title: 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.
abstract: OBJECTIVE
  To evaluate the feasibility and effectiveness of an intensive, multifactorial cardiovascular risk reduction intervention in a clinic-based setting.
  
  
  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.
authors.affiliation: Department of Clinical and Experimental Medicine, Federico II University, Naples, Italy. ovaccaro@unina.it
authors.forename: Olga
authors.initials: O
authors.lastname: Vaccaro
authors.forename: Laura
authors.initials: L
authors.lastname: Franzini
authors.forename: Roberto
authors.initials: R
authors.lastname: Miccoli
authors.forename: Franco
authors.initials: F
authors.lastname: Cavalot
authors.forename: Diego
authors.initials: D
authors.lastname: Ardigò
authors.forename: Massimo
authors.initials: M
authors.lastname: Boemi
authors.forename: Pierpaolo
authors.initials: P
authors.lastname: De Feo
authors.forename: Gianpaolo
authors.initials: G
authors.lastname: Reboldi
authors.forename: Angela Albarosa
authors.initials: AA
authors.lastname: Rivellese
authors.forename: Mariella
authors.initials: M
authors.lastname: Trovati
authors.forename: Ivana
authors.initials: I
authors.lastname: Zavaroni
mesh_terms: D000465:Algorithms; D002318:Cardiovascular Diseases / Q000378:metabolism / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000378:metabolism / Q000628:therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D006442:Glycated Hemoglobin