Nephropathy In Type 2 Diabetes and Cardio-Renal Events
Information source: Second University of Naples
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Nephropathy
Intervention: current therapy (Drug); irbesartan (Drug); ramipril (Drug); hydrochlorothiazide (Drug); furosemide (Drug); amlodipine (Drug); atenolol (Drug); doxazosin (Drug); clonidine (Drug); insulin (Drug); simvastatin (Drug); fibrate (Drug); erythropoietin (Drug); aspirin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Second University of Naples Official(s) and/or principal investigator(s):
Ferdinando C Sasso, MD, PhD, Principal Investigator, Affiliation: Second University of Naples
Roberto Torella, Prof, MD, Study Director, Affiliation: Second University of Naples
Luca De Nicola, Prof, MD, Study Chair, Affiliation: Second University of Naples
Summary
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.
Clinical Details
Official title: Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-Renal Events.
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: CV events (total CV mortality, non fatal IMA, non fatal stroke, TIA, major amputations, by-pass or PTCA)
Secondary outcome: 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
Detailed 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).
Eligibility
Minimum age: 40 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Department of Clinical and Experimental Medicine, Second University of Naples, Naples I-80131, Italy
Additional Information
Starting date: March 2003
Ending date: December 2010
Last updated: October 1, 2007
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