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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447251
First Posted: October 6, 2011
Last Update Posted: October 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Military Hospital:

Primary Outcome Measures:
  • Number of participants with a change in their seven serum biomarker panel results [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Number of participants with increased Continuous Positive Airway Pressure (CPAP)Compliance [ Time Frame: 12 months ]

Enrollment: 70
Study Start Date: September 2011
Study Completion Date: July 2014
Primary Completion Date: July 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447251


Locations
United States, Nevada
Mike O'Callaghan Federal Hospital/Nellis AFB
Las Vegas, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
Principal Investigator: Laura Walpole, D.O, Capt Mike O'Callaghan Federal Hospital/Nellis AFB
  More Information

Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT01447251     History of Changes
Other Study ID Numbers: FWH20110089H
First Submitted: September 30, 2011
First Posted: October 6, 2011
Last Update Posted: October 13, 2014
Last Verified: October 2014

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

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