Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver

This study is not yet open for participant recruitment.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kathleen E Corey, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01849081
First received: May 6, 2013
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Non-alcoholic Fatty Liver Disease
Device: CPAP
Behavioral: LIfestyle
Phase 2
Phase 3

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
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)
Arms Assigned Interventions
Experimental: CPAP
Subjects in this arm with receive treatment with CPAP for fatty liver disease.
Device: CPAP
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.
Behavioral: LIfestyle
Subjects will undergo 12 weeks of dietary counseling.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01849081

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Kathleen E Corey, MD    617-724-1685    kcorey@partners.org   
Principal Investigator: Kathleen E Corey, MD, MPH         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Kathleen E Corey, MD, MPH Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Kathleen E Corey, Instructor in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01849081     History of Changes
Other Study ID Numbers: 2013P000688
Study First Received: May 6, 2013
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Non-alcoholic fatty liver disease
Obstructive sleep apnea

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014