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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: yulianto Kusnadi, MD, DR
- Número de teléfono: +62-711-354088
- Correo electrónico: yulianto.kusnadi@unsri.ac.id
Copia de seguridad de contactos de estudio
- Nombre: Rita Sriwulandari, MD
Ubicaciones de estudio
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South Sumatera
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Palembang, South Sumatera, Indonesia, 30126
- Universitas Sriwijaya
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
Otros nombres:
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Flow-Mediated Dilatation (FMD) of the Brachial Artery
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Fasting Blood Glucose
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
- Director de estudio: Rita Sriwulandari, MD, Division of Endocrinology, FK UNSRI / RSMH Palembang
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Enfermedades Nutricionales y Metabólicas
- Diabetes Mellitus, Tipo 2
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Fenoles
- Derivados de benceno
- Aguas
- Compuestos de bencilideno
- Estilbestrols
- Polifenoles
- Resveratrol
Otros números de identificación del estudio
- USriwijaya
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Diabetes mellitus tipo 2
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Instituto Nacional de Ciencias Medicas y Nutricion...Activo, no reclutando
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ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi Demirsoy... y otros colaboradoresAún no reclutandoDiabetes tipo 2 | Diabetes mellitus tipo 2Turquía (Türkiye)
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Endogenex, Inc.Aún no reclutandoDiabetes Mellitus, Tipo 2 | Diabetes | Diabetes mellitus tipo 2 | Diabetes tipo 2 | Diabetes tipo 2
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University of SalamancaUniversity of Salamanca; Instituto Piaget; Escola Superior de Tecnologia da Saúde...Inscripción por invitaciónDiabetes mellitus tipo 2 | Envejecimiento | Hiperglucemia por diabetes mellitus tipo 2Portugal
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Endogenex, Inc.Aún no reclutandoDiabetes Mellitus, Tipo 2 | Diabetes | Diabetes tipo 2 | Diabetes mellitus tipo 2 (DM2) | Diabetes tipo 2
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El Katib HospitalAún no reclutandoDiabetes mellitus tipo 2 (DM2)
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He Eye HospitalAún no reclutando
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Diabetes Solutions InternationalDexCom, Inc.; Tidepool; MAVEN ProjectReclutamientoDiabetes mellitus tipo 2 (DM2)Estados Unidos
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Ohio State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Aún no reclutandoDM2 (Diabetes Mellitus Tipo 2)Estados Unidos
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Global Institute of Stem Cell Therapy and ResearchAún no reclutando
Ensayos clínicos sobre Resveratrol
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Hagar Ahmed Ali Mohammed ElzainMansoura UniversityActivo, no reclutando
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Ain Shams UniversityTerminado
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University at BuffaloKaleida HealthTerminadoObesidad | Resistencia a la insulina | Diabetes tipo 2Estados Unidos
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Bernard FiorettiTerminadoNutritivo; Exceso | Problema de uso del productoItalia
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Jupiter Orphan Therapeutics Inc.National Institute on Aging (NIA)TerminadoFarmacocinética | Interacción alimentos-fármacos | La seguridadEstados Unidos
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Maastricht University Medical CenterDSM Nutritional Products, Inc.Terminado
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Universidade Estadual Paulista Júlio de Mesquita...TerminadoEnfermedad de la arteria coronaria | Presión arterial | Ritmo cardiaco | Enfermedad del sistema nervioso autónomoBrasil
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MaineHealthAmerican Heart AssociationActivo, no reclutandoEnfermedad de la arteria coronaria | Diabetes Mellitus, Tipo 2Estados Unidos
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Albert Einstein College of MedicineAmerican Diabetes AssociationTerminadoIntolerancia a la glucosaEstados Unidos
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Federal University of Rio Grande do SulCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Terminado