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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: yulianto Kusnadi, MD, DR
- 전화번호: +62-711-354088
- 이메일: yulianto.kusnadi@unsri.ac.id
연구 연락처 백업
- 이름: Rita Sriwulandari, MD
연구 장소
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South Sumatera
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Palembang, South Sumatera, 인도네시아, 30126
- Universitas Sriwijaya
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Flow-Mediated Dilatation (FMD) of the Brachial Artery
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Fasting Blood Glucose
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Yulianto Kusnadi, MD, DR, Faculty of Medicine Universitas Sriwijaya / RSUP Dr. Mohammad Hoesin Palembang
- 연구 책임자: Rita Sriwulandari, MD, Division of Endocrinology, FK UNSRI / RSMH Palembang
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- USriwijaya
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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