title: METformin in DIastolic Dysfunction of MEtabolic syndrome (MET-DIME) trial: rationale and study design : MET-DIME trial.
abstract: OBJECTIVE
  Insulin resistance plays a central role in the pathophysiology of metabolic syndrome (MS). Its cardiac deleterious effects are characterized by an increase in fibrous tissue that increases myocardial stiffness and contributes to subclinical left ventricular diastolic dysfunction (LVDD) and heart failure with preserved ejection fraction in patients with MS. In addition to lifestyle counseling (LC), metformin treatment may attenuate or even reverse diastolic dysfunction in these patients. This trial aims to evaluate if treating non-diabetic patients with MS and LVDD with metformin in addition to LC improves diastolic function and assess its impact in functional capacity and health-related quality of life (HRQoL).
  
  
  METHODS
  MET-DIME is a phase II prospective, randomized, open-label, blinded-endpoint trial with a scheduled follow-up of 24 months. Fifty-four patients (adults 40-65 years old with AHA/NHLBI criteria of MS and rest LVDD) will be randomized by minimization to LC only or LC plus metformin (target dose of 1,000 mg twice daily). The primary endpoint will be change in mean of early diastolic mitral annular velocity, an echocardiographic parameter highly correlated with myocardial fibrosis (serial measurements will be performed at 6, 12 and 24 months). The secondary endpoints will include change in diastolic parameters at rest; metabolic, inflammatory and remodeling biomarkers; functional capacity; adipose tissue volumes and HRQoL.
  
  
  CONCLUSIONS
  MET-DIME is a pragmatic trial designed to evaluate if adding metformin to the standard treatment of patients with MS improves diastolic dysfunction, assessing its impact in metabolic homeostasis, proinflammatory state, functional capacity and HRQoL.
authors: Department of Physiology and Cardiothoracic Surgery, Faculty of Medicine of the University of Porto, Alameda Prof. Hernâni Monteiro, 4200-319, Porto, Portugal, ricardoladeiraslopes@gmail.com.
authors: Ricardo
authors: R
authors: Ladeiras-Lopes
authors: Ricardo
authors: R
authors: Fontes-Carvalho
authors: Nuno
authors: N
authors: Bettencourt
authors: Francisco
authors: F
authors: Sampaio
authors: Vasco
authors: V
authors: Gama
authors: Adelino F
authors: AF
authors: Leite-Moreira
mesh_terms: D000328:Adult; D000368:Aged; D003971:Diastole / Q000187:drug effects*; D004452:Echocardiography / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D024821:Metabolic Syndrome / Q000188:drug therapy*; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy*; D016277:Ventricular Function, Left / Q000187:drug effects
chemical_list: D008687:Metformin