Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis

Recruiting

• Conditions: Cirrhosis
• Interventions: Procedure: blood draw and muscle biopsy

• Registration Number: NCT03225677
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Study Start: 2017-08-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
controls	blood draw and muscle biopsy	control group should have serum ALT and AST within normal range and a blood draw and muscle biopsy will be performed
Patients with Cirrhosis	blood draw and muscle biopsy	Patients with a diagnosis of cirrhosis will have a blood draw and muscle biopsy will be performed.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States