Ethanol's effect on muscle autophagy in alcoholic liver disease
Official title: Mechanisms of Skeletal Muscle Proteolysis With Ethanol Consumption: an Integrated Molecular Metabolic Approach
Run by The Cleveland Clinic · NCT03209791 · Data updated 2026-11-12
This study is testing how alcohol affects muscle health in people with alcoholic liver disease by looking at how it breaks down certain proteins in their muscles.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | May 18, 2015 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT03209791 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-65 with diagnosed alcoholic liver disease or healthy controls with normal liver function.
✕Probably not a fit
Patients with poorly controlled diabetes, significant renal or cardiac disease, or those on medications affecting muscle metabolism may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to demonstrate how ethanol induces skeletal muscle autophagy, specifically targeting the degradation of MAA adducts formed by ethanol-mediated modifications of skeletal muscle proteins. Patients with alcoholic liver disease, including those with alcoholic steatosis, hepatitis, and cirrhosis, will be recruited from the liver transplant nutrition clinic and hepatology inpatient service. Their body composition will be assessed using various methods, including anthropometry and bioelectrical impedance analysis. Control subjects with normal clinical histories will also be recruited to compare findings.
Why it matters
Potential benefit: If successful, this study could provide insights into the mechanisms of muscle degradation in patients with alcoholic liver disease, potentially leading to improved treatment strategies.
How similar studies have gone: While the specific approach of this study is novel, similar studies have explored the effects of ethanol on muscle metabolism, indicating potential pathways for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 * 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.
Where it's running
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Cleveland Clinic
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Srinivasan Dasarathy, MD — The Cleveland Clinic
- Study coordinator: Revathi Penumatsa, MPH
- Email: penumar@ccf.org
- Phone: 2164450688
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.