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临床试验/NCT03308578
NCT03308578已完成1 期

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

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月8日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
50
试验地点
1
主要终点
Changes in prevalence of dual positive p16IND4A and gamma H2AX cells in adipose tissue

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Atorvastatin (Drug)

Placebo Oral Capsule

Placebo Comparator

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

干预措施: Placebo oral capsule (Drug)

结局指标

主要结局

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

时间窗: Approximately 6 months

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.

次要结局

  • Changes in prevalence of phosphorylated p53 (pp53) in adipose tissue(approximately 6months)
  • Changes in vascular endothelial function(approximately 6months)
  • Changes in insulin sensitivity(approximately 6months)
  • Changes in body composition(approximately 6months)
  • Changes in 24- h mean arterial pressure(approximately 6months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Virend Somers, MD, PhD

Principal Investigator

Mayo Clinic

研究点 (1)

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