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

May 7, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rita Sriwulandari, MD

Study Locations

  • Indonesia
    • South Sumatera
      • Palembang, South Sumatera, Indonesia, 30126
        • Universitas Sriwijaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resveratrol Group
Participants receive resveratrol 50 mg orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
Drug: Resveratrol
Resveratrol 50 mg administered orally once daily for 12 weeks.
Other Names:
  • Lecitrol
Placebo Comparator: Placebo Group
Participants receive placebo orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
Drug: Placebo
Matching placebo administered orally once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
Change in LDL Cholesterol
Time Frame: Baseline and 12 weeks
LDL cholesterol levels will be measured before and after intervention.
Baseline and 12 weeks
Change in HDL Cholesterol
Time Frame: Baseline and 12 weeks
HDL cholesterol levels will be measured before and after intervention.
Baseline and 12 weeks
Change in Triglyceride Levels
Time Frame: Baseline and 12 weeks
Triglyceride levels will be measured before and after intervention.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sriwijaya

Investigators

  • Principal Investigator: Yulianto Kusnadi, MD, DR, Faculty of Medicine Universitas Sriwijaya / RSUP Dr. Mohammad Hoesin Palembang
  • Study Director: Rita Sriwulandari, MD, Division of Endocrinology, FK UNSRI / RSMH Palembang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USriwijaya

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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