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NCT Number: NCT05746650

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

Recruiting

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Key information

Conditions

Muscle Injury

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location status: Recruiting

Location contact

Grith Stougaard Højfeldt, PhD

CONTACT

[email protected]

+4561651061

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical stimulation

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Difference in muscle protein synthesis in regenerating muscle, myotendinous junction tissue with or without growth hormone

    Time frame: 2 years

    Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue

  2. Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue

    Time frame: 2 years

    Dynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins

  3. Single protein synthesis in regenerating muscle and myotendinous junction tissue with or without growth hormone

    Time frame: 2 years

    Dynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins

  4. Tendon tissue synthesis from injured muscle vs. control muscle

    Time frame: 2 years

    FSR based on D2O intake and D-alanine label in tissue

  5. Difference in muscle protein synthesis in regenerating muscle, myotendinous junction, and tendon tissue with or without growth hormone

    Time frame: 2 years

    Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue

  6. Difference in muscle protein synthesis in regenerating vs. control muscle, myotendinous junction, and tendon tissue

    Time frame: 2 years

    Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue

  7. Number of satellite cells, fibroblasts and immune cells in renereting vs. control tissue, with and without growth hormone

    Time frame: 2 years

    Histochemical staining of muscle cross sections

  8. Mechanical properties of tissue with and without growth hormone

    Time frame: 2 years

    Ex vivo mechanical stress test

Study contacts

Contact information is provided by the study sponsor or research team.

Grith Stougaard Højfeldt, PhD

CONTACT

[email protected]

+45 61651061

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Acronym: GH-MTJ

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2023
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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