Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis
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: blood draw and muscle biopsy.
- Who it may be relevant to
- Registry conditions: Cirrhosis. Basic parameters: from 18 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 →
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Official title
Multiple Tracer Using Single Muscle Biopsy Technique in Evaluating Protein Synthesis and Break Down in Muscles of Cirrhotic Patients
Overview
To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in cirrhotic patients by using multiple tracers and single muscle biopsies.
Detailed description
The goal of this study is to identify the molecular regulatory mechanisms that result in loss of skeletal muscle in cirrhotic patients. Current strategies involve prolonged tracer infusion and multiple muscle biopsies. We will use an innovative approach to determine the rates of skeletal muscle protein synthesis and breakdown using multiple tracers administered at short intervals followed by a single muscle biopsy. These studies are likely to provide a conceptual advance in determining the cellular and molecular responses of the skeletal muscle in cirrhosis.
Interventions
- Procedure blood draw and muscle biopsy
One venous catheter will be used for bolus injection of multiple labeled AA at the beginning .The second venous catheter will inserted in the other arm for 5 ml of arterialized venous blood draw.Following the infusions, a single muscle biopsy will be performed from the vastus lateralis of the thigh using the Bergstromm needle.
Primary outcome measures
- Fractional Synthesis Rate [Time frame: 4 hours]
Eligibility criteria
Inclusion criteria
- The diagnosis of cirrhosis based on liver biopsy and/or clinical, biochemical, and imaging criteria.
- Patients with Child Pugh score from A5- to B7
- Control group: Subject in control group should have serum ALT and AST within normal range.
Exclusion Criteria for both groups (cirrhotic and control) are:
- diabetes
- cancer
- kidney failure
- pregnancy
- recent surgery (bowel resection or Gastric bypass operation)
- Advanced cardiac or pulmonary disease
- patient with thyroid disease \& 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.
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Cleveland Clinic Foundation — Cleveland
Identifiers
NCT: NCT03225677 · 14-1476