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临床试验/NCT02726542
NCT02726542已完成早期 1 期

Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年5月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Change in Hepatic Fat Fraction

研究概览

简要总结

Fatty liver disease is an increasing problem in overweight and obese young adults. The purpose of this study is to test the effect of growth hormone on liver fat in obese young adults ages 18-29y with increased liver fat.

详细描述

Non-alcoholic fatty liver disease (NAFLD) is a significant health problem in obese adolescents. Obese children and adolescents have significant reductions in growth hormone secretion, and we hypothesize that augmenting growth hormone in this population will decrease liver fat. Growth hormone inhibits hepatic de novo lipogenesis, which is an important source of hepatic lipid. Patients with pituitary GH deficiency have a higher prevalence of NAFLD and non-alcoholic steatohepatitis (NASH) than the general population, and replacement of GH in these individuals reduces signs of liver damage. The purpose of this study is to test the hypothesis that growth hormone treatment will decrease liver fat quantity in young adults who begin the trial with more than 5% liver fat measured by magnetic resonance spectroscopy.

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
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Growth hormone

Experimental

Somatropin given by daily subcutaneous injection. Dose will begin at 1mg and be titrated based on insulin-like growth factor 1 (IGF-1) levels.

干预措施: somatropin (Drug)

结局指标

主要结局

Change in Hepatic Fat Fraction

时间窗: 24 weeks

change in hepatic fat fraction between baseline and 24 weeks as measured by hydrogen magnetic resonance spectroscopy

次要结局

  • Change in Aspartate Aminotransferase (AST)(24 weeks)
  • Change in Visceral Adipose Tissue(24 weeks)
  • Change in Alanine Aminotransferase (ALT)(24 weeks)
  • Change in Gamma Glutamyl Transferase (GGT)(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Takara Stanley

Assistant Professor of Pediatrics

Massachusetts General Hospital

研究点 (1)

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