Relationship of Central Blood Pressure and Pulse Wave Velocity With Target Organ Damage

Diabetes Clinical Trial

— LOD-DIABETES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065155
• Other study ID #: 428/A/09
• Status: Completed
• Start date: February 2010
• Est. completion date: March 2016

Study information

• Verified date: February 2020
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2016
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes

Locations

Country	Name	City	State
Spain	Primary care Research unit. La Alamedilla health centre	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular target organ damage (renal, cardiac and vascular) and new cardiovascular events		four years