Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle
研究概览
简要总结
The study is a 2-week human study where 40 patients who are scheduled to undergo reconstructive knee surgery are randomized to administration of GH or placebo following or without neuromuscular electrical stimulation of hamstring muscles.The overall aim is to determine, the role of muscle connective tissue protein synthesis in muscle injury and repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women scheduled to undergo reconstructive knee surgery
- •BMI 18-35
排除标准
- •Former or current use of growth hormone or anabolic steroids
- •Use of corticosteroids in the past 3 months
- •Use of any medication known to affect muscle or tendon turnover
- •Former participation in a study using deuterated water
- •Chronic diseases
研究组 & 干预措施
1) Electrical stimulation + growth hormone
One bout of electrical stimulation with 200 eccentric contractions. This is followed by daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.
干预措施: Electrical stimulation (Procedure)
1) Electrical stimulation + growth hormone
One bout of electrical stimulation with 200 eccentric contractions. This is followed by daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.
干预措施: Growth hormone (somatropin) (Drug)
2) Electrical stimulation
One bout of electrical stimulation with 200 eccentric contractions
干预措施: Electrical stimulation (Procedure)
3) Growth hormone
Daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.
干预措施: Growth hormone (somatropin) (Drug)
4) Control
No intervention
干预措施: Control (No electrical stimulation, nor growth hormone) (Other)
结局指标
主要结局
Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle
时间窗: 2 years
Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue
次要结局
- Difference in muscle protein synthesis in regenerating muscle, myotendinous junction tissue with or without growth hormone(2 years)
- Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue(2 years)
- Difference in muscle protein synthesis in regenerating muscle, myotendinous junction, and tendon tissue with or without growth hormone(2 years)
- Tendon tissue synthesis from injured muscle vs. control muscle(2 years)
- Difference in muscle protein synthesis in regenerating vs. control muscle, myotendinous junction, and tendon tissue(2 years)
- Single protein synthesis in regenerating muscle and myotendinous junction tissue with or without growth hormone(2 years)
- Number of satellite cells, fibroblasts and immune cells in renereting vs. control tissue, with and without growth hormone(2 years)
- Mechanical properties of tissue with and without growth hormone(2 years)
研究者
Grith Højfeldt
Principal Investigator
Bispebjerg Hospital