Multifactorial Intervention in Type 2 Diabetes - Italy

NCT ID: NCT01240070

Last Updated: 2011-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1461 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2011-12-31

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.

Detailed Description

The study is multi-centric, randomized, open label, active treatment controlled, two parallel-group, pragmatical intervention trial with 5 years of follow-up, to assess superiority of an intensive treat-to-target strategy (including lifestyle and pharmacological interventions) for correction of major cardiovascular risk factors compared to usual care in decreasing incidence of first cardiovascular events in non complicated type 2 diabetic patients at high risk, as defined by presence of 2 or more cardiovascular risk factors. All high-risk patients identified during phase 1 who accepted to participated were allocated to usual or intensive treatment based on the recruiting center. Centers were randomly assigned to treatment arm before phase 2 beginning. Investigators from Intensive Care centers received centralized training to ensure the application of the intensive care program on their patients.

HbA1c values and lipid profile are assessed in peripheral laboratories (one per each study site) with an external, centralized, quality control program and the adjustment for systematic differences among study labs.

Participating investigators are left free to decide upon patient's treatments. In intensive-care centers, investigators are provided with a multi-factorial step-wise protocol to support the application of a treat-to-target approach. Intensive care strategy includes intervention on lifestyle.

Dietary intervention goals: BMI<25 or 5% reduction of body weight; dietary assumption of saturated fat <10% of total caloric intake; fibers= 15-20 g/1000 Kcal. Methods defined to reach the dietary goal: A) Patients with BMI 25-30 kg/m2: reduction of caloric intake = 300-500 Cal/d; B) Patients with BMI >30: reduction of caloric intake 500-800 Cal/d.

Physical activity intervention goal: 200-300 calories per day. Example: brisk walking for 30 min every day or biking (18-25Km/h 45-60 min). Alternatives: swimming 1h , dancing 1h, gym exercise 1h;-avoiding isometric exercise and exercise with intensity >50-60 % of maximal oxygen consumption. Frequency: everyday or at least 3 times a week; Pharmacological intervention: Blood glucose control, multi-step intervention. In obese patients: 1) Metformin (M, 500-2500mg); 2) M+Sulphonylureas (S) or S-like drugs, increasing progressively the dose; 3) M+S+Acarbose; 4) M+S+insulin bed-time; 5) insulin basal-bolus. In normal weight patients: 1) S; 2) S+acarbose; 3) S+ bed-time insulin; 4) insulin basal bolus; Blood pressure control --> 1) Ace-inhibitors or AT-II receptor antagonists; 2) add long acting calcium-channel blockers or beta-blockers or low dose diuretics; 3) add a third drug; lipid control: 1) diet + physical activity; 2) if LDL > 130 mg/dL statins (with a stepwise increase of dose if necessary); if triglycerides > 200 mg/dL fibrates; anti-platelet treatment: aspirin 100 mg/d in all patients (alternative drugs for aspirin-intolerants).

The scheduled visits were defined as follows:

• Intensive-care group: mandatory visit every three months with annual visit for MIND.IT data collection.
• Usual-care group: at least one MIND.IT visit every year + the usual organization of the center.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual Care

Clinical practice in type 2 diabetes treatment

Group Type: ACTIVE_COMPARATOR

Intensive care

Intervention Type: OTHER

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

Intensive Care

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.

Group Type: ACTIVE_COMPARATOR

Intensive care

Intervention Type: OTHER

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

Interventions

Intensive care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italian Society of Diabetology

OTHER

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

University of Parma

OTHER

Sponsor Role: lead

Responsible Party

Italian Society of Diabetology

Principal Investigators

Ivana Zavaroni, MD

Role: STUDY_CHAIR

University of Parma

Angela A Rivellese, MD

Role: STUDY_DIRECTOR

Federico II University of Naples

Olga Vaccaro, MD

Role: STUDY_DIRECTOR

Federico II University of Naples

Roberto Miccoli, MD

Role: STUDY_DIRECTOR

University of Pisa

Mariella Trovati, MD

Role: STUDY_DIRECTOR

University of Turin, Italy

Franco Cavalot, MD

Role: STUDY_DIRECTOR

University of Turin, Italy

Massimo Boemi, MD

Role: STUDY_DIRECTOR

INRCA of Ancona

PierPaolo DeFeo, MD

Role: STUDY_DIRECTOR

University Of Perugia

Locations

Francesco Giorgino

Bari, , Italy

Maria Dolci

Carrara, , Italy

Lamberto De Giorgio

La Spezia, , Italy

Giuseppe Derosa

Pavia, , Italy

PierPaolo DeFeo

Perugia, , Italy

Donatella Zavaroni

Piacenza, , Italy

Roberto Miccoli

Pisa, , Italy

Giovanni Ghirlanda

Roma, , Italy

Mariela Trovati

Torino, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 17426738 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18093594 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23863908 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23147277 (View on PubMed)

Other Identifiers

MINDIT2000

Identifier Type: -

Identifier Source: org_study_id