Recruiting

Ethanol

Sponsor:

The Cleveland Clinic

Code:

NCT03209791

Conditions

Alcoholic Liver Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Biopsies

Study Details

Brief summary:

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

Conditions

Alcoholic Liver Disease

Study ID

NCT03209791

Start date

May 18, 2015

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Alcoholic Steatosis

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

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

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

controls

This group will consist of 10 patients who are healthy and have no liver disease diagnosis and muscle biopsies will be performed

Interventions

Biopsies

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

Primary outcome measure

  • Skeletal Muscle Autophagy [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Revathi Penumatsa, MPH

2164450688penumar@ccf.org

Annette Bellar, MSLA

2166365247bellara@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Revathi Penumatsa

216-445-0688penumar@ccf.org

Annette Bellar

2166365247bellara@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-01-09.