Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03420144
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2018-01-11
Brief Title:
Growth Hormone Therapy in Liver Cirrhosis
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Growth Hormone Therapy and Its Effect on Nitrogen Metabolism and Malnutrition in Liver Cirrhosis
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 prognosisThe 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None