NCT01041599

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

2.2 years

First QC Date

December 30, 2009

Last Update Submit

August 29, 2016

Conditions

Diabetes MellitusHypertensionAlbuminuriaVascular Stiffness

Keywords

Diabetes MellitusHypertensionAlbuminuriavascular stiffness

Outcome Measures

Primary Outcomes (1)

  • Correlation between albuminuria and arterial stiffness

    Albuminuria and arterial stiffness will be assessed simultaneously (i.e. in the same morning)

Study Arms (3)

Diabetic patients

Hypertensive and normotensive patients with type 2 diabetes mellitus

Hypertensive patients

Patients with essential hypertension

Healthy subjects

Healthy subjects

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diabetes, patients with hypertension and healthy subjects

You may qualify if:

  • Diabetes Mellitus
  • Hypertension
  • Healthy subjects

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine

Istanbul, 34390, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine samples.

MeSH Terms

Conditions

Diabetes MellitusHypertensionAlbuminuria

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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 CHAIR

  • Fatih Tufan, MD

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

    STUDY DIRECTOR

  • Tevfik Ecder, Prof

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

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc prof MD

Study Record Dates

First Submitted

December 30, 2009

First Posted

January 1, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

yes

Locations

TU(1)