Nephropathy In Type 2 Diabetes and Cardio-renal Events

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second University of Naples; University of Campania "Luigi Vanvitelli"
• Treatments: Amlodipine; Aspirin; Atenolol; Clofibric Acid; Clonidine; Doxazosin; Epoetin Alfa; Furosemide; Hydrochlorothiazide; Insulin; Irbesartan; Ramipril; Simvastatin

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