Evaluating muscle protein metabolism in patients with cirrhosis
Multiple Tracer Using Single Muscle Biopsy Technique in Evaluating Protein Synthesis and Break Down in Muscles of Cirrhotic Patients
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 type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT03225677 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with cirrhosis who have a Child Pugh score ranging from A5 to B7.
Not a fit: Patients with conditions such as diabetes, cancer, kidney failure, or advanced cardiac or pulmonary disease may not benefit from this study.
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 performed: While this approach is innovative, similar studies have not been widely reported, indicating a novel exploration in this area.
Eligibility criteria
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 this trial is running
Cleveland, Ohio
- 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
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.