Sleep Apnea and Vascular Function

Mayo Clinic

Status: Completed

Conditions: OSA

Treatments: Other: Sleep Study

Study type: Interventional

Funder types: Other

Identifiers

NCT01717339

12-006285

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Normal Subjects

Other group

Description:

Non-OSA (Obstructive sleep apnea) patients

Treatment:

Other: Sleep Study

OSA subjects

Other group

Description:

(Obstructive sleep apnea) OSA subjects

Treatment:

Other: Sleep Study