CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention (CORDIOPREV)
2021年5月31日 更新者：Francisco Perez Jimenez、Hospital Universitario Reina Sofia de Cordoba
Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.
調査の概要
詳細な説明
Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: <30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; <10% SAT) and b) Mediterranean Diet: >35% fat (22% MUFA; 6% PUFA ; <10% SAT).
Primary Objective:
Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death).
Secondary Objectives:
Those related in the Outcome Measures section of this webpage
研究の種類
介入
入学 (実際)
1002
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Cordoba、スペイン、14001
- Reina Sofia University Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Informed Consent
Clinical: Unstable coronary disease with documented vessel/myocardial damage
- Acute Myocardial Infarction
- Revascularization
Exclusion Criteria:
- Age < 20 or > 75 years (or life expectancy lower than 5 years).
- Patients already planned for revascularization.
- Patients submitted to revascularization in the last 6 months
- Grade II-IV Heart failure.
- Left ventricle dysfunction with ejection fraction lower than 35%.
- Patients unable to follow a protocol.
- Patients with severe uncontrol of Diabetes Mellitus, or those with Renal Insufficiency with plasma creatinine higher than 2mg/dl, or cerebral complications of Diabetes mellitus.
Other chronic diseases:
- Psychiatric diseases
- Renal Insufficiency
- Chronic Hepatopathy
- Active Malignancy
- Chronic obstructive pulmonary disease
- Diseases of the digestive tract Endocrine disorders
- Patients participating in other Clinical trials (in the enrollment moment or 30 days prior).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Low Fat Diet
Dietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids)
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Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
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実験的：Mediterranean Diet
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
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Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
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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 |
|---|---|---|
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Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years.
時間枠：Seven Years
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Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years.
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Seven Years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
時間枠：Seven Years
|
Data from clinical and/or diagnostic tests will be analyzed
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Seven Years
|
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Concentration of LDL cholesterol.
時間枠：Seven Years
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Concentration of LDL cholesterol in blood samples
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Seven Years
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Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
時間枠：Seven Years
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Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study
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Seven Years
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Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c).
時間枠：Seven Years
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Study of the metabolism of carbohydrates during the trial
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Seven Years
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Blood pressure.
時間枠：Seven Years
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Study of blood pressure in response to the study
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Seven Years
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Incidence of malignancy.
時間枠：Seven Years
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Appearance of malignancy
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Seven Years
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Progression of Cognitive Decline.
時間枠：Seven Years
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Cognitive decline will be evaluated by validated questionnaires
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Seven Years
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Extended composite of cardiovascular disease progression
時間枠：Seven Years
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Incidence of cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac transplant, stroke, symptomatic heart failure, or any other clinical manifestation of cardiovascular event.
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Seven Years
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Extended composite of heart events
時間枠：Seven Years
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Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
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Seven Years
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Incidence of type 2 Diabetes Mellitus
時間枠：Up to Seven Years
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Incidence of type 2 Diabetes Mellitus during the study
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Up to Seven Years
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Anthropometric changes. Metabolic disease
時間枠：Up to Seven Years
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Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study
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Up to Seven Years
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Gut Microbiota
時間枠：Up to Seven Years
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Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.
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Up to Seven Years
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Arrhythmias
時間枠：Up to Seven Years
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Study of relationship between existing or new Arrhythmias on clinical events
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Up to Seven Years
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Individual evaluation of all components of the primary outcome.
時間枠：Up to Seven Years
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Individual apparition of hard cardiovascular events:
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Up to Seven Years
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Global Metabolomics
時間枠：Up to Seven Years
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Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc.
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Up to Seven Years
|
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Specific metabolomics
時間枠：Up to Seven Years
|
Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc
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Up to Seven Years
|
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Gene Expression
時間枠：Up to Seven Years
|
Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
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Up to Seven Years
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Inflammation and oxidative stress
時間枠：Up to Seven Years
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Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
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Up to Seven Years
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AGEs
時間枠：Up to Seven Years
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Metabolism of advanced glycation end products.
|
Up to Seven Years
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Mineral metabolism
時間枠：Up to Seven Years
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Impact of mineral metabolism on atherosclerosis
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Up to Seven Years
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Echographic markers of cardiac function and clinical outcomes
時間枠：Up to Seven Years
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Cardiac function studies by Echocardiography at baseline and during the study
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Up to Seven Years
|
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Microparticles
時間枠：Up to Seven Years
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Study of endothelial microparticles (vesicles formed from endothelial cells membrane after injury).
