Effectiveness of Resveratrol Addition in Improving Endothelial Dysfunction and Metabolic Control in Type 2 Diabetes Mellitus Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Flow-Mediated Dilatation (FMD) of the Brachial Artery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Resveratrol and placebo will be identical in appearance and packaging.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Resveratrol Group
Participants receive resveratrol 50 mg orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
干预措施: Resveratrol (Drug)
Placebo Group
Participants receive placebo orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Flow-Mediated Dilatation (FMD) of the Brachial Artery
时间窗: 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.
Change in Serum Endothelial Nitric Oxide Synthase (eNOS) Levels
时间窗: Baseline and 12 weeks
Serum endothelial nitric oxide synthase (eNOS) levels will be measured to assess endothelial function before and after intervention.
次要结局
- Change in Fasting Blood Glucose(Baseline and 12 weeks)
- Change in Postprandial Blood Glucose(Baseline and 12 weeks)
- Change in Hemoglobin A1c (HbA1c)(Baseline and 12 weeks)
- Change in LDL Cholesterol(Baseline and 12 weeks)
- Change in HDL Cholesterol(Baseline and 12 weeks)
- Change in Triglyceride Levels(Baseline and 12 weeks)