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Relationship of Central Blood Pressure and Pulse Wave Velocity With Target Organ Damage (LOD-DIABETES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065155
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : February 21, 2020
Information provided by (Responsible Party):
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Brief 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.

Condition or disease
Diabetes Cardiovascular Disease

Detailed Description:


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.

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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : February 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2016

Median central blood pressure
Median central blood pressure, lower median group 1 and higher group 2.

Primary Outcome Measures :
  1. Cardiovascular target organ damage (renal, cardiac and vascular) and new cardiovascular events [ Time Frame: four years ]

Biospecimen Retention:   Samples Without DNA
blood and urine).

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065155

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Primary care Research unit. La Alamedilla health centre
Salamanca, Spain, 37003
Sponsors and Collaborators
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
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Principal Investigator: Manuel A Gomez, MD Fundacion para la investigación y formacion en ciencias de la salud
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Fundacion para la Investigacion y Formacion en Ciencias de la Salud Identifier: NCT01065155    
Other Study ID Numbers: 428/A/09
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Cardiovascular Diseases