The quantification of the EPCs and EMPs will be performed by flow cytometry
|
Up to Seven Years
|
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Subgroup analysis
時間枠：Up to Seven Years
|
27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
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Up to Seven Years
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Endothelial function (Flow mediated dilation)
時間枠：Up to Seven Years
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Endothelium response to ischemia in the brachial artery.
Area under the curve, flow peak and time to maximum flow will be performed
|
Up to Seven Years
|
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genetics, genomics and epigenetics
時間枠：Up to seven years
|
Influence of genetic data in the development clinical outcomes
|
Up to seven years
|
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postprandial lipaemia
時間枠：Up to seven years
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Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables
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Up to seven years
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Study of other Clinical events
時間枠：Up to seven years
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Clinical events not qualifying as primary endpoint nor in the secondary objectives 1 and 2, especially those associated with cardiovascular disease
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Up to seven years
|
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Subgroup Studies
時間枠：Up to seven years
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Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
|
Up to seven years
|
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Further Studies
時間枠：Up to Seven Years
|
Additional secondary objectives will be carried out in light of current and/or future knowledge of ischemic heart disease risk factors, prognostic factors and pathophysiological pathways, and will include, but not be limited to, endothelial function, inflammation, cell biology, molecular biology, proteomics, genetics and epigenetics
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Up to Seven Years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Francisco Perez-Jimenez, MD,PhD、Reina Sofia University Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Mora-Ortiz M, Alcala-Diaz JF, Rangel-Zuniga OA, Arenas-de Larriva AP, Abollo-Jimenez F, Luque-Cordoba D, Priego-Capote F, Malagon MM, Delgado-Lista J, Ordovas JM, Perez-Martinez P, Camargo A, Lopez-Miranda J. Metabolomics analysis of type 2 diabetes remission identifies 12 metabolites with predictive capacity: a CORDIOPREV clinical trial study. BMC Med. 2022 Oct 27;20(1):373. doi: 10.1186/s12916-022-02566-z.
- Yubero-Serrano EM, Gutierrez-Mariscal FM, Gomez-Luna P, Alcala-Diaz JF, Perez-Martinez P, Lopez-Miranda J. Dietary modulation of advanced glycation end products metabolism on carotid intima-media thickness in type 2 diabetes patients: From the CORDIOPREV study. Clin Investig Arterioscler. 2022 Sep 29:S0214-9168(22)00113-9. doi: 10.1016/j.arteri.2022.08.004. Online ahead of print. English, Spanish.
- Delgado-Lista J, Alcala-Diaz JF, Torres-Pena JD, Quintana-Navarro GM, Fuentes F, Garcia-Rios A, Ortiz-Morales AM, Gonzalez-Requero AI, Perez-Caballero AI, Yubero-Serrano EM, Rangel-Zuniga OA, Camargo A, Rodriguez-Cantalejo F, Lopez-Segura F, Badimon L, Ordovas JM, Perez-Jimenez F, Perez-Martinez P, Lopez-Miranda J; CORDIOPREV Investigators. Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial. Lancet. 2022 May 14;399(10338):1876-1885. doi: 10.1016/S0140-6736(22)00122-2. Epub 2022 May 4.
- Cano-Ibanez N, Quintana-Navarro GM, Alcala-Diaz JF, Rangel-Zuniga OA, Camargo A, Yubero-Serrano EM, Perez-Corral I, Arenas-de Larriva AP, Garcia-Rios A, Perez-Martinez P, Delgado-Lista J, Lopez-Miranda J. Long-term effect of a dietary intervention with two-healthy dietary approaches on food intake and nutrient density in coronary patients: results from the CORDIOPREV trial. Eur J Nutr. 2022 Sep;61(6):3019-3036. doi: 10.1007/s00394-022-02854-7. Epub 2022 Mar 29. Erratum In: Eur J Nutr. 2022 Dec;61(8):4223-4225.
- Podadera-Herreros A, Alcala-Diaz JF, Gutierrez-Mariscal FM, Jimenez-Torres J, Cruz-Ares S, Arenas-de Larriva AP, Cardelo MP, Torres-Pena JD, Luque RM, Ordovas JM, Delgado-Lista J, Lopez-Miranda J, Yubero-Serrano EM. Long-term consumption of a mediterranean diet or a low-fat diet on kidney function in coronary heart disease patients: The CORDIOPREV randomized controlled trial. Clin Nutr. 2022 Feb;41(2):552-559. doi: 10.1016/j.clnu.2021.12.041. Epub 2022 Jan 6.
