Renal Insufficiency And Cardiovascular Events (RIACE)

February 9, 2015 updated by: Giuseppe Pugliese, Diabetic Nephropathy Study Group

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

15628

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ascoli Piceno, Italy, 63100
        • Mazzoni Hospital, Division of Diabetology
      • Bari, Italy, 70124
        • Policlinico Hospital, Division of Endocrinology
      • Bergamo, Italy, 24128
        • Ospedali Riuniti di Bergamo, Division of Diabetology
      • Cagliari, Italy, 09042
        • Monserrato Hospital, Division of Diabetology
      • Catanzaro, Italy, 88100
        • Mater Domini Hospital, Division of Internal Medicine
      • Foggia, Italy, 71100
        • Policlinico Hospital, Division of Endocrinology
      • Latina, Italy, 04100
        • Santa Maria Goretti Hospital, Division of Diabetology
      • Milano, Italy, 20132
        • San Raffaele Hospital
      • Milano, Italy, 20122
        • Policlinico - Maggiore Hospital, Division of Endocrinology and Diabetology
      • Milano, Italy, 20123
        • San Giuseppe Hospital, Division of Endocrinology
      • Milano, Italy, 20142
        • San Paolo Hospital, Division of Internal Medicine
      • Orbassano-Torino, Italy, 10043
        • San Luigi Gonzaga Hospital, Division of Diabetes and Metabolic Diseases
      • Padova, Italy, 35128
        • Policlinico Hospital, Division of Diabetology
      • Pisa, Italy, 56124
        • Cisanello Hospital, Divisions of Diabetology
      • Pisa, Italy, 56126
        • Santa Chiara Hospital, Division of Internal Medicine
      • Rome, Italy, 00161
        • Policlinico Hospital, Division of Internal Medicine
      • Rome, Italy, 00189
        • Sant'Andrea Hospital, Division of Diabetology
      • Siena, Italy, 53100
        • Policlinico Le Scotte, Division of Diabetology
      • Torino, Italy, 10126
        • Le Molinette - San Giovanni Battista Hospital, Division of Diabetology
      • Verona, Italy, 37126
        • Maggiore Hospital, Division of Endocrinology and Metabolic Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Outpatients clinics

Description

Inclusion Criteria:

type 2 diabetes

Exclusion Criteria:

dyalisis or renal transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cardiovascular morbidity and mortality
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
eGFR, as classified according to the National Kidney Foundation criteria
Time Frame: 4 years
4 years
micro/macroalbuminuria
Time Frame: 4 years
4 years
traditional cardiovascular risk factors
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diabetic Nephropathy Study Group

Collaborators

Italian Society of Diabetology

Investigators

  • Principal Investigator: Giuseppe Pugliese, MD, PhD, Diabetic Nephropathy Study Group
  • Study Director: Anna Solini, MD, PhD, Diabetic Nephropathy Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 10, 2008

First Submitted That Met QC Criteria

July 10, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNSG-SID 0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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