Glucocorticoid Induced Inhibition of IGF-I Activity: Exploring Underlying Mechanisms.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment.
研究概览
简要总结
The main purpose of the trial is to advance our knowledge on the possible mechanism underlying the catabolic effects of long-term treatment with glucocorticoid.
详细描述
Long-term treatment with glucocorticoid induces a general state of catabolism and increases insulin resistance. The underlying mechanisms are insufficiently characterized, however glucocorticoid induced changes of Growth Hormone (GH) and the Insulin-like growth factor I (IGF-I) appear to be of outmost importance.
We wish to investigate the mechanism behind glucocorticoid induced catabolism and insulin resistance.
More specific we wish to investigate:
- Whether glucocorticoid induces IGF-I inhibiting substances in serum or interstitial fluid that block the ability of IGF-I to phosphorylate its receptor in vitro
- Whether glucocorticoid inhibits intracellular IGF-I and insulin signaling in vitro and in vivo
- The mechanisms by which growth hormone counteracts the CG-mediated inhibition of IGF-I action
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •signed and dated informed consent
- •healthy subjects
- •sex: male
- •age 20-30 years
- •BMI 19-26 kg/m2
- •normal HbA1c
排除标准
- •suspected og known allergy to the trial drug or similar medications.
- •known current illness including diabetes mellitus, ischemic heart disease or cardiac arrhythmia.
- •Daily drug intake (excluding Over-the-Counter medicines).
- •Known or previous mental illness
- •Current participation or previous participation in experiments using ionizing radiation for a year prior to inclusion in this study.
- •Participation in a larger X-ray examinations in trial period.
研究组 & 干预措施
Calcium supplement
Capsule with tablet of calclium supplement
干预措施: Calcium Supplement (Drug)
Glucocorticoids
Capsule with tablet of Prednisolone 37,5mg
干预措施: Glucocorticoids (Drug)
结局指标
主要结局
Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment.
时间窗: day 1, 3 and 5
Blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolone treatment.
次要结局
- Intracellular signaling of IGF-I under the influence/abscence of prednisolone.(day 5)
- Insulin sensitivity under the influence/abscence of prednisolone.(Day 5)