Relationship of Central Blood Pressure and Pulse Wave Velocity With Target Organ Damage (LOD-DIABETES)
Central Blood Pressure and Pulse Wave Velocity: Relationship to Target Organ Damage and Cardiovascular Morbidity-mortality in Diabetic Patients. An Observational Prospective Study. LOD-DIABETES: Study Protocol
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Salamanca, Spanje, 37003
- Primary care Research unit. La Alamedilla health centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- diagnosed of Diabetes Mellitus type 2, and
- aged 20-80 years.
Exclusion Criteria:
- psychological and/or cognitive disorders,
- failure to cooperate,
- educational limitations and problems for understanding written language, failure to sign the informed consent document
- patients participating or who will participate in a clinical trial during the study,
- patients with serious comorbidities representing a threat to life over the subsequent 12 months.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Median central blood pressure
Median central blood pressure, lower median group 1 and higher group 2.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Cardiovascular target organ damage (renal, cardiac and vascular) and new cardiovascular events
Tijdsspanne: four years
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four years
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Manuel A Gomez, MD, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Publicaties en nuttige links
Algemene publicaties
- Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Agudo-Conde C, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Gomez-Sanchez L, Gomez-Sanchez M, Garcia-Ortiz L; LOD-DIABETES Group. Evolution of target organ damage and haemodynamic parameters over 4 years in patients with increased insulin resistance: the LOD-DIABETES prospective observational study. BMJ Open. 2016 Jun 1;6(6):e010400. doi: 10.1136/bmjopen-2015-010400.
- Gomez-Marcos MA, Recio-Rodriguez JI, Gomez-Sanchez L, Agudo-Conde C, Rodriguez-Sanchez E, Maderuelo-Fernandez J, Gomez-Sanchez M, Garcia-Ortiz L; LOD-DIABETES Group. Gender differences in the progression of target organ damage in patients with increased insulin resistance: the LOD-DIABETES study. Cardiovasc Diabetol. 2015 Oct 1;14:132. doi: 10.1186/s12933-015-0293-1.
- Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Agudo-Conde C, Gomez-Sanchez L, Gomez-Sanchez M, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Garcia-Ortiz L; LOD-DIABETES Group. Cardio-ankle vascular index is associated with cardiovascular target organ damage and vascular structure and function in patients with diabetes or metabolic syndrome, LOD-DIABETES study: a case series report. Cardiovasc Diabetol. 2015 Jan 16;14:7. doi: 10.1186/s12933-014-0167-y.
- Gomez-Marcos MA, Recio-Rodriguez JI, Rodriguez-Sanchez E, Castano-Sanchez Y, de Cabo-Laso A, Sanchez-Salgado B, Rodriguez-Martin C, Castano-Sanchez C, Gomez-Sanchez L, Garcia-Ortiz L. Central blood pressure and pulse wave velocity: relationship to target organ damage and cardiovascular morbidity-mortality in diabetic patients or metabolic syndrome. An observational prospective study. LOD-DIABETES study protocol. BMC Public Health. 2010 Mar 18;10:143. doi: 10.1186/1471-2458-10-143.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 428/A/09
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