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- Ensaio Clínico NCT00715481
Renal Insufficiency And Cardiovascular Events (RIACE)
Reduced Estimated Glomerular Filtration Rate (eGFR)and Prediction of Cardiovascular Disease and Renal Outcome in Subjects With Type 2 Diabetes: Italian Multicenter Study
Reduced glomerular filtration rate (GFR) has been recently shown to be a powerful predictor of cardiovascular morbidity and mortality in the general population, independent of traditional cardiovascular risk factors.
This observational study is aimed at assessing the association of reduced estimated GFR with cardiovascular morbidity and mortality in a large italian population (at least 15,000 subjects) of type 2 diabetic outpatients over a 4-year follow-up.
Visão geral do estudo
Status
Condições
Descrição detalhada
Reduced GFR has been recently shown to be a powerful predictor of cardiovascular morbidity and mortality in the general population, independent of traditional cardiovascular risk factors. Since type 2 diabetic patients show increased cardiovascular morbidity and mortality as compared with the general population, the identification of predictors of cardiovascular disease in these patients is of fundamental importance for clinical purposes. One of these predictors is increased urinary albumin excretion rate, which is associated with an increased risk of cardiovascular disease more than of end-stage renal disease. However, a growing body of evidence indicates that a significant proportion of normoalbuminuric diabetic patients, particularly with type 2 diabetes, may exhibit reduced GFR. It is currently unknown the predictive role of this abnormality toward cardiovascular events and death, independent of albuminuria and other known risk factors, in the diabetic population.
This observational study is aimed at assessing the association of reduced estimated GFR with cardiovascular morbidity and mortality in a large italian population (at least 15,000 subjects) of type 2 diabetic nondialytic outpatients over a 4-year follow-up.
Secondary endpoints are to assess in this population:
- the prevalence and incidence of reduced GFR, as classified according to the National Kidney Foundation criteria, and its association with traditional cardiovascular risk factors;
- the prevalence, incidence and cardiovascular predictivity of micro and macroalbuminuria.
Patients will be recruited from electronic records of 20 italian outpatients diabetic clinics.
Routine anamnestic, clinical, laboratory and instrumental data will be recorded at baseline and over 4 years to obtain information about:
- renal function (albumin/creatinine ratio, serum creatinine with estimation of glomerular filtration rate [eGFR]);
- cardiovascular risk factors (smoking, physical activity, family history of diabetes, dyslipidemia, hypertension and cardiovascular disease, BMI and waist circumference, total, LDL, HDL and non-HDL cholesterol, triglycerides, arterial blood pressure and HbA1c);
- current glucose-, lipid- and blood pressure-lowering and anti-platelet or anti-coagulant treatment;
- other illnesses;
- cardiovascular events (myocardial infarction, stroke, lower limb ulcer/gangrene/amputation and coronary, carotid and lower limb revascularization, endovascular/surgical) and deaths.
These data will be derived from the electronic database of each participating center.
