Non-diabetic Chronic Kidney DiseaseNCT01701830
Serum Omentin-1 and Carotid Atherosclerosis In Non-Diabetic Chronic Kidney Disease
An observational study of Non-diabetic Chronic Kidney Disease and Atherosclerosis, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate whether a low level of serum omentin-1 is associated with carotid atherosclerosis and mediated by inflammation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-diabetic Chronic Kidney Disease, Atherosclerosis
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2012to May 2013
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Department of Nephrology, Check-up clinic
Who may be able to join
- between ages of 18 - 65 years old chronic kidney disease of stage 3-4
Who cannot join
- Chronic kidney disease of stage 5
- The history of ischemic cardiovascular disease (myocardial infarction, unstable angina, stroke, peripheral artery disease, or cardiovascular revascularization)
- Severe heart failure
- Stage 2 hypertension
- Diabetes mellitus
- Corticosteroid therapy
Show all 11Show fewer
- Severe hepatic disease
- Smoking
- Inflammatory disease
- Acute infectious disease
- Malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Nephrology, Check-up Clinic,Kocaeli Derince Education and Traning Hospital
İzmit, Kocaeli, 41100
Rabia TERZI, MD, 90262 317 80 00 ext. 8110, drrabia1@yahoo.com
Erkan SENGUL, MD
About this study
Official title: The Relationship Between Serum Omentin-1 and IL-6 and Carotid Atherosclerosis In Non-Diabetic Chronic Kidney Disease
The aim of the study is to evaluate whether a low level of serum omentin-1 is associated with carotid atherosclerosis and mediated by inflammation.
Read the detailed description
Atherosclerotic cardiovascular disease is markedly increased in chronic kidney disease. There are a lot of risk factor, along with conventional risk factors. Serum onemtin-1 is a adipokine and suggested as a new marker for vascular disease.It has some anti-atherogenic properties. Studies investigating serum omentin-1 level have usually conducted in patients with diabetes mellitus.
- Keywords
- omentin-1, carotid atherosclerosis, kidney disease
- Medical subject headings
- Atherosclerosis, Carotid Artery Diseases, Kidney Diseases
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 |
|---|---|---|
| Case Group | Patients with chronic kidney disease of stage 3-4. | |
| Control group | 30 healthy subject |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startOct 2012
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-diabetic Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erkan SENGUL, MD, Principal investigator, Kocaeli Derince Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701830
- Sponsor's protocol ID
- 2012/02
- Status last verified
- Oct 2012
- First submitted
- 3 Oct 2012
- Last updated
- 5 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Serum Omentin-1 and IL-6 and Carotid Atherosclerosis In Non-Diabetic Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01701830
- Acronym / sponsor ID
- 2012/02
- Keywords
- omentin-1, carotid atherosclerosis, kidney disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Study completion
- May 2013 (estimated)
- First posted
- 5 Oct 2012 (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 aim of the study is to evaluate whether a low level of serum omentin-1 is associated with carotid atherosclerosis and mediated by inflammation.
Detailed description
Atherosclerotic cardiovascular disease is markedly increased in chronic kidney disease. There are a lot of risk factor, along with conventional risk factors. Serum onemtin-1 is a adipokine and suggested as a new marker for vascular disease.It has some anti-atherogenic properties. Studies investigating serum omentin-1 level have usually conducted in patients with diabetes mellitus.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | –Patients with chronic kidney disease of stage 3-4. |
| Control group | – | –30 healthy subject |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Nephrology, Check-up clinic
Key inclusion criteria (1 listed)
- between ages of 18 - 65 years old chronic kidney disease of stage 3-4
Key exclusion criteria (11 listed)
- Chronic kidney disease of stage 5
- The history of ischemic cardiovascular disease (myocardial infarction, unstable angina, stroke, peripheral artery disease, or cardiovascular revascularization)
- Severe heart failure
- Stage 2 hypertension
- Diabetes mellitus
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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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.
Department of Nephrology, Check-up Clinic,Kocaeli Derince Education and Traning Hospital
İzmit, Turkey (Türkiye)
Erkan SENGUL, MD principal investigator
Kocaeli Derince Education and Training Hospital
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 Non-diabetic Chronic Kidney Disease and Atherosclerosis, run by Kocaeli Derince Education and Research Hospital 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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 5 Oct 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 5 Oct 2012.