Understanding Muscle Changes in Cirrhosis

This observational study aims to understand how muscle protein (the building blocks of muscle) is made and broken down in people with cirrhosis (severe liver scarring). Researchers will use special tracer methods, involving blood draws and a single muscle biopsy (a small tissue sample), to measure these processes. The goal is to find out why people with cirrhosis often lose muscle. You might be able to join if you have cirrhosis with a Child-Pugh score of A5-B7, or if you are a healthy control with normal liver enzyme levels. You cannot participate if you have diabetes, cancer, kidney failure, are pregnant, or recently had surgery. The study will measure how quickly muscle protein is made over 4 hours.

Study design
This is an observational study with a planned enrollment of 20 participants. It includes both people with cirrhosis and healthy volunteers.
What's involved
You will have two venous catheters inserted for blood draws and injections. Following these, you will have a single muscle biopsy taken from your thigh.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement for the study is taken at 4 hours.

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NCT03225677

Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis

Recruiting
Not specifiedAges 18+Observational
The Cleveland Clinic
~20 participants
Updated 2025-12-01 on ClinicalTrials.gov
What's tested:blood draw and muscle biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fractional Synthesis Rate
Measured over 4 hours
Cirrhosis
1 sites across 1 states
Ohio1
  • Srinivasan Dasarathy, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

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Eligibility criteria

Inclusion

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

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)
  • Fractional Synthesis Rate4 hours

    Fractional synthesis rate (FSR)for each patient is measured by the rate of tracer incorporation from the MIF pool to the bound pool.