Endothelial Dysfunction, Type 2 Diabetes Mellitus
Conditions
Keywords
Resveratrol, Flow-Mediated Dilatation, eNOS, Endothelial Function, Glycemic Control, Randomized Controlled Trial
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.
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.
Interventions
DRUGResveratrol
Resveratrol 50 mg administered orally once daily for 12 weeks.
DRUGPlacebo
Matching placebo administered orally once daily for 12 weeks.
Sponsors
Universitas Sriwijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Resveratrol and placebo will be identical in appearance and packaging.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Flow-Mediated Dilatation (FMD) of the Brachial Artery | 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 | Baseline and 12 weeks | Serum endothelial nitric oxide synthase (eNOS) levels will be measured to assess endothelial function before and after intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Blood Glucose | Baseline and 12 weeks | Fasting blood glucose levels will be measured to assess glycemic control before and after intervention. |
| Change in Postprandial Blood Glucose | Baseline and 12 weeks | Postprandial blood glucose levels will be measured to assess glycemic control before and after intervention. |
| Change in Hemoglobin A1c (HbA1c) | Baseline and 12 weeks | HbA1c levels will be measured to evaluate long-term glycemic control before and after intervention. |
| Change in LDL Cholesterol | Baseline and 12 weeks | LDL cholesterol levels will be measured before and after intervention. |
| Change in HDL Cholesterol | Baseline and 12 weeks | HDL cholesterol levels will be measured before and after intervention. |
| Change in Triglyceride Levels | Baseline and 12 weeks | Triglyceride levels will be measured before and after intervention. |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORYulianto Kusnadi, MD, DR
Faculty of Medicine Universitas Sriwijaya / RSUP Dr. Mohammad Hoesin Palembang
STUDY_DIRECTORRita Sriwulandari, MD
Division of Endocrinology, FK UNSRI / RSMH Palembang
Outcome results
None listed