Phenotyping Individuals With Neo-diagnosed Type 2 Diabetes at Risk for All-cause Mortality
Condition: Type 2 Diabetes; Vascular Diseases; Cardiac Disease
MeSH terms: Vascular Diseases; Heart Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Prevalence of type 2 diabetes (T2D) is increasing worldwide over the last two decades; in
      these patients the rate of all-cause and cardiovascular (CV) mortality is several folds
      higher than in the general population, configuring a major public health problem. The
      clinical phenotype is the main determinant of such high mortality risk; however, a relevant
      role is played by the disease duration, with a significant interaction with metabolic
      control. However, for T2D the diagnosis does not correspond to the true onset of the disease,
      and a high lethality rate also in patients with recent onset of the disease cannot be
      excluded. Robust evidence supports this hypothesis, showing as in subjects with new-onset
      T2D, the mortality risk is superimposable, and even higher, than that observed in people with
      overt and long-term T2D. In this complex scenario, it would be desirable an early
      identification of high-risk patients, in which an accurate estimation of risk of
      complications, coupled with appropriate and timely interventions, might help in reducing the
      risk of encountering premature mortality. The present study was design to address this
      specific issue.
    

Detailed description: 
      Patients referring for the first time to the outpatient diabetes clinic in the department of
      Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria
      were recruited.

      Diagnosis was confirmed on the basis of the Oral Glucose Tolerance Test (OGTT) or HbA1c ≥6.5%
      plus fasting blood glucose ≥126 mg/dl.

      Anthropometric measurements were recorded, arterial pressure and vital parameters were
      registered, and blood samples were collected for routine analyses. Complete blood count,
      glucose, HbA1c, Serum Glutamic Oxaloacetic Transaminase (sGOT), Serum Glutamic Pyruvic
      Transaminase (sGPT), uric acid, were determined by standard techniques. Total and HDL
      cholesterol and triglycerides were assayed through the automated spectrophotometer, enzymatic
      colorimetric method, COBAS INTEGRA using commercial kits (Roche Diagnostics). Serum
      creatinine was measured by Jaffe' method, and estimated glomerular filtration rate (eGFR) was
      calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
      formula.

      Previous major acute CV events, including myocardial infarction, stroke, foot
      ulcer/gangrene/amputation and coronary, carotid and lower limb revascularisation, were
      adjudicated based on hospital discharge records.

      At the end of the baseline visit, patients were treated according to the good clinical
      practice recommended by the international guidelines, and followed a six-month or an yearly
      calendar of follow-up visits, until death or until 31 December 2018. All-cause mortality was
      assessed by checking the vital status of study participants on 31 December 2018; to this aim,
      investigators interrogated the Italian Health Card database, which provides updated
      information on all current Italian residents.

      Incident major acute cardiovascular events were registered on the basis of clinical records
      every year; retinopathy onset was assessed by fundoscopy on a yearly basis.
    

Intervention name(s): standard treatments
Intervention type(s): Other
Intervention description(s): patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referring for the first time to the outpatient diabetes clinic in the department
        of Internal Medicine between January 2008 and December 2015 and matching the inclusion
        criteria.
      
Keywords: neo-diagnosed type 2 diabetes; all-cause mortality; cardiovascular mortality