A Phase 2/3 interventional study of Standard Medical Therapy and Growth Hormone in Cirrhosis, Liver, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 2/3, Interventional, and Treatment
Liver cirrhosis (LC) is a leading cause of morbidity and mortality worldwide. Life- threatening complications of liver cirrhosis are ascites, gastrointestinal bleeding, variceal bleed, hepatic encephalopathy and hepatocellular carcinoma (HCC) which are associated with poor prognosis.The leading causes of liver cirrhosis include excess alcohol consumption, viral hepatitis and non-alcoholic fatty liver disease. Malnutrition is common in end-stage liver disease (cirrhosis) and is often associated with a poor prognosis. It occurs in all forms of cirrhosis with different etiology and prevalence ranges from 65 to 100% depending upon the methods used for nutritional assessment and the severity of liver disease. Nutritional state influences survival in patients with decompensated cirrhosis. Protein malnutrition manifested by reduced skeletal muscle mass and hypoalbuminemia, exist in patients with cirrhosis despite apparent adequate food consumption and these patients have a higher rate of complications and, overall, an increased mortality rate. Also, Malnutrition has significant implications for liver transplantation; patients with poor nutritional status before transplantation have increased complications and higher mortality rates postoperatively. Screening all patients with chronic liver disease for nutritional abnormalities can identify those at risk of developing preventable complications.
Malnutrition is commonly associated with protein catabolism and the protein catabolic state of cirrhosis is associated with severe growth hormone (GH) resistance, with low levels of insulin-like growth factor (IGF)-I and its major binding protein (IGFBP)-3.
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 shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis.
However there is 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 nitrogen economy, malnutrition and liver regeneration in patients with cirrhosis.
Exclusion Criteria:
Standard medical therapy: diuretics, lactulose, rifaximin, diuretics, albumin infusion, nutritional support (as required)
Drug: Standard Medical Therapy
Growth Hormone: GH therapy is initiated at a low dose of 1U/day and titrated slowly upward to a maximum dose of 3U/day (based on IGF-1 levels) subcutaneously for 1 year.
Drug: Standard Medical Therapy · Drug: Growth Hormone
Standard Medical Therapy will include nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics as required
GH therapy is initiated at a low dose of 1U/day and titrated slowly upward to a maximum dose of 3U/day (depending on IGF-1 levels) subcutaneously for 1 year.
Improvement in Nutritional status based on CT L3 SMI score.
Nutritional status will be assesses by skeletal muscle index measurement using CT scan measurements at L3 level
Time frame: One year
Improvement in BMI
Time frame: One Year
Improvement in Mid arm muscle circumference(MAMC)
Time frame: One year
Improvement in hand grip strength
Hand grip strength will be measured with the hydraulic hand dyanamometer in Kg/force.
Time frame: One year
Clinical improvement in liver function
Occurrence of decompensations namely ascites, hepatic encephalopathy and variceal bleed
Time frame: One Year
Biochemical improvement in liver function
Improvment in MELD score
Time frame: One year
Improvement in Quality of life
Quality of life will be assessed using SF-36V2 Health Survey questionnaire
Time frame: One Year
Improvement in liver regeneration
By measuring hepatic parenchymal cell specific marker (CD 133) and cell proliferation marker (Ki-67) by immunohistochemistry.
Time frame: One Year
Plan to share: No
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Post Graduate Institute of Medical Education and Research, Chandigarh