Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01849081|
Recruitment Status : Not yet recruiting
First Posted : May 8, 2013
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-alcoholic Fatty Liver Disease||Device: CPAP Behavioral: LIfestyle||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2018|
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.
- Steatosis by MRS [ Time Frame: 12 weeks ]Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|