Apelin in Willis Ekbom Disease

Restless Legs Syndrome Clinical Trial

Official title:

Oxidative Stress and Apelin Level in Willis Ekbom Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02264600
• Other study ID #: AWED-31014
• Status: Not yet recruiting
• Phase: N/A
• First received: October 3, 2014
• Last updated: October 10, 2014
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2014
• Source: Acibadem University
• Contact: Selda Korkmaz, Assist. Prof. Dr.
• Phone: 00905325807889
• Email: korkmazs78[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Restless Legs Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

References & Publications (4)

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. — View Citation

Boucher J, Masri B, Daviaud D, Gesta S, Guigné C, Mazzucotelli A, Castan-Laurell I, Tack I, Knibiehler B, Carpéné 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. Epub 2005 Jan 27. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum apelin level in WED patients and healthy controls		Two months	No

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