Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03225677
• Other study ID #: 14-1476
• Status: Recruiting
• Start date: July 3, 2017
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: The Cleveland Clinic
• Contact: Annette Bellar, MSLA
• Phone: 2164450688
• Email: bellara[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours