An observational study in Diabetes and Cardiovascular Disease, sponsored by Fundacion para la Investigacion y Formacion en Ciencias de la Salud. Completed at 1 site in Spain. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by Fundacion para la Investigacion y Formacion en Ciencias de la Salud · Observational
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 110 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Fundacion para la Investigacion y Formacion en Ciencias de la Salud is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
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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.
Exclusion Criteria:
Median central blood pressure, lower median group 1 and higher group 2.
Cardiovascular target organ damage (renal, cardiac and vascular) and new cardiovascular events
Time frame: four years
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Fundacion para la Investigacion y Formacion en Ciencias de la Salud