Nephropathy In Type 2 Diabetes and Cardio-renal Events
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 2
Intervention: SoC therapy; irbesartan; ramipril; hydrochlorothiazide; furosemide; amlodipine; atenolol; doxazosin; clonidine; insulin; simvastatin; fibrate; erythropoietin; aspirin
Intervention description: 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
Intervention MeSH terms: Aspirin; Atenolol; Amlodipine; Hydrochlorothiazide; Clonidine; Ramipril; Irbesartan; Doxazosin; Furosemide; Epoetin Alfa; Simvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 850.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: type 2 diabetes; nephropathy; cardiovascular (CV) events

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetic patients

          -  albumin extraction rate (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 outpatients clinic for at least 12 months

        Exclusion Criteria:

          -  type 1 diabetic patients

          -  <40 years old