- Villasanta-Gonzalez A, Alcala-Diaz JF, Vals-Delgado C, Arenas AP, Cardelo MP, Romero-Cabrera JL, Rodriguez-Cantalejo F, Delgado-Lista J, Malagon MM, Perez-Martinez P, Schulze MB, Camargo A, Lopez-Miranda J. A plasma fatty acid profile associated to type 2 diabetes development: from the CORDIOPREV study. Eur J Nutr. 2022 Mar;61(2):843-857. doi: 10.1007/s00394-021-02676-z. Epub 2021 Oct 5.
- Jimenez-Torres J, Alcala-Diaz JF, Torres-Pena JD, Gutierrez-Mariscal FM, Leon-Acuna A, Gomez-Luna P, Fernandez-Gandara C, Quintana-Navarro GM, Fernandez-Garcia JC, Perez-Martinez P, Ordovas JM, Delgado-Lista J, Yubero-Serrano EM, Lopez-Miranda J. Mediterranean Diet Reduces Atherosclerosis Progression in Coronary Heart Disease: An Analysis of the CORDIOPREV Randomized Controlled Trial. Stroke. 2021 Nov;52(11):3440-3449. doi: 10.1161/STROKEAHA.120.033214. Epub 2021 Aug 10. Erratum In: Stroke. 2021 Nov;52(11):e754.
- Vals-Delgado C, Alcala-Diaz JF, Roncero-Ramos I, Leon-Acuna A, Molina-Abril H, Gutierrez-Mariscal FM, Romero-Cabrera JL, de la Cruz-Ares S, van Ommen B, Castano JP, Ordovas JM, Perez-Martinez P, Delgado-Lista J, Camargo A, Lopez-Miranda J. A microbiota-based predictive model for type 2 diabetes remission induced by dietary intervention: From the CORDIOPREV study. Clin Transl Med. 2021 Apr;11(4):e326. doi: 10.1002/ctm2.326. No abstract available.
- Yubero-Serrano EM, Alcala-Diaz JF, Gutierrez-Mariscal FM, Arenas-de Larriva AP, Pena-Orihuela PJ, Blanco-Rojo R, Martinez-Botas J, Torres-Pena JD, Perez-Martinez P, Ordovas JM, Delgado-Lista J, Gomez-Coronado D, Lopez-Miranda J. Association between cholesterol efflux capacity and peripheral artery disease in coronary heart disease patients with and without type 2 diabetes: from the CORDIOPREV study. Cardiovasc Diabetol. 2021 Mar 25;20(1):72. doi: 10.1186/s12933-021-01260-3. Erratum In: Cardiovasc Diabetol. 2021 Apr 17;20(1):79.
- Yubero-Serrano EM, Fernandez-Gandara C, Garcia-Rios A, Rangel-Zuniga OA, Gutierrez-Mariscal FM, Torres-Pena JD, Marin C, Lopez-Moreno J, Castano JP, Delgado-Lista J, Ordovas JM, Perez-Martinez P, Lopez-Miranda J. Mediterranean diet and endothelial function in patients with coronary heart disease: An analysis of the CORDIOPREV randomized controlled trial. PLoS Med. 2020 Sep 9;17(9):e1003282. doi: 10.1371/journal.pmed.1003282. eCollection 2020 Sep.
- Jimenez-Lucena R, Alcala-Diaz JF, Roncero-Ramos I, Lopez-Moreno J, Camargo A, Gomez-Delgado F, Quintana-Navarro GM, Vals-Delgado C, Rodriguez-Cantalejo F, Luque RM, Delgado-Lista J, Ordovas JM, Perez-Martinez P, Rangel-Zuniga OA, Lopez-Miranda J. MiRNAs profile as biomarkers of nutritional therapy for the prevention of type 2 diabetes mellitus: From the CORDIOPREV study. Clin Nutr. 2021 Mar;40(3):1028-1038. doi: 10.1016/j.clnu.2020.06.035. Epub 2020 Jul 15.
- Leon-Acuna A, Torres-Pena JD, Alcala-Diaz JF, Vals-Delgado C, Roncero-Ramos I, Yubero-Serrano E, Tinahones FJ, Castro-Clerico M, Delgado-Lista J, Ordovas JM, Lopez-Miranda J, Perez-Martinez P. Lifestyle factors modulate postprandial hypertriglyceridemia: From the CORDIOPREV study. Atherosclerosis. 2019 Nov;290:118-124. doi: 10.1016/j.atherosclerosis.2019.09.025. Epub 2019 Sep 28.
