Diabetes MellitusNCT01041599
Correlation of Albuminuria With Arterial Stiffness
An observational study of Diabetes Mellitus and Hypertension, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aim to investigate the relationship between albuminuria and arterial stiffness in diabetic patients, hypertensive patients and healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Albuminuria
- How many people
- 152 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2009to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with diabetes, patients with hypertension and healthy subjects
Who may be able to join
- Diabetes Mellitus
- Hypertension
- Healthy subjects
Who cannot join
- Symptomatic cardiovascular diseases (heart failure, history of myocardial infarction, etc.)
- Renal failure
- Pregnancy
- Diseases of the aorta
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Istanbul, 34390
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Hypertension, Albuminuria, Vascular Stiffness
- Keywords
- Diabetes Mellitus, Hypertension, Albuminuria, vascular stiffness
- Medical subject headings
- Diabetes Mellitus, Hypertension, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Hypertensive and normotensive patients with type 2 diabetes mellitus | |
| Hypertensive patients | Patients with essential hypertension | |
| Healthy subjects | Healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between albuminuria and arterial stiffness
Measured: Albuminuria and arterial stiffness will be assessed simultaneously (i.e. in the same morning)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Tufan, Istanbul University
- Investigators
- Omer Kaya, MD, Study chair, Istanbul Univesity Istanbul Medical Faculty Department of Internal MedicineAbdullah Ozkok, MD, Study chair, Istanbul Univesity Istanbul Medical Faculty Department of Internal MedicineBahtiyar Toz, MD, Study chair, Istanbul Univesity Istanbul Medical Faculty Department of Internal MedicineKadri Atay, MD, Study chair, Istanbul Univesity Istanbul Medical Faculty Department of Internal MedicineHamza Ugur Bozbey, MD, Study chair, Istanbul Univesity Istanbul Medical Faculty Department of Internal MedicineErcan Bicakci, MD, Study chair, Istanbul Univesity Istanbul Medical Faculty Department of Internal MedicineMehmet Besiroglu, MD, Study chair, Istanbul Univesity Istanbul Medical Faculty Department of Internal MedicineFatih Tufan, MD, Study director, Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine Division of Geriatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041599
- Sponsor's protocol ID
- 4154
- Status last verified
- Aug 2016
- First submitted
- 30 Dec 2009
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Association Between Albuminuria and Arterial Stiffness in Diabetic Patients, Hypertensive Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT01041599
- Acronym / sponsor ID
- 4154
- Conditions
- Diabetes Mellitus, Hypertension, Albuminuria, Vascular Stiffness
- Keywords
- Diabetes Mellitus, Hypertension, Albuminuria, vascular stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to investigate the relationship between albuminuria and arterial stiffness in diabetic patients, hypertensive patients and 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | –Hypertensive and normotensive patients with type 2 diabetes mellitus |
| Hypertensive patients | – | –Patients with essential hypertension |
| Healthy subjects | – | –Healthy subjects |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes, patients with hypertension and healthy subjects
Key inclusion criteria (3 listed)
- Diabetes Mellitus
- Hypertension
- Healthy subjects
Key exclusion criteria (4 listed)
- Symptomatic cardiovascular diseases (heart failure, history of myocardial infarction, etc.)
- Renal failure
- Pregnancy
- Diseases of the aorta
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between albuminuria and arterial stiffness
Time frame: Albuminuria and arterial stiffness will be assessed simultaneously (i.e. in the same morning)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Individual participant dataSharing planned: Yes. yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Kaya, MD study chair
Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Abdullah Ozkok, MD study chair
Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
Bahtiyar Toz, MD study chair
Istanbul Univesity Istanbul Medical Faculty Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Hypertension, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between albuminuria and arterial stiffness (time frame: Albuminuria and arterial stiffness will be assessed simultaneously (i.e. in the same morning)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.