Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrical stimulation, Growth hormone (somatropin), Control (No electrical stimulation, nor growth hormone).
- Who it may be relevant to
- Registry conditions: Muscle Injury. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury
Overview
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.
Interventions
- Procedure Electrical stimulation
Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles - Drug Growth hormone (somatropin)
Daily injection of growth hormone - Other Control (No electrical stimulation, nor growth hormone)
No electrical stimulation, nor growth hormone
Primary outcome measures
- Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle [Time frame: 2 years]
Secondary outcome measures (8)
- Difference in muscle protein synthesis in regenerating muscle, myotendinous junction tissue with or without growth hormone [Time frame: 2 years]
- Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue [Time frame: 2 years]
- Single protein synthesis in regenerating muscle and myotendinous junction tissue with or without growth hormone [Time frame: 2 years]
- Tendon tissue synthesis from injured muscle vs. control muscle [Time frame: 2 years]
- Difference in muscle protein synthesis in regenerating muscle, myotendinous junction, and tendon tissue with or without growth hormone [Time frame: 2 years]
- Difference in muscle protein synthesis in regenerating vs. control muscle, myotendinous junction, and tendon tissue [Time frame: 2 years]
- Number of satellite cells, fibroblasts and immune cells in renereting vs. control tissue, with and without growth hormone [Time frame: 2 years]
- Mechanical properties of tissue with and without growth hormone [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Healthy men and women scheduled to undergo reconstructive knee surgery
- BMI 18-35
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Bispebjerg Hospital — Copenhagen
Identifiers
NCT: NCT05746650 · BBH158