Nephropathy In Type 2 Diabetes and Cardio-renal Events
This trial is active, not recruiting.
|Treatments||current therapy, irbesartan, ramipril, hydrochlorothiazide, furosemide, amlodipine, atenolol, doxazosin, clonidine, insulin, simvastatin, fibrate, erythropoietin, aspirin|
|Sponsor||Second University of Naples|
|Start date||March 2003|
|End date||July 2012|
|Trial size||850 participants|
|Trial identifier||NCT00535925, 246813579|
The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases:
Phase 1(observational study, completed at 2007): after the identification of a type-2 diabetic population with typical DN, to study of the rate of renal and cardiovascular events during a middle term follow-up.
Phase 2(interventional study, started at 2007): after randomization in two groups, a group (intervention group) is treated with an intensive multifactorial intervention whose aim is to reduce morbidity and mortality due to diabetic complications. The other group (control group) continues the conventional therapy . To avoid bias in the treatment in each center, the randomization was performed for centre.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
CV events (total CV mortality, non fatal IMA, non fatal stroke, TIA, major amputations, by-pass or PTCA)
time frame: 4 years
A) (In patients with microalbuminuria) • Progression to macroalbuminuria • Regression to normoalbuminuria B) (In patients with macroalbuminuria) • Doubling time of serum creatinine • Reduction of proteinuria to <0,5 g/die
time frame: 4 years
Male or female participants from 40 years up to 70 years old.
Inclusion Criteria: - type 2 diabetic patients - AER >30 mg/die (micro- or macro-albuminuric ranges) in at least two determinations in the last six months - diabetic retinopathy - patients followed in the outpatient clinic for at least 12 months Exclusion Criteria: - type 1 diabetic patients - <40 years old
|Official title||Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.|
|Principal investigator||Ferdinando C Sasso, MD, PhD|
|Description||The same patients that completed the first phase of the NID-2 study (observation) were enrolled for the phase 2 of the study (intervention).|
Call for more information