Clinical trial NCT01041599: Correlation of Albuminuria With Arterial Stiffness
Official title: Assessment of the Association Between Albuminuria and Arterial Stiffness in Diabetic Patients, Hypertensive Patients and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Hypertension
Albuminuria
Vascular Stiffness
Keywords: Diabetes Mellitus
Hypertension
Albuminuria
vascular stiffness
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2010-01-01
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes, patients with hypertension and healthy subjects

Brief summary: The investigators aim to investigate the relationship between albuminuria and arterial stiffness in diabetic patients, hypertensive patients and healthy subjects.

Detailed description: CONTEXT: Albuminuria is an important cardiovascular risk factor. Arterial stiffness also gives important information about atherosclerosis. Oscillometric methods may be useful in assessing arterial stiffness in a mainly operator independent way.

OBJECTIVE: We aim to investigate the relationship between albuminuria and arterial stiffness measured with an oscillometric device in diabetic patients, hypertensive patients and healthy subjects.

METHODS: 152 diabetic patients, 152 hypertensive patients and 152 healthy subjects are planned to be enrolled in this study. The measurements will be done between 9:00 and 13:00. After the measurements, blood and urine samples will be obtained, centrifugated and kept in -80°C until assayed. Afterwards, echocardiographic left ventricle mass index will be calculated. The correlation between albuminuria and arterial stiffness will be assessed as the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus
* Hypertension
* Healthy subjects

Exclusion Criteria:

* Symptomatic cardiovascular diseases (heart failure, history of myocardial infarction, etc.)
* Renal failure
* Pregnancy
* Diseases of the aorta

Primary outcomes:
measure: Correlation between albuminuria and arterial stiffness
timeFrame: Albuminuria and arterial stiffness will be assessed simultaneously (i.e. in the same morning)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Study officials:
affiliation: Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
name: Omer Kaya, MD
role: STUDY_CHAIR
affiliation: Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
name: Abdullah Ozkok, MD
role: STUDY_CHAIR
affiliation: Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
name: Bahtiyar Toz, MD
role: STUDY_CHAIR
affiliation: Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
name: Kadri Atay, MD
role: STUDY_CHAIR
affiliation: Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
name: Hamza Ugur Bozbey, MD
role: STUDY_CHAIR
affiliation: Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
name: Ercan Bicakci, MD
role: STUDY_CHAIR
affiliation: Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
name: Mehmet Besiroglu, MD
role: STUDY_CHAIR
affiliation: Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine Division of Geriatrics
name: Fatih Tufan, MD
role: STUDY_DIRECTOR
affiliation: Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine Division of Nephrology
name: Tevfik Ecder, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute, Pecs University Faculty of Medicine, Pecs/Hungary
name: Miklos Illyes, MD, Ph. D
role: STUDY_DIRECTOR
affiliation: Szent Janos Hospital Radiology Department, Budapest/Hungary
name: Kamil Nas, MD
role: STUDY_DIRECTOR
affiliation: Tensiomed Arterial Stiffness Centre, Budapest/Hungary
name: Molnar Ferenc
role: STUDY_DIRECTOR
References: