Renal Insufficiency And Cardiovascular Events

NCT ID: NCT00715481

Last Updated: 2015-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15628 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

type 2 diabetes

Exclusion Criteria

dyalisis or renal transplantation
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Italian Society of Diabetology

OTHER

Sponsor Role collaborator

Diabetic Nephropathy Study Group

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Pugliese

Professor of Endocrinology and Metabolism

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Policlinico Hospital, Division of Endocrinology

Bari, , Italy

Site Status

Ospedali Riuniti di Bergamo, Division of Diabetology

Bergamo, , Italy

Site Status

Monserrato Hospital, Division of Diabetology

Cagliari, , Italy

Site Status

Mater Domini Hospital, Division of Internal Medicine

Catanzaro, , Italy

Site Status

Policlinico Hospital, Division of Endocrinology

Foggia, , Italy

Site Status

Santa Maria Goretti Hospital, Division of Diabetology

Latina, , Italy

Site Status

Policlinico - Maggiore Hospital, Division of Endocrinology and Diabetology

Milan, , Italy

Site Status

San Giuseppe Hospital, Division of Endocrinology

Milan, , Italy

Site Status

San Raffaele Hospital

Milan, , Italy

Site Status

San Paolo Hospital, Division of Internal Medicine

Milan, , Italy

Site Status

San Luigi Gonzaga Hospital, Division of Diabetes and Metabolic Diseases

Orbassano-Torino, , Italy

Site Status

Policlinico Hospital, Division of Diabetology

Padua, , Italy

Site Status

Cisanello Hospital, Divisions of Diabetology

Pisa, , Italy

Site Status

Santa Chiara Hospital, Division of Internal Medicine

Pisa, , Italy

Site Status

Policlinico Hospital, Division of Internal Medicine

Rome, , Italy

Site Status

Sant'Andrea Hospital, Division of Diabetology

Rome, , Italy

Site Status

Policlinico Le Scotte, Division of Diabetology

Siena, , Italy

Site Status

Le Molinette - San Giovanni Battista Hospital, Division of Diabetology

Torino, , Italy

Site Status

Maggiore Hospital, Division of Endocrinology and Metabolic Diseases

Verona, , Italy

Site Status

Countries

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Italy

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.

Reference Type DERIVED
PMID: 40557728 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39449120 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38845288 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38714557 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38218843 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38200621 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36461034 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35902419 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33715620 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33516215 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32665314 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31023377 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30032426 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29574497 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26155957 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25942403 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24624891 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23829205 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23565931 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23491522 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23093684 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23020932 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21441399 (View on PubMed)

Other Identifiers

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DNSG-SID 0601

Identifier Type: -

Identifier Source: org_study_id

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