Laboratory analyses will be performed in each centre laboratory after proper standardization of analytical techniques.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Ascoli Piceno, Itália, 63100
- Mazzoni Hospital, Division of Diabetology
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Bari, Itália, 70124
- Policlinico Hospital, Division of Endocrinology
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Bergamo, Itália, 24128
- Ospedali Riuniti di Bergamo, Division of Diabetology
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Cagliari, Itália, 09042
- Monserrato Hospital, Division of Diabetology
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Catanzaro, Itália, 88100
- Mater Domini Hospital, Division of Internal Medicine
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Foggia, Itália, 71100
- Policlinico Hospital, Division of Endocrinology
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Latina, Itália, 04100
- Santa Maria Goretti Hospital, Division of Diabetology
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Milano, Itália, 20132
- San Raffaele Hospital
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Milano, Itália, 20122
- Policlinico - Maggiore Hospital, Division of Endocrinology and Diabetology
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Milano, Itália, 20123
- San Giuseppe Hospital, Division of Endocrinology
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Milano, Itália, 20142
- San Paolo Hospital, Division of Internal Medicine
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Orbassano-Torino, Itália, 10043
- San Luigi Gonzaga Hospital, Division of Diabetes and Metabolic Diseases
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Padova, Itália, 35128
- Policlinico Hospital, Division of Diabetology
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Pisa, Itália, 56124
- Cisanello Hospital, Divisions of Diabetology
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Pisa, Itália, 56126
- Santa Chiara Hospital, Division of Internal Medicine
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Rome, Itália, 00161
- Policlinico Hospital, Division of Internal Medicine
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Rome, Itália, 00189
- Sant'Andrea Hospital, Division of Diabetology
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Siena, Itália, 53100
- Policlinico Le Scotte, Division of Diabetology
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Torino, Itália, 10126
- Le Molinette - San Giovanni Battista Hospital, Division of Diabetology
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Verona, Itália, 37126
- Maggiore Hospital, Division of Endocrinology and Metabolic Diseases
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
type 2 diabetes
Exclusion Criteria:
dyalisis or renal transplantation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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cardiovascular morbidity and mortality
Prazo: 4 years
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4 years
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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eGFR, as classified according to the National Kidney Foundation criteria
Prazo: 4 years
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4 years
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micro/macroalbuminuria
Prazo: 4 years
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4 years
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traditional cardiovascular risk factors
Prazo: 4 years
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4 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Giuseppe Pugliese, MD, PhD, Diabetic Nephropathy Study Group
- Diretor de estudo: Anna Solini, MD, PhD, Diabetic Nephropathy Study Group
Publicações e links úteis
Publicações Gerais
- Orsi E, Solini A, Bonora E, Vitale M, Garofolo M, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Laviola L, Morano S, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Risk of all-cause mortality according to the European Society of Cardiology risk categories in individuals with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study. Acta Diabetol. 2022 Oct;59(10):1369-1381. doi: 10.1007/s00592-022-01942-8. Epub 2022 Jul 28.
- Penno G, Solini A, Orsi E, Bonora E, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Zerbini G, Lamacchia O, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Insulin resistance, diabetic kidney disease, and all-cause mortality in individuals with type 2 diabetes: a prospective cohort study. BMC Med. 2021 Mar 15;19(1):66. doi: 10.1186/s12916-021-01936-3.
- Orsi E, Penno G, Solini A, Bonora E, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Morano S, Baroni MG, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Independent association of atherogenic dyslipidaemia with all-cause mortality in individuals with type 2 diabetes and modifying effect of gender: a prospective cohort study. Cardiovasc Diabetol. 2021 Jan 30;20(1):28. doi: 10.1186/s12933-021-01224-7.
- Penno G, Orsi E, Solini A, Bonora E, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Gruden G, Laviola L, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Renal hyperfiltration is independently associated with increased all-cause mortality in individuals with type 2 diabetes: a prospective cohort study. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001481. doi: 10.1136/bmjdrc-2020-001481.
- Solini A, Penno G, Orsi E, Bonora E, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Lamacchia O, Baroni MG, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Is resistant hypertension an independent predictor of all-cause mortality in individuals with type 2 diabetes? A prospective cohort study. BMC Med. 2019 Apr 25;17(1):83. doi: 10.1186/s12916-019-1313-x.
- Penno G, Solini A, Orsi E, Bonora E, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Lamacchia O, Scardapane M, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Non-albuminuric renal impairment is a strong predictor of mortality in individuals with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian multicentre study. Diabetologia. 2018 Nov;61(11):2277-2289. doi: 10.1007/s00125-018-4691-2. Epub 2018 Jul 21.
- Penno G, Solini A, Bonora E, Orsi E, Fondelli C, Zerbini G, Trevisan R, Vedovato M, Cavalot F, Laviola L, Nicolucci A, Pugliese G; Renal Insufficiency and Cardiovascular Events (RIACE) Study Group. Defining the contribution of chronic kidney disease to all-cause mortality in patients with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study. Acta Diabetol. 2018 Jun;55(6):603-612. doi: 10.1007/s00592-018-1133-z. Epub 2018 Mar 24.
