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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01041599
Other study ID # 4154
Secondary ID
Status Completed
Phase N/A
First received December 30, 2009
Last updated August 29, 2016
Start date October 2009
Est. completion date February 2012

Study information

Verified date August 2016
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date February 2012
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
Turkey Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between albuminuria and arterial stiffness Albuminuria and arterial stiffness will be assessed simultaneously (i.e. in the same morning) No
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