Growth Hormone Therapy in Liver Cirrhosis
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|ClinicalTrials.gov Identifier: NCT03420144|
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis, Liver||Drug: Standard Medical Therapy Drug: Growth Hormone||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Growth Hormone Therapy and Its Effect on Nitrogen Metabolism and Malnutrition in Liver Cirrhosis|
|Actual Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Standard Medical Therapy
Standard medical therapy: diuretics, lactulose, rifaximin, diuretics, albumin infusion, nutritional support (as required)
Drug: Standard Medical Therapy
Standard Medical Therapy will include nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics as required
Active Comparator: Growth hormone
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
Standard Medical Therapy will include nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics as requiredDrug: Growth Hormone
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. [ Time Frame: One year ]Nutritional status will be assesses by skeletal muscle index measurement using CT scan measurements at L3 level
- Improvement in BMI [ Time Frame: One Year ]
- Improvement in Mid arm muscle circumference(MAMC) [ Time Frame: One year ]
- Improvement in hand grip strength [ Time Frame: One year ]Hand grip strength will be measured with the hydraulic hand dyanamometer in Kg/force.
- Clinical improvement in liver function [ Time Frame: One Year ]Occurrence of decompensations namely ascites, hepatic encephalopathy and variceal bleed
- Biochemical improvement in liver function [ Time Frame: One year ]Improvment in MELD score
- Improvement in Quality of life [ Time Frame: One Year ]Quality of life will be assessed using SF-36V2 Health Survey questionnaire
- Improvement in liver regeneration [ Time Frame: One Year ]By measuring hepatic parenchymal cell specific marker (CD 133) and cell proliferation marker (Ki-67) by immunohistochemistry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420144
|Contact: Virendra Singh, DMemail@example.com|
|Contact: Sunita Kumari, M.Techfirstname.lastname@example.org|
|Post Graduate Institute of Medical Education and Research||Recruiting|
|Chandigarh, India, 160012|
|Contact: Virendra Singh, DM 7087009338 email@example.com|
|Contact: Sunita Kumari, M.Tech 9413601016 firstname.lastname@example.org|