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Correlation of Albuminuria With Arterial Stiffness

This study is currently recruiting participants.
Verified June 2011 by Istanbul University
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT01041599
First received: December 30, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition
Diabetes Mellitus
Hypertension
Albuminuria
Arterial Stiffness

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessment of the Association Between Albuminuria and Arterial Stiffness in Diabetic Patients, Hypertensive Patients and Healthy Controls

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Istanbul University:

Primary Outcome Measures:
  • Correlation between albuminuria and arterial stiffness [ Time Frame: Albuminuria and arterial stiffness will be assessed simultaneously (i.e. in the same morning) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum and urine samples.


Estimated Enrollment: 456
Study Start Date: October 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetic patients
Hypertensive and normotensive patients with type 2 diabetes mellitus
Hypertensive patients
Patients with essential hypertension
Healthy subjects
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with diabetes, patients with hypertension and healthy subjects

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041599

Contacts
Contact: Fatih Tufan, MD 902124142000 ext 31478 fatihtufan@gmail.com
Contact: Tevfik Ecder, Prof. 902124142000 ecder@istanbul.edu.tr

Locations
Turkey
Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine Recruiting
Istanbul, Turkey, 34390
Contact: Fatih Tufan, MD     902124142000 ext 31330     fatihtufan@gmail.com    
Contact: Tevfik Ecder, MD     902124142000 ext 31385     ecder@istanbul.edu.tr    
Sponsors and Collaborators
Istanbul University
Investigators
Study Chair: Omer Kaya, MD Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Study Chair: Abdullah Ozkok, MD Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Study Chair: Bahtiyar Toz, MD Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Study Chair: Kadri Atay, MD Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Study Chair: Hamza Ugur Bozbey, MD Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Study Chair: Ercan Bicakci, MD Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Study Chair: Mehmet Besiroglu, MD Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Study Director: Fatih Tufan, MD Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine Division of Geriatrics
Principal Investigator: Tevfik Ecder, Prof Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine Division of Nephrology
Study Director: Miklos Illyes, MD, Ph. D Heart Institute, Pecs University Faculty of Medicine, Pecs/Hungary
Study Director: Kamil Nas, MD Szent Janos Hospital Radiology Department, Budapest/Hungary
Study Director: Molnar Ferenc Tensiomed Arterial Stiffness Centre, Budapest/Hungary
  More Information

No publications provided

Responsible Party: Tevfik Ecder, Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
ClinicalTrials.gov Identifier: NCT01041599     History of Changes
Other Study ID Numbers: 4154
Study First Received: December 30, 2009
Last Updated: June 22, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Istanbul University:
Diabetes Mellitus
Hypertension
Albuminuria
Arterial stiffness

Additional relevant MeSH terms:
Albuminuria
Diabetes Mellitus
Hypertension
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
 Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013