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NCT Number: NCT03225677

Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis

To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in cirrhotic patients by using multiple tracers and single muscle biopsies.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Annette Bellar, MSLA

CONTACT

[email protected]

216-445-0688

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Fractional Synthesis Rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annette Bellar, MSLA

CONTACT

[email protected]

2164450688

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2017
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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