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Completed

NCT Number: NCT07569744

Resveratrol for Endothelial Dysfunction and Metabolic Control in Type 2 Diabetes

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Sriwijaya

Palembang, South Sumatera, 30126, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Drug

Resveratrol 50 mg administered orally once daily for 12 weeks.

Other names: Lecitrol

Placebo

Drug

Matching placebo administered orally once daily for 12 weeks.

Primary outcomes

  1. Change in Flow-Mediated Dilatation (FMD) of the Brachial Artery

    Time frame: 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.

  2. Change in Serum Endothelial Nitric Oxide Synthase (eNOS) Levels

    Time frame: Baseline and 12 weeks

    Serum endothelial nitric oxide synthase (eNOS) levels will be measured to assess endothelial function before and after intervention.

Secondary outcomes

  1. Change in Fasting Blood Glucose

    Time frame: Baseline and 12 weeks

    Fasting blood glucose levels will be measured to assess glycemic control before and after intervention.

  2. Change in Postprandial Blood Glucose

    Time frame: Baseline and 12 weeks

    Postprandial blood glucose levels will be measured to assess glycemic control before and after intervention.

  3. Change in Hemoglobin A1c (HbA1c)

    Time frame: Baseline and 12 weeks

    HbA1c levels will be measured to evaluate long-term glycemic control before and after intervention.

  4. Change in LDL Cholesterol

    Time frame: Baseline and 12 weeks

    LDL cholesterol levels will be measured before and after intervention.

  5. Change in HDL Cholesterol

    Time frame: Baseline and 12 weeks

    HDL cholesterol levels will be measured before and after intervention.

  6. Change in Triglyceride Levels

    Time frame: Baseline and 12 weeks

    Triglyceride levels will be measured before and after intervention.

Sponsors and collaborators

Lead sponsor

Universitas Sriwijaya

Other

Registry information

Official study title

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

Acronym: RESENDO-DM2

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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