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

Not Applicable

Withdrawn

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Behavioral: LIfestyle; Device: CPAP

• Registration Number: NCT01849081
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-08
• Study Start: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-02
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	LIfestyle	Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling.
CPAP	CPAP	Subjects in this arm with receive treatment with CPAP for fatty liver disease.

Primary Outcome Measures

Name	Time	Method
Steatosis by MRS	12 weeks	Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States