NCT01717339

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

5 years

First QC Date

October 25, 2012

Last Update Submit

November 8, 2017

Conditions

OSA

Outcome Measures

Primary Outcomes (1)

  • Change in Brachial artery diameter in response to 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.

    Baseline and 15 min after hyperemia

Study Arms (2)

Normal Subjects

OTHER

Non-OSA (Obstructive sleep apnea) patients

Other: Sleep Study

OSA subjects

OTHER

(Obstructive sleep apnea) OSA subjects

Other: Sleep Study

Interventions

Sleep StudyOTHER
Normal SubjectsOSA subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Virend K Somers, MD PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 25, 2012

First Posted

October 30, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

US(1)