Correlation of Albuminuria With Arterial Stiffness

NCT ID: NCT01041599

Last Updated: 2016-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-02-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus Hypertension Albuminuria Vascular Stiffness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diabetic patients

Hypertensive and normotensive patients with type 2 diabetes mellitus

No interventions assigned to this group

Hypertensive patients

Patients with essential hypertension

No interventions assigned to this group

Healthy subjects

Healthy subjects

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Fatih Tufan

assoc prof MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omer Kaya, MD

Role: STUDY_CHAIR

Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine

Abdullah Ozkok, MD

Role: STUDY_CHAIR

Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine

Bahtiyar Toz, MD

Role: STUDY_CHAIR

Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine

Kadri Atay, MD

Role: STUDY_CHAIR

Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine

Hamza Ugur Bozbey, MD

Role: STUDY_CHAIR

Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine

Ercan Bicakci, MD

Role: STUDY_CHAIR

Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine

Mehmet Besiroglu, MD

Role: STUDY_CHAIR

Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine

Fatih Tufan, MD

Role: STUDY_DIRECTOR

Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine Division of Geriatrics

Tevfik Ecder, Prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine Division of Nephrology

Miklos Illyes, MD, Ph. D

Role: STUDY_DIRECTOR

Heart Institute, Pecs University Faculty of Medicine, Pecs/Hungary

Kamil Nas, MD

Role: STUDY_DIRECTOR

Szent Janos Hospital Radiology Department, Budapest/Hungary

Molnar Ferenc

Role: STUDY_DIRECTOR

Tensiomed Arterial Stiffness Centre, Budapest/Hungary

Locations

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Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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4154

Identifier Type: -

Identifier Source: org_study_id

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