Type 2 DiabetesPhase 4MINDITNCT01240070
Multifactorial Intervention in Type 2 Diabetes - Italy
A Phase 4 study testing Intensive care in people with Type 2 Diabetes, run by University of Parma at 9 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Intensive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,461 participants
- Where
- 9 sitesItaly
- Study dates
- Jan 2002to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
Francesco Giorgino
Bari
Maria Dolci
Carrara
Lamberto De Giorgio
La Spezia
Giuseppe Derosa
Pavia
PierPaolo DeFeo
Perugia
Donatella Zavaroni
Piacenza
Roberto Miccoli
Pisa
Giovanni Ghirlanda
Roma
Mariela Trovati
Torino
About this study
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
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.
Read the 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
- Being tested
- Intensive care
- Keywords
- diabetes,, cardiovascular, risk factor, cardiovascular event, intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive careOther
Intensive multi-factorial treat-to-target intervention program designed according to international guidelines
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Clinical practice in type 2 diabetes treatment Receives: 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. Receives: Other: Intensive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years of follow up
Secondary outcomes (1)
cardiovascular risk factors changes
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.
Measured: 2 years and 5 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startJan 2002
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,461 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Society of Diabetology, AstraZeneca, Daiichi Sankyo
- Investigators
- Ivana Zavaroni, MD, Study chair, University of ParmaAngela A Rivellese, MD, Study director, Federico II University of NaplesOlga Vaccaro, MD, Study director, Federico II University of NaplesRoberto Miccoli, MD, Study director, University of PisaMariella Trovati, MD, Study director, University of Turin, ItalyFranco Cavalot, MD, Study director, University of Turin, ItalyMassimo Boemi, MD, Study director, INRCA of AnconaPierPaolo DeFeo, MD, Study director, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240070
- Sponsor's protocol ID
- MINDIT2000
- Acronym
- MINDIT
- Status last verified
- Oct 2010
- First submitted
- 12 Nov 2010
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17426738Vaccaro 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.
PubMed 18093594Vaccaro 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.
PubMed 23863908Ardigo 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.
PubMed 23147277
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01240070
- Acronym / sponsor ID
- MINDIT / MINDIT2000
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes,, cardiovascular, risk factor, cardiovascular event, intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,461 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- Italian Society of Diabetology, AstraZeneca, Daiichi Sankyo
- Study start
- Jan 2002
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Intensive careClinical practice in type 2 diabetes treatment |
| Intensive Care | Active comparator | Other: Intensive careIntensive 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive careIntensive multi-factorial treat-to-target intervention program designed according to international guidelines | Other | Intensive Care, Usual Care |
Primary outcome
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
1 secondary outcome
cardiovascular risk factors changes
Time frame: 2 years and 5 years of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
- Background: PubMed 17426738Rivellese 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.
- Background: PubMed 18093594Vaccaro 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.
- Derived from this study: PubMed 23863908Vaccaro 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.
- Derived from this study: PubMed 23147277Ardigo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivana Zavaroni, MD study chair
University of Parma
Angela A Rivellese, MD study director
Federico II University of Naples
Olga Vaccaro, MD study director
Federico II University of Naples
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intensive care in people with Type 2 Diabetes, run by University of Parma at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: 5 years of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240070, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2011.