日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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