Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT03225677

Conditions

Cirrhosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

blood draw and muscle biopsy

Study Details

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

Study ID

NCT03225677

Start date

Aug 3, 2017

Status verified date

Nov, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Cirrhosis

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

controls

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

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.

Primary outcome measure

  • Fractional Synthesis Rate [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Annette Bellar, MSLA

2164450688bellara@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Annette Bellar, MSLA

216-445-0688bellara@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Dec 1, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-12-01.