Study Results
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Basic Information
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COMPLETED
15628 participants
OBSERVATIONAL
2008-06-30
2015-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
80 Years
ALL
No
Sponsors
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Italian Society of Diabetology
OTHER
Diabetic Nephropathy Study Group
OTHER
Responsible Party
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Giuseppe Pugliese
Professor of Endocrinology and Metabolism
Principal Investigators
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Giuseppe Pugliese, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Diabetic Nephropathy Study Group
Anna Solini, MD, PhD
Role: STUDY_DIRECTOR
Diabetic Nephropathy Study Group
Locations
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Mazzoni Hospital, Division of Diabetology
Ascoli Piceno, , Italy
Policlinico Hospital, Division of Endocrinology
Bari, , Italy
Ospedali Riuniti di Bergamo, Division of Diabetology
Bergamo, , Italy
Monserrato Hospital, Division of Diabetology
Cagliari, , Italy
Mater Domini Hospital, Division of Internal Medicine
Catanzaro, , Italy
Policlinico Hospital, Division of Endocrinology
Foggia, , Italy
Santa Maria Goretti Hospital, Division of Diabetology
Latina, , Italy
Policlinico - Maggiore Hospital, Division of Endocrinology and Diabetology
Milan, , Italy
San Giuseppe Hospital, Division of Endocrinology
Milan, , Italy
San Raffaele Hospital
Milan, , Italy
San Paolo Hospital, Division of Internal Medicine
Milan, , Italy
San Luigi Gonzaga Hospital, Division of Diabetes and Metabolic Diseases
Orbassano-Torino, , Italy
Policlinico Hospital, Division of Diabetology
Padua, , Italy
Cisanello Hospital, Divisions of Diabetology
Pisa, , Italy
Santa Chiara Hospital, Division of Internal Medicine
Pisa, , Italy
Policlinico Hospital, Division of Internal Medicine
Rome, , Italy
Sant'Andrea Hospital, Division of Diabetology
Rome, , Italy
Policlinico Le Scotte, Division of Diabetology
Siena, , Italy
Le Molinette - San Giovanni Battista Hospital, Division of Diabetology
Torino, , Italy
Maggiore Hospital, Division of Endocrinology and Metabolic Diseases
Verona, , Italy
Countries
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References
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Garofolo M, Penno G, Solini A, Orsi E, Vitale M, Resi V, Bonora E, Fondelli C, Trevisan R, Vedovato M, Nicolucci A, Pugliese G; Renal Insufficiency And Cariovascular Events (RIACE) Study Group. Association of Albuminuria Within the Normoalbuminuric Range With All-Cause Mortality in People With Type 2 Diabetes. Diabetes Metab Res Rev. 2025 Jul;41(5):e70061. doi: 10.1002/dmrr.70061.
Garofolo M, Vitale M, Penno G, Solini A, Orsi E, Grancini V, Bonora E, Fondelli C, Trevisan R, Vedovato M, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Prognostic impact of switching to the 2021 chronic kidney disease epidemiology collaboration creatinine-based equation in Caucasian patients with type 2 diabetes: the Renal Insufficiency and Cardiovascular events (RIACE) Italian Multicenter Study. Cardiovasc Diabetol. 2024 Oct 24;23(1):377. doi: 10.1186/s12933-024-02450-5.
Garofolo M, Penno G, Solini A, Orsi E, Vitale M, Resi V, Bonora E, Fondelli C, Trevisan R, Vedovato M, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Relationship between degree of risk factor control and all-cause mortality in individuals with type 2 diabetes: A prospective cohort study. Eur J Intern Med. 2024 Oct;128:53-62. doi: 10.1016/j.ejim.2024.05.034. Epub 2024 Jun 6.
Vitale M, Orsi E, Solini A, Garofolo M, Grancini V, Bonora E, Fondelli C, Trevisan R, Vedovato M, Penno G, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group*. Association between age at diagnosis and all-cause mortality in type 2 diabetes: the Renal Insufficiency and Cardiovascular Events (RIACE) Italian Multicenter Study. Acta Diabetol. 2024 Sep;61(9):1107-1116. doi: 10.1007/s00592-024-02294-1. Epub 2024 May 7.
Vitale M, Orsi E, Solini A, Garofolo M, Resi V, Bonora E, Fondelli C, Trevisan R, Vedovato M, Penno G, Pugliese G. Independent association of history of diabetic foot with all-cause mortality in patients with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study. Cardiovasc Diabetol. 2024 Jan 13;23(1):34. doi: 10.1186/s12933-023-02107-9.
Solini A, Orsi E, Vitale M, Garofolo M, Resi V, Bonora E, Fondelli C, Trevisan R, Vedovato M, Nicolucci A, Penno G, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Independent association of estimated pulse-wave velocity with all-cause mortality in individuals with type 2 diabetes. QJM. 2024 Jul 1;117(7):495-502. doi: 10.1093/qjmed/hcae012.
Orsi E, Solini A, Penno G, Bonora E, Fondelli C, Trevisan R, Vedovato M, Cavalot F, Lamacchia O, Haxhi J, Nicolucci A, Pugliese G; Renal Insufficiency And Cardiovascular Events (RIACE) Study Group. Body mass index versus surrogate measures of central adiposity as independent predictors of mortality in type 2 diabetes. Cardiovasc Diabetol. 2022 Dec 2;21(1):266. doi: 10.1186/s12933-022-01706-2.
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.
Other Identifiers
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DNSG-SID 0601
Identifier Type: -
Identifier Source: org_study_id
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