Fat Biology, Sleep Disorders, and Cardiovascular Disease

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01229501
First received: October 26, 2010
Last updated: June 12, 2013
Last verified: June 2013

October 26, 2010
June 12, 2013
March 2010
March 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01229501 on ClinicalTrials.gov Archive Site
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Fat Biology, Sleep Disorders, and Cardiovascular Disease
Fat Biology, Sleep Disorders, and Cardiovascular Disease

Endothelial dysfunction, or abnormal functioning of the lining of blood vessels, appears to be a key process in the development of cardiovascular disease. Endothelial dysfunction appears to be caused by both sleep disordered breathing and obesity. As endothelial dysfunction is among the first clinical marker that predicts future cardiovascular events, understanding molecular mechanisms leading to impairment of endothelial function is very important. Endothelial function requires the proper functioning of endothelial nitric oxide synthase (eNOS). eNOS activity is tightly regulated by caveolin-1, a protein important in the formation of cellular structures called caveolae. Low levels of caveolin-1 facilitate optimal nitric oxide synthesis in endothelial cells as caveolin-1 helps to spatially organize eNOS in close proximity to signaling proteins that are important for eNOS activation. In certain diseases however, the balance of caveolin-1 and eNOS can be disrupted resulting in impaired nitric oxide synthesis and leading to endothelial dysfunction.

The investigators therefore seek to characterize levels of caveolin-1, and correlate this with the presence or absence of sleep disordered breathing, obesity, and cardiovascular disease. The current IRB protocol covers the performance of fat biopsies on subjects who have recently completed a sleep study either in the Center for Sleep Medicine or in our sleep laboratory and were found to have sleep disordered breathing or no sleep disordered breathing, subject with sleep disordered breathing who have been treated successfully with continuous positive airway pressure for 3-6 months, and subjects undergoing other studies in our lab who are obese or non-obese and subjects who have known cardiovascular disease and subjects without known cardiovascular disease.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Serum and plasma.

Non-Probability Sample

With sleep disordered breathing, Without sleep disordered breathing, With cardiovascular disease, Without cardiovascular disease, Sleep disordered breathing using CPAP.

  • Sleep Disordered Breathing
  • Cardiovascular Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
March 2014
March 2014   (final data collection date for primary outcome measure)

Lac of contraindication for fat biopsy, inability to provide informed consent.

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01229501
10-001282
No
Virend Somers, MD, PhD, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Virend Somers, MD, PhD Mayo Clinic
Mayo Clinic
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP