Status:
COMPLETED
Assessing the Risk of Developing Type II Diabetes Using Serum Biomarkers in Patients Diagnosed With Obstructive Sleep Apnea
Lead Sponsor:
Mike O'Callaghan Military Hospital
Conditions:
Obstructive Sleep Apnea
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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 (DM...
Eligibility Criteria
Inclusion
- Inclusion:
- 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
- Exclusion:
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01447251
Start Date
September 1 2011
End Date
July 1 2014
Last Update
October 13 2014
Active Locations (1)
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1
Mike O'Callaghan Federal Hospital/Nellis AFB
Las Vegas, Nevada, United States, 89191