Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating muscle protein metabolism in patients with cirrhosis

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

Run by The Cleveland Clinic · NCT03225677 · Data updated 2026-11-12

This study is testing how muscle protein is made and broken down in people with cirrhosis to better understand why they lose muscle.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorThe Cleveland Clinic
Academic / other
Locations1 site (Cleveland, Ohio)
StatusRecruiting
StartedAugust 3, 2017
Main results expectedSeptember 30, 2028
Study endsSeptember 30, 2028
Registry record updatedSeptember 24, 2026
Trial IDNCT03225677 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients diagnosed with cirrhosis who have a Child Pugh score ranging from A5 to B7.

Probably not a fit

Patients with conditions such as diabetes, cancer, kidney failure, or advanced cardiac or pulmonary disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the rates and mechanisms of skeletal muscle protein synthesis and breakdown in patients with cirrhosis. By utilizing multiple tracers administered at short intervals and performing a single muscle biopsy, the researchers seek to identify the molecular regulatory mechanisms responsible for muscle loss in these patients. This innovative approach is expected to advance our understanding of the cellular and molecular responses of skeletal muscle in the context of cirrhosis.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for managing muscle loss in cirrhotic patients.

How similar studies have gone: While this approach is innovative, similar studies have not been widely reported, indicating a novel exploration in this area.

Who can join: the full rules

Show full inclusion / 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)

Where it's running

  • Cleveland Clinic Foundation
    Cleveland, Ohio, United States
    Recruiting

Study contacts

  • Principal investigator: Srinivasan Dasarathy, MD — The Cleveland Clinic
  • Study coordinator: Annette Bellar, MSLA
  • Email: bellara@ccf.org
  • Phone: 2164450688

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.