Observational Study on Ethanol and Muscle Autophagy in Liver Disease

This study is looking into how alcohol (ethanol) affects your muscles, specifically if it causes a process called autophagy (where cells break down and recycle their own parts). Researchers believe that alcohol changes muscle proteins, which then triggers this autophagy. They are studying people aged 18 to 65 with alcoholic liver disease, including those with fatty liver (steatosis), hepatitis, or cirrhosis. They are also including healthy control volunteers. The main goal is to see if skeletal muscle autophagy increases after 4 hours. This study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 40 participants. It includes groups of patients with alcoholic liver disease and healthy controls.
What's involved
Participants will undergo a biopsy of the Vastus Lateralis muscle. Body composition will be measured using various methods.
Compensation
Not stated in the trial record.
Follow-up
Skeletal muscle autophagy will be measured at 4 hours after the intervention.

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NCT03209791

Ethanol Induces Skeletal Muscle Autophagy

Recruiting
Not specifiedAges 18–65Observational
The Cleveland Clinic
~40 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:Biopsies

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Skeletal Muscle Autophagy
Measured over 4 hours
Alcoholic Liver Disease
1 sites across 1 states
Ohio1
  • Srinivasan Dasarathy, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

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Eligibility criteria

Inclusion

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

Exclusion

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.
  • Skeletal Muscle Autophagy4 hours

    We will measure Malonyldialdehyde Acetaldehyde protein adducts to see skeletal muscle proteolysis during a one time muscle biopsy