- Roncero-Ramos I, Alcala-Diaz JF, Rangel-Zuniga OA, Gomez-Delgado F, Jimenez-Lucena R, Garcia-Rios A, Vals-Delgado C, Romero-Baldonado C, Luque RM, Ordovas JM, Perez-Martinez P, Camargo A, Lopez-Miranda J. Prediabetes diagnosis criteria, type 2 diabetes risk and dietary modulation: The CORDIOPREV study. Clin Nutr. 2020 Feb;39(2):492-500. doi: 10.1016/j.clnu.2019.02.027. Epub 2019 Feb 21.
- Gomez-Marin B, Gomez-Delgado F, Lopez-Moreno J, Alcala-Diaz JF, Jimenez-Lucena R, Torres-Pena JD, Garcia-Rios A, Ortiz-Morales AM, Yubero-Serrano EM, Del Mar Malagon M, Lai CQ, Delgado-Lista J, Ordovas JM, Lopez-Miranda J, Perez-Martinez P. Long-term consumption of a Mediterranean diet improves postprandial lipemia in patients with type 2 diabetes: the Cordioprev randomized trial. Am J Clin Nutr. 2018 Nov 1;108(5):963-970. doi: 10.1093/ajcn/nqy144.
- Corina A, Rangel-Zuniga OA, Jimenez-Lucena R, Alcala-Diaz JF, Quintana-Navarro G, Yubero-Serrano EM, Lopez-Moreno J, Delgado-Lista J, Tinahones F, Ordovas JM, Lopez-Miranda J, Perez-Martinez P. Low Intake of Vitamin E Accelerates Cellular Aging in Patients With Established Cardiovascular Disease: The CORDIOPREV Study. J Gerontol A Biol Sci Med Sci. 2019 May 16;74(6):770-777. doi: 10.1093/gerona/gly195.
- Camargo A, Jimenez-Lucena R, Alcala-Diaz JF, Rangel-Zuniga OA, Garcia-Carpintero S, Lopez-Moreno J, Blanco-Rojo R, Delgado-Lista J, Perez-Martinez P, van Ommen B, Malagon MM, Ordovas JM, Perez-Jimenez F, Lopez-Miranda J. Postprandial endotoxemia may influence the development of type 2 diabetes mellitus: From the CORDIOPREV study. Clin Nutr. 2019 Apr;38(2):529-538. doi: 10.1016/j.clnu.2018.03.016. Epub 2018 Apr 11.
- Torres-Pena JD, Garcia-Rios A, Delgado-Casado N, Gomez-Luna P, Alcala-Diaz JF, Yubero-Serrano EM, Gomez-Delgado F, Leon-Acuna A, Lopez-Moreno J, Camargo A, Tinahones FJ, Delgado-Lista J, Ordovas JM, Perez-Martinez P, Lopez-Miranda J. Mediterranean diet improves endothelial function in patients with diabetes and prediabetes: A report from the CORDIOPREV study. Atherosclerosis. 2018 Feb;269:50-56. doi: 10.1016/j.atherosclerosis.2017.12.012. Epub 2017 Dec 8.
- Rangel-Zuniga OA, Cruz-Teno C, Haro C, Quintana-Navarro GM, Camara-Martos F, Perez-Martinez P, Garcia-Rios A, Garaulet M, Tena-Sempere M, Lopez-Miranda J, Perez-Jimenez F, Camargo A. Differential menopause- versus aging-induced changes in oxidative stress and circadian rhythm gene markers. Mech Ageing Dev. 2017 Jun;164:41-48. doi: 10.1016/j.mad.2017.04.002. Epub 2017 Apr 10.
- Gomez-Delgado F, Delgado-Lista J, Lopez-Moreno J, Rangel-Zuniga OA, Alcala-Diaz JF, Leon-Acuna A, Corina A, Yubero-Serrano E, Torres-Pena JD, Camargo A, Garcia-Rios A, Caballero J, Castano J, Ordovas JM, Lopez-Miranda J, Perez-Martinez P. Telomerase RNA Component Genetic Variants Interact With the Mediterranean Diet Modifying the Inflammatory Status and its Relationship With Aging: CORDIOPREV Study. J Gerontol A Biol Sci Med Sci. 2018 Mar 2;73(3):327-332. doi: 10.1093/gerona/glw194.
- Rangel-Zuniga OA, Corina A, Lucena-Porras B, Cruz-Teno C, Gomez-Delgado F, Jimenez-Lucena R, Alcala-Diaz JF, Haro-Mariscal C, Yubero-Serrano EM, Delgado-Lista J, Lopez-Moreno J, Rodriguez-Cantalejo F, Camargo A, Tinahones FJ, Ordovas JM, Lopez-Miranda J, Perez-Martinez P. TNFA gene variants related to the inflammatory status and its association with cellular aging: From the CORDIOPREV study. Exp Gerontol. 2016 Oct;83:56-62. doi: 10.1016/j.exger.2016.07.015. Epub 2016 Jul 29.
