Ethanol Induces Skeletal Muscle Autophagy

Alcoholic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209791
• Other study ID #: 14-1287
• Status: Recruiting
• Start date: May 18, 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: The Cleveland Clinic
• Contact: Revathi Penumatsa, MPH
• Phone: 2164450688
• Email: penumar[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study we plan to demonstrate that ethanol induces skeletal muscle autophagy to degrade MAA adducts.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Other:
• Biopsies
Biopsy will be done on the Vastus Lateralis muscle in all groups

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal Muscle Autophagy	We will measure Malonyldialdehyde Acetaldehyde protein adducts to see skeletal muscle proteolysis during a one time muscle biopsy	4 hours