NCT00395590

Brief Summary

Obstructive sleep apnea is a common sleep disorder. It is known to be related with increased body mass, abdominal obesity, insulin resistance and hypertension. It is currently believed to be a feature of the metabolic syndrome. Other features of the metabolic syndrome-such as insulin resistace were found related to inflammation and inflammatory cytokines. Several polymorphisms in the genes that encode interleukin 6,inteleukin 10 and TNF-alpha have significant influence on the amounts of cytokine production. we thus hypothesize that polymorphisms related to increased pruduction are more common in subjects with OSA than in matched controls

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2006

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 3, 2006

Status Verified

February 1, 2005

First QC Date

November 2, 2006

Last Update Submit

November 2, 2006

Conditions

Sleep Apnea

Keywords

OSA inflammatory cytokines, metabolic syndrome

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients attending the sleep apnea clinic for evaluation

You may not qualify if:

  • patients known to have inflammatory conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea SyndromesMetabolic Syndrome

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • mates mates, MD

    Ben-Gurion University of the Negev

    STUDY DIRECTOR

Central Study Contacts

michal mates, MD

CONTACT

02-6555111rheum@szmc.org.il

Gheona Altarescu

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 2006

First Posted

November 3, 2006

Study Start

November 1, 2006

Study Completion

November 1, 2007

Last Updated

November 3, 2006

Record last verified: 2005-02