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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：yulianto Kusnadi, MD, DR
- 電話番号：+62-711-354088
- メール：yulianto.kusnadi@unsri.ac.id
研究連絡先のバックアップ
- 名前：Rita Sriwulandari, MD
研究場所
-
-
South Sumatera
-
Palembang、South Sumatera、インドネシア、30126
- Universitas Sriwijaya
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Resveratrol Group
Participants receive resveratrol 50 mg orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
|
Resveratrol 50 mg administered orally once daily for 12 weeks.
他の名前：
|
|
プラセボコンパレーター：Placebo Group
Participants receive placebo orally once daily for 12 weeks in addition to standard therapy for type 2 diabetes mellitus.
|
Matching placebo administered orally once daily for 12 weeks.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Flow-Mediated Dilatation (FMD) of the Brachial Artery
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Fasting Blood Glucose
時間枠：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
時間枠：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)
時間枠：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
時間枠：Baseline and 12 weeks
|
LDL cholesterol levels will be measured before and after intervention.
|
Baseline and 12 weeks
|
|
Change in HDL Cholesterol
時間枠：Baseline and 12 weeks
|
HDL cholesterol levels will be measured before and after intervention.
|
Baseline and 12 weeks
|
|
Change in Triglyceride Levels
時間枠：Baseline and 12 weeks
|
Triglyceride levels will be measured before and after intervention.
|
Baseline and 12 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Yulianto Kusnadi, MD, DR、Faculty of Medicine Universitas Sriwijaya / RSUP Dr. Mohammad Hoesin Palembang
- スタディディレクター：Rita Sriwulandari, MD、Division of Endocrinology, FK UNSRI / RSMH Palembang
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- USriwijaya
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。