Renal Insufficiency And Cardiovascular Events (RIACE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Italian Society of Diabetology
Information provided by (Responsible Party):
Giuseppe Pugliese, Diabetic Nephropathy Study Group
ClinicalTrials.gov Identifier:
NCT00715481
First received: July 10, 2008
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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.


Condition
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Diabetic Nephropathy Study Group:

Primary Outcome Measures:
  • cardiovascular morbidity and mortality [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • eGFR, as classified according to the National Kidney Foundation criteria [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • micro/macroalbuminuria [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • traditional cardiovascular risk factors [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 15628
Study Start Date: June 2008
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatients clinics

Criteria

Inclusion Criteria:

type 2 diabetes

Exclusion Criteria:

dyalisis or renal transplantation

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715481

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

Additional Information:
No publications provided by Diabetic Nephropathy Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Giuseppe Pugliese, Professor of Endocrinology and Metabolism, Diabetic Nephropathy Study Group
ClinicalTrials.gov Identifier: NCT00715481     History of Changes
Other Study ID Numbers: DNSG-SID 0601
Study First Received: July 10, 2008
Last Updated: August 23, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Diabetic Nephropathy Study Group:
Type 2 diabetes
Cardiovascular disease
Diabetic Nephropathy
Glomerular filtration rate
Albuminuria

Additional relevant MeSH terms:
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014