Muscle InjuryGH-MTJNCT05746650
Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury
A study testing Electrical stimulation and Growth hormone (somatropin) in people with Muscle Injury, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Injury
- What is being tested?
- Electrical stimulation and Growth hormone (somatropin)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Feb 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women scheduled to undergo reconstructive knee surgery
- BMI 18-35
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, 2400
Grith Stougaard Højfeldt, PhD, +4561651061, grith.stougaard.hoejfeldt@regionh.dk
About this study
Official title: Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury
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.
- Conditions
- Muscle Injury
- Being tested
- Electrical stimulation, Growth hormone (somatropin), Control (No electrical stimulation, nor growth hormone)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationProcedure or surgery
Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles
Growth hormone (somatropin)Drug
Daily injection of growth hormone
Control (No electrical stimulation, nor growth hormone)Other
No electrical stimulation, nor growth hormone
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Electrical stimulation; Drug: Growth hormone (somatropin) |
| 2) Electrical stimulation | Experimental | One bout of electrical stimulation with 200 eccentric contractions Receives: Procedure: Electrical stimulation |
| 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. Receives: Drug: Growth hormone (somatropin) |
| 4) Control | Placebo comparator | No intervention Receives: Other: Control (No electrical stimulation, nor growth hormone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (8)
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
Measured: 2 years
Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue
Dynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins
Measured: 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
Measured: 2 years
Tendon tissue synthesis from injured muscle vs. control muscle
FSR based on D2O intake and D-alanine label in tissue
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Mechanical properties of tissue with and without growth hormone
Ex vivo mechanical stress test
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start24 Feb 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grith Højfeldt, Bispebjerg Hospital
- Investigators
- Grith Højfeldt, PhD, Principal investigator, Institute of Sports Medicine, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746650
- Sponsor's protocol ID
- BBH158
- Acronym
- GH-MTJ
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury
- ClinicalTrials.gov ID
- NCT05746650
- Acronym / sponsor ID
- GH-MTJ / BBH158
- Conditions
- Muscle Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1) Electrical stimulation + growth hormone | Experimental | Procedure: Electrical stimulation, Drug: Growth hormone (somatropin)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 | Procedure: Electrical stimulationOne bout of electrical stimulation with 200 eccentric contractions |
| 3) Growth hormone | Active comparator | Drug: Growth hormone (somatropin)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 | Other: Control (No electrical stimulation, nor growth hormone)No intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women scheduled to undergo reconstructive knee surgery
- BMI 18-35
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulationExperimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles | Procedure or surgery | 1) Electrical stimulation + growth hormone, 2) Electrical stimulation |
| Growth hormone (somatropin)Daily injection of growth hormone | Drug | 1) Electrical stimulation + growth hormone, 3) Growth hormone |
| Control (No electrical stimulation, nor growth hormone)No electrical stimulation, nor growth hormone | Other | 4) Control |
Primary outcome
Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle
Time frame: 2 years
Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grith Højfeldt, PhD principal investigator
Institute of Sports Medicine, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation and Growth hormone (somatropin) in people with Muscle Injury, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grith Stougaard Højfeldt, PhD (+45 61651061, grith.stougaard.hoejfeldt@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.