Clinical trial NCT02264600: Apelin in Willis Ekbom Disease
Official title: Oxidative Stress and Apelin Level in Willis Ekbom Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Restless Legs Syndrome
Keywords: Restless Legs Syndrome, Apelin, Oxidative Stress
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are administered to Kayseri Acibadem Hospital Sleep Medicine Unit, outpatient clinic.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Serum apelin level in WED patients and healthy controls
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Acibadem University Faculty of Medicine, School of Electroneurophysiology
name: Murat Aksu, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Baskol 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.
citation: Boucher 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.
citation: Lv 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.