HMB Enriched Amino Acids to Reverse Muscle Loss in Cirrhosis
Loss of skeletal muscle mass or sarcopenia is the most common and potentially reversible complication in cirrhosis that increases morbidity and mortality before, during and after liver transplantation. No proven treatments exist for the prevention or reversal of sarcopenia in cirrhosis, primarily because the mechanisms
| Condition(s) | Cirrhosis, Liver |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Loss of skeletal muscle mass or sarcopenia is the most common and potentially reversible complication in cirrhosis that increases morbidity and mortality before, during and after liver transplantation. No proven treatments exist for the prevention or reversal of sarcopenia in cirrhosis, primarily because the mechanisms responsible for this are unknown. Based on compelling preliminary studies and those of the co investigator, investigators hypothesize that the mechanism of reduced skeletal muscle mass in cirrhosis is due to a myostatin mediated impaired mTOR (mechanistic target of rapamycin) signaling resulting in reduced protein synthesis and increased autophagy. Investigators further postulate that leucine, a direct stimulant of mTOR, will reverse the impaired mTOR phosphorylation in the |
| Who can participate | Inclusion Criteria: * Diagnosis of cirrhosis of the liver * Child-Pugh score of 5-8 Exclusion Criteria: * Recent gastrointestinal bleeding (\<3m) * Active infection * Overt encephalopathy * Renal failure on dialysis * Pedal edema * Uncontrolled diabetes (HbA1C \> 7.9mg/dL) * Advanced cardiac, lung, kidney disease * Metastatic cancer * Medications that alter muscle protein metabolism * Pregnancy * Recent bowel resection or gastric bypass surgery, * INR \>1.7, platelets \<60,000/ml, serum creatinine \>2mg/dL * Medications that interfere with blood clotting |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Lead sponsor | The Cleveland Clinic |
| Locations | Cleveland, Ohio, United States |
| Start date | 2021-11-30 |
| NCT ID | NCT05166499 |
| Official listing | https://clinicaltrials.gov/study/NCT05166499 |