Sarcopenia Clinical Trial
Official title:
Impact of Repurposed Growth Hormone Treatment on Clinical, Nutritional, Immunological and Regenerative Parameters in Decompensated Liver Cirrhosis: a Randomized Control Trial
Globally, cirrhosis and liver cancer carries a huge burden and accounts for about 3.5% (2 million) of all deaths every year. Once decompensated, i.e. development of ascites, variceal bleed, encephalopathy, and jaundice, the life expectancy is markedly reduced to a median of two years. The definitive treatment in this stage, i.e., liver transplantation is limited by cost, lack of donors, and life-long immunosuppression. In addition to complications due to portal hypertension and hepatic insufficiency, decompensated cirrhosis is associated with malnutrition, sarcopenia, immune dysfunction, and impaired regeneration. Patients with cirrhosis are growth hormone (GH) resistant, with reduced insulin-like growth factor, which are linked to malnutrition and poor liver regeneration in cirrhosis. Diverse preclinical and clinical investigations in vitro and in vivo, have shown a benefit of GH in GH deficient, elderly and HIV positive patients. GH therapy in cirrhosis has been shown to improve nitrogen economy and to improve the GH resistance in a small pilot study by Donaghy et al. Also, GH therapy of short duration has shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis. GH therapy has also been shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis. However, there is a scarcity of data on clinical impact of long term administration of GH therapy in patients of cirrhosis. Hence, we undertook the present study to study the effect of growth hormone on clinical outcomes, malnutrition, immune cells and liver regeneration in patients with cirrhosis.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | January 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age above 18 years. 2. Patients having confirmed diagnosis of decompensated cirrhosis, any etiology. 3. Patients having given an informed and written consent for participation in the study. Exclusion Criteria: 1. Acute on chronic liver failure. 2. Diagnosis of concomitant hepatocellular carcinoma or other active malignancy. 3. Severe cardiac dysfunction NYHA grade III/IV, Chronic obstructive pulmonary disease GOLD C or above. 4. Active alcohol abuse in last 3 months. 5. Known hypersensitivity to GH. 6. Human immunodeficiency virus seropositivity. 7. Patients on antiviral therapy for HCV, HBV or corticosteroid for autoimmune hepatitis those who have received it within the last 6 months. 8. TIPS insertion within 6 months prior to study inclusion. 9. Pregnancy & lactation. 10. Uncontrolled diabetes (Hb A1c = 9) or diabetic retinopathy. 11. Active sepsis. |
Country | Name | City | State |
---|---|---|---|
India | Postgraduate Institute of Medical education and Research | Chandigarh | UT |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complication free survival | Complications of cirrhosis - Ascites, Hepatic encephalopathy, Gastrointestinal bleeding, Bacterial infections, Acute kidney injury | 12 Month | |
Primary | Transplant free survival | Transplant free survival where event is transplant or death | 12 Month | |
Primary | Incidence of complications of cirrhosis and infections | Complications of cirrhosis - Ascites, Hepatic encephalopathy, Gastrointestinal bleeding, Bacterial infections, Acute kidney injury | 12 Month | |
Primary | Change in disease severity scores (CTP score) | The Child-Turcotte-Pugh (CTP) score is used to assess the prognosis of patients with cirrhosis. The Pugh-Child score is determined by scoring five clinical measures of liver disease (Encephalopathy, Ascites, Albumin, Bilirubin and INR). A score of 1, 2, or 3 is given to each measure, with 3 being the most severe. | 12 Month | |
Primary | Change in disease severity scores (MELD Na) | The MELD/Na score is a scoring system for accessing the severity of chronic liver disease using values as serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time and sodium, to predict survival. | 12 Month | |
Primary | Treatment related adverse events | Any adverse events related to growth hormone | 12 Month | |
Secondary | Assessment of sarcopenia | Sarcopenia will be assessed by calculation of Skeletal muscle index by taking cross sectional area of the psoas muscle at the level of the third lumbar vertebra on abdomen CT scans. | 12 Month | |
Secondary | Change in liver frailty index | LFI (Liver frailty index) will be calculated by FrAILT software© | 12 Month | |
Secondary | Change in nitrogen balance | Nitrogen balance will be calculated by using formula - Nitrogen intake - nitrogen output | 12 Month | |
Secondary | Change in myostatin levels | Myostatin in the serum will be measured in serum | 12 Month | |
Secondary | Change in Functional capacity of monocytes | Phagocytic capacity of monocytes will be assessed using flow cytometry | 12 Month | |
Secondary | Change in Functional capacity of Neutrophils | Phagocytic capacity of neutrophils will be assessed using flow cytometry | 12 Month | |
Secondary | Change in cytokine levels | Pro-inflammatory and anti-inflammatory cytokines will be assessed in serum using Multiplex ELISA. | 12 Month | |
Secondary | Immunophenotyping of T cells | Immunophenotyping of T cells will be performed using flow-cytometry. | 12 Month | |
Secondary | Immunophenotyping of B cells | Immunophenotyping of B cells will be performed using flow-cytometry. | 12 Month | |
Secondary | Immunophenotyping of NK cells | Immunophenotyping of NK will be performed using flow-cytometry. | 12 Month | |
Secondary | Immunophenotyping of monocytes | Immunophenotyping of monocytes will be performed using flow-cytometry. | 12 Month | |
Secondary | Immunophenotyping of neutrophils | Immunophenotyping of neutrophils will be performed using flow-cytometry. | 12 Month | |
Secondary | Change in cell death markers | Markers of cell death - M30 & M65 will be assessed in serum using ELISA | 12 Month | |
Secondary | Change in surrogate markers for hepatic regeneration | surrogate markers for hepatic regeneration- Hepatocytes growth factor will be assessed in serum using ELISA. | 12 Month |
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