Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis
ConditionCirrhosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in cirrhotic patients by using multiple tracers and single muscle biopsies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
diabetes
cancer
kidney failure
pregnancy
Trial population
Study population: Adults with the diagnosis of cirrhosis will be recruited from the hepatology inpatient service, outpatient clinics and liver transplant clinics at the Cleveland Clinic Foundation. The diagnosis of cirrhosis will be based on liver biopsy and/or clinical, biochemical, and imaging criteria. Will include patient with Child Pugh score from A5- to B7
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
blood draw and muscle biopsy
Procedure/SurgeryOne 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Patients with Cirrhosis1 intervention
Group B: controls1 intervention
Trial outcomes
Primary outcomes
1
Fractional Synthesis Rate
Fractional synthesis rate (FSR)for each patient is measured by the rate of tracer incorporation from the MIF pool to the bound pool.
Time frame
4 hoursSponsors and contacts
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Source ClinicalTrials.gov