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Sleep Apnea and Vascular Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01717339
First Posted: October 30, 2012
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic
  Purpose
Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but given the association between OSA and obesity, adipose-derived hormones (adipokines) are likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown to be associated with deleterious effects on vascular function resulting in impaired endothelial function. This proposal is directed at investigating the molecular mechanisms of endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction associated with OSA is a result of molecular alterations within endothelial cells. As a part of these studies we will look at NO signaling pathways in adipose tissue and microvessels from normal and OSA subjects.

Condition Intervention
OSA Other: Sleep Study

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sleep Apnea and Vascular Function

Resource links provided by NLM:


Further study details as provided by Virend Somers, Mayo Clinic:

Primary Outcome Measures:
  • Change in Brachial artery diameter in response to hyperemia. [ Time Frame: Baseline and 15 min after hyperemia ]
    Endothelial function test - Arterial endothelial function will be assessed non-invasively by ultrasound examination of the arterial endothelium dependent vasodilation response to reactive hyperemia. The right brachial artery, proximal to the antecubital fossa, will be imaged longitudinally using a linear-array transducer. Flow-mediated endothelium-dependent vasodilation will be assessed by measuring the brachial artery diameter at baseline and during reactive hyperemia. Reactive hyperemia will be induced by deflating a cuff previously inflated to 200 mmHg for 5 minutes in the forearm. Variables will be measured for three consecutive cardiac cycles and the average will be taken.


Enrollment: 45
Study Start Date: November 2012
Study Completion Date: November 2017
Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Normal Subjects
Non-OSA (Obstructive sleep apnea) patients
Other: Sleep Study
OSA subjects
(Obstructive sleep apnea) OSA subjects
Other: Sleep Study

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non OSA, and newly diagnosed OSA subjects, naïve to CPAP treatment, aged 18-65 years, with BMI less than or equal to 55 kg/m2, who are free of all chronic diseases including diabetes, and cardiovascular diseases, will be recruited for our study. Subjects with dyslipidemia and hypertension will be allowed to participate in the study. Subjects taking anti-depressents, and anithypertensives will be allowed to participate in the study. Also, subjects taking beta blockers and beta agonists will be allowed to participate in the study.

If a subject is on aspirin or any other anti-inflammatory medication but free of known vascular disease and depending on the indication, the study doctor may ask the subject to suspend aspirin or anti-inflammatory therapy for 7 days prior to participation in the study. In the event that the subjects does not stop the aspirin or other anti-inflammatory medication, they will not be able to participate in the study because of the risk of bleeding during the fat biopsy.

Exclusion Criteria:

  • Body weight >450 pounds (204.5kg)
  • Pregnancy.
  • Anemic (hemoglobin <13.5 g/dL for men and <12.0 g/dL for women.
  • Postmenopausal
  • Smoking
  • Use of chronic Medications (aspirin, statins, anti-inflammatory drugs)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717339


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Virend K Somers, MD PhD Mayo Clinic
  More Information

Responsible Party: Virend Somers, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01717339     History of Changes
Other Study ID Numbers: 12-006285
First Submitted: October 25, 2012
First Posted: October 30, 2012
Last Update Posted: November 10, 2017
Last Verified: November 2017