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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Fundacion para la Investigacion y Formacion en Ciencias de la Salud.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Luis Garcia Ortiz, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier:
NCT01065155
First received: February 6, 2010
Last updated: March 4, 2014
Last verified: March 2011
  Purpose

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
Diabetes
Cardiovascular Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:

Primary Outcome Measures:
  • Cardiovascular target organ damage (renal, cardiac and vascular) and new cardiovascular events [ Time Frame: four years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

blood and urine).


Estimated Enrollment: 110
Study Start Date: February 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Median central blood pressure
Median central blood pressure, lower median group 1 and higher group 2.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065155

Locations
Spain
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
Investigators
Principal Investigator: Manuel A Gomez, MD Fundacion para la investigación y formacion en ciencias de la salud
  More Information

No publications provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luis Garcia Ortiz, Dr, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT01065155     History of Changes
Other Study ID Numbers: 428/A/09
Study First Received: February 6, 2010
Last Updated: March 4, 2014
Health Authority: Spain: Ministry of Health and Consumption

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 01, 2014