Alcoholic Liver DiseaseNCT03209791
Ethanol Induces Skeletal Muscle Autophagy
An observational study of Alcoholic Liver Disease, run by The Cleveland Clinic at 1 site in United States.
Trial summary
In this study we plan to demonstrate that ethanol induces skeletal muscle autophagy to degrade MAA adducts. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholic Liver Disease
- What is being tested?
- Biopsies
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2015to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Histologically characterized patients with alcoholic steatosis, hepatitis and cirrhosis (n=10 each) will be recruited from the liver transplant nutrition clinic or the hepatology inpatient service and their body composition quantified using protocols already established by the PI.
Who may be able to join
- Alcoholic liver disease:
- clinical, biochemical, imaging criteria and liver biopsy where available
- Age 18 - 65 years old
- Controls:
- Serum liver transaminases (i.e. ALT and AST) 40 IU/L
- Normal liver ultrasound
- Age 18 - 65 years old
Who cannot join
- For both groups - alcoholic liver disease and controls:
- Poorly controlled diabetes mellitus (HbA1C>9.5 g/dl)
- Untreated Hyper- / hypo- thyroidism
- Patients on dialysis, renal disease with serum creatinine 1.5 mg/dL
- Active intravenous drug use
- History of bowel surgery or gastric bypass surgery
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- Medications known to alter muscle protein metabolism (i.e. corticosteroids, tamoxifen, high-dose estrogen, testosterone or anabolic steroids)
- Metastatic disease, Advanced cardiac or pulmonary disease
- Pregnancy
- Coagulopathy- INR >1.4 and platelet count <80,000/ml.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Revathi Penumatsa, 216-445-0688, penumar@ccf.org
Annette Bellar, 2166365247, bellara@ccf.org
About this study
Official title: Mechanisms of Skeletal Muscle Proteolysis With Ethanol Consumption: an Integrated Molecular Metabolic Approach
In this study we plan to demonstrate that ethanol induces skeletal muscle autophagy to degrade MAA adducts.
Read the detailed description
Hypothesis: Ethanol mediated modification of skeletal muscle proteins to form MAA adducts that in turn induce skeletal muscle autophagy.
Patients with alcoholic steatosis, hepatitis and cirrhosis (n=10 each) will be recruited from the liver transplant nutrition clinic or the hepatology inpatient service and their body composition quantified using anthropometry, bioelectrical impedance analysis, CT image analysis and DEXA if available.
Control Subjects. Controls will be recruited by advertisement. All control subjects will have a normal clinical history, physical examination, and screening chemistries. They will not have any significant medical conditions requiring the use of medications. Their nutritional status within 20% of normal as defined by ideal body weight.
- Conditions
- Alcoholic Liver Disease
- Being tested
- Biopsies
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsiesOther
Biopsy will be done on the Vastus Lateralis muscle in all groups
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic Steatosis | This group will have 10 patients with alcoholic steatosis which is milder disease and muscle biopsies will be performed Receives: Other: Biopsies | |
| Cirrhosis | This group will consist of 10 patients with cirrhosis. We anticipate a 50% difference in these patients and the controls in the autophagy readouts and muscle biopsies will be performed Receives: Other: Biopsies | |
| Steatohepatitis | This group will have 10 patients with alcoholic steatohepatitis that have more severe necroinflammation in the liver but for a shorter duration of illness and muscle biopsies will be performed Receives: Other: Biopsies | |
| controls | This group will consist of 10 patients who are healthy and have no liver disease diagnosis and muscle biopsies will be performed Receives: Other: Biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Autophagy
We will measure Malonyldialdehyde Acetaldehyde protein adducts to see skeletal muscle proteolysis during a one time muscle biopsy
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start18 May 2015
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivasan Dasarathy, The Cleveland Clinic
- Investigators
- Srinivasan Dasarathy, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209791
- Sponsor's protocol ID
- 14-1287
- Status last verified
- Jan 2026
- First submitted
- 14 Apr 2017
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Skeletal Muscle Proteolysis With Ethanol Consumption: an Integrated Molecular Metabolic Approach
- ClinicalTrials.gov ID
- NCT03209791
- Acronym / sponsor ID
- 14-1287
- Conditions
- Alcoholic Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 18 May 2015 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jul 2017 (actual)
- 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.
In this study we plan to demonstrate that ethanol induces skeletal muscle autophagy to degrade MAA adducts.
Detailed description
Hypothesis: Ethanol mediated modification of skeletal muscle proteins to form MAA adducts that in turn induce skeletal muscle autophagy.
Patients with alcoholic steatosis, hepatitis and cirrhosis (n=10 each) will be recruited from the liver transplant nutrition clinic or the hepatology inpatient service and their body composition quantified using anthropometry, bioelectrical impedance analysis, CT image analysis and DEXA if available.
Control Subjects. Controls will be recruited by advertisement. All control subjects will have a normal clinical history, physical examination, and screening chemistries. They will not have any significant medical conditions requiring the use of medications. Their nutritional status within 20% of normal as defined by ideal body weight.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcoholic Steatosis | – | Other: BiopsiesThis group will have 10 patients with alcoholic steatosis which is milder disease and muscle biopsies will be performed |
| Cirrhosis | – | Other: BiopsiesThis group will consist of 10 patients with cirrhosis. We anticipate a 50% difference in these patients and the controls in the autophagy readouts and muscle biopsies will be performed |
| Steatohepatitis | – | Other: BiopsiesThis group will have 10 patients with alcoholic steatohepatitis that have more severe necroinflammation in the liver but for a shorter duration of illness and muscle biopsies will be performed |
| controls | – | Other: BiopsiesThis group will consist of 10 patients who are healthy and have no liver disease diagnosis and muscle biopsies will be performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically characterized patients with alcoholic steatosis, hepatitis and cirrhosis (n=10 each) will be recruited from the liver transplant nutrition clinic or the hepatology inpatient service and their body composition quantified using protocols already established by the PI.
Key inclusion criteria (7 listed)
- clinical, biochemical, imaging criteria and liver biopsy where available
- Age 18 - 65 years old
- Serum liver transaminases (i.e. ALT and AST) 40 IU/L
- Normal liver ultrasound
- Age 18 - 65 years old
Key exclusion criteria (10 listed)
- Poorly controlled diabetes mellitus (HbA1C>9.5 g/dl)
- Untreated Hyper- / hypo- thyroidism
- Patients on dialysis, renal disease with serum creatinine 1.5 mg/dL
- Active intravenous drug use
- History of bowel surgery or gastric bypass surgery
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 |
|---|---|---|
| BiopsiesBiopsy will be done on the Vastus Lateralis muscle in all groups | Other | Alcoholic Steatosis, Cirrhosis, Steatohepatitis, controls |
Primary outcome
Skeletal Muscle Autophagy
Time frame: 4 hours
We will measure Malonyldialdehyde Acetaldehyde protein adducts to see skeletal muscle proteolysis during a one time muscle biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Srinivasan Dasarathy, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Liver Disease, run by The Cleveland Clinic 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Revathi Penumatsa, MPH (2164450688, penumar@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Autophagy (time frame: 4 hours). 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 9 Jan 2026.