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
Vaccaro O.,University of Naples Federico II |
Franzini L.,University of Parma |
Miccoli R.,University of Pisa |
Cavalot F.,University of Turin |
And 7 more authors.
Diabetes Care | Year: 2013
OBJECTIVE-To evaluate the feasibility and effectiveness of an intensive, multifactorial cardiovascular risk reduction intervention in a clinic-based setting. RESEARCH DESIGN AND METHODS-The study was a pragmatic, cluster randomized trial,with the diabetes clinic as the unit of randomization. Clinics were randomly assigned to either continue their usual care (n = 5) or to apply an intensive intervention aimed at the optimal control of cardiovascular disease (CVD) risk factors and hyperglycemia (n = 4). To account for clustering, mixed model regression techniques were used to compare differences in CVD risk factors and HbA1c. Analyses were performed both by intent to treat and as treated per protocol. RESULTS-Nine clinics completed the study; 1,461 patients with type 2 diabetes and no previous cardiovascular events were enrolled. After 2 years, participants in the interventional group had significantly lower BMI, HbA1c, LDL cholesterol, and triglyceride levels and significantly higher HDL cholesterol level than did the usual care group. The proportion of patients reaching the treatment goals was systematically higher in the interventional clinics (35%vs. 24% for LDL cholesterol, P = 0.1299; 93% vs. 82% for HDL cholesterol, P = 0.0005; 80% vs. 64% for triglycerides, P = 0.0002; 39% vs. 22% for HbA1c, P = 0.0259; 13%vs. 5%for blood pressure, P = 0.1638). The analysis as treated per protocol confirmed these findings, showing larger and always significant differences between the study arms for all targets. CONCLUSIONS-A multifactorial intensive intervention in type 2 diabetes is feasible and effective in clinical practice and it is associated with significant and durable improvement in HbA1c and CVD risk profile. © 2013 by the American Diabetes Association.
Spazzafumo L.,Biostatistical Center |
Olivieri F.,Marche Polytechnic University |
Olivieri F.,Inrca National Institute |
Abbatecola A.M.,Scientific Direction |
And 15 more authors.
Age | Year: 2013
Factor structure analyses have revealed the presence of specific biological system markers in healthy humans and diseases. However, this type of approach in very old persons and in type 2 diabetes (T2DM) is lacking. A total sample of 2,137 Italians consisted of two groups: 1,604 healthy and 533 with T2DM. Age (years) was categorized as adults (≤65), old (66-85), oldest old (>85-98) and centenarians (≥99). Specific biomarkers of routine haematological and biochemical testing were tested across each age group. Exploratory factorial analysis (EFA) by principal component method with Varimax rotation was used to identify factors including related variables. Structural equation modelling (SEM) was applied to confirm factor solutions for each age group. EFA and SEM identified specific factor structures according to age in both groups. An age-associated reduction of factor structure was observed from adults to oldest old in the healthy group (explained variance 60.4% vs 50.3%) and from adults to old in the T2DM group (explained variance 57.4% vs 44.2%). Centenarians showed three-factor structure similar to those of adults (explained variance 58.4%). The inflammatory component became the major factor in old group and was the first one in T2DM. SEM analysis in healthy subjects suggested that the glucose levels had an important role in the oldest old. Factorial structure change during healthy ageing was associated with a decrease in complexity but showed an increase in variability and inflammation. Structural relationship changes observed in healthy subjects appeared earlier in diabetic patients and later in centenarians. © 2011 American Aging Association.
Monesi L.,Laboratory of General Practice Research |
Tettamanti M.,Laboratory of Geriatric Neuropsychiatry |
Cortesi L.,Laboratory of General Practice Research |
Baviera M.,Laboratory of General Practice Research |
And 11 more authors.
