Universitas Sriwijaya
Palembang, South Sumatera, 30126, Indonesia
NCT Number: NCT07569744
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Palembang, South Sumatera, 30126, Indonesia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Resveratrol 50 mg administered orally once daily for 12 weeks.
Other names: Lecitrol
Matching placebo administered orally once daily for 12 weeks.
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.
Time frame: Baseline and 12 weeks
Serum endothelial nitric oxide synthase (eNOS) levels will be measured to assess endothelial function before and after intervention.
Time frame: Baseline and 12 weeks
Fasting blood glucose levels will be measured to assess glycemic control before and after intervention.
Time frame: Baseline and 12 weeks
Postprandial blood glucose levels will be measured to assess glycemic control before and after intervention.
Time frame: Baseline and 12 weeks
HbA1c levels will be measured to evaluate long-term glycemic control before and after intervention.
Time frame: Baseline and 12 weeks
LDL cholesterol levels will be measured before and after intervention.
Time frame: Baseline and 12 weeks
HDL cholesterol levels will be measured before and after intervention.
Time frame: Baseline and 12 weeks
Triglyceride levels will be measured before and after intervention.
Universitas Sriwijaya
Other
Effectiveness of Resveratrol Addition in Improving Endothelial Dysfunction and Metabolic Control in Type 2 Diabetes Mellitus Patients: A Randomized Controlled Trial
Acronym: RESENDO-DM2
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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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