DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Nephropathy In Type 2 Diabetes and Cardio-renal Events

Information source: Second University of Naples
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

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
Last updated: December 20, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017