Status:
COMPLETED
Statins and CPAP in Adipose Tissue of OSA
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 con...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participated in IRB 17-003825
- Apnea hypopnea index, AHI/RDI ≥10, or AHI/RDI \>5 with significant nocturnal hypoxemia documented by a fall in oxygen saturation to 90% or below.
- Women of child-bearing age will be allowed to participate if they agree to use acceptable birth control during the study period.
- TSH levels in range of 0.3-6 mIU/L (TSH above 6 mIU/L will be allowed if free thyroxine (free T4) is within normal range)
- Exclusion Criteria
- Elevated ALT (\>3 times upper normal limit)
- Fasting glucose \>120 mg/dL and/or HbA1c ≥ 6.5 %
- 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
Exclusion
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03308578
Start Date
January 8 2018
End Date
December 12 2023
Last Update
December 16 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905