Assessing the Risk of Developing Type II Diabetes Using Serum Biomarkers in Patients Diagnosed With Obstructive Sleep Apnea
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Diabetes |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | September 2011 |
| End Date: | March 2014 |
| Contact: | Jill M Clark, MBA/HCM, CCRP, CCRC |
| Email: | jill.clark.3.ctr@us.af.mil |
| Phone: | 7026533298 |
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.
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.
Male and female subjects 18 years or older will be recruited, over a 12 month time frame, at
the Mike O'Callaghan Federal Hospital (MOFH) Family Practice, Internal Medicine, and Medical
Specialty Clinics. 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)
- Patients will have the following blood test drawn which include:
- Biomarker Panel(PreDxTM Diabetes Risk Score),(5-10 mls, approximately 2-4
teaspoons of blood per blood draw)(research-driven) Group 3 & 4 will be shown a
sample PreDx Diabetes Risk Report and it will be explained to them. Their report
will be mailed to them along with the brochure "A Guide to Understanding Your
PreDx Diabetes Risk Score (DRS)".
- 2-hour OGTT via 2 venipunctures(5-10 mls, approximately 2-4 teaspoons of blood per
blood draw)(research-driven)
- Obtain Epworth Sleepiness Score, age, sex, race, height, weight, BMI, neck and waist
circumference, smoking history, blood pressure and heart rate (research-driven)
- Patients in group 1 & 2 will be told to fast for at least 10 hours prior to Visit 2.
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)
• Patients will come in and their personalized PreDx Diabetes Risk Report will be explained
to them. They will be given the brochure "A Guide to Understanding Your PreDx Diabetes Risk
Score (DRS)".
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 in Groups 1 and 2 only will be assessed
- Review of sleep study data and SD card (flash memory card) data as appropriate to
assess for CPAP compliance over the last 30 days (standard of care)
- 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)
- Obtain Epworth Sleepiness Score, weight, BMI, neck and waist circumference, smoking
history, blood pressure and heart rate (research-driven)
Visit 2 Follow-Up (Groups 1 and 2 only):
• Patients will come in and their personalized PreDx Diabetes Risk Report will be explained
to them. They will be given the brochure "A Guide to Understanding Your PreDx Diabetes Risk
Score (DRS)".
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.
the Mike O'Callaghan Federal Hospital (MOFH) Family Practice, Internal Medicine, and Medical
Specialty Clinics. 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)
- Patients will have the following blood test drawn which include:
- Biomarker Panel(PreDxTM Diabetes Risk Score),(5-10 mls, approximately 2-4
teaspoons of blood per blood draw)(research-driven) Group 3 & 4 will be shown a
sample PreDx Diabetes Risk Report and it will be explained to them. Their report
will be mailed to them along with the brochure "A Guide to Understanding Your
PreDx Diabetes Risk Score (DRS)".
- 2-hour OGTT via 2 venipunctures(5-10 mls, approximately 2-4 teaspoons of blood per
blood draw)(research-driven)
- Obtain Epworth Sleepiness Score, age, sex, race, height, weight, BMI, neck and waist
circumference, smoking history, blood pressure and heart rate (research-driven)
- Patients in group 1 & 2 will be told to fast for at least 10 hours prior to Visit 2.
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)
• Patients will come in and their personalized PreDx Diabetes Risk Report will be explained
to them. They will be given the brochure "A Guide to Understanding Your PreDx Diabetes Risk
Score (DRS)".
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 in Groups 1 and 2 only will be assessed
- Review of sleep study data and SD card (flash memory card) data as appropriate to
assess for CPAP compliance over the last 30 days (standard of care)
- 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)
- Obtain Epworth Sleepiness Score, weight, BMI, neck and waist circumference, smoking
history, blood pressure and heart rate (research-driven)
Visit 2 Follow-Up (Groups 1 and 2 only):
• Patients will come in and their personalized PreDx Diabetes Risk Report will be explained
to them. They will be given the brochure "A Guide to Understanding Your PreDx Diabetes Risk
Score (DRS)".
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.
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
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