Apelin in Willis Ekbom Disease | NCT02264600

Studies
Apelin in Willis Ekbom Disease

NCT02264600

Sponsor

Acibadem University

Status

Unknown status

Last Update Posted

Oct 15, 2014Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Restless Legs Syndrome

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Feb 2015Estimated

Completion Date

Apr 2015Estimated

First Submitted Date

Oct 3, 2014

First Submission Date that Met QC Criteria

Oct 10, 2014

First Posted Date

Oct 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2014

Last Update Posted Date

Oct 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Selda Korkmaz, Assist. Prof. Dr.	Contact	00905325807889		korkmazs78@gmail.com
Tugce Bilecenoglu, M.D.	Contact	00905386275515		nedimetugche@yahoo.com

Overall Officials

Name	Affiliation	Role
Murat Aksu, Prof. Dr.	Acibadem University Faculty of Medicine, School of Electroneurophysiology	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21250984	Background	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.
22469072	Background

ID	Term
D009422	Nervous System Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders