Multifactorial Intervention in Type 2 Diabetes - Italy (MINDIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Parma.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Italian Society of Diabetology
AstraZeneca
Daiichi Sankyo Inc.
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT01240070
First received: November 12, 2010
Last updated: August 11, 2011
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Other: Intensive care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Parma:

Primary Outcome Measures:
  • Cardiovascular events [ Time Frame: 5 years of follow up ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • cardiovascular risk factors changes [ Time Frame: 2 years and 5 years of follow up ] [ Designated as safety issue: No ]

    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.



Enrollment: 1461
Study Start Date: January 2002
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240070

Locations
Italy
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
Sponsors and Collaborators
University of Parma
Italian Society of Diabetology
AstraZeneca
Daiichi Sankyo Inc.
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
Study Director: Franco Cavalot, MD University of Turin
Study Director: Massimo Boemi, MD INRCA of Ancona
Study Director: PierPaolo DeFeo, MD University Of Perugia
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: FoRiSID, Research Foundation of the Italian Society of Diabetology, Italian Society of Diabetology
ClinicalTrials.gov Identifier: NCT01240070     History of Changes
Other Study ID Numbers: MINDIT2000
Study First Received: November 12, 2010
Last Updated: August 11, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Parma:
diabetes,
cardiovascular
risk factor
cardiovascular event
intervention

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014