Effects of PAP Treatment of OSA in Patients With Heart Failure (OSA-MRI)
The purpose of this study is to see if treatment of OSA with the CPAP device makes a difference to insulin resistance and heart disease.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Effects of Positive Airway Pressure (PAP) Treatment of Obstructive Sleep Apnea (OSA) in Patients With Heart Failure|
- Increase in circulating levels of adiponectin (Ad) and/or high-molecular-weight (HMW) Ad. [ Time Frame: One month ] [ Designated as safety issue: No ]
- Increased levels of Ad and/or HMW Ad associate with improvements in insulin sensitivity and heart function in patients with known left ventricular (LV) systolic dysfunction. [ Time Frame: One month ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Active Comparator: CPAP Arm
Receive effective CPAP treatment for one month
Device: CPAP Treatment
Effective CPAP treatment for one month
Other Name: CPAP
No Intervention: Control Arm
Receive no treatment for one month
Obstructive Sleep Apnea (OSA) has been seen frequently in persons who develop insulin resistance and heart disease. Insulin resistance is a condition in which the body produces insulin but does not use it properly. Insulin helps the body use glucose for energy. Insulin resistance increases the chance of developing type II diabetes and heart disease.
One method of treatment for OSA is with continuous positive airway pressure (CPAP). This treatment is given by a device named CPAP. There are many different types of CPAPs available on the market that are FDA approved.
The purpose of this study is to see if treatment of OSA with the CPAP device makes a difference to insulin resistance and heart disease. This study will measure insulin resistance by testing the glucose level in the blood, and testing the levels of special protein found in blood, that are known to increase the sensitivity to insulin and decrease progression of heart disease. The heart disease will be measured by cardiac MRI. Glucose testing and cardiac MRI's are normal testing procedures for people who have OSA and heart disease, however will be conducted more frequently than normal and therefore are for research purposes. The specialized blood testing is for research purposes only.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136122
|Contact: Pulmonary Clinical Trials Office||614-293-4978||Lung.Research@osumc.edu|
|United States, Ohio|
|The Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43221|
|Contact: Pulmonary Clinical Trials Office 614-293-4978 Lung.Research@osumc.edu|
|Contact: Melissa Michetti 614-366-2761 Melissa.Michetti@osumc.edu|
|Principal Investigator: Ulysses Magalang, M.D.|
|Principal Investigator:||Ulysses Magalang, M.D.||Ohio State University|