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Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Enrolling

Conditions

Cirrhosis

Treatments

Procedure: blood draw and muscle biopsy

Study type

Observational

Funder types

Other

Identifiers

NCT03225677
14-1476

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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)

Trial design

20 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Annette Bellar, MSLA

Data sourced from clinicaltrials.gov

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