Sleep Apnea and Vascular Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01717339
First received: October 25, 2012
Last updated: March 23, 2015
Last verified: March 2015
  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: Open Label
Primary Purpose: Basic Science
Official Title: Sleep Apnea and Vascular Function

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Brachial artery diameter in response to hyperemia. [ Time Frame: Baseline and 15 min after hyperemia ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717339

Contacts
Contact: Somers_CPL Lab CPL@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Somers_CPL Lab       CPL@mayo.edu   
Principal Investigator: Virend K Somers, MD PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Virend K Somers, MD PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Virend Somers, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01717339     History of Changes
Other Study ID Numbers: 12-006285
Study First Received: October 25, 2012
Last Updated: March 23, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 02, 2015