Sleep Apnea and Vascular Function
This study is not yet open for participant recruitment.
Verified October 2012 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01717339
First received: October 25, 2012
Last updated: October 26, 2012
Last verified: October 2012
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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: | 20 Years to 55 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 20-55 years, with BMI less than 40 kg/m2, who are free of all chronic diseases including hypertension, diabetes, and cardiovascular diseases, will be recruited for our study.
Exclusion Criteria:
- Pregnancy.
- Anemic (hemoglobin <13.5 g/dL for men and <12.0 g/dL for women.
- Postmenopausal
- Smoking
- Use of chronic Medications (aspirin, beta agonist, anti-inflammatory drugs)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717339
Contacts
| Contact: Diane E Davison, RN, MA | 507-255-8794 | Davison.Diane@mayo.edu |
Locations
| United States, Minnesota | |
| Mayo Clinic | Not yet recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Diane E Davison, RN, MA 507-255-8794 Davison.Diane@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: | October 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Sleep Apnea Syndromes Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013