An interventional study of PreDx Diabetes Risk Score in Obstructive Sleep Apnea and Diabetes Mellitus, sponsored by Mike O'Callaghan Military Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-13.
Sponsored by Mike O'Callaghan Military Hospital · Not applicable, Interventional, and Prevention
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.
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:
Visit 1 (Day 1):
(see attached Data Collection Form)
Patients will have the following blood test drawn which include:
There will be no follow-up of the study patients in Groups 3 and 4 and their participation in this study is completed after Visit 1.
Visit 1 Follow-Up (Group 1 ONLY)
Groups 1 and 2 will have a Visit 2 after 6 months to assess CPAP compliance via SD card review.
Visit 2 (180 days after Visit 1 Follow Up) Groups 1 and 2 only:
(see attached Data Collection Form)
Patients will have the following blood test drawn which include:
o Biomarker Panel (PreDxTM Diabetes Risk Score),(5-10 mls, approximately 2-4 teaspoons of blood per blood draw)(research-driven)
Visit 2 Follow-Up (Groups 1 and 2 only):
Subjects will be told the results of their 2-hour OGTT by their PCM.
Patients in groups 1 \& 2, their participation ends after Visit 2 Follow-Up. Patients in groups 3 \& 4, their participation ends after Visit 1.
All patients will receive standard of care treatment regardless of their participation in this research study.
If at any time during the study, the subjects with OSA decided to withdraw from the study, they will be referred to their Primary Care Manager (PCM) to continue standard of care treatment. If the healthy subjects decide to withdraw from the study, no follow up is required. Subjects who are pregnant will be excluded from the study because the changes in a woman's hormones during pregnancy may bias the results of the blood work. Also, women who are breastfeeding may not participate in this study. Study subjects will be told if their Epworth Sleepiness Score is within the normal (0-9) or abnormal (10-24) range; subjects with abnormal Epworth scores will be instructed to follow-up with their PCM. If the healthy subjects decide to withdraw from the study, no follow up is required. If a subject is diagnosed as being diabetic or pre-diabetic as part of this study, they will be referred to their PCM for standard of care treatment. If patients are withdrawn from the study, no further testing as part of this study is required. If patients decide to withdraw from the study, any remaining portion of their blood sample will be destroyed. However, any data already obtained by researchers from their sample will continue to be used for research purposes discussed in this protocol.
Diabetes Risk Score (Pre Dx DRS) The PreDx DRS test sample will be collected as follows: Tethys Biosciences will send prepared collection kits and packing materials. Blood will be drawn in 2 tubes containing 8.5 mL and 4 mL respectively by lab personnel after the patient has been fasting for 10 hours, requiring one venipuncture. The collection kit will be assigned a de-identified number. We will keep a locked master list of the code number associated with the patient's identification. The collected blood will be processed and stored according to manufacturers'specifications. The lab kits will be shipped to Tethys Biosciences within 7 days. From the sample, Tethys Bioscience will measure 7 predictive biomarkers -Adiponectin, C-reactive protein (CRP), Ferritin, Glucose, Insulin, IL-2 and HbA1c. Using a proprietary algorithm a risk score is calculated. In order to calculate the risk score, Tethys will need the patients' dates of birth and gender in addition to the fasting blood sample. The PreDx DRS model provides a continuous measure of risk of progressing to DM2 within five years. There are three risk strata, with low risk defined as PreDx DRS \<4.5, moderate risk as PreDx DRS ≥4.5 and \<8.0, and high risk as PreDx DRS ≥8.0. Tethys Bioscience will send the results of the PreDx DRS test to the Clinical Research Coordinator.
The Tethys Biosciences Clinical Laboratory is Clinical Laboratory Improvement Amendments (CLIA) certified and will use these procedures when processing Laboratory specimens mentioned in this research project.
This test was developed and its performance characteristics determined by the Tethys Clinical Laboratory. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 70 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Mike O'Callaghan Military Hospital is the lead sponsor of 31 studies on the registry; none are open to participants now.
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Exclusion:
patients who have newly-diagnosed obstructive sleep apnea (OSA) requiring continuous positive airway pressure (CPAP) therapy without diabetes and are given the result of the diabetes risk score
Behavioral: PreDx Diabetes Risk Score
patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are not given the result of the diabetes risk score
Behavioral: PreDx Diabetes Risk Score
age, sex, and BMI-matched controls without OSA or diabetes
Behavioral: PreDx Diabetes Risk Score
age, sex, BMI, and OSA severity matched patients on CPAP therapy for OSA
Behavioral: PreDx Diabetes Risk Score
The PreDx DRS measures 7 predictive biomarkers -Adiponectin, C-reactive protein (CRP), Ferritin, Glucose, Insulin, IL-2 and HbA1c, using a proprietary algorithm a risk score in order to calculate a risk score. There are three risk strata, with low risk defined as PreDx DRS \<4.5, moderate risk as PreDx DRS ≥4.5 and \<8.0, and high risk as PreDx DRS ≥8.0.
Number of participants with a change in their seven serum biomarker panel results
Time frame: 12 months
Number of participants with increased Continuous Positive Airway Pressure (CPAP)Compliance
Time frame: 12 months
The record gives a start of Sep 2011, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Mike O'Callaghan Military Hospital