Apelin in Willis Ekbom Disease

October 10, 2014 updated by: Selda Korkmaz, Acibadem University

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are administered to Kayseri Acibadem Hospital Sleep Medicine Unit, outpatient clinic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum apelin level in WED patients and healthy controls
Time Frame: Two months
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Study Director: Murat Aksu, Prof. Dr., Acibadem University Faculty of Medicine, School of Electroneurophysiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

October 3, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 10, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWED-31014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Restless Legs Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe