CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention (CORDIOPREV)
31 мая 2021 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
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
Тип исследования
Интервенционный
Регистрация (Действительный)
1002
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Cordoba, Испания, 14001
- Reina Sofia University Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 20 лет до 75 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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).
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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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.
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
Временное ограничение: Seven Years
|
Data from clinical and/or diagnostic tests will be analyzed
|
Seven Years
|
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Concentration of LDL cholesterol.
Временное ограничение: Seven Years
|
Concentration of LDL cholesterol in blood samples
|
Seven Years
|
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Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
Временное ограничение: Seven Years
|
Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study
|
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).
Временное ограничение: Seven Years
|
Study of the metabolism of carbohydrates during the trial
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Seven Years
|
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Blood pressure.
Временное ограничение: Seven Years
|
Study of blood pressure in response to the study
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Seven Years
|
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Incidence of malignancy.
Временное ограничение: Seven Years
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Appearance of malignancy
|
Seven Years
|
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Progression of Cognitive Decline.
Временное ограничение: Seven Years
|
Cognitive decline will be evaluated by validated questionnaires
|
Seven Years
|
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Extended composite of cardiovascular disease progression
Временное ограничение: Seven Years
|
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.
|
Seven Years
|
|
Extended composite of heart events
Временное ограничение: Seven Years
|
Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
|
Seven Years
|
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Incidence of type 2 Diabetes Mellitus
Временное ограничение: Up to Seven Years
|
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
Временное ограничение: 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
|
Up to Seven Years
|
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Gut Microbiota
Временное ограничение: Up to Seven Years
|
Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.
|
Up to Seven Years
|
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Arrhythmias
Временное ограничение: Up to Seven Years
|
Study of relationship between existing or new Arrhythmias on clinical events
|
Up to Seven Years
|
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Individual evaluation of all components of the primary outcome.
Временное ограничение: Up to Seven Years
|
Individual apparition of hard cardiovascular events:
|
Up to Seven Years
|
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Global Metabolomics
Временное ограничение: 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
Временное ограничение: Up to Seven Years
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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
Временное ограничение: Up to Seven Years
|
Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
|
Up to Seven Years
|
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Inflammation and oxidative stress
Временное ограничение: Up to Seven Years
|
Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
|
Up to Seven Years
|
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AGEs
Временное ограничение: Up to Seven Years
|
Metabolism of advanced glycation end products.
|
Up to Seven Years
|
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Mineral metabolism
Временное ограничение: Up to Seven Years
|
Impact of mineral metabolism on atherosclerosis
|
Up to Seven Years
|
|
Echographic markers of cardiac function and clinical outcomes
Временное ограничение: Up to Seven Years
|
Cardiac function studies by Echocardiography at baseline and during the study
|
Up to Seven Years
|
|
Microparticles
Временное ограничение: Up to Seven Years
|
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
Временное ограничение: 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
|
Up to Seven Years
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Endothelial function (Flow mediated dilation)
Временное ограничение: 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
Временное ограничение: Up to seven years
|
Influence of genetic data in the development clinical outcomes
|
Up to seven years
|
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postprandial lipaemia
Временное ограничение: Up to seven years
|
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
Временное ограничение: Up to seven years
|
Clinical events not qualifying as primary endpoint nor in the secondary objectives 1 and 2, especially those associated with cardiovascular disease
|
Up to seven years
|
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Subgroup Studies
Временное ограничение: Up to seven years
|
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
Временное ограничение: Up to Seven Years
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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
|
Up to Seven Years
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Francisco Perez-Jimenez, MD,PhD, Reina Sofia University Hospital
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 ноября 2009 г.
Первичное завершение (Действительный)
1 июля 2018 г.
Завершение исследования (Действительный)
1 мая 2021 г.
Даты регистрации исследования
Первый отправленный
18 июня 2009 г.
Впервые представлено, что соответствует критериям контроля качества
18 июня 2009 г.
Первый опубликованный (Оценивать)
19 июня 2009 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
3 июня 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
31 мая 2021 г.
Последняя проверка
1 мая 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Психические расстройства
- Ишемия
- Патологические процессы
- Некроз
- Ишемия миокарда
- Сердечные заболевания
- Сердечно-сосудистые заболевания
- Сосудистые заболевания
- Нарушения метаболизма глюкозы
- Метаболические заболевания
- Боль
- Неврологические проявления
- Нейрокогнитивные расстройства
- Резистентность к инсулину
- Гиперинсулинизм
- Когнитивные расстройства
- Боль в груди
- Стенокардия
- Инфаркт миокарда
- Инфаркт
- Метаболический синдром
- Когнитивная дисфункция
- Стенокардия, нестабильная
Другие идентификационные номера исследования
- CORDIOPREV
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .