Correlation of Albuminuria With Arterial Stiffness

August 29, 2016 updated by: Fatih Tufan, Istanbul University

Assessment of the Association Between Albuminuria and Arterial Stiffness in Diabetic Patients, Hypertensive Patients and Healthy Controls

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34390
        • Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetes, patients with hypertension and healthy subjects

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy subjects
Diabetic patients
Hypertensive and normotensive patients with type 2 diabetes mellitus
Hypertensive patients
Patients with essential hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between albuminuria and arterial stiffness
Time Frame: Albuminuria and arterial stiffness will be assessed simultaneously (i.e. in the same morning)
Albuminuria and arterial stiffness will be assessed simultaneously (i.e. in the same morning)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

December 30, 2009

First Submitted That Met QC Criteria

December 31, 2009

First Posted (Estimate)

January 1, 2010

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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