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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) Electrical stimulation + growth hormone | Experimental | 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. |
|
| 2) Electrical stimulation | Experimental | One bout of electrical stimulation with 200 eccentric contractions |
|
| 3) Growth hormone | Active Comparator | Daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks. |
|
| 4) Control | Placebo Comparator | No intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical stimulation | Procedure | Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle | Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in muscle protein synthesis in regenerating muscle, myotendinous junction tissue with or without growth hormone | Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue | 2 years |
| Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grith Stougaard Højfeldt, PhD | Contact | +45 61651061 | grith.stougaard.hoejfeldt@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Grith Højfeldt, PhD | Institute of Sports Medicine, Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Recruiting | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| D013006 | Growth Hormone |
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
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| Growth hormone (somatropin) | Drug | Daily injection of growth hormone |
|
| Control (No electrical stimulation, nor growth hormone) | Other | No electrical stimulation, nor growth hormone |
|
Dynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins |
| 2 years |
| Single protein synthesis in regenerating muscle and myotendinous junction tissue with or without growth hormone | Dynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins | 2 years |
| Tendon tissue synthesis from injured muscle vs. control muscle | FSR based on D2O intake and D-alanine label in tissue | 2 years |
| Difference in muscle protein synthesis in regenerating muscle, myotendinous junction, and tendon tissue with or without growth hormone | Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue | 2 years |
| Difference in muscle protein synthesis in regenerating vs. control muscle, myotendinous junction, and tendon tissue | Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue | 2 years |
| Number of satellite cells, fibroblasts and immune cells in renereting vs. control tissue, with and without growth hormone | Histochemical staining of muscle cross sections | 2 years |
| Mechanical properties of tissue with and without growth hormone | Ex vivo mechanical stress test | 2 years |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |