- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT00924937
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention (CORDIOPREV)
Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Cordoba, Spanyolország, 14001
- Reina Sofia University Hospital
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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).
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Aktív összehasonlító: 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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Kísérleti: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
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.
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
Időkeret: Seven Years
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Data from clinical and/or diagnostic tests will be analyzed
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Seven Years
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Concentration of LDL cholesterol.
Időkeret: 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.
Időkeret: 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).
Időkeret: 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.
Időkeret: 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.
Időkeret: Seven Years
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Appearance of malignancy
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Seven Years
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Progression of Cognitive Decline.
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Up to Seven Years
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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
Időkeret: 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
Időkeret: Up to Seven Years
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Metabolism of advanced glycation end products.
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Up to Seven Years
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Mineral metabolism
Időkeret: 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
Időkeret: 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
Időkeret: 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
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Up to Seven Years
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Subgroup analysis
Időkeret: Up to Seven Years
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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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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Endothelial function (Flow mediated dilation)
Időkeret: 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
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Up to Seven Years
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genetics, genomics and epigenetics
Időkeret: Up to seven years
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Influence of genetic data in the development clinical outcomes
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Up to seven years
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postprandial lipaemia
Időkeret: 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
Időkeret: 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
Időkeret: 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
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Up to seven years
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Further Studies
Időkeret: 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
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Up to Seven Years
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Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Francisco Perez-Jimenez, MD,PhD, Reina Sofia University Hospital
Publikációk és hasznos linkek
Általános kiadványok
- 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.
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Mentális zavarok
- Ischaemia
- Patológiás folyamatok
- Elhalás
- Szívizom ischaemia
- Szívbetegségek
- Szív-és érrendszeri betegségek
- Érrendszeri betegségek
- Glükóz anyagcserezavarok
- Anyagcsere-betegségek
- Fájdalom
- Neurológiai megnyilvánulások
- Neurokognitív zavarok
- Inzulinrezisztencia
- Hiperinzulinizmus
- Kogníciós zavarok
- Mellkasi fájdalom
- Angina pectoris
- Miokardiális infarktus
- Infarktus
- Metabolikus szindróma
- Kognitív diszfunkció
- Angina, instabil
Egyéb vizsgálati azonosító számok
- CORDIOPREV
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Low Fat Diet
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Malaysia Palm Oil BoardUniversiti Putra Malaysia; International Medical UniversityBefejezve
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Klein Buendel, Inc.Pennington Biomedical Research CenterBefejezveAlvásmegvonás | Túlsúly és elhízás | Egészségügyi ViselkedésEgyesült Államok
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University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical Research... és más munkatársakToborzás
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Riphah International UniversityToborzásIzomfeszességPakisztán
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Memorial University of NewfoundlandNL SUPPORT Strategy for Patient-Oriented ResearchBefejezveDiagnosztikai képalkotó felhasználásKanada
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Young 1oveUniversity of OxfordToborzásTerhességhez kapcsolódó | Viselkedés, egészségBotswana
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University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI); Arizona Pharmaceuticals Inc.Befejezve
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University of CadizInstituto de investigación e innovación biomédica de CádizToborzásCukorbetegség, 2-es típusúSpanyolország
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Alopexx Oncology, LLCMegszűntB-sejtes non-Hodgkin limfómaEgyesült Államok