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Ethanol Induces Skeletal Muscle Autophagy

Mechanisms of Skeletal Muscle Proteolysis With Ethanol Consumption: an Integrated Molecular Metabolic Approach

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03209791
Enrollment
40
Registered
2017-07-06
Start date
2015-05-18
Completion date
2027-12-31
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Liver Disease

Brief summary

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.

Interventions

OTHERBiopsies

Biopsy will be done on the Vastus Lateralis muscle in all groups

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Skeletal Muscle Autophagy4 hoursWe will measure Malonyldialdehyde Acetaldehyde protein adducts to see skeletal muscle proteolysis during a one time muscle biopsy

Countries

United States

Contacts

Primary ContactRevathi Penumatsa, MPH
penumar@ccf.org2164450688
Backup ContactAnnette Bellar, MSLA
bellara@ccf.org2166365247

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026