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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03209791
Other study ID # 14-1287
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 18, 2015
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source The Cleveland Clinic
Contact Revathi Penumatsa, MPH
Phone 2164450688
Email penumar@ccf.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skeletal Muscle Autophagy We will measure Malonyldialdehyde Acetaldehyde protein adducts to see skeletal muscle proteolysis during a one time muscle biopsy 4 hours
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