Sleep Apnea and Vascular Function

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.

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Key information

Conditions

OSA

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sleep Study

Other

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Oct 30, 2012
Registry last updated: Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed