Multifactorial Intervention in Type 2 Diabetes - Italy

Summary

Despite several clinical trials have clearly demonstrated that the correction of a single cardiovascular risk factor in patients with type 2 diabetes decreases the incidence of myocardial infarction and other cardiovascular disease (CVD) events, only the Steno study has been evaluating the effect of a multifactorial intervention strategy on macrovascular complications of diabetes. For this reason, the disease management approach currently endorsed by international guidelines (i.e correction of all major CVD risk factors to target levels usually lower than lower risk populations) has not been extensively investigated in terms of prevalence of application in current clinical practice and in terms of real efficacy.

The Multifactorial INtervention in type 2 Diabetes - ITaly (MIND.IT) is a multicentric two-phase study involving 9 Diabetes Care Units throughout Italy with the overall aims of: (1) investigating the degree of application of the international guidelines for CVD prevention in type 2 diabetic patients and (2) verifying whether the application of an intensive multi-factorial intervention inspired by these guidelines is feasible and effective in decreasing the incidence of new CVD events.

Conditions

• Type 2 Diabetes

Interventions

OTHER

Intensive care

Intensive multi-factorial treat-to-target intervention program designed according to international guidelines

Sponsors & Collaborators

• Italian Society of Diabetology

  collaborator OTHER

• AstraZeneca

  collaborator INDUSTRY

• Daiichi Sankyo

  collaborator INDUSTRY

• University of Parma

  lead OTHER

Principal Investigators

• Ivana Zavaroni, MD · University of Parma

• Angela A Rivellese, MD · Federico II University of Naples

• Olga Vaccaro, MD · Federico II University of Naples

• Roberto Miccoli, MD · University of Pisa

• Mariella Trovati, MD · University of Turin, Italy

• Franco Cavalot, MD · University of Turin, Italy

• Massimo Boemi, MD · INRCA of Ancona

• PierPaolo DeFeo, MD · University Of Perugia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-01-31

Primary Completion

2011-12-31

Completion

2011-12-31

Countries

• Italy

Study Locations