Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury (GH-MTJ)

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Injury
• Intervention / Treatment: Other: Control (No electrical stimulation, nor growth hormone); Procedure: Electrical stimulation; Drug: Growth hormone (somatropin)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grith Stougaard Højfeldt, PhD; Phone Number: +45 61651061; Email: grith.stougaard.hoejfeldt@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Recruiting
    • Bispebjerg Hospital
    • Contact: Grith Stougaard Højfeldt, PhD; Phone Number: +4561651061; Email: grith.stougaard.hoejfeldt@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1) Electrical stimulation + growth hormone; 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.	Procedure: Electrical stimulation; Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles; Drug: Growth hormone (somatropin); Daily injection of growth hormone
Experimental: 2) Electrical stimulation; One bout of electrical stimulation with 200 eccentric contractions	Procedure: Electrical stimulation; Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles
Active Comparator: 3) Growth hormone; Daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.	Drug: Growth hormone (somatropin); Daily injection of growth hormone
Placebo Comparator: 4) Control; No intervention	Other: Control (No electrical stimulation, nor growth hormone); No electrical stimulation, nor growth hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tendon tissue synthesis from injured muscle vs. control muscle	FSR based on D2O intake and D-alanine label 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
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	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
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

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Grith Højfeldt, PhD, Institute of Sports Medicine, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Investigative Techniques; Pituitary Hormones; Pituitary Hormones, Anterior; Physical Stimulation; Human Growth Hormone; Electric Stimulation; Growth Hormone
• Other Study ID Numbers: BBH158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No