Relationship of Central Blood Pressure and Pulse Wave Velocity With Target Organ Damage
Condition: Diabetes; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Diabetic patients show an increased prevalence of non dipping arterial pressure pattern,
      target organ damage and elevated arterial stiffness. These alterations are associated with
      increased cardiovascular risk.

      The objectives of this study are the following: to evaluate the prognostic value of central
      arterial pressure and pulse wave velocity in relation to the incidence and outcome of target
      organ damage and the appearance of cardiovascular episodes (cardiovascular mortality,
      myocardial infarction, chest pain and stroke) in patients with type 2 diabetes mellitus.
    

Detailed description: 
      METHODS/DESIGN:

      Type of study: This is an observational prospective study with a duration of 5 years, of
      which the first year corresponds to patient inclusion and initial evaluation, and the
      remaining four years to follow-up.

      Setting: The study will be carried out in the urban primary care setting. Study population:
      Consecutive sampling will be used to include patients diagnosed with type 2 diabetes between
      20-80 years of age. A total of 110 patients meeting all the inclusion criteria and none of
      the exclusion criteria will be included.

      Measurements: Patient age and sex, family and personal history of cardiovascular disease, and
      cardiovascular risk factors. Height, weight, heart rate and abdominal circumference.
      Laboratory tests: hemoglobin, lipid profile, creatinine, microalbuminuria, glomerular
      filtration rate, blood glucose, glycosylated hemoglobin, blood insulin, fibrinogen and high
      sensitivity C reactive protein. Clinical and 24-hour ambulatory (home) blood pressure
      monitoring and self-measured blood pressure. Common carotid artery ultrasound for the
      determination of mean carotid intima-media thickness. Electrocardiogram for assessing left
      ventricular hypertrophy. Ankle-brachial index. Retinal vascular study based on funduscopy
      with non-mydriatic retinography and evaluation of pulse wave morphology and pulse wave
      velocity using the SphygmoCor system. The medication used for diabetes, arterial hypertension
      and hyperlipidemia will be registered, together with antiplatelet drugs.

      DISCUSSION: The results of this study will help to know and quantify the prognostic value of
      central arterial pressure and pulse wave velocity in relation to the evolution of the
      subclinical target organ damage markers and the possible incidence of cardiovascular events
      in patients with type 2 diabetes mellitus.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive inclusion will be made of the patients referred to the research unit and who
        meet the corresponding inclusion criteria, i.e., patients diagnosed with DM2 and aged 20-80
        years A total of 52 patients are required in each group, estimating a loss to follow-up of
        10%. A final total of 110 patients therefore will be included.
      
Biospecimen description: 
      blood and urine).