Resveratrol for Endothelial Dysfunction and Metabolic Control in Type 2 Diabetes

NCT07569744 | Not Yet Recruiting

• 1 other identifier: USriwijaya
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Endothelial Dysfunction

Keywords

Resveratrol; Flow-Mediated Dilatation; eNOS; Endothelial Function; Glycemic Control; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

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

  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

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

  Baseline and 12 weeks

Secondary Outcomes (4)

• 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 Lipid Profile (LDL, HDL, Triglycerides)

  Baseline and 12 weeks

Study Arms (2)

Resveratrol Group

EXPERIMENTAL

Participants receive resveratrol 50 mg orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.

Drug: Resveratrol

Placebo Group

PLACEBO COMPARATOR

Participants receive placebo orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.

Drug: Placebo

Interventions

Resveratrol DRUG

Resveratrol 50 mg administered orally once daily for 12 weeks.

Also known as: Lecitrol

Resveratrol Group

Placebo DRUG

Matching placebo administered orally once daily for 12 weeks.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Sriwijaya: lead

Study Sites (1)

Universitas Sriwijaya

Palembang, South Sumatera, 30126, Indonesia

Location

Related Publications (7)

• Marassi M, Fadini GP. The cardio-renal-metabolic connection: a review of the evidence. Cardiovasc Diabetol. 2023 Jul 31;22(1):195. doi: 10.1186/s12933-023-01937-x.

  PMID: 37525273 RESULT

• Triggle CR, Ding H, Marei I, Anderson TJ, Hollenberg MD. Why the endothelium? The endothelium as a target to reduce diabetes-associated vascular disease. Can J Physiol Pharmacol. 2020 Jul;98(7):415-430. doi: 10.1139/cjpp-2019-0677. Epub 2020 Mar 9.

  PMID: 32150686 RESULT

• Li J, Zhong Z, Yuan J, Chen X, Huang Z, Wu Z. Resveratrol improves endothelial dysfunction and attenuates atherogenesis in apolipoprotein E-deficient mice. J Nutr Biochem. 2019 May;67:63-71. doi: 10.1016/j.jnutbio.2019.01.022. Epub 2019 Feb 10.

  PMID: 30856465 RESULT

• Huang DD, Shi G, Jiang Y, Yao C, Zhu C. A review on the potential of Resveratrol in prevention and therapy of diabetes and diabetic complications. Biomed Pharmacother. 2020 May;125:109767. doi: 10.1016/j.biopha.2019.109767. Epub 2020 Feb 12.

  PMID: 32058210 RESULT

• Fourny N, Lan C, Seree E, Bernard M, Desrois M. Protective Effect of Resveratrol against Ischemia-Reperfusion Injury via Enhanced High Energy Compounds and eNOS-SIRT1 Expression in Type 2 Diabetic Female Rat Heart. Nutrients. 2019 Jan 6;11(1):105. doi: 10.3390/nu11010105.

  PMID: 30621358 RESULT

• Seyyedebrahimi S, Khodabandehloo H, Nasli Esfahani E, Meshkani R. The effects of resveratrol on markers of oxidative stress in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled clinical trial. Acta Diabetol. 2018 Apr;55(4):341-353. doi: 10.1007/s00592-017-1098-3. Epub 2018 Jan 22.

  PMID: 29357033 RESULT

• Gimblet CJ, Kruse NT, Geasland K, Michelson J, Sun M, Mandukhail SR, Wendt LH, Eyck PT, Pierce GL, Jalal DI. Effect of Resveratrol on Endothelial Function in Patients with CKD and Diabetes: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):161-168. doi: 10.2215/CJN.0000000000000337. Epub 2023 Oct 16.

  PMID: 37843843 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Yulianto Kusnadi, MD, DR

  Faculty of Medicine Universitas Sriwijaya / RSUP Dr. Mohammad Hoesin Palembang

  PRINCIPAL INVESTIGATOR

• Rita Sriwulandari, MD

  Division of Endocrinology, FK UNSRI / RSMH Palembang

  STUDY DIRECTOR

Central Study Contacts

yulianto Kusnadi, MD, DR

CONTACT

+62-711-354088; yulianto.kusnadi@unsri.ac.id

Rita Sriwulandari, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Resveratrol and placebo will be identical in appearance and packaging.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with type 2 diabetes mellitus and endothelial dysfunction will be randomized into two parallel groups to receive either resveratrol 50 mg or placebo for 12 weeks.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)