Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis

Multiple Tracer Using Single Muscle Biopsy Technique in Evaluating Protein Synthesis and Break Down in Muscles of Cirrhotic Patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03225677

Enrollment

Registered

2017-07-21

Start date

2017-08-03

Completion date

2027-09-30

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Brief summary

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

PROCEDUREblood 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.

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Fractional Synthesis Rate	4 hours	Fractional synthesis rate (FSR)for each patient is measured by the rate of tracer incorporation from the MIF pool to the bound pool.

Countries

United States

Contacts

Primary ContactAnnette Bellar, MSLA

bellara@ccf.org2164450688

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026