Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain

Not Applicable

Completed

• Conditions: Muscle; Injury, Quadriceps (Thigh); Tendon Strain
• Interventions: Other: Neuromuscular electrical stimulation

• Registration Number: NCT05809947
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

The study is a 5-week human study including 24 18-35 year old healthy men. Each participant will have muscle injury and tendon strain induced in one leg using neuromuscular electrical stimulation in conjunction with forced lengthening contractions. The investigators will monitor the recovery from injury/strain over a 4 week period, in which half of the subjects will receive growth hormone (somatropin) to stimulate the connective tissue synthesis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-30
• Study Start: 2023-04-11
• Study First Posted: 2023-04-12
• Status Verified: 2024-01
• Primary Completion: 2024-01-03
• Study Completion: 2024-01-03
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Healthy men
• BMI between 18.5-30 kg/m^2

Exclusion Criteria

• Smoking
• Regular strength training within the last 3 months
• Current or former use of anabolic steroids or growth hormone
• Use of corticosteroids in the last 3 months
• Use of blood thinning medication
• Use of medication which can affect muscle protein synthesis
• Current or former drug og alcohol abuse
• Knee pain
• Previous participation in studies using deuterated water or alanine tracers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Growth hormone/somatropin	Neuromuscular electrical stimulation	Somatropin over two weeks (33.3 ug/kg/day in the first week, 50 ug/kg/day in the second week)
Placebo	Neuromuscular electrical stimulation	Injections of placebo/saline over two weeks

Primary Outcome Measures

Name	Time	Method
Effect of somatropin on muscle protein synthesis 14 days after injury	14 days	The difference in fractional synthesis rate in muscle proteins 14 days after injury with or without 14 days treatment with somatropin. Measured using deuterated water

Secondary Outcome Measures

Name	Time	Method
Muscle protein breakdown 14 days after injury	14 days	The difference in fractional synthesis rate in muscle proteins 14 days after injury vs. control (no injury) with or without 14 days treatment with somatropin. Measured using stable isotop labelled alanine.
Muscle protein synthesis 7 days after injury	7 days	The difference in fractional synthesis rate in muscle proteins 7 days after injury vs control (no injury) with or without 7 days treatment with somatropin. Measured using deuterated water
Muscle protein synthesis 14 days after injury	14 days	The difference in fractional synthesis rate in muscle proteins 14 days after injury compared to control leg (no injury). Measured using deuterated water.
Muscle protein breakdown 7 days after injury	7 days	The difference in fractional synthesis rate in muscle proteins 7 days after injury vs. control (no injury) with or without 7 days treatment with somatropin. Measured using stable isotop labelled alanine.
Muscle protein breakdown 28 days after injury	28 days	The difference in fractional synthesis rate in muscle proteins 28 days after injury vs. control (no injury) with or without 14 days treatment with somatropin. Measured using stable isotop labelled alanine.
Histochemical staining of muscle cross sections 7 days after injury	7 days	Number of satellite cells, fibroblasts and immune cells in injured vs. control tissue (no injury), with and without growth hormone. Measured using histochemical staining of muscle cross sections
Histochemical staining of muscle cross sections 14 days after injury	14 days	Number of satellite cells, fibroblasts and immune cells in injured vs. control tissue (no injury), with and without growth hormone. Measured using histochemical staining of muscle cross sections
Histochemical staining of muscle cross sections 28 days after injury	28 days	Number of satellite cells, fibroblasts and immune cells in injured vs. control tissue (no injury), with and without growth hormone. Measured using histochemical staining of muscle cross sections
The effect of somatropin on tendon tissue synthesis	7 days	The difference in fractional synthesis rate in tendon proteins after 7 days placebo/treatment with somatropin. Measured using deuterated water
Tendon tissue synthesis 7 days after strain	7 days	The difference in fractional synthesis rate in tendon proteins 7 days after strain compared to control leg (no strain). Measured using deuterated water
Tendon tissue synthesis 7 days after strain with/without somatropin	7 days	The difference in fractional synthesis rate in tendon proteins 7 days after strain compared to control leg (no strain) with or without somatropin. Measured using deuterated water
Isometric muscle force output 7 days following injury	7 days	The difference in isometric muscle force output 7 days after injury vs. control (no injury) with or without 7 days treatment with somatropin.
Isometric muscle force output 14 days following injury	14 days	The difference in isometric muscle force output 14 days after injury vs. control (no injury) with or without 14 days treatment with somatropin.
Isometric muscle force output 28 days following injury	28 days	The difference in isometric muscle force output 28 days after injury vs. control (no injury) with or without 14 days treatment with somatropin.

Trial Locations

Locations (1)

Institute of Sports Medicine Copenhagen; 🇩🇰 Copenhagen, Denmark