Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
850 participants
INTERVENTIONAL
2005-10-31
2019-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard of Care (SoC) therapy
Control group patients will continue their SoC therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist.
SoC therapy
the patients have to be treated according the standard good medical practice by any center
Multifactorial Intensified therapy
An intensive multifactorial intervention according Scientific Guidelines 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).
irbesartan
Therapy for hypertension:
\- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die
ramipril
Therapy for hypertension:
\- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die
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)
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)
amlodipine
Therapy for hypertension
\- Step 3: amlodipine up to 10 mg/die
atenolol
Therapy for hypertension
\- Step 4: atenolol up to 100 mg/die
doxazosin
Therapy for hypertension
\- Step 5: doxazosin up to 4 mg/die
clonidine
Therapy for hypertension
\- Step 6: clonidine
insulin
Therapy for Hyperglycaemia (to achieve HbA1c \<7):
\- insulin
simvastatin
Therapy for hypercholesterolemia:
\- for reducing LDL cholesterol \< 100 mg/dl: simvastatin up to 80 mg/die
fibrate
Therapy for hypertriglyceridemia
\- for reducing triglycerides \< 150 mg/dl and/or increasing HDL cholesterol \> 40-50 mg/dl: a fibrate
erythropoietin
Treatment of anaemia:
\- erythropoietin
aspirin
Antiplatelet therapy (in all patients without contraindications):
\- aspirin up to 160 mg/die
Interventions
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SoC therapy
the patients have to be treated according the standard good medical practice by any center
irbesartan
Therapy for hypertension:
\- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die
ramipril
Therapy for hypertension:
\- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die
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)
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)
amlodipine
Therapy for hypertension
\- Step 3: amlodipine up to 10 mg/die
atenolol
Therapy for hypertension
\- Step 4: atenolol up to 100 mg/die
doxazosin
Therapy for hypertension
\- Step 5: doxazosin up to 4 mg/die
clonidine
Therapy for hypertension
\- Step 6: clonidine
insulin
Therapy for Hyperglycaemia (to achieve HbA1c \<7):
\- insulin
simvastatin
Therapy for hypercholesterolemia:
\- for reducing LDL cholesterol \< 100 mg/dl: simvastatin up to 80 mg/die
fibrate
Therapy for hypertriglyceridemia
\- for reducing triglycerides \< 150 mg/dl and/or increasing HDL cholesterol \> 40-50 mg/dl: a fibrate
erythropoietin
Treatment of anaemia:
\- erythropoietin
aspirin
Antiplatelet therapy (in all patients without contraindications):
\- aspirin up to 160 mg/die
Eligibility Criteria
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Inclusion Criteria
* 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
* \<40 years old
40 Years
70 Years
ALL
No
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
Responsible Party
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Ferdinando Carlo Sasso, MD, PhD
AssociateProfessor
Principal Investigators
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Ferdinando C Sasso, MD, PhD
Role: STUDY_DIRECTOR
Università della Campania "Luigi Vanvitelli", Naples, Italy
Roberto Minutolo, MD, MD
Role: PRINCIPAL_INVESTIGATOR
Università della Campania "Luigi Vanvitelli", Naples, Italy
Luca De Nicola, MD, MD
Role: STUDY_CHAIR
Università della Campania "Luigi Vanvitelli", Naples, Italy
Locations
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Department of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy
Naples, , Italy
Countries
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References
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Sasso FC, De Nicola L, Carbonara O, Nasti R, Minutolo R, Salvatore T, Conte G, Torella R. Cardiovascular risk factors and disease management in type 2 diabetic patients with diabetic nephropathy. Diabetes Care. 2006 Mar;29(3):498-503. doi: 10.2337/diacare.29.03.06.dc05-1776.
Minutolo R, Sasso FC, Chiodini P, Cianciaruso B, Carbonara O, Zamboli P, Tirino G, Pota A, Torella R, Conte G, De Nicola L. Management of cardiovascular risk factors in advanced type 2 diabetic nephropathy: a comparative analysis in nephrology, diabetology and primary care settings. J Hypertens. 2006 Aug;24(8):1655-61. doi: 10.1097/01.hjh.0000239303.93872.31.
Sasso FC, Simeon V, Galiero R, Caturano A, De Nicola L, Chiodini P, Rinaldi L, Salvatore T, Lettieri M, Nevola R, Sardu C, Docimo G, Loffredo G, Marfella R, Adinolfi LE, Minutolo R; NID-2 study group Investigators. The number of risk factors not at target is associated with cardiovascular risk in a type 2 diabetic population with albuminuria in primary cardiovascular prevention. Post-hoc analysis of the NID-2 trial. Cardiovasc Diabetol. 2022 Nov 7;21(1):235. doi: 10.1186/s12933-022-01674-7.
Sasso FC, Pafundi PC, Simeon V, De Nicola L, Chiodini P, Galiero R, Rinaldi L, Nevola R, Salvatore T, Sardu C, Marfella R, Adinolfi LE, Minutolo R; NID-2 Study Group Investigators. Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease. Cardiovasc Diabetol. 2021 Jul 16;20(1):145. doi: 10.1186/s12933-021-01343-1.
Sasso FC, Lascar N, Ascione A, Carbonara O, De Nicola L, Minutolo R, Salvatore T, Rizzo MR, Cirillo P, Paolisso G, Marfella R; NID-2 study group. Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy. A multicenter prospective 8 years follow up study. Cardiovasc Diabetol. 2016 Oct 13;15(1):147. doi: 10.1186/s12933-016-0463-9.
Other Identifiers
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246813579
Identifier Type: -
Identifier Source: org_study_id
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