- Penno G, Solini A, Zoppini G, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Gruden G, Lamacchia O, Laviola L, Orsi E, Pugliese G; Renal Insufficiency Cardiovascular Events (RIACE) Study Group. Independent correlates of urinary albumin excretion within the normoalbuminuric range in patients with type 2 diabetes: The Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicentre Study. Acta Diabetol. 2015 Oct;52(5):971-81. doi: 10.1007/s00592-015-0789-x. Epub 2015 Jul 10.
- Penno G, Solini A, Zoppini G, Fondelli C, Trevisan R, Vedovato M, Gruden G, Lamacchia O, Pontiroli AE, Arosio M, Orsi E, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Hypertriglyceridemia Is Independently Associated with Renal, but Not Retinal Complications in Subjects with Type 2 Diabetes: A Cross-Sectional Analysis of the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study. PLoS One. 2015 May 5;10(5):e0125512. doi: 10.1371/journal.pone.0125512. eCollection 2015.
- Pugliese G, Solini A, Bonora E, Orsi E, Zerbini G, Fondelli C, Gruden G, Cavalot F, Lamacchia O, Trevisan R, Vedovato M, Penno G; RIACE Study Group. Distribution of cardiovascular disease and retinopathy in patients with type 2 diabetes according to different classification systems for chronic kidney disease: a cross-sectional analysis of the renal insufficiency and cardiovascular events (RIACE) Italian multicenter study. Cardiovasc Diabetol. 2014 Mar 13;13:59. doi: 10.1186/1475-2840-13-59.
- Penno G, Solini A, Zoppini G, Orsi E, Fondelli C, Zerbini G, Morano S, Cavalot F, Lamacchia O, Trevisan R, Vedovato M, Pugliese G; Renal Insufficiency and Cardiovascular Events (RIACE) Study Group. Hemoglobin A1c variability as an independent correlate of cardiovascular disease in patients with type 2 diabetes: a cross-sectional analysis of the renal insufficiency and cardiovascular events (RIACE) Italian multicenter study. Cardiovasc Diabetol. 2013 Jul 5;12:98. doi: 10.1186/1475-2840-12-98.
- Penno G, Solini A, Bonora E, Fondelli C, Orsi E, Zerbini G, Trevisan R, Vedovato M, Gruden G, Laviola L, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) study, group. Gender differences in cardiovascular disease risk factors, treatments and complications in patients with type 2 diabetes: the RIACE Italian multicentre study. J Intern Med. 2013 Aug;274(2):176-91. doi: 10.1111/joim.12073. Epub 2013 Apr 22.
- Penno G, Solini A, Bonora E, Fondelli C, Orsi E, Zerbini G, Morano S, Cavalot F, Lamacchia O, Laviola L, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events Study Group. HbA1c variability as an independent correlate of nephropathy, but not retinopathy, in patients with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian multicenter study. Diabetes Care. 2013 Aug;36(8):2301-10. doi: 10.2337/dc12-2264. Epub 2013 Mar 14.
- Penno G, Solini A, Zoppini G, Orsi E, Zerbini G, Trevisan R, Gruden G, Cavalot F, Laviola L, Morano S, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Rate and determinants of association between advanced retinopathy and chronic kidney disease in patients with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian multicenter study. Diabetes Care. 2012 Nov;35(11):2317-23. doi: 10.2337/dc12-0628.
- Pugliese G, Solini A, Zoppini G, Fondelli C, Zerbini G, Vedovato M, Cavalot F, Lamacchia O, Buzzetti R, Morano S, Nicolucci A, Penno G; Renal Insufficiency and Cardiovascular Events (RIACE) Study Group. High prevalence of advanced retinopathy in patients with type 2 diabetes from the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study. Diabetes Res Clin Pract. 2012 Nov;98(2):329-37. doi: 10.1016/j.diabres.2012.09.006. Epub 2012 Sep 26.
- Pugliese G, Solini A, Fondelli C, Trevisan R, Vedovato M, Nicolucci A, Penno G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Reproducibility of albuminuria in type 2 diabetic subjects. Findings from the Renal Insufficiency And Cardiovascular Events (RIACE) study. Nephrol Dial Transplant. 2011 Dec;26(12):3950-4. doi: 10.1093/ndt/gfr140. Epub 2011 Mar 25.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
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Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- DNSG-SID 0601
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