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Resveratrol for Endothelial Dysfunction and Metabolic Control in Type 2 Diabetes (RESENDO-DM2)

7. maj 2026 opdateret af: Universitas Sriwijaya

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Rita Sriwulandari, MD

Studiesteder

  • Indonesien
    • South Sumatera
      • Palembang, South Sumatera, Indonesien, 30126
        • Universitas Sriwijaya

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Resveratrol Group
Participants receive resveratrol 50 mg orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
Medicin: Resveratrol
Resveratrol 50 mg administered orally once daily for 12 weeks.
Andre navne:
  • Lecitrol
Placebo komparator: Placebo Group
Participants receive placebo orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
Medicin: Placebo
Matching placebo administered orally once daily for 12 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Flow-Mediated Dilatation (FMD) of the Brachial Artery
Tidsramme: 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.
Baseline and 12 weeks
Change in Serum Endothelial Nitric Oxide Synthase (eNOS) Levels
Tidsramme: Baseline and 12 weeks
Serum endothelial nitric oxide synthase (eNOS) levels will be measured to assess endothelial function before and after intervention.
Baseline and 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Fasting Blood Glucose
Tidsramme: Baseline and 12 weeks
Fasting blood glucose levels will be measured to assess glycemic control before and after intervention.
Baseline and 12 weeks
Change in Postprandial Blood Glucose
Tidsramme: Baseline and 12 weeks
Postprandial blood glucose levels will be measured to assess glycemic control before and after intervention.
Baseline and 12 weeks
Change in Hemoglobin A1c (HbA1c)
Tidsramme: Baseline and 12 weeks
HbA1c levels will be measured to evaluate long-term glycemic control before and after intervention.
Baseline and 12 weeks
Change in LDL Cholesterol
Tidsramme: Baseline and 12 weeks
LDL cholesterol levels will be measured before and after intervention.
Baseline and 12 weeks
Change in HDL Cholesterol
Tidsramme: Baseline and 12 weeks
HDL cholesterol levels will be measured before and after intervention.
Baseline and 12 weeks
Change in Triglyceride Levels
Tidsramme: Baseline and 12 weeks
Triglyceride levels will be measured before and after intervention.
Baseline and 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universitas Sriwijaya

Efterforskere

  • Ledende efterforsker: Yulianto Kusnadi, MD, DR, Faculty of Medicine Universitas Sriwijaya / RSUP Dr. Mohammad Hoesin Palembang
  • Studieleder: Rita Sriwulandari, MD, Division of Endocrinology, FK UNSRI / RSMH Palembang

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • USriwijaya

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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