Institute of Sports Medicine Copenhagen
Copenhagen, 2400, Denmark
Completed
NCT Number: NCT05809947
Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain
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.
Completed
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Notify MeKey information
Age range
18 year–35 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Neuromuscular electrical stimulation
OtherOne bout of neuromuscular electrical stimulation in conjunction with forced lengthening contractions on one leg
Other names: Neuromuscular electrical stimulation using Theta 4 channel stimulator from Chattanooga. Coupled with forced eccentric contractions.
Primary outcomes
-
Effect of somatropin on muscle protein synthesis 14 days after injury
Time frame: 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 outcomes
-
Muscle protein synthesis 7 days after injury
Time frame: 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
Time frame: 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 14 days after injury
Time frame: 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 breakdown 7 days after injury
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Bispebjerg Hospital
Other
Registry information
Official study title
Regulation of Human Tendon and Skeletal Muscle Protein Turnover Following Tissue Injury: Mechanisms Behind Regeneration and Injury Preventive Adaptations
Important dates
- Study start
- 2023
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Apr 12, 2023
- Registry last updated
- Jan 9, 2024
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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