Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine
研究概览
简要总结
The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1 (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors differently.
详细描述
Insulin-like growth factor-1 (IGF-1) in some circumstances acts as the mediator of the metabolic effects of growth hormone. However, there is some evidence to suggest that growth hormone (GH) and IGF-1 act differently in some metabolic pathways. We will study the differences between GH and IGF-1 when provided as therapy for growth hormone deficiency in adults. Specifically we will be assessing if either medication impacts cardiovascular risk factors and if so do they impact risk factors differently. Ten adult males ages 18-65 who are growth hormone deficient on stable medications and with stable magnetic resonance imaging (MRI) findings (in the event of a known pituitary mass) will be recruited for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male age 25-65 with documented growth hormone deficiency on stable doses x 3 months (at least) of any hormone replacement therapies and with stable MRIs x 2 years in the setting of a known pituitary mass.
排除标准
- •Female gender
- •current GH use or GH use within three months of the study
- •hypoglycemia
- •liver or kidney disease
- •use of drugs that could increase GH secretion (i.e. L-dopa)
- •alcohol or substance abuse
- •use of investigational drugs within four weeks of our study and use of supraphysiologic doses of steroids within the previous six months.
研究组 & 干预措施
Recombinant Human Growth Hormone first
Subjects will take rhGH for eight weeks followed by a two month wash out period and then will cross over to rhIGF1 for eight weeks.
干预措施: Recombinant Human Growth Hormone (Drug)
Recombinant Human Growth Hormone first
Subjects will take rhGH for eight weeks followed by a two month wash out period and then will cross over to rhIGF1 for eight weeks.
干预措施: Recombinant Human IGF-1 (Drug)
Recombinant Human IGF-1
Subjects will take rhIGF1 for eight weeks followed by a two month wash out period and then will cross over to rhGH for eight weeks.
干预措施: Recombinant Human Growth Hormone (Drug)
Recombinant Human IGF-1
Subjects will take rhIGF1 for eight weeks followed by a two month wash out period and then will cross over to rhGH for eight weeks.
干预措施: Recombinant Human IGF-1 (Drug)
结局指标
主要结局
Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine
时间窗: 2 months
次要结局
- Changes in Endothelial Cell Function(2 months)
- Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids(2 months)
研究者
Pamela U. Freda
Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Endocrinology
Columbia University