Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6 Months.
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United States. A subset of these will develop progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy (1H-MRS).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 - 65 yr
- •NAFLD defined as demonstration of hepatic steatosis by imaging or biopsy in absence of significant alcohol consumption and other causes of hepatic steatosis. If liver imaging or biopsy has not been performed clinically, liver ultrasound will be performed as part of the screening visit.
排除标准
- •Serum creatinine > 2 times the upper limit of normal
- •History of cancer, except for non-melanoma skin cancers
- •Active carpel tunnel syndrome
- •Diabetes mellitus, defined as a hemoglobin A1C >6.5 or use of any medications prescribed to treat hyperglycemia. The exception is that the use of metformin is acceptable in patients whose HbA1c has been =<6.0 on two visits and whose weight has remained stable for six months.
- •Contraindications to magnetic resonance imaging (MRI).
- •Pregnancy or desire to become pregnant. Participants of reproductive age must agree to use contraception.
- •Breastfeeding
- •Aspartate and aminotransferase levels >10x upper limit of normal
研究组 & 干预措施
Growth hormone
Growth hormone (somatropin) administered by daily injection at starting dose of 0.3 mg daily for women and 0.2 mg daily for men, with dose titration for goal IGF-1 in the upper quartile of normal for age.
干预措施: Growth hormone (Drug)
Placebo
Placebo will be administered by daily injection in this double blind study design. Sham dosing will be performed to maintain blinding.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6 Months.
时间窗: 6 months
Change in Intrahepatic lipid content by 1H-MRS over 6 months in the GH vs placebo group
次要结局
- Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months.(6 months)
研究者
Karen Klahr Miller, MD
Neuroendocrine Unit Chief
Massachusetts General Hospital