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临床试验/NCT03420144
NCT03420144已完成2 期

Growth Hormone Therapy and Its Effect on Nitrogen Metabolism and Malnutrition in Liver Cirrhosis

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年1月15日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
Improvement in Nutritional status based on CT L3 SMI score.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Decompensated Cirrhosis of liver irrespective of etiology

排除标准

  • Acute on chronic liver failure (fulfilling either APASL or CANONIC criteria of ACLF)
  • Splenic diameter of more than 18 cm
  • Concomitant HCC or other active malignancy
  • Upper gastrointestinal bleeding in the previous 7 days
  • Portal vein thrombosis
  • Severe renal dysfunction as defined by creatnine > 1.5mg/dl
  • Severe cardiac dysfunction
  • Uncontrolled diabetes (Hb A 1c ≥ 9) or diabetic retinopathy
  • Acute infection or disseminate intravascular coagulation
  • Active alcohol abuse in last 3 months
  • Known hypersensitivity to GH
  • HIV co-infection
  • Pregnancy
  • Refusal to give informed consent

研究组 & 干预措施

Standard Medical Therapy

Active Comparator

Standard medical therapy: diuretics, lactulose, rifaximin, diuretics, albumin infusion, nutritional support (as required)

干预措施: Standard Medical Therapy (Drug)

Growth hormone

Active Comparator

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.

干预措施: Standard Medical Therapy (Drug)

Growth hormone

Active Comparator

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.

干预措施: Growth Hormone (Drug)

结局指标

主要结局

Improvement in Nutritional status based on CT L3 SMI score.

时间窗: One year

Nutritional status will be assesses by skeletal muscle index measurement using CT scan measurements at L3 level

次要结局

  • Improvement in BMI(One Year)
  • Improvement in Mid arm muscle circumference(MAMC)(One year)
  • Improvement in liver regeneration(One Year)
  • Clinical improvement in liver function(One Year)
  • Improvement in hand grip strength(One year)
  • Biochemical improvement in liver function(One year)
  • Improvement in Quality of life(One Year)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.Virendra Singh

Professor of Hepatology

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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