Using leucine to reverse muscle loss in cirrhosis
Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis
This study is testing if a special mixture of amino acids, including leucine, can help people with cirrhosis regain lost muscle and improve their strength.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT03208868 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are cirrhotic patients with a Child's Pugh score of 5-9 who have abstained from alcohol and recreational drugs for at least six months.
Not a fit: Patients with a Child's score greater than 9, concurrent serious illnesses, or those on medications affecting muscle mass may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve muscle mass and overall health in patients with cirrhosis.
How similar studies have performed: While the approach is based on preliminary studies, there is limited evidence from similar studies, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.