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Search / Trial NCT03209791

Ethanol Induces Skeletal Muscle Autophagy

Launched by THE CLEVELAND CLINIC · Jul 3, 2017

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how ethanol, the type of alcohol found in drinks, affects skeletal muscle in people with alcoholic liver disease. The researchers want to see if drinking alcohol can help the body break down certain harmful substances in the muscles. They believe that this process, called autophagy, might help improve muscle health in these patients.

To participate in the trial, you need to be between 18 and 65 years old and have been diagnosed with alcoholic liver disease. Healthy volunteers are also welcome if they have normal liver function. However, certain health conditions may exclude you from participating, such as uncontrolled diabetes, kidney disease, or specific medication use that affects muscle metabolism. If you join, you will undergo assessments to track how your body responds to the study's focus on muscle health. This trial is currently recruiting participants, and it aims to provide valuable insights into the connection between alcohol and muscle health in individuals with liver disease.

Gender

ALL

Eligibility criteria

  • 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.

About The Cleveland Clinic

The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Srinivasan Dasarathy, MD

Principal Investigator

The Cleveland Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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