Assessing the Risk of Developing Type II Diabetes Using Serum Biomarkers in Patients Diagnosed With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of participants with a change in their seven serum biomarker panel results
研究概览
简要总结
The investigators plan to recruit 140 patients (35 subjects in each group) over a period of 18 months in a prospective study of matched/paired case-control subjects across the four groups to measure the 5-year risk of developing DM2 in each group and if knowledge of the 5-year risk of developing diabetes will affect continuous positive airway pressure (CPAP) compliance. The study will have four arms: 1) patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are given the result of the diabetes risk score; 2) patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are not given the result of the diabetes risk score; 3) age, sex, and BMI-matched controls without OSA or diabetes; 4) age, sex, BMI, and OSA severity matched patients on CPAP therapy for OSA. The investigators will document that the patients are compliant with CPAP based on review of SD card data recorded by the CPAP machine. Each patient will have serum drawn for the biomarker panel as well as the standard diagnostic measures of DM2 (oral glucose tolerance test (OGTT) upon enrollment in the study. An Epworth Sleepiness Score, BMI, neck and waist circumference, smoking history, blood pressure, and other standard vital signs will also be collected.
There will be no follow-up of the study subjects in groups 3 and 4 and their participation in this study is completed after Visit 1. Groups 1 and 2 will be followed for 6 months after enrollment to assess whether or not there is any change in CPAP compliance as measured by SD card.
详细描述
A total of 140 subjects will be recruited (35 subjects with newly-diagnosed obstructive sleep apnea (OSA) without diabetes who will be told their 5-year risk of developing diabetes mellitus type 2 (DM2) prior to starting CPAP therapy, 35 subjects with newly-diagnosed OSA without diabetes who will not be told their 5-year risk of developing DM2 prior to starting continuous positive airway pressure (CPAP) therapy, 35 healthy subjects without OSA or diabetes, and 35 subjects with OSA > 12 months on CPAP therapy). The patients who are newly-diagnosed with OSA will need to be assessed to require CPAP therapy by their treating physician. The investigators will use "A" (ex: A001) before the subject numbers of those subjects newly-diagnosed OSA requiring CPAP therapy without diabetes and are given the result of the diabetes risk score (group 1); and "B" (ex: B001) before the subject numbers of those subjects who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are not given the result of the diabetes risk score (group 2). The investigators will use a "C" (ex: C001) before the subject numbers of the healthy subjects (age, sex, and BMI-matched controls) without OSA or diabetes (group 3). The investigators will use a "D" (ex: D001) before the subject numbers of the (age, sex, BMI, and OSA severity matched) patients on CPAP therapy for OSA (group 4).
Screening Visit:
- Obtain signed Informed Consent document and HIPAA Authorization (research-driven)
- Women of child bearing potential will have a serum pregnancy test (5-10 milliliters (mls), approximately 1-2 teaspoons of blood) (research-driven).
- Review of sleep study data and SD card (flash memory card) data as appropriate to assess for good CPAP compliance as defined by average daily use of >= 4 hours for at least 5 days/week for the 30 days preceding enrollment (standard of care)
- Patients will be told to fast for at least 10 hours prior to Visit 1.
Visit 1 (Day 1):
(see attached Data Collection Form)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Tricare beneficiaries (military insurance) eligible for care at Nellis AFB.
- •Male or Female > 18 years old
- •Groups 1 and 2: newly diagnosed with OSA and determined to need continuous positive airway pressure (CPAP) therapy by their treating physician
- •Group 4: known diagnosis of obstructive sleep apnea (OSA) treated with CPAP therapy for 12-24 months with demonstrated compliance after review of SD card
- •Tricare Beneficiaries
排除标准
- •Diagnosed as being diabetic by having a positive oral glucose tolerance test for diabetes
- •Pregnant or breastfeeding
- •Groups 1 and 2: being diagnosed for OSA for greater than one month
- •Groups 1, 2, and 4: being diagnosed for OSA but not needing CPAP therapy
- •Groups 1, 2, and 4: treatment of OSA with CPAP therapy but CPAP machine does not have SD card
- •Group 3: being diagnosed with OSA
- •Group 4: being diagnosed for OSA for less than one year
- •All non-English speaking subjects or those who do not demonstrate the ability to understand the study or the willingness to sign the written informed consent document will be excluded from the study
结局指标
主要结局
Number of participants with a change in their seven serum biomarker panel results
时间窗: 12 months
次要结局
- Number of participants with increased Continuous Positive Airway Pressure (CPAP)Compliance(12 months)