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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014