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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Mike O'Callaghan Federal Hospital
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01447251
First received: September 30, 2011
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Diabetes Mellitus
Behavioral: PreDx Diabetes Risk Score

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessing the Risk of Developing Type II Diabetes Using Serum Biomarkers in Patients Diagnosed With Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Mike O'Callaghan Federal Hospital:

Primary Outcome Measures:
  • Number of participants with a change in their seven serum biomarker panel results [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with increased Continuous Positive Airway Pressure (CPAP)Compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: September 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Newly Diagnosed/CPAP/NO DM/PreDx DRS
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
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.
Experimental: B: Newly Diagnosed/CPAP/NO DM/NO PreDx DRS
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
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.
Active Comparator: C: Controls
age, sex, and BMI-matched controls without OSA or diabetes
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.
Active Comparator: D: Controls on CPAP
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447251

Contacts
Contact: Jill M Clark, MBA/HCM, CCRP, CCRC 7026533298 jill.clark.3.ctr@us.af.mil

Locations
United States, Nevada
Mike O'Callaghan Federal Hospital/Nellis AFB Recruiting
Las Vegas, Nevada, United States, 89191
Contact: Jill M Clark, MBA/HCM, CCRP, CCRC    7026533298    jill.clark.3.ctr@us.af.mil   
Principal Investigator: Laura Walpole, DO         
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Investigators
Principal Investigator: Laura Walpole, D.O, Capt Mike O'Callaghan Federal Hospital/Nellis AFB
  More Information

No publications provided

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01447251     History of Changes
Other Study ID Numbers: FWH20110089H
Study First Received: September 30, 2011
Last Updated: November 21, 2013
Health Authority: United States: Federal Government

Keywords provided by Mike O'Callaghan Federal Hospital:
Obstructive Sleep Apnea
Diabetes Mellitus type 2
DM2
OSA
CPAP
continuous positive airway pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Sleep Disorders, Intrinsic
Sleep Disorders
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014