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

Not Applicable

Recruiting

• Conditions: Muscle Injury
• Interventions: Procedure: Electrical stimulation; Other: Control (No electrical stimulation, nor growth hormone); Drug: Growth hormone (somatropin)

• Registration Number: NCT05746650
• Lead Sponsor: Bispebjerg Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-24
• Study Start: 2023-02-24
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-02-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1) Electrical stimulation + growth hormone	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	Electrical stimulation	One bout of electrical stimulation with 200 eccentric contractions
3) Growth hormone	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.
1) Electrical stimulation + growth hormone	Electrical stimulation	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.
4) Control	Control (No electrical stimulation, nor growth hormone)	No intervention

Primary Outcome Measures

Name	Time	Method
Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle	2 years	Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue

Secondary Outcome Measures

Name	Time	Method
Difference in muscle protein synthesis in regenerating muscle, myotendinous junction tissue with or without growth hormone	2 years	Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue
Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue	2 years	Dynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins
Difference in muscle protein synthesis in regenerating muscle, myotendinous junction, and tendon tissue with or without growth hormone	2 years	Fractional 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 tissue	2 years	Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue
Single protein synthesis in regenerating muscle and myotendinous junction tissue with or without growth hormone	2 years	Dynamic 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 muscle	2 years	FSR based on D2O intake and D-alanine label in tissue
Number of satellite cells, fibroblasts and immune cells in renereting vs. control tissue, with and without growth hormone	2 years	Histochemical staining of muscle cross sections
Mechanical properties of tissue with and without growth hormone	2 years	Ex vivo mechanical stress test

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark