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Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury

Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05746650
Acronym
GH-MTJ
Enrollment
40
Registered
2023-02-28
Start date
2023-02-24
Completion date
2027-09-01
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Injury

Brief 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 synthesis in muscle injury and repair.

Interventions

PROCEDUREElectrical stimulation

Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles

Daily injection of growth hormone

OTHERControl (No electrical stimulation, nor growth hormone)

No electrical stimulation, nor growth hormone

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle2 yearsFractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue

Secondary

MeasureTime frameDescription
Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue2 yearsDynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins
Single protein synthesis in regenerating muscle and myotendinous junction tissue with or without growth hormone2 yearsDynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins
Tendon tissue synthesis from injured muscle vs. control muscle2 yearsFSR based on D2O intake and D-alanine label in tissue
Difference in muscle protein synthesis in regenerating muscle, myotendinous junction tissue with or without growth hormone2 yearsFractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue
Difference in muscle protein synthesis in regenerating vs. control muscle, myotendinous junction, and tendon tissue2 yearsFractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue
Number of satellite cells, fibroblasts and immune cells in renereting vs. control tissue, with and without growth hormone2 yearsHistochemical staining of muscle cross sections
Mechanical properties of tissue with and without growth hormone2 yearsEx vivo mechanical stress test
Difference in muscle protein synthesis in regenerating muscle, myotendinous junction, and tendon tissue with or without growth hormone2 yearsFractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue

Countries

Denmark

Contacts

Primary ContactGrith Stougaard Højfeldt, PhD
grith.stougaard.hoejfeldt@regionh.dk+45 61651061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026