Resveratrol for Endothelial Dysfunction and Metabolic Control in Type 2 Diabetes (RESENDO-DM2)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: yulianto Kusnadi, MD, DR
- Número de telefone: +62-711-354088
- E-mail: yulianto.kusnadi@unsri.ac.id
Estude backup de contato
- Nome: Rita Sriwulandari, MD
Locais de estudo
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South Sumatera
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Palembang, South Sumatera, Indonésia, 30126
- Universitas Sriwijaya
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Resveratrol Group
Participants receive resveratrol 50 mg orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
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Resveratrol 50 mg administered orally once daily for 12 weeks.
Outros nomes:
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Comparador de Placebo: Placebo Group
Participants receive placebo orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
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Matching placebo administered orally once daily for 12 weeks.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Flow-Mediated Dilatation (FMD) of the Brachial Artery
Prazo: Baseline and 12 weeks
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Flow-mediated dilatation (FMD) will be measured as the percentage change in brachial artery diameter using ultrasound before and after intervention.
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Baseline and 12 weeks
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Change in Serum Endothelial Nitric Oxide Synthase (eNOS) Levels
Prazo: Baseline and 12 weeks
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Serum endothelial nitric oxide synthase (eNOS) levels will be measured to assess endothelial function before and after intervention.
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Baseline and 12 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Fasting Blood Glucose
Prazo: Baseline and 12 weeks
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Fasting blood glucose levels will be measured to assess glycemic control before and after intervention.
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Baseline and 12 weeks
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Change in Postprandial Blood Glucose
Prazo: Baseline and 12 weeks
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Postprandial blood glucose levels will be measured to assess glycemic control before and after intervention.
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Baseline and 12 weeks
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Change in Hemoglobin A1c (HbA1c)
Prazo: Baseline and 12 weeks
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HbA1c levels will be measured to evaluate long-term glycemic control before and after intervention.
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Baseline and 12 weeks
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Change in LDL Cholesterol
Prazo: Baseline and 12 weeks
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LDL cholesterol levels will be measured before and after intervention.
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Baseline and 12 weeks
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Change in HDL Cholesterol
Prazo: Baseline and 12 weeks
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HDL cholesterol levels will be measured before and after intervention.
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Baseline and 12 weeks
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Change in Triglyceride Levels
Prazo: Baseline and 12 weeks
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Triglyceride levels will be measured before and after intervention.
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Baseline and 12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yulianto Kusnadi, MD, DR, Faculty of Medicine Universitas Sriwijaya / RSUP Dr. Mohammad Hoesin Palembang
- Diretor de estudo: Rita Sriwulandari, MD, Division of Endocrinology, FK UNSRI / RSMH Palembang
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças Metabólicas
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Doenças Nutricionais e Metabólicas
- Diabetes Mellitus, Tipo 2
- Produtos químicos orgânicos
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Hidrocarbonetos, aromáticos
- Fenóis
- Derivados de benzeno
- Stilbenes
- Compostos de benzilideno
- Stilbestrols
- Polifenóis
- Resveratrol
Outros números de identificação do estudo
- USriwijaya
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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