Non-alcoholic Fatty Liver DiseaseNCT01849081
Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver
A study testing CPAP and LIfestyle in people with Non-alcoholic Fatty Liver Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- CPAP and LIfestyle
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2019to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
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.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- CPAP, LIfestyle
- Keywords
- Non-alcoholic fatty liver disease, Obstructive sleep apnea
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Subjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night.
LIfestyleBehavioural
Subjects will undergo 12 weeks of dietary counseling.
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | Subjects in this arm with receive treatment with CPAP for fatty liver disease. Receives: Device: CPAP |
| Lifestyle Intervention | Active comparator | Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling. Receives: Behavioral: LIfestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steatosis by MRS
Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMar 2019 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: Change in priorities, study closed prior to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kathleen E Corey, Massachusetts General Hospital
- Investigators
- Kathleen E Corey, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849081
- Sponsor's protocol ID
- 2013P000688
- Status last verified
- Oct 2020
- First submitted
- 6 May 2013
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT01849081
- Acronym / sponsor ID
- 2013P000688
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Non-alcoholic fatty liver disease, Obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in priorities, study closed prior to enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: CPAPSubjects in this arm with receive treatment with CPAP for fatty liver disease. |
| Lifestyle Intervention | Active comparator | Behavioral: LIfestyleSubjects in the lifestyle arm will undergo 12 weeks of dietary counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPSubjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night. | Device | CPAP |
| LIfestyleSubjects will undergo 12 weeks of dietary counseling. | Behavioural | Lifestyle Intervention |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen E Corey, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and LIfestyle in people with Non-alcoholic Fatty Liver Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steatosis by MRS (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.