Multifactorial Intervention in Type 2 Diabetes - Italy (MINDIT)

August 11, 2011 updated by: University of Parma

Multicenter, Randomized Trial Designed to Evaluate the Applicability of the Guidelines of the Italian Society of Diabetology for the Prevention of Cardiovascular Diseases in Type 2 Diabetes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1461

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy
        • Francesco Giorgino
      • Carrara, Italy
        • Maria Dolci
      • La Spezia, Italy
        • Lamberto De Giorgio
      • Pavia, Italy
        • Giuseppe Derosa
      • Perugia, Italy
        • PierPaolo DeFeo
      • Piacenza, Italy
        • Donatella Zavaroni
      • Pisa, Italy
        • Roberto Miccoli
      • Roma, Italy
        • Giovanni Ghirlanda
      • Torino, Italy
        • Mariela Trovati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Usual Care
Clinical practice in type 2 diabetes treatment
Other: Intensive care
Intensive multi-factorial treat-to-target intervention program designed according to international guidelines
ACTIVE_COMPARATOR: 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.
Other: Intensive care
Intensive multi-factorial treat-to-target intervention program designed according to international guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular events
Time Frame: 5 years of follow up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular risk factors changes
Time Frame: 2 years and 5 years of follow up

To assess whether the intensive treatment is able to significantly improve cardiovascular risk factors with increased multiple-target achievement. A pre-planned interim analysis after two years of follow-up was foreseen by the study protocol.

To verify that the intesive protocol implemented on the basis of national and international guidelines is actually feasible in a real world clinical setting.
2 years and 5 years of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Parma

Collaborators

AstraZeneca
Daiichi Sankyo, Inc.
Italian Society of Diabetology

Investigators

  • Study Chair: Ivana Zavaroni, MD, University of Parma
  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (ESTIMATE)

November 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2011

Last Update Submitted That Met QC Criteria

August 11, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MINDIT2000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Intensive care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe