Statins and CPAP in Adipose Tissue of OSA



Status:Enrolling by invitation
Conditions:Insomnia Sleep Studies, Pulmonary, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:January 8, 2018
End Date:July 2023

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Statins and CPAP in Adipose Tissue: A Randomized Clinical Trial in Obstructive Sleep Apnea

This study is aimed at examining the alterations in adipose tissue in obstructive sleep apnea
(OSA) patients in response to treatment with atorvastatin in continuation with standard
treatment with continuous positive airway pressure (CPAP).

In recent years the role adipose tissue to the development of cardiometabolic disorders has
been increasingly recognized. Dysfunctional adipose tissue is an important source for
systemic inflammation and FFA, thus increasing CV risk in obese and aging populations. Even
though heightened cardiovascular risk in OSA patients is acknowledged, adipose tissue from
OSA patients has not been investigated.

CPAP is standard therapy for OSA, but has shown mixed results for improvement of vascular
function, insulin sensitivity, and BP, and does not reduce CV events and mortality, even in
patients with established CV disease. Hence, eliminating IH alone may not be sufficient to
repair preexisting damage; additional adjunct strategies aimed at cellular repair may be
required to reduce cardiometabolic burden and CV risk. Statins have pleiotropic effects
including reducing inflammation, and improving BP. The aim of this study is to examine the
longitudinal changes in the cellular and molecular composition of adipose tissue in OSA
subjects in response to 6 months combination therapy of CPAP and atorvastatin. We hypothesize
that the combination therapy will reduce adipose tissue cellular damage (p16INK4A+γ-H2AX dual
positive cells). Also, decreases in adipose tissue cellular damage will be associated with
improved cardiometabolic profile. These studies will provide pivotal insights into potential
therapeutic strategies which may reduce cardiometabolic burden in OSA population.

Inclusion Criteria

- Participated in IRB 17-003825

- Apnea hypopnea index, AHI≥15

- Women of child-bearing age will be allowed to participate if they agree to use
acceptable birth control during the study period.

- More than 50% obstructive apneic events.

- TSH levels in range of 0.3-4.2 mIU/L

Exclusion Criteria

- Elevated ALT (>3 times upper normal limit)

- Fasting glucose >120 mg/dL

- Females planning to be pregnant in next six months will not be included in the study

- Known serious or hypersensitivity to HMG-CoA reductase inhibitors.

- Alcohol consumption >3 units/day
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-255-8794
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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