Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 10, 2008
August 23, 2013
June 2008
November 2008   (final data collection date for primary outcome measure)
cardiovascular morbidity and mortality [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00715481 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Renal Insufficiency And Cardiovascular Events
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Outpatients clinics

Cardiovascular Disease
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15628
November 2013
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

type 2 diabetes

Exclusion Criteria:

dyalisis or renal transplantation

Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00715481
DNSG-SID 0601
No
Giuseppe Pugliese, Diabetic Nephropathy Study Group
Diabetic Nephropathy Study Group
Italian Society of Diabetology
Principal Investigator: Giuseppe Pugliese, MD, PhD Diabetic Nephropathy Study Group
Study Director: Anna Solini, MD, PhD Diabetic Nephropathy Study Group
Diabetic Nephropathy Study Group
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP