Restless Legs SyndromeNCT02264600
Apelin in Willis Ekbom Disease
An observational study of Restless Legs Syndrome, run by Acibadem University.
Trial summary
The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been reported in recent studies. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Apr 2015
- How long will I take part?
- 2 Days
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who are administered to Kayseri Acibadem Hospital Sleep Medicine Unit, outpatient clinic.
Who may be able to join
- Patients diagnosed as RLS/WED according to International Classification of Sleep Disorders (ICSD-3) criteria
- Patients with idiopathic RLS/WED
- Moderate and severe RLS/WED according to International Restless Legs Syndrome Rating Scale
- Periodic Leg Movements Index above 5 in polysomnography record
- BMI below 25
Who cannot join
- Disorders which cause symptomatic RLS(Iron deficiency anemia, kidney failure, diabetes mellitus, pregnancy, Parkinson's disease, multiple sclerosis, neuropathy)
- Systemic diseases which cause possible oxidative stress status (cardiovascular diseases, obesity, diabetes mellitus, use of any medical drugs especially ACE inhibitors e.g.)
- Another sleep disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Oxidative Stress and Apelin Level in Willis Ekbom Disease
The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been reported in recent studies. Increased oxidative stress is thought to play an important role in cardiovascular complications of WED patients. Apelin is a novel described antioxidant bioactive peptide. The investigators hypothesize that patients with WED have lower plasma apelin level than healthy subjects based on presence of oxidative stress of WED.
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, Apelin, Oxidative Stress
- Medical subject headings
- Restless Legs Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum apelin level in WED patients and healthy controls
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies 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
- 30 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Korkmaz, Acibadem University
- Investigators
- Murat Aksu, Prof. Dr., Study director, Acibadem University Faculty of Medicine, School of Electroneurophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264600
- Sponsor's protocol ID
- AWED-31014
- Status last verified
- Oct 2014
- First submitted
- 3 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cikrikcioglu MA, Hursitoglu M, Erkal H, Kinas BE, Sztajzel J, Cakirca M, Arslan AG, Erek A, Halac G, Tukek T. Oxidative stress and autonomic nervous system functions in restless legs syndrome. Eur J Clin Invest. 2011 Jul;41(7):734-42. doi: 10.1111/j.1365-2362.2010.02461.x. Epub 2011 Jan 20.
PubMed 21250984Baskol G, Korkmaz S, Erdem F, Caniklioglu A, Kocyigit M, Aksu M. Assessment of nitric oxide, advanced oxidation protein products, malondialdehyde, and thiol levels in patients with restless legs syndrome. Sleep Med. 2012 Apr;13(4):414-8. doi: 10.1016/j.sleep.2011.11.012.
PubMed 22469072Boucher J, Masri B, Daviaud D, Gesta S, Guigne C, Mazzucotelli A, Castan-Laurell I, Tack I, Knibiehler B, Carpene C, Audigier Y, Saulnier-Blache JS, Valet P. Apelin, a newly identified adipokine up-regulated by insulin and obesity. Endocrinology. 2005 Apr;146(4):1764-71. doi: 10.1210/en.2004-1427. Epub 2005 Jan 27.
PubMed 15677759Lv SY, Qin YJ, Wang HT, Xu N, Yang YJ, Chen Q. Centrally administered apelin-13 induces depression-like behavior in mice. Brain Res Bull. 2012 Sep 1;88(6):574-80. doi: 10.1016/j.brainresbull.2012.06.003. Epub 2012 Jun 21.
PubMed 22728209
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress and Apelin Level in Willis Ekbom Disease
- ClinicalTrials.gov ID
- NCT02264600
- Acronym / sponsor ID
- AWED-31014
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, Apelin, Oxidative Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 15 Oct 2014 (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 purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been reported in recent studies. Increased oxidative stress is thought to play an important role in cardiovascular complications of WED patients. Apelin is a novel described antioxidant bioactive peptide. The investigators hypothesize that patients with WED have lower plasma apelin level than healthy subjects based on presence of oxidative stress of WED.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who are administered to Kayseri Acibadem Hospital Sleep Medicine Unit, outpatient clinic.
Key inclusion criteria (5 listed)
- Patients diagnosed as RLS/WED according to International Classification of Sleep Disorders (ICSD-3) criteria
- Patients with idiopathic RLS/WED
- Moderate and severe RLS/WED according to International Restless Legs Syndrome Rating Scale
- Periodic Leg Movements Index above 5 in polysomnography record
- BMI below 25
Key exclusion criteria (3 listed)
- Disorders which cause symptomatic RLS(Iron deficiency anemia, kidney failure, diabetes mellitus, pregnancy, Parkinson's disease, multiple sclerosis, neuropathy)
- Systemic diseases which cause possible oxidative stress status (cardiovascular diseases, obesity, diabetes mellitus, use of any medical drugs especially ACE inhibitors e.g.)
- Another sleep disorder
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
Serum apelin level in WED patients and healthy controls
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
- Background: PubMed 21250984Cikrikcioglu MA, Hursitoglu M, Erkal H, Kinas BE, Sztajzel J, Cakirca M, Arslan AG, Erek A, Halac G, Tukek T. Oxidative stress and autonomic nervous system functions in restless legs syndrome. Eur J Clin Invest. 2011 Jul;41(7):734-42. doi: 10.1111/j.1365-2362.2010.02461.x. Epub 2011 Jan 20.
- Background: PubMed 22469072Baskol G, Korkmaz S, Erdem F, Caniklioglu A, Kocyigit M, Aksu M. Assessment of nitric oxide, advanced oxidation protein products, malondialdehyde, and thiol levels in patients with restless legs syndrome. Sleep Med. 2012 Apr;13(4):414-8. doi: 10.1016/j.sleep.2011.11.012.
- Background: PubMed 15677759Boucher J, Masri B, Daviaud D, Gesta S, Guigne C, Mazzucotelli A, Castan-Laurell I, Tack I, Knibiehler B, Carpene C, Audigier Y, Saulnier-Blache JS, Valet P. Apelin, a newly identified adipokine up-regulated by insulin and obesity. Endocrinology. 2005 Apr;146(4):1764-71. doi: 10.1210/en.2004-1427. Epub 2005 Jan 27.
- Background: PubMed 22728209Lv SY, Qin YJ, Wang HT, Xu N, Yang YJ, Chen Q. Centrally administered apelin-13 induces depression-like behavior in mice. Brain Res Bull. 2012 Sep 1;88(6):574-80. doi: 10.1016/j.brainresbull.2012.06.003. Epub 2012 Jun 21.
- Related InfoLink provided by the sponsor.
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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.
Murat Aksu, Prof. Dr. study director
Acibadem University Faculty of Medicine, School of Electroneurophysiology
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome, run by Acibadem University.
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 5 inclusion and 3 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Selda Korkmaz, Assist. Prof. Dr. (00905325807889, korkmazs78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum apelin level in WED patients and healthy controls (time frame: Two 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 NCT02264600, which also lists 4 linked publications.
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 15 Oct 2014.