Cardiovascular DiseaseRIACENCT00715481
Renal Insufficiency And Cardiovascular Events
An observational study of Cardiovascular Disease, run by Diabetic Nephropathy Study Group at 20 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 15,628 participants
- Where
- 20 sitesItaly
- Study dates
- Jun 2008to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients clinics
Who may be able to join
- type 2 diabetes
Who cannot join
- dyalisis or renal transplantation
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Mazzoni Hospital, Division of Diabetology
Ascoli Piceno, 63100
Policlinico Hospital, Division of Endocrinology
Bari, 70124
Ospedali Riuniti di Bergamo, Division of Diabetology
Bergamo, 24128
Monserrato Hospital, Division of Diabetology
Cagliari, 09042
Mater Domini Hospital, Division of Internal Medicine
Catanzaro, 88100
Policlinico Hospital, Division of Endocrinology
Foggia, 71100
Santa Maria Goretti Hospital, Division of Diabetology
Latina, 04100
Policlinico - Maggiore Hospital, Division of Endocrinology and Diabetology
Milan, 20122
San Giuseppe Hospital, Division of Endocrinology
Milan, 20123
San Raffaele Hospital
Milan, 20132
San Paolo Hospital, Division of Internal Medicine
Milan, 20142
San Luigi Gonzaga Hospital, Division of Diabetes and Metabolic Diseases
Orbassano-Torino, 10043
Policlinico Hospital, Division of Diabetology
Padova, 35128
Cisanello Hospital, Divisions of Diabetology
Pisa, 56124
Santa Chiara Hospital, Division of Internal Medicine
Pisa, 56126
Policlinico Hospital, Division of Internal Medicine
Rome, 00161
Sant'Andrea Hospital, Division of Diabetology
Rome, 00189
Policlinico Le Scotte, Division of Diabetology
Siena, 53100
Le Molinette - San Giovanni Battista Hospital, Division of Diabetology
Torino, 10126
Maggiore Hospital, Division of Endocrinology and Metabolic Diseases
Verona, 37126
About this study
Official title: 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.
Read the detailed description
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
- Cardiovascular Disease
- Keywords
- Type 2 diabetes, Cardiovascular disease, Diabetic Nephropathy, Glomerular filtration rate, Albuminuria
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Albuminuria
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular morbidity and mortality
Measured: 4 years
Secondary outcomes (3)
eGFR, as classified according to the National Kidney Foundation criteria
Measured: 4 years
micro/macroalbuminuria
Measured: 4 years
traditional cardiovascular risk factors
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetic Nephropathy Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Society of Diabetology
- Responsible party
- Principal investigator, Giuseppe Pugliese, Diabetic Nephropathy Study Group
- Investigators
- Giuseppe Pugliese, MD, PhD, Principal investigator, Diabetic Nephropathy Study GroupAnna Solini, MD, PhD, Study director, Diabetic Nephropathy Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715481
- Sponsor's protocol ID
- DNSG-SID 0601
- Acronym
- RIACE
- Status last verified
- Feb 2015
- First submitted
- 10 Jul 2008
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40557728Garofolo 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.
PubMed 39449120Garofolo 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.
PubMed 38845288Vitale 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.
PubMed 38714557Vitale 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.
PubMed 38218843Solini 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.
PubMed 38200621Orsi 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.
PubMed 36461034Orsi 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.
PubMed 35902419Penno 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.
PubMed 33715620Orsi 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.
PubMed 33516215Penno 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.
PubMed 32665314Solini 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.
PubMed 31023377Penno 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.
PubMed 30032426Penno 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.
PubMed 29574497Penno 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.
PubMed 26155957
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Estimated Glomerular Filtration Rate (eGFR)and Prediction of Cardiovascular Disease and Renal Outcome in Subjects With Type 2 Diabetes: Italian Multicenter Study
- ClinicalTrials.gov ID
- NCT00715481
- Acronym / sponsor ID
- RIACE / DNSG-SID 0601
- Conditions
- Cardiovascular Disease
- Keywords
- Type 2 diabetes, Cardiovascular disease, Diabetic Nephropathy, Glomerular filtration rate, Albuminuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,628 participants (actual)
- Lead sponsor
- Diabetic Nephropathy Study GroupUniversity, hospital or other
- Collaborators
- Italian Society of Diabetology
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients clinics
Key inclusion criteria (1 listed)
- type 2 diabetes
Key exclusion criteria (1 listed)
- dyalisis or renal transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiovascular morbidity and mortality
Time frame: 4 years
3 secondary outcomes
eGFR, as classified according to the National Kidney Foundation criteria
Time frame: 4 years
micro/macroalbuminuria
Time frame: 4 years
traditional cardiovascular risk factors
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Derived from this study: PubMed 40557728Garofolo 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.
- Derived from this study: PubMed 39449120Garofolo 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.
- Derived from this study: PubMed 38845288Garofolo 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.
- Derived from this study: PubMed 38714557Vitale 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.
- Derived from this study: PubMed 38218843Vitale 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.
- Derived from this study: PubMed 38200621Solini 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.
- Derived from this study: PubMed 36461034Orsi 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.
- Derived from this study: PubMed 35902419Orsi 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.
- Derived from this study: PubMed 33715620Penno 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.
- Derived from this study: PubMed 33516215Orsi 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.
- Derived from this study: PubMed 32665314Penno 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.
- Derived from this study: PubMed 31023377Solini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Pugliese, MD, PhD principal investigator
Diabetic Nephropathy Study Group
Anna Solini, MD, PhD study director
Diabetic Nephropathy Study Group
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Diabetic Nephropathy Study Group at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular morbidity and mortality (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00715481, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.