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Ethanol Induces Skeletal Muscle Autophagy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209791
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Srinivasan Dasarathy, The Cleveland Clinic

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

Condition or disease Intervention/treatment
Alcoholic Liver Disease Other: Biopsies

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Mechanisms of Skeletal Muscle Proteolysis With Ethanol Consumption: an Integrated Molecular Metabolic Approach
Actual Study Start Date : May 18, 2015
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Alcoholic Steatosis
This group will have 10 patients with alcoholic steatosis which is milder disease and muscle biopsies will be performed
Other: Biopsies
Biopsy will be done on the Vastus Lateralis muscle in all groups

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

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

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




Primary Outcome Measures :
  1. Skeletal Muscle Autophagy [ Time Frame: 4 hours ]
    We will measure Malonyldialdehyde Acetaldehyde protein adducts to see skeletal muscle proteolysis during a one time muscle biopsy



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209791


Contacts
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Contact: Revathi Penumatsa, MPH 2164450688 penumar@ccf.org
Contact: Annette Bellar, MSLA 2166365247 bellara@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Revathi Penumatsa    216-445-0688    penumar@ccf.org   
Contact: Annette Bellar    2166365247    bellara@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Srinivasan Dasarathy, MD The Cleveland Clinic
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Responsible Party: Srinivasan Dasarathy, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03209791    
Other Study ID Numbers: 14-1287
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Liver Diseases, Alcoholic
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders