Statins and CPAP in Adipose Tissue of OSA

NCT03308578 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17-005119R01HL065176
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 continuous positive airway pressure (CPAP).

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive sleep apnea; Adipose tissue

Outcome Measures

Primary Outcomes (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.

  Approximately 6 months

Secondary Outcomes (5)

• Changes in prevalence of phosphorylated p53 (pp53) in adipose tissue

  approximately 6months

• Changes in 24- h mean arterial pressure

  approximately 6months

• Changes in vascular endothelial function

  approximately 6months

• Changes in insulin sensitivity

  approximately 6months

• Changes in body composition

  approximately 6months

Study Arms (2)

Atorvastatin

EXPERIMENTAL

Subjects 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.

Drug: Atorvastatin

Placebo Oral Capsule

PLACEBO COMPARATOR

Subjects randomized to this arm will receive placebo capsules matching study drug.

Drug: Placebo oral capsule

Interventions

Atorvastatin DRUG

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

Atorvastatin

Placebo oral capsule DRUG

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

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• 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. 2025 Oct 10:hpaf202. doi: 10.1093/ajh/hpaf202. Online ahead of print.

  PMID: 41072928 DERIVED

• 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. 2025 Mar 15:10.1007/s40615-025-02389-7. doi: 10.1007/s40615-025-02389-7. Online ahead of print.

  PMID: 40088388 DERIVED

• 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.

  PMID: 39502777 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Virend Somers, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 12, 2017
• Study Start: January 8, 2018
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

US (1)