- Blanco-Rojo R, Delgado-Lista J, Lee YC, Lai CQ, Perez-Martinez P, Rangel-Zuniga O, Smith CE, Hidalgo B, Alcala-Diaz JF, Gomez-Delgado F, Parnell LD, Arnett DK, Tucker KL, Lopez-Miranda J, Ordovas JM. Interaction of an S100A9 gene variant with saturated fat and carbohydrates to modulate insulin resistance in 3 populations of different ancestries. Am J Clin Nutr. 2016 Aug;104(2):508-17. doi: 10.3945/ajcn.116.130898. Epub 2016 Jul 20.
- Leon-Acuna A, Alcala-Diaz JF, Delgado-Lista J, Torres-Pena JD, Lopez-Moreno J, Camargo A, Garcia-Rios A, Marin C, Gomez-Delgado F, Caballero J, Van-Ommen B, Malagon MM, Perez-Martinez P, Lopez-Miranda J. Hepatic insulin resistance both in prediabetic and diabetic patients determines postprandial lipoprotein metabolism: from the CORDIOPREV study. Cardiovasc Diabetol. 2016 Apr 19;15:68. doi: 10.1186/s12933-016-0380-y.
- Talavera-Garcia E, Delgado-Lista J, Garcia-Rios A, Delgado-Casado N, Gomez-Luna P, Gomez-Garduno A, Gomez-Delgado F, Alcala-Diaz JF, Yubero-Serrano E, Marin C, Perez-Caballero AI, Fuentes-Jimenez FJ, Camargo A, Rodriguez-Cantalejo F, Tinahones FJ, Ordovas JM, Perez-Jimenez F, Perez-Martinez P, Lopez-Miranda J. Influence of Obesity and Metabolic Disease on Carotid Atherosclerosis in Patients with Coronary Artery Disease (CordioPrev Study). PLoS One. 2016 Apr 11;11(4):e0153096. doi: 10.1371/journal.pone.0153096. eCollection 2016. Erratum In: PLoS One. 2016;11(6):e0157213.
- Haro C, Montes-Borrego M, Rangel-Zuniga OA, Alcala-Diaz JF, Gomez-Delgado F, Perez-Martinez P, Delgado-Lista J, Quintana-Navarro GM, Tinahones FJ, Landa BB, Lopez-Miranda J, Camargo A, Perez-Jimenez F. Two Healthy Diets Modulate Gut Microbial Community Improving Insulin Sensitivity in a Human Obese Population. J Clin Endocrinol Metab. 2016 Jan;101(1):233-42. doi: 10.1210/jc.2015-3351. Epub 2015 Oct 27.
- Blanco-Rojo R, Alcala-Diaz JF, Wopereis S, Perez-Martinez P, Quintana-Navarro GM, Marin C, Ordovas JM, van Ommen B, Perez-Jimenez F, Delgado-Lista J, Lopez-Miranda J. The insulin resistance phenotype (muscle or liver) interacts with the type of diet to determine changes in disposition index after 2 years of intervention: the CORDIOPREV-DIAB randomised clinical trial. Diabetologia. 2016 Jan;59(1):67-76. doi: 10.1007/s00125-015-3776-4. Epub 2015 Oct 16.
- Perez-Martinez P, Alcala-Diaz JF, Delgado-Lista J, Garcia-Rios A, Gomez-Delgado F, Marin-Hinojosa C, Rodriguez-Cantalejo F, Delgado-Casado N, Perez-Caballero AI, Fuentes-Jimenez FJ, Camargo A, Tinahones FJ, Ordovas JM, Perez-Jimenez F, Lopez-Miranda J. Metabolic phenotypes of obesity influence triglyceride and inflammation homoeostasis. Eur J Clin Invest. 2014 Nov;44(11):1053-64. doi: 10.1111/eci.12339.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2009年11月1日
一次修了 (実際)
2018年7月1日
研究の完了 (実際)
2021年5月1日
試験登録日
最初に提出
2009年6月18日
QC基準を満たした最初の提出物
2009年6月18日
最初の投稿 (見積もり)
2009年6月19日
学習記録の更新
投稿された最後の更新 (実際)
2021年6月3日
QC基準を満たした最後の更新が送信されました
2021年5月31日
最終確認日
2021年5月1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
- CORDIOPREV
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?
いいえ
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。
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