Multifactorial Intervention in Type 2 Diabetes - Italy

NCT01240070 | Unknown Phase 4 DMC

• 1 other identifier: MINDIT2000
• Study Type: interventional
• Target: 1,461
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

diabetes,; cardiovascular; risk factor; cardiovascular event; intervention

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events

  To verify if an intensive care intervention compared to usual care is able to significantly decrease the incidence of first cardiovascular event. Composite primary end-point = mortality for cardiovascular causes, proven acute myocardial infarction (STEMI or NSTEMI), acute coronary syndrome requiring hospitalization, proven ischemic stroke, coronary or carotid revascularization procedure

  5 years of follow up

Secondary Outcomes (1)

• cardiovascular risk factors changes

  2 years and 5 years of follow up

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Clinical practice in type 2 diabetes treatment

Other: Intensive care

Intensive Care

ACTIVE COMPARATOR

Intensive multi-factorial treat-to-target intervention, according to international guidelines, that includes both lifestyle intervention and a step-wise strategy for pharmacological treatment with a treat-to-target approach.

Other: Intensive care

Interventions

Intensive care OTHER

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

Intensive Care; Usual Care

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders
• age 50-70 years
• Type two diabetes with at least two-year history of disease and without insulin treatment in the first two years after diagnosis
• Negative medical history for documented previous cardiovascular events or macrovascular complications
• Written consent to participate
• Presence of at least 2 of the following risk factors:
• LDL cholesterol \> 130 mg/dL (regardless of treatment)
• Triglycerides \> 200 mg/dL
• HDL cholesterol \< 35 (males) or 45 (females) mg/dL
• Blood pressure \> 140/90 mmHg
• Cigarette smoking

You may not qualify if:

• Age below 50 or above 70 years
• Type 1 diabetes, diagnosis before 40 years of age, known presence of auto-antibodies or insulin requirement in the first 2 years of disease.
• Chronic kidney failure (plasma creatinine \> 2 mg/dL)
• Significant liver damage (AST and/or ALT \> 2 times the upper limits of normality)
• History of previous cardiovascular events
• Active neoplasms or any concomitant disease limiting life expectancy

Sponsors & Collaborators

• University of Parma: lead
• Italian Society of Diabetology: collaborator
• AstraZeneca: collaborator
• Daiichi Sankyo: collaborator

Study Sites (9)

Francesco Giorgino

Bari, Italy

Location

Maria Dolci

Carrara, Italy

Location

Lamberto De Giorgio

La Spezia, Italy

Location

Giuseppe Derosa

Pavia, Italy

Location

PierPaolo DeFeo

Perugia, Italy

Location

Donatella Zavaroni

Piacenza, Italy

Location

Roberto Miccoli

Pisa, Italy

Location

Giovanni Ghirlanda

Roma, Italy

Location

Mariela Trovati

Torino, Italy

Location

Related Publications (4)

• Rivellese AA, Boemi M, Cavalot F, Costagliola L, De Feo P, Miccoli R, Patti L, Trovati M, Vaccaro O, Zavaroni I; Mind.it Study Group. Dietary habits in type II diabetes mellitus: how is adherence to dietary recommendations? Eur J Clin Nutr. 2008 May;62(5):660-4. doi: 10.1038/sj.ejcn.1602755. Epub 2007 Apr 11.

  PMID: 17426738 BACKGROUND

• Vaccaro O, Boemi M, Cavalot F, De Feo P, Miccoli R, Patti L, Rivellese AA, Trovati M, Ardigo D, Zavaroni I; MIND-IT Study Group. The clinical reality of guidelines for primary prevention of cardiovascular disease in type 2 diabetes in Italy. Atherosclerosis. 2008 Jun;198(2):396-402. doi: 10.1016/j.atherosclerosis.2007.10.026. Epub 2008 Feb 21.

  PMID: 18093594 BACKGROUND

• Vaccaro O, Franzini L, Miccoli R, Cavalot F, Ardigo D, Boemi M, De Feo P, Reboldi G, Rivellese AA, Trovati M, Zavaroni I; MIND.IT Study Group. Feasibility and effectiveness in clinical practice of a multifactorial intervention for the reduction of cardiovascular risk in patients with type 2 diabetes: the 2-year interim analysis of the MIND.IT study: a cluster randomized trial. Diabetes Care. 2013 Sep;36(9):2566-72. doi: 10.2337/dc12-1781. Epub 2013 Jul 17.

  PMID: 23863908 DERIVED

• Ardigo D, Vaccaro O, Cavalot F, Rivellese AA, Franzini L, Miccoli R, Patti L, Boemi M, Trovati M, Zavaroni I; MIND.IT study group. Effectiveness of treat-to-target strategy for LDL-cholesterol control in type 2 diabetes: post-hoc analysis of data from the MIND.IT study. Eur J Prev Cardiol. 2014 Apr;21(4):456-63. doi: 10.1177/2047487312467746. Epub 2012 Nov 12.

  PMID: 23147277 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Critical Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ivana Zavaroni, MD

  University of Parma

  STUDY CHAIR

• Angela A Rivellese, MD

  Federico II University of Naples

  STUDY DIRECTOR

• Olga Vaccaro, MD

  Federico II University of Naples

  STUDY DIRECTOR

• Roberto Miccoli, MD

  University of Pisa

  STUDY DIRECTOR

• Mariella Trovati, MD

  University of Turin, Italy

  STUDY DIRECTOR

• Franco Cavalot, MD

  University of Turin, Italy

  STUDY DIRECTOR

• Massimo Boemi, MD

  INRCA of Ancona

  STUDY DIRECTOR

• PierPaolo DeFeo, MD

  University Of Perugia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 15, 2010
• Study Start: January 1, 2002
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 12, 2011

Record last verified: 2010-10

Locations

IT (9)