Polycystic Kidney, Autosomal DominantNCT01589705
The Relation Between Uric Acid Level and Endothelial Dysfunction in Patients With Polycystic Kidney Disease
An observational study of Polycystic Kidney, Autosomal Dominant, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
There are substantial data demonstrating increased endothelial dysfunction, inflammation and oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the association between serum uric acid level and endothelial dysfunction has not been elucidated yet in these patients. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Polycystic Kidney, Autosomal Dominant
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Apr 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with early stage(preserved renal function) Autosomal dominant polycystic kidney disease (n = 91) from two academic medical center.We also excluded the patients with a previous diagnosis of hypertension, gout, diabetes, current use of oral antidiabetic medication, insulin, thiazide, allopurinol or uricosuric, or a fasting glucose level 126 mg/dl. In addition, the subjects with a history of smoking or current use of any anti-hypertensive medication and statins were excluded
Who may be able to join
- ADPKD patients with normal renal function,
- Normotensive ADPKD patients
Who cannot join
- Patients with impaired kidney function,
- Atherosclerotic disorders,
- Diagnosis of hypertension, gout, diabetes,
- Using of insulin, thiazide, allopurinol or uricosuric drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Medical School
Kayseri, 38039
About this study
Official title: Endothelial Dysfunction in Patients With Polycystic Kidney Disease
There are substantial data demonstrating increased endothelial dysfunction, inflammation and oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the association between serum uric acid level and endothelial dysfunction has not been elucidated yet in these patients. Therefore, in this study, the investigators aimed to examine the relationship between the uric acid level and the ED in normotensive ADPKD patients with preserved renal function.
Read the detailed description
This is the first study to evaluate the relationship between uric acid and endothelial dysfunction in patients with early stage ADPKD
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Keywords
- Uric acid, polycystic kidney disease
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Polycystic 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 |
|---|---|---|
| polycystic kidney ,no hypertension | The study evaluated the association of serum uric acid levels with endothelial dysfunction in early ADPKD patients with normal renal function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of asymmetric dimethylarginine (ADMA) and flow mediated dilatation (FMD)
ADMA,FMD and uric acid measurements were performed to determine endothelial dysfunction in ADPKD patients
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Patients recruitment and analysis were terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Kidney, Autosomal DominantStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Kocyigit, TC Erciyes University
- Investigators
- Bulent Tokgoz, Professor, Study director, Erciyes University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589705
- Sponsor's protocol ID
- Erciyes 2011/273
- Status last verified
- Jul 2012
- First submitted
- 30 Apr 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kocyigit I, Yilmaz MI, Orscelik O, Sipahioglu MH, Unal A, Eroglu E, Kalay N, Tokgoz B, Axelsson J, Oymak O. Serum uric acid levels and endothelial dysfunction in patients with autosomal dominant polycystic kidney disease. Nephron Clin Pract. 2013;123(3-4):157-64. doi: 10.1159/000353730. Epub 2013 Jul 25.
PubMed 23887359
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction in Patients With Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT01589705
- Acronym / sponsor ID
- Erciyes 2011/273
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Keywords
- Uric acid, polycystic kidney disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patients recruitment and analysis were terminated
- Enrolment
- 150 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 2 May 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.
There are substantial data demonstrating increased endothelial dysfunction, inflammation and oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the association between serum uric acid level and endothelial dysfunction has not been elucidated yet in these patients. Therefore, in this study, the investigators aimed to examine the relationship between the uric acid level and the ED in normotensive ADPKD patients with preserved renal function.
Detailed description
This is the first study to evaluate the relationship between uric acid and endothelial dysfunction in patients with early stage ADPKD
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| polycystic kidney ,no hypertension | – | –The study evaluated the association of serum uric acid levels with endothelial dysfunction in early ADPKD patients with normal renal function |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with early stage(preserved renal function) Autosomal dominant polycystic kidney disease (n = 91) from two academic medical center.We also excluded the patients with a previous diagnosis of hypertension, gout, diabetes, current use of oral antidiabetic medication, insulin, thiazide, allopurinol or uricosuric, or a fasting glucose level 126 mg/dl. In addition, the subjects with a history of smoking or current use of any anti-hypertensive medication and statins were excluded
Key inclusion criteria (2 listed)
- ADPKD patients with normal renal function,
- Normotensive ADPKD patients
Key exclusion criteria (4 listed)
- Patients with impaired kidney function,
- Atherosclerotic disorders,
- Diagnosis of hypertension, gout, diabetes,
- Using of insulin, thiazide, allopurinol or uricosuric drugs
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
Measurement of asymmetric dimethylarginine (ADMA) and flow mediated dilatation (FMD)
Time frame: 4 months
ADMA,FMD and uric acid measurements were performed to determine endothelial dysfunction in ADPKD patients
Results and safety
The study was stopped early (reason given: Patients recruitment and analysis were terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Derived from this study: PubMed 23887359Kocyigit I, Yilmaz MI, Orscelik O, Sipahioglu MH, Unal A, Eroglu E, Kalay N, Tokgoz B, Axelsson J, Oymak O. Serum uric acid levels and endothelial dysfunction in patients with autosomal dominant polycystic kidney disease. Nephron Clin Pract. 2013;123(3-4):157-64. doi: 10.1159/000353730. Epub 2013 Jul 25.
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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.
Bulent Tokgoz, Professor study director
Erciyes University Medical School
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 Polycystic Kidney, Autosomal Dominant, run by TC Erciyes 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 2 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: stopped early, as of the sponsor's last update on 31 Jul 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?
The study was stopped early (reason given: Patients recruitment and analysis were terminated). Results are not available in the source record.
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?
Measurement of asymmetric dimethylarginine (ADMA) and flow mediated dilatation (FMD) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01589705, which also lists 1 linked publication.
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 31 Jul 2012.