Assessing the Risk of Developing Type II Diabetes Using Serum Biomarkers in Patients Diagnosed With Obstructive Sleep Apnea (OSA & DM)

Will continuous positive airway pressure (CPAP) therapy for treatment of obstructive sleep apnea (OSA) affect the score of a seven serum biomarker panel that predicts the risk of developing diabetes mellitus type 2 (DM2)? Will knowledge of the diabetes risk score affect CPAP compliance?

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.

Subjects will be told the results of their 2-hour OGTT by their PCM. The biomarker panel results from visit 1 will be mailed to all groups except for 1 and 2 along with the educational brochure titled "A Guide to Understanding Your PreDx Diabetes Risk Score (DRS)", which will explain the report in detail to the patient. Group 1 will review their biomarker results during a follow-up visit that occurs 2 weeks after Visit 1. Group 2 will not receive their biomarker results until follow up Visit 2, which is at the end of the study after CPAP compliance over a 6 month period has been measured.

All patients will receive standard of care treatment regardless of their participation in this research study.