Growth Hormone Therapy in Liver Cirrhosis
Condition: Cirrhosis, Liver
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    


Intervention name(s): Standard Medical Therapy; Growth Hormone
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Growth hormone; cirrhosis