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临床试验/NCT00969644
NCT00969644Unknown不适用

The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
12
试验地点
1
主要终点
The relationship between changes in serum levels of Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and YKL-40 vs. changes in serum levels og IGF-I

研究概览

简要总结

Observations in patients with growth hormone (GH)-disturbances have suggested that GH/IGF-I might have anti-inflammatory effects. To elucidate this hypothesis the investigators have planned a study to investigate if 3 weeks administration of GH and subsequently the GH antagonist Pegvisomant (or vice versa) influence serum levels of different inflammatory markers in healthy volunteers.

详细描述

To investigate if administration of 3 weeks og GH (10-30 microgram/kg/day) and subsequent Pegvisomant (10-15 mg/day) influence serum concentrations of the inflammatory variables Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and the newly discovered acute phase protein YKL-40. The study involves 12 healthy volunteers age from 22-65 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
22 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy, normal blood tests

排除标准

  • Previous cancer

研究组 & 干预措施

GH

Active Comparator

干预措施: Somatropin (Drug)

Pegvisomant

Active Comparator

干预措施: Pegvisomant (Drug)

结局指标

主要结局

The relationship between changes in serum levels of Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and YKL-40 vs. changes in serum levels og IGF-I

时间窗: 1/9 2009 - 1/3 2010

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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