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Trial record 1 of 418 for:    Renal Insufficiency and Cardiovascular Events
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Renal Insufficiency And Cardiovascular Events (RIACE)

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ClinicalTrials.gov Identifier: NCT00715481
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : February 10, 2015
Sponsor:
Collaborator:
Italian Society of Diabetology
Information provided by (Responsible Party):
Giuseppe Pugliese, Diabetic Nephropathy Study Group

Brief 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.


Condition or disease
Cardiovascular Disease

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.

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Study Type : Observational
Actual Enrollment : 15628 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. cardiovascular morbidity and mortality [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. eGFR, as classified according to the National Kidney Foundation criteria [ Time Frame: 4 years ]
  2. micro/macroalbuminuria [ Time Frame: 4 years ]
  3. traditional cardiovascular risk factors [ Time Frame: 4 years ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatients clinics
Criteria

Inclusion Criteria:

type 2 diabetes

Exclusion Criteria:

dyalisis or renal transplantation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715481


Locations
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Sponsors and Collaborators
Diabetic Nephropathy Study Group
Italian Society of Diabetology
Investigators
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Principal Investigator: Giuseppe Pugliese, MD, PhD Diabetic Nephropathy Study Group
Study Director: Anna Solini, MD, PhD Diabetic Nephropathy Study Group
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Giuseppe Pugliese, Professor of Endocrinology and Metabolism, Diabetic Nephropathy Study Group
ClinicalTrials.gov Identifier: NCT00715481    
Other Study ID Numbers: DNSG-SID 0601
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Keywords provided by Giuseppe Pugliese, Diabetic Nephropathy Study Group:
Type 2 diabetes
Cardiovascular disease
Diabetic Nephropathy
Glomerular filtration rate
Albuminuria
Additional relevant MeSH terms:
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Cardiovascular Diseases