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Nephropathy In Type 2 Diabetes and Cardio-renal Events (NID-2)

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ClinicalTrials.gov Identifier: NCT00535925
Recruitment Status : Unknown
Verified December 2011 by Sasso Ferdinando Carlo, University of Campania "Luigi Vanvitelli".
Recruitment status was:  Active, not recruiting
First Posted : September 27, 2007
Last Update Posted : December 21, 2011
Sponsor:
Information provided by (Responsible Party):
Sasso Ferdinando Carlo, University of Campania "Luigi Vanvitelli"

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: 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 Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.
Study Start Date : March 2003
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: 1
Control group patients will continue their usual therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.
Drug: current therapy
the patients have to be treated according the standard good medical practice by any center

Experimental: 2

An intensive multifactorial intervention is performed to achieve the goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia.

In particular, new antihypertensive drugs will be added one by one until the achievement of blood pressure target (<130/80 mmHg).

Drug: irbesartan

Therapy for hypertension:

- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die


Drug: ramipril

Therapy for hypertension:

- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die


Drug: hydrochlorothiazide

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)


Drug: furosemide

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)


Drug: amlodipine

Therapy for hypertension

- Step 3: amlodipine up to 10 mg/die


Drug: atenolol

Therapy for hypertension

- Step 4: atenolol up to 100 mg/die


Drug: doxazosin

Therapy for hypertension

- Step 5: doxazosin up to 4 mg/die


Drug: clonidine

Therapy for hypertension

- Step 6: clonidine


Drug: insulin

Therapy for Hyperglycaemia (to achieve HbA1c <7):

- insulin


Drug: simvastatin

Therapy for hypercholesterolemia:

- for reducing LDL cholesterol < 100 mg/dl: simvastatin up to 80 mg/die


Drug: fibrate

Therapy for hypertriglyceridemia

- for reducing triglycerides < 150 mg/dl and/or increasing HDL cholesterol > 40-50 mg/dl: a fibrate


Drug: erythropoietin

Treatment of anaemia:

- erythropoietin


Drug: aspirin

Antiplatelet therapy (in all patients without contraindications):

- aspirin up to 160 mg/die





Primary Outcome Measures :
  1. CV events (total CV mortality, non fatal IMA, non fatal stroke, TIA, major amputations, by-pass or PTCA) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 4 years ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535925


Locations
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Italy
Department of Clinical and Experimental Medicine, Second University of Naples
Naples, Italy, I-80131
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
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Principal Investigator: Ferdinando C Sasso, MD, PhD University of Campania "Luigi Vanvitelli"
Study Director: Roberto Torella, Prof, MD University of Campania "Luigi Vanvitelli"
Study Chair: Luca De Nicola, Prof, MD University of Campania "Luigi Vanvitelli"

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sasso Ferdinando Carlo, Assistant Professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT00535925     History of Changes
Other Study ID Numbers: 246813579
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: December 21, 2011
Last Verified: December 2011
Keywords provided by Sasso Ferdinando Carlo, University of Campania "Luigi Vanvitelli":
type 2 diabetes
nephropathy
CV events
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Aspirin
Insulin
Atenolol
Amlodipine
Hydrochlorothiazide
Clonidine
Ramipril
Irbesartan
Doxazosin
Furosemide
Epoetin Alfa
Simvastatin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents