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Sleep Apnea, ObstructivePhase 1/2SCAT-OSANCT03308578

Statins and CPAP in Adipose Tissue of OSA

A Phase 1/2 study testing Atorvastatin in people with Sleep Apnea, Obstructive, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 continuous positive airway pressure (CPAP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sleep Apnea, Obstructive
What is being tested?
Atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited States
Study dates
8 Jan 2018to 12 Dec 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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).

Read the 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, AngII, 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.

Being tested
Atorvastatin, Placebo oral capsule
Keywords
Obstructive sleep apnea, Adipose tissue
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

    Subjects randomized to this arm will receive 40 mg capsules, once daily dose for the first 4 weeks followed by 2X40mg capsules, once daily dose for remaining 5 months of the study

  • Placebo oral capsuleDrug

    Subjects randomized to this arm will receive placebo capsules, once daily dose for the first 4 weeks followed by 2X40mg capsules, once daily dose for remaining 5 months of the study

Study groups in NCT03308578
Study groupRoleWhat they receive
AtorvastatinExperimentalSubjects randomized to this arm will be started on a lower dose of atorvastatin 40 mg daily for the first 4 weeks. If they are tolerating this dose without significant problems, atorvastatin will be increased to 80 mg daily.
Receives: Drug: Atorvastatin
Placebo Oral CapsulePlacebo comparatorSubjects randomized to this arm will receive placebo capsules matching study drug.
Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in prevalence of dual positive p16IND4A and gamma H2AX cells in adipose tissue

    Positivity for both (p16^IND4A and γH2AX) serves as a marker of cellular damage. Fat biopsy from the will be performed to obtain up to 1 gm of adipose tissue. These fat samples will be batched for analysis to determine the prevalence of cellular damage. Biopsy will be obtained at 3 months and 6 month follow-up.

    Measured: Approximately 6 months

Secondary outcomes (5)

  1. Changes in prevalence of phosphorylated p53 (pp53) in adipose tissue

    Presence of pp53 as a ratio of phospho to total p53 to access cellular damage in adipose tissue at 3 month and 6 month follow-up

    Measured: approximately 6months

  2. Changes in 24- h mean arterial pressure

    Changes in ambulatory measure of blood pressure at 3 month and 6 month.

    Measured: approximately 6months

  3. Changes in vascular endothelial function

    Comparison of change in brachial artery diameter in response to hyperemia at 3 month and 6 month follow-up.

    Measured: approximately 6months

  4. Changes in insulin sensitivity

    Changes in the measure for area under the curve for glucose and insulin as determined during oral glucose tolerance test at 3 month and 6 month.

    Measured: approximately 6months

  5. Changes in body composition

    Changes in percentage body fat content at 3 month and 6 month.

    Measured: approximately 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2017
  2. Study start8 Jan 2018
  3. Primary completion12 Dec 2023
  4. Study completion12 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03308578
Sponsor's protocol ID
17-005119
Other IDs
R01HL065176
Acronym
SCAT-OSA
Status last verified
Dec 2024
First submitted
9 Oct 2017
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Bock JM, Vungarala S, Sompalli S, Covassin N, Bukartyk J, Karim S, Louis ES, Wright RS, Singh P, Somers VK. High-Intensity Atorvastatin and 24-Hour Blood Pressure in Obstructive Sleep Apnea: A Randomized, -Double-Blind, Placebo-Controlled Pilot Study. Am J Hypertens. 2026 Mar 1;39(3):390-399. doi: 10.1093/ajh/hpaf202.

    PubMed 41072928

  • Greenlund IM, Bock JM, Govindan N, Kantas D, Singh P, Covassin N, Somers VK. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. J Racial Ethn Health Disparities. 2026 Jun;13(3):1961-1966. doi: 10.1007/s40615-025-02389-7. Epub 2025 Mar 15.

    PubMed 40088388

  • Greenlund I, Bock J, Govindan N, Kantas D, Singh P, Covassin N, Somers V. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. Res Sq [Preprint]. 2024 Oct 21:rs.3.rs-4925722. doi: 10.21203/rs.3.rs-4925722/v1.

    PubMed 39502777

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Atorvastatin in people with Sleep Apnea, Obstructive, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in prevalence of dual positive p16IND4A and gamma H2AX cells in adipose tissue (time frame: Approximately 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03308578, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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