The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases: Phase 1(observational study, completed in September 2005): after the identification of a type-2 diabetic population with typical Diabetic Nephropathy (DN), to study of the rate of renal and cardiovascular events during a middle term follow-up. Phase 2(interventional study, started in October 2005): 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.
The same patients that completed the first phase of the NID-2 study (observation) were enrolled for the phase 2 of the study (intervention).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
850
the patients have to be treated according the standard good medical practice by any center
Therapy for hypertension: \- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die
Therapy for hypertension: \- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die
Therapy for hypertension \- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine \<2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)
Therapy for hypertension \- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine \<2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)
Therapy for hypertension \- Step 3: amlodipine up to 10 mg/die
Therapy for hypertension \- Step 4: atenolol up to 100 mg/die
Therapy for hypertension \- Step 5: doxazosin up to 4 mg/die
Therapy for hypertension \- Step 6: clonidine
Therapy for Hyperglycaemia (to achieve HbA1c \<7): \- insulin
Therapy for hypercholesterolemia: \- for reducing LDL cholesterol \< 100 mg/dl: simvastatin up to 80 mg/die
Therapy for hypertriglyceridemia \- for reducing triglycerides \< 150 mg/dl and/or increasing HDL cholesterol \> 40-50 mg/dl: a fibrate
Treatment of anaemia: \- erythropoietin
Antiplatelet therapy (in all patients without contraindications): \- aspirin up to 160 mg/die
Department of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy
Naples, Italy
"Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)"
number of MACEs in the two groups are reported. In addition, The primary endpoint was analyzed with event curves for the time-to-first event based on Kaplan-Meier analysis. Cox regression model was used to calculate hazard ratio (HR) and 95% Confidence Interval (CI). Due to the cluster randomized study design, a Cox shared-frailty model was fitted. multivariable model was adjusted for selected potential confounders: age, sex, systolic blood pressure (SBP), hemoglobin, estimated glomerular filtration rate (eGFR), albuminuria, HbA1c, total cholesterol and triglycerides (log-scaled) to reduce risk of bias.
Time frame: 4 years (in the case the number of events needed by sample size is not reached at the expected 4-year time frame, primary end point will be assessed after the follow-up phase)
"Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase"
Achievement of targets at end of intervention was performed applying generalized estimating equation (GEE) models, further adjusting for baseline values as covariate.
Time frame: 13 years
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