Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis

NCT03225677 | Recruiting

• 1 other identifier: 14-1476
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients with Cirrhosis

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

Procedure: blood draw and muscle biopsy

controls

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

Procedure: blood draw and muscle biopsy

Interventions

blood draw and muscle biopsy 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.

Patients with Cirrhosis; controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population: Adults with the diagnosis of cirrhosis will be recruited from the hepatology inpatient service, outpatient clinics and liver transplant clinics at the Cleveland Clinic Foundation. The diagnosis of cirrhosis will be based on liver biopsy and/or clinical, biochemical, and imaging criteria. Will include patient with Child Pugh score from A5- to B7

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Srinivasan Dasarathy, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annette Bellar, MSLA

CONTACT

2164450688; bellara@ccf.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: July 21, 2017
• Study Start: August 3, 2017
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)