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Extracellular microRNA: Biomarkers of Endothelial Dysfunction in Obese Adolescents & Adults With Obstructive Sleep Apnea

2018年6月1日 更新者：Rakesh Bhattacharjee、University of California, San Diego

Extracellular Micro RNA (miR) (Extracellular Vesicle (EV)-Associated & Non-EV-associated miRs) Identify and Mediate Endothelial Dysfunction in Obesity and Obstructive Sleep Apnea in Adolescents & Young Adults

Using a prospective observational approach and a clinical trial design comparing the effectiveness of continuous positive airway pressure to diet and exercise, investigators plan to evaluate how obstructive sleep apnea (OSA) leads to endothelial dysfunction in adolescents and young adults and whether treatment of OSA can improve endothelial dysfunction. Concurrently, investigators will measure miR 92a/miR 210 levels in all subjects at baseline and following therapy to determine whether miR 92a/miR 210 levels reliably predict endothelial dysfunction in patients and responses to therapy.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Investigators will randomize 100 OSA patients (age 13-21) to receive either continuous positive airway pressure (CPAP) plus baseline diet/exercise (n=50) or medical management (intensive diet and exercise; n=50). Only children in whom adenotonsillectomy is contraindicated (morbid obesity, history of adenotonsillectomy, lack of adenotonsillar hypertrophy) will be included. Investigators will conduct a randomized prospective comparative effectiveness study to assess the impact of treatment on OSA on endothelial function (peripheral arterial tonometry-EndoPAT). In addition to diagnostic polysomnography and EndoPAT at baseline, EV (extracellular vesicle) and non EV derived miR 92a/miR 210 concentrations, inflammatory cytokines concentrations, and body anthropometry will be measured. Following 3 mos of therapy and after 6mos of therapy, investigators will re-evaluate EndoPAT, EV and non EV derived miR 92a/miR 210 concentrations, inflammatory cytokines, and body anthropometry.

Throughout the study, investigators will maintain weekly telephone contact and monthly face-to-face visits as per standard of care in both groups to ensure ongoing success. In the medical management group (intensive diet and exercise), diet and exercise will be tracked by maintaining weekly telephone contact and monthly face-to-face visits with a registered dietician. For the CPAP group, investigators will also maintain weekly telephone contact and monthly face-to-face visits with a sleep technician to review mask fitting, and adherence reports, to optimize adherence to CPAP therapy.

Following completion at six months, polysomnography will be repeated.

研究类型

介入性

注册 (预期的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Rakesh Bhattacharjee, MD
  • 电话号码：858-966-5846
  • 邮箱：rakesh@ucsd.edu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 21年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Otherwise healthy children and young adults with a diagnosis of obstructive sleep apnea based on polysomnography criteria of an obstructive apnea hypopnea index > 10 events/hr.
  • For children a BMI range up to 99.7% and for adults BMI up to 32 kg/m2 is used.

Exclusion Criteria:

  • The presence of elevated blood pressure
  • The presence of diabetes or pre-diabetes
  • The presence of craniofacial anomalies
  • The presence of neuromuscular disorders
  • The presence of syndromic or defined genetic abnormalities
  • Pregnancy
  • History of smoking (any smoking within the prior 6 mos or >5 pack years total)
  • The presence of infectious disease (e.g. including hepatitis B, C, HIV etc.)
  • The presence of collagen vascular disease (e.g. lupus, arthritis, scleroderma, polymyositis, mixed-connective tissue disease, vasculitis etc)
  • The presence of hepatic disease (including hepatitis fatty liver or cirrhosis)
  • The presence of renal disease (including azotemia or clinical proteinuria)
  • The presence of cardiopulmonary disease (e.g. known asthma, cystic fibrosis, congenital heart disease)
  • Individuals using medications which could affect sleep or breathing (including hypnotics)
  • Individuals using chronic anti-inflammatory therapy
  • Individuals with any subjects with acute or chronic illness.
  • Individuals using anti-hypertensive therapies
  • Children with a a BMI > 99.7%
  • Adults with a BMI > 32 kg/m2

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：CPAP
This arm will consist of patients with obstructive sleep apnea who will be asked to use CPAP nightly to treat their OSA for six months
设备：Continuous Positive Airway Pressure
This device delivers air pressure non invasively through a mask to stent open the upper airway to prevent obstruction during sleep. This is an FDA approved device that has been used for several decades to treat OSA.
其他名称：
  • 呼吸机
有源比较器：Diet and Exercise
This arm will consist of patients with obstructive sleep apnea who will be asked to engage in dietary management and regular exercise for six months.
其他：Diet And Exercise
This will consist of weekly telephone and monthly face to face visits to monitor and suggest measures to improve diet and regular exercise as conducted by a registered dietician.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Peripheral Arterial Tonometry - Reactive Hyperemic Index
大体时间：At baseline.
EndoPAT
At baseline.
Peripheral Arterial Tonometry - Reactive Hyperemic Index
大体时间：At three months.
EndoPAT
At three months.
Peripheral Arterial Tonometry - Reactive Hyperemic Index
大体时间：At six months.
EndoPAT
At six months.

次要结果测量

结果测量
措施说明
大体时间
miRNA 92a and miRNA 210 levels
大体时间：At baseline.
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
At baseline.
miR 92a and miR 210 levels
大体时间：At three months.
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
At three months.
miR 92a and miR 210 levels
大体时间：At six months.
Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
At six months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of California, San Diego

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2019年4月1日

初级完成 (预期的)

2024年7月30日

研究完成 (预期的)

2024年12月31日

研究注册日期

首次提交

2018年5月21日

首先提交符合 QC 标准的

2018年6月1日

首次发布 (实际的)

2018年6月6日

研究记录更新

最后更新发布 (实际的)

2018年6月6日

上次提交的符合 QC 标准的更新

2018年6月1日

最后验证

2018年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 170408

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Intellectual property and data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.

As a part of this application will involve human subjects, investigators believe that the rights and privacy of people who will participate in the research project must be protected at all times. In case other investigators express interest in working with the data, every effort will be made to provide the data to them free of identifiers. However, such endeavors will have to be individually considered and also approved by the University of California (UC) San Diego Human Research Protection Program before any commitments can be made.

IPD 共享时间框架

5 years (during the study period)

IPD 共享访问标准

Only investigators that are listed as co-investigators with the UC San Diego Human Research Protection Program

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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