Assessing the Risk of Developing Type II Diabetes Using Serum Biomarkers in Patients Diagnosed With Obstructive Sleep Apnea

NCT01447251 | Completed

• 1 other identifier: FWH20110089H
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obstructive Sleep Apnea; Diabetes Mellitus

Keywords

Obstructive Sleep Apnea; Diabetes Mellitus type 2; DM2; OSA; CPAP; continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

• Number of participants with a change in their seven serum biomarker panel results

  12 months

Secondary Outcomes (1)

• Number of participants with increased Continuous Positive Airway Pressure (CPAP)Compliance

  12 months

Study Arms (4)

A: Newly Diagnosed/CPAP/NO DM/PreDx DRS

EXPERIMENTAL

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

B: Newly Diagnosed/CPAP/NO DM/NO PreDx DRS

EXPERIMENTAL

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

C: Controls

ACTIVE COMPARATOR

age, sex, and BMI-matched controls without OSA or diabetes

Behavioral: PreDx Diabetes Risk Score

D: Controls on CPAP

ACTIVE COMPARATOR

age, sex, BMI, and OSA severity matched patients on CPAP therapy for OSA

Behavioral: PreDx Diabetes Risk Score

Interventions

PreDx Diabetes Risk Score BEHAVIORAL

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.

A: Newly Diagnosed/CPAP/NO DM/PreDx DRS; B: Newly Diagnosed/CPAP/NO DM/NO PreDx DRS; C: Controls; D: Controls on CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Hospital/Nellis AFB

Las Vegas, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Laura Walpole, D.O, Capt

  Mike O'Callaghan Federal Hospital/Nellis AFB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 6, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 13, 2014

Record last verified: 2014-10

Locations

US (1)