Skip to content

Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain

Regulation of Human Tendon and Skeletal Muscle Protein Turnover Following Tissue Injury: Mechanisms Behind Regeneration and Injury Preventive Adaptations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05809947
Enrollment
25
Registered
2023-04-12
Start date
2023-04-11
Completion date
2024-01-03
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle; Injury, Quadriceps (Thigh), Tendon Strain

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.

Interventions

OTHERNeuromuscular electrical stimulation

One bout of neuromuscular electrical stimulation in conjunction with forced lengthening contractions on one leg

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of somatropin on muscle protein synthesis 14 days after injury14 daysThe 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

MeasureTime frameDescription
Muscle protein synthesis 14 days after injury14 daysThe 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 injury14 daysThe 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 injury7 daysThe 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 injury28 daysThe 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 injury7 daysNumber 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 injury14 daysNumber 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
Muscle protein synthesis 7 days after injury7 daysThe 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
The effect of somatropin on tendon tissue synthesis7 daysThe 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 strain7 daysThe 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 somatropin7 daysThe 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 injury7 daysThe 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 injury14 daysThe 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 injury28 daysThe difference in isometric muscle force output 28 days after injury vs. control (no injury) with or without 14 days treatment with somatropin.
Histochemical staining of muscle cross sections 28 days after injury28 daysNumber 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026