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Recruiting NCT03209791

Ethanol Induces Skeletal Muscle Autophagy

— Observational Alcoholic Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsies.
Who it may be relevant to
Registry conditions: Alcoholic Liver Disease. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Skeletal Muscle Autophagy [Time frame: 4 hours]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT03209791 · 14-1287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