NCT00715481

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,628

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

5 months

First QC Date

July 10, 2008

Last Update Submit

February 9, 2015

Conditions

Cardiovascular Disease

Keywords

Type 2 diabetesCardiovascular diseaseDiabetic NephropathyGlomerular filtration rateAlbuminuria

Outcome Measures

Primary Outcomes (1)

  • cardiovascular morbidity and mortality

    4 years

Secondary Outcomes (3)

  • eGFR, as classified according to the National Kidney Foundation criteria

    4 years

  • micro/macroalbuminuria

    4 years

  • traditional cardiovascular risk factors

    4 years

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatients clinics

You may qualify if:

  • type 2 diabetes

You may not qualify if:

  • dyalisis or renal transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Mazzoni Hospital, Division of Diabetology

Ascoli Piceno, 63100, Italy

Location

Policlinico Hospital, Division of Endocrinology

Bari, 70124, Italy

Location

Ospedali Riuniti di Bergamo, Division of Diabetology

Bergamo, 24128, Italy

Location

Monserrato Hospital, Division of Diabetology

Cagliari, 09042, Italy

Location

Mater Domini Hospital, Division of Internal Medicine

Catanzaro, 88100, Italy

Location

Policlinico Hospital, Division of Endocrinology

Foggia, 71100, Italy

Location

Santa Maria Goretti Hospital, Division of Diabetology

Latina, 04100, Italy

Location

Policlinico - Maggiore Hospital, Division of Endocrinology and Diabetology

Milan, 20122, Italy

Location

San Giuseppe Hospital, Division of Endocrinology

Milan, 20123, Italy

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

San Paolo Hospital, Division of Internal Medicine

Milan, 20142, Italy

Location

San Luigi Gonzaga Hospital, Division of Diabetes and Metabolic Diseases

Orbassano-Torino, 10043, Italy

Location

Policlinico Hospital, Division of Diabetology

Padua, 35128, Italy

Location

Cisanello Hospital, Divisions of Diabetology

Pisa, 56124, Italy

Location

Santa Chiara Hospital, Division of Internal Medicine

Pisa, 56126, Italy

Location

Policlinico Hospital, Division of Internal Medicine

Rome, 00161, Italy

Location

Sant'Andrea Hospital, Division of Diabetology

Rome, 00189, Italy

Location

Policlinico Le Scotte, Division of Diabetology

Siena, 53100, Italy

Location

Le Molinette - San Giovanni Battista Hospital, Division of Diabetology

Torino, 10126, Italy

Location

Maggiore Hospital, Division of Endocrinology and Metabolic Diseases

Verona, 37126, Italy

Location

Related Publications (23)

  • 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.

    PMID: 40557728DERIVED

  • 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.

    PMID: 39449120DERIVED

  • 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.

    PMID: 38845288DERIVED

  • 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.

    PMID: 38714557DERIVED

  • 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.

    PMID: 38218843DERIVED

  • 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.

    PMID: 38200621DERIVED

  • 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.

    PMID: 36461034DERIVED

  • 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.

    PMID: 35902419DERIVED

  • 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.

    PMID: 33715620DERIVED

  • 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.

    PMID: 33516215DERIVED

  • 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.

    PMID: 32665314DERIVED

  • 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.

    PMID: 31023377DERIVED

  • 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.

    PMID: 30032426DERIVED

  • 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.

    PMID: 29574497DERIVED

  • 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.

    PMID: 26155957DERIVED

  • 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.

    PMID: 25942403DERIVED

  • 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.

    PMID: 24624891DERIVED

  • 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.

    PMID: 23829205DERIVED

  • 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.

    PMID: 23565931DERIVED

  • 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.

    PMID: 23491522DERIVED

  • 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.

    PMID: 23093684DERIVED

  • 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.

    PMID: 23020932DERIVED

  • 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.

    PMID: 21441399DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus, Type 2Diabetic NephropathiesAlbuminuria

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsProteinuriaUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Giuseppe Pugliese, MD, PhD

    Diabetic Nephropathy Study Group

    PRINCIPAL INVESTIGATOR

  • Anna Solini, MD, PhD

    Diabetic Nephropathy Study Group

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endocrinology and Metabolism

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 15, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2008

Study Completion

February 1, 2015

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

IT(20)