Renal Insufficiency And Cardiovascular Events

Cardiovascular Disease Clinical Trial

— RIACE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715481
• Other study ID #: DNSG-SID 0601
• Status: Completed
• Phase: N/A
• First received: July 10, 2008
• Last updated: February 9, 2015
• Start date: June 2008
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Diabetic Nephropathy Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15628
• Est. completion date: February 2015
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

type 2 diabetes

Exclusion Criteria:

dyalisis or renal transplantation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
Italy	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	Milano
Italy	San Giuseppe Hospital, Division of Endocrinology	Milano
Italy	San Paolo Hospital, Division of Internal Medicine	Milano
Italy	San Raffaele Hospital	Milano
Italy	San Luigi Gonzaga Hospital, Division of Diabetes and Metabolic Diseases	Orbassano-Torino
Italy	Policlinico Hospital, Division of Diabetology	Padova
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

Sponsors (2)

Lead Sponsor	Collaborator
Diabetic Nephropathy Study Group	Italian Society of Diabetology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular morbidity and mortality		4 years	No
Secondary	eGFR, as classified according to the National Kidney Foundation criteria		4 years	No
Secondary	micro/macroalbuminuria		4 years	No
Secondary	traditional cardiovascular risk factors		4 years	No

External Links

•   online database