IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Fractional synthesis rate of collagen in tendon, muscle and skin
研究概览
简要总结
The investigators want to inject insulin-like growth factor-I (IGF-I) into the patella tendon of Ehlers-Danlos patients and healthy controls to evaluate the response in collagen synthesis. Furthermore collagen synthesis is measured in muscle connective tissue and in skin.
The hypothesis is that the connective tissue in Ehlers-Danlos patients is more compliant and poorer in collagen than healthy controls, but that collagen synthesis can be stimulated by IGF-I.
详细描述
IGF-I will be injected with ultrasound guidance to one patella tendon and the other one will be injected with saline as control. Injections will be performed double blinded and timed 24 hours and 6 hours before tissue sampling.
Collagen synthesis will be measured as fractional synthesis rate based on stabile isotope technique using labelled proline.
10 patients diagnosed with Classical form of Ehlers-Danlos syndrome will be included and matched with 10 healthy controls based on age, gender, BMI and activity level.
The muscle biopsy will be taken from vastus lateralis muscle and the skin biopsy from the buttocks. The biopsies will if the size permits it also be used for histology and mRNA analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Classic form of Ehlers-Danlos syndrome OR healthy matched control
排除标准
- •Malignity, cardiac diseases, diabetes, tendinopathy in patella tendons
研究组 & 干预措施
Saline + healthy control
干预措施: Saline (Drug)
mecasermin + Ehlers-Danlos
干预措施: mecasermin (Drug)
Saline + Ehlers-Danlos
干预措施: Saline (Drug)
Mecasamin + healthy control
干预措施: mecasermin (Drug)
结局指标
主要结局
Fractional synthesis rate of collagen in tendon, muscle and skin
时间窗: 6 hours
A flood primed infusion of proline labelled with a stable isotope is used to calculate fractional synthesis rate of collagen in the 3 types of tissues. The infusion continues for 6 hours and tissue sampling is performed afterwards.
次要结局
- Electron microscopy
- mRNA
研究者
Rie Harboe Nielsen
Principal Investigator
Bispebjerg Hospital