Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver
We are doing this research study to evaluate whether continuous positive airway pressure (CPAP), a treatment for sleep apnea, will also help treat fatty liver disease. Sleep apnea is a disease where a person has interruptions in their breathing while they are sleep. This can lead to low oxygen levels in the blood. CPAP is a mask that delivers oxygen at high pressure to the lungs to prevent a decrease in blood oxygen levels. CPAP is a known treatment for sleep apnea.
Non-alcoholic Fatty Liver Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)|
- Steatosis by MRS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Subjects in this arm with receive treatment with CPAP for fatty liver disease.
Subjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night.
Active Comparator: Lifestyle Intervention
Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling.
Subjects will undergo 12 weeks of dietary counseling.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01849081
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Kathleen E Corey, MD 617-724-1685 firstname.lastname@example.org|
|Principal Investigator: Kathleen E Corey, MD, MPH|
|Principal Investigator:||Kathleen E Corey, MD, MPH||Massachusetts General Hospital|