Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2015-05-18
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Alcoholic Steatosis
This group will have 10 patients with alcoholic steatosis which is milder disease and muscle biopsies will be performed
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
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
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
Biopsies
Biopsy will be done on the Vastus Lateralis muscle in all groups
Interventions
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Biopsies
Biopsy will be done on the Vastus Lateralis muscle in all groups
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Srinivasan Dasarathy
Staff Physician
Principal Investigators
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Srinivasan Dasarathy, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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14-1287
Identifier Type: -
Identifier Source: org_study_id
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