Ethanol Induces Skeletal Muscle Autophagy

NCT03209791 | Recruiting

• 1 other identifier: 14-1287
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcoholic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Skeletal Muscle Autophagy

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

  4 hours

Study Arms (4)

Alcoholic Steatosis

This group will have 10 patients with alcoholic steatosis which is milder disease and muscle biopsies will be performed

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

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

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

Other: Biopsies

Interventions

Biopsies OTHER

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

Alcoholic Steatosis; Cirrhosis; Steatohepatitis; controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Srinivasan Dasarathy, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Revathi Penumatsa, MPH

CONTACT

2164450688; penumar@ccf.org

Annette Bellar, MSLA

CONTACT

2166365247; bellara@ccf.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: July 6, 2017
• Study Start: May 18, 2015
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)