Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis

NCT ID: NCT03225677

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-03
• Study Completion Date: 2027-09-30

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.

Conditions

Cirrhosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Patients with Cirrhosis

Patients with a diagnosis of cirrhosis will have a blood draw and muscle biopsy will be performed.

blood draw and muscle biopsy

Intervention Type: PROCEDURE

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.

controls

control group should have serum ALT and AST within normal range and a blood draw and muscle biopsy will be performed

blood draw and muscle biopsy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Srinivasan Dasarathy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Srinivasan Dasarathy, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Annette Bellar, MSLA

Role: CONTACT

bellara@ccf.org

2164450688

Facility Contacts

Annette Bellar, MSLA

Role: primary

bellara@ccf.org

216-445-0688

Other Identifiers

14-1476

Identifier Type: -

Identifier Source: org_study_id