Back to resultsEvaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP
LIfestyle
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Non-alcoholic fatty liver disease, Obstructive sleep apnea
Eligibility Criteria
Inclusion Criteria:
- Adults 18 years of age or older with a previous liver biopsy showing NASH and at least grade 2 steatosis
- Obstructive sleep apnea diagnosed by sleep study.
Exclusion Criteria:
- Other causes of chronic liver disease
- cirrhosis
- less than 33% steatosis identified on magnetic resonance spectroscopy (MRS)
- Alcohol use >2 units per day for women or >3 units per day for men
- Intolerance to or refusal of CPAP therapy
- overnight desaturation (more than 10% of the sleep time with oxygen desaturation below 85%)
- underlying sever sleepiness (Epworth scale more than 15)
- uncontrolled hypertension
- Severe heart failure (ejection fracture less than 30%)
- cardiac arrhythmias (atrial fibrillation or history of ventricular tachycardia)
- those who are commercial drivers
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CPAP
Lifestyle Intervention
Arm Description
Subjects in this arm with receive treatment with CPAP for fatty liver disease.
Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling.
Outcomes
Primary Outcome Measures
Steatosis by MRS
Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.
Secondary Outcome Measures
Full Information
NCT ID
NCT01849081
First Posted
May 6, 2013
Last Updated
October 2, 2020
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT01849081
Brief Title
Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver
Official Title
Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Change in priorities, study closed prior to enrollment
Study Start Date
March 2019 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
Non-alcoholic fatty liver disease, Obstructive sleep apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP
Arm Type
Experimental
Arm Description
Subjects in this arm with receive treatment with CPAP for fatty liver disease.
Arm Title
Lifestyle Intervention
Arm Type
Active Comparator
Arm Description
Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling.
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Subjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night.
Intervention Type
Behavioral
Intervention Name(s)
LIfestyle
Intervention Description
Subjects will undergo 12 weeks of dietary counseling.
Primary Outcome Measure Information:
Title
Steatosis by MRS
Description
Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults 18 years of age or older with a previous liver biopsy showing NASH and at least grade 2 steatosis
Obstructive sleep apnea diagnosed by sleep study.
Exclusion Criteria:
Other causes of chronic liver disease
cirrhosis
less than 33% steatosis identified on magnetic resonance spectroscopy (MRS)
Alcohol use >2 units per day for women or >3 units per day for men
Intolerance to or refusal of CPAP therapy
overnight desaturation (more than 10% of the sleep time with oxygen desaturation below 85%)
underlying sever sleepiness (Epworth scale more than 15)
uncontrolled hypertension
Severe heart failure (ejection fracture less than 30%)
cardiac arrhythmias (atrial fibrillation or history of ventricular tachycardia)
those who are commercial drivers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen E Corey, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver
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