Using leucine to reverse muscle loss in cirrhosis

Is this trial a fit for you?

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

What this trial studies

This study investigates the use of a leucine enriched essential amino acid mixture to combat sarcopenia, a common complication in patients with cirrhosis. The researchers hypothesize that leucine can stimulate mTOR signaling, which may enhance protein synthesis and reduce muscle loss. By administering this amino acid mixture, the study aims to quantify changes in skeletal muscle mass in cirrhotic patients. The approach is based on preliminary findings suggesting that impaired mTOR signaling contributes to muscle loss in these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Cirrhotic patients:
* Cirrhosis diagnosed by liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis.
* Abstinence from alcohol and/or other recreational drugs for at least 6 months
* Child's Pugh score 5-9 (inclusive).

Exclusion

* Cirrhotic patients:
* Child's score \>9
* Pedal edema above the ankle
* Presence of concurrent illnesses (renal, cardiac, pulmonary, cerebrovascular, malignancy) or medication (anabolic steroids, corticosteroids) intake that affect skeletal muscle mass.
* Diabetes mellitus
* Active gastrointestinal bleeding
* Sepsis, encephalopathy
* Renal failure
* Hepatocellular carcinoma outside of Milan criteria
* Unwilling to sign informed consent or follow research procedures
* Does not meet inclusion criteria

Where it's running

• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

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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.