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NCT Number: NCT00535925

Nephropathy In Type 2 Diabetes and Cardio-renal Events

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.

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy

Naples, I-80131, Italy

About this study

The same patients that completed the first phase of the NID-2 study (observation) were enrolled for the phase 2 of the study (intervention).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOC therapy

Drug

the patients have to be treated according the standard good medical practice by any center

Irbesartan

Drug

Therapy for hypertension:

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

Ramipril

Drug

Therapy for hypertension:

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

Hydrochlorothiazide

Drug

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

Drug

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

Drug

Therapy for hypertension

  • Step 3: amlodipine up to 10 mg/die

Atenolol

Drug

Therapy for hypertension

  • Step 4: atenolol up to 100 mg/die

Doxazosin

Drug

Therapy for hypertension

  • Step 5: doxazosin up to 4 mg/die

Clonidine

Drug

Therapy for hypertension

  • Step 6: clonidine

Insulin

Drug

Therapy for Hyperglycaemia (to achieve HbA1c <7):

  • insulin

simvastatin

Drug

Therapy for hypercholesterolemia:

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

fibrate

Drug

Therapy for hypertriglyceridemia

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

Erythropoietin

Drug

Treatment of anaemia:

  • erythropoietin

Aspirin

Drug

Antiplatelet therapy (in all patients without contraindications):

  • aspirin up to 160 mg/die

Primary outcomes

  1. "Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)"

    Time frame: 4 years (in the case the number of events needed by sample size is not reached at the expected 4-year time frame, primary end point will be assessed after the follow-up phase)

    number of MACEs in the two groups are reported. In addition, The primary endpoint was analyzed with event curves for the time-to-first event based on Kaplan-Meier analysis. Cox regression model was used to calculate hazard ratio (HR) and 95% Confidence Interval (CI). Due to the cluster randomized study design, a Cox shared-frailty model was fitted. multivariable model was adjusted for selected potential confounders: age, sex, systolic blood pressure (SBP), hemoglobin, estimated glomerular filtration rate (eGFR), albuminuria, HbA1c, total cholesterol and triglycerides (log-scaled) to reduce risk of bias.

Secondary outcomes

  1. "Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase"

    Time frame: 13 years

    Achievement of targets at end of intervention was performed applying generalized estimating equation (GEE) models, further adjusting for baseline values as covariate.

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.

Acronym: NID-2

Important dates

Study start
2005
Primary completion
2011
Study completion
2019
First posted
Sep 27, 2007
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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