Nutrition, Metabolism and Cardiovascular Diseases | Year: 2014
Aims: To investigate the incidence of major cardiovascular complications and mortality in the first years of follow-up in patients with newly diagnosed diabetes. Methods and results: We examined incidence rates of hospitalization for cardiovascular reasons and death among new patients with diabetes using the administrative health database of the nine million inhabitants of Lombardy followed from 2002 to 2007. Age and sex-adjusted rates were calculated and hazard ratios (HR) were estimated with a matched population without diabetes of the same sex, age (±1 year) and general practitioner.There were 158,426 patients with newly diagnosed diabetes and 314,115 subjects without diabetes. Mean follow-up was 33.0 months (SD ± 17.5). 9.7% of patients with diabetes were hospitalized for cardiovascular events vs. 5.4% of subjects without diabetes; mortality rate was higher in patients with diabetes (7.7% vs. 4.4%). The estimated probability of hospitalization during the follow up was higher in patients with diabetes than in subjects without for coronary heart disease (HR 1.4, 95% CI 1.3-1.4), cerebrovascular disease (HR 1.3.95% CI 1.2-1.3), heart failure (HR 1.4, 95% CI 1.3-1.4) as was mortality (HR 1.4, 95% CI 1.4-1.4).Younger patients with diabetes had a risk of death or hospital admission for cardio-cerebrovascular events similar to subjects without diabetes ten years older. Conclusions: The elevated morbidity and mortality risks were clear since the onset of diabetes and rose over time. These data highlight the importance of prompt and comprehensive patients care in addition to anti-diabetic therapy in patients with newly diagnosed diabetes. © 2013 Elsevier B.V.
Piccini B.,Diabetology Unit |
Capirchio L.,University of Florence |
Bresci C.,Neonatal Intensive Care Unit |
Casalini E.,University of Florence |
And 2 more authors.
Blood Coagulation and Fibrinolysis | Year: 2014
We describe the case of a newborn presenting with multicystic encephalomalacy, hydrocephalus and bilateral hemovitreous. An underlying coagulation disorder was suspected and laboratory tests revealed severe protein C deficiency. At 25 days of life, after the appearance of purpura fulminans, replacement therapy with intravenous protein C concentrate (Ceprotin; Baxter, Vienna, Austria) was started. Due to difficulties in getting peripheral venous access and to repeated loss of the venous access, continuous subcutaneous infusion of protein C was started with an insulin pump (VEO 754; Medtronic, Minneapolis, Minnesota, USA), normally adopted in patients with type 1 diabetes mellitus. Protein C values increased into the normal range and the resolution of the purpuric skin lesion was achieved. Chronic prophylaxis with low-molecular-weight heparin failed and, due to cutaneous and cerebral recrudescence, replacement therapy with the pump was started again. The insulin pump allowed us to reduce the number of injections per day and to deal with the difficulties in getting peripheral venous access, permitting medical and paramedical staff an easier management of the therapy. The dosing schedule could be easily adapted with the insulin pump and the continuous subcutaneous administration of small amounts of protein C concentrate prevented fluctuation in trough levels of protein C. This is the first reported case of a novel, successful use of an insulin pump in an extremely rare disease, to administer a drug different from insulin, which needs to be further analyzed, underlining the importance of a multidisciplinary team approach in order to provide effective and efficient care in high-complexity diseases. Copyright © 2014 Lippincott Williams & Wilkins.
Culeddu N.,CNR Institute of Biomolecular Chemistry |
Chessa M.,Sardinian Mediterranean Imaging Research Group |
Porcu M.C.,CNR Institute of Biomolecular Chemistry |
Fresu P.,University of Sassari |
And 3 more authors.
Metabolomics | Year: 2012
The genetic homogeneity of the people of Sardinia makes it an ideal place to study genetic related diseases such as type 1 diabetes, which in this island has one of the highest incidence worldwide. The principal objective of this study was to use 1H high-resolution NMR spectroscopy and supervised methods of multivariate data analysis to highlight the importance of the variation of low concentration metabolites between healthy and diabetic Sardinian children. To achieve this goal, statistical analyses were performed after removal of the prevailing signals of sugars and citrate (related to carbohydrate metabolism) and of hippurate (a metabolite of bacterial origins) whose presence overwhelmed all the other compounds effects on classification. The variable influence in the statistical model showed that other metabolites deriving from gut microbial metabolism (p-cresol sulphate and phenylacetylglycine) were heavily involved in classification. This suggests the importance of changes in gut microbiota composition associated with type 1 diabetes in children. © 2012 Springer Science+Business Media, LLC.