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Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain

Primary Purpose

Muscle; Injury, Quadriceps (Thigh), Tendon Strain

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle; Injury, Quadriceps (Thigh)

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Sports Medicine CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Growth hormone/somatropin

Placebo

Arm Description

Somatropin over two weeks (33.3 ug/kg/day in the first week, 50 ug/kg/day in the second week)

Injections of placebo/saline over two weeks

Outcomes

Primary Outcome Measures

Effect of somatropin on muscle protein synthesis 14 days after injury
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

Muscle protein synthesis 7 days after injury
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
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
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
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
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
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
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
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
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
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
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
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
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
The difference in isometric muscle force output 28 days after injury vs. control (no injury) with or without 14 days treatment with somatropin.

Full Information

First Posted
March 17, 2023
Last Updated
April 12, 2023
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05809947
Brief Title
Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain
Official Title
Regulation of Human Tendon and Skeletal Muscle Protein Turnover Following Tissue Injury: Mechanisms Behind Regeneration and Injury Preventive Adaptations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle; Injury, Quadriceps (Thigh), Tendon Strain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Growth hormone/somatropin
Arm Type
Experimental
Arm Description
Somatropin over two weeks (33.3 ug/kg/day in the first week, 50 ug/kg/day in the second week)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Injections of placebo/saline over two weeks
Intervention Type
Other
Intervention Name(s)
Neuromuscular electrical stimulation
Other Intervention Name(s)
Neuromuscular electrical stimulation using Theta 4 channel stimulator from Chattanooga. Coupled with forced eccentric contractions.
Intervention Description
One bout of neuromuscular electrical stimulation in conjunction with forced lengthening contractions on one leg
Primary Outcome Measure Information:
Title
Effect of somatropin on muscle protein synthesis 14 days after injury
Description
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
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Muscle protein synthesis 7 days after injury
Description
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
Time Frame
7 days
Title
Muscle protein synthesis 14 days after injury
Description
The difference in fractional synthesis rate in muscle proteins 14 days after injury compared to control leg (no injury). Measured using deuterated water.
Time Frame
14 days
Title
Muscle protein breakdown 14 days after injury
Description
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.
Time Frame
14 days
Title
Muscle protein breakdown 7 days after injury
Description
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.
Time Frame
7 days
Title
Muscle protein breakdown 28 days after injury
Description
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.
Time Frame
28 days
Title
Histochemical staining of muscle cross sections 7 days after injury
Description
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
Time Frame
7 days
Title
Histochemical staining of muscle cross sections 14 days after injury
Description
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
Time Frame
14 days
Title
Histochemical staining of muscle cross sections 28 days after injury
Description
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
Time Frame
28 days
Title
The effect of somatropin on tendon tissue synthesis
Description
The difference in fractional synthesis rate in tendon proteins after 7 days placebo/treatment with somatropin. Measured using deuterated water
Time Frame
7 days
Title
Tendon tissue synthesis 7 days after strain
Description
The difference in fractional synthesis rate in tendon proteins 7 days after strain compared to control leg (no strain). Measured using deuterated water
Time Frame
7 days
Title
Tendon tissue synthesis 7 days after strain with/without somatropin
Description
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
Time Frame
7 days
Title
Isometric muscle force output 7 days following injury
Description
The difference in isometric muscle force output 7 days after injury vs. control (no injury) with or without 7 days treatment with somatropin.
Time Frame
7 days
Title
Isometric muscle force output 14 days following injury
Description
The difference in isometric muscle force output 14 days after injury vs. control (no injury) with or without 14 days treatment with somatropin.
Time Frame
14 days
Title
Isometric muscle force output 28 days following injury
Description
The difference in isometric muscle force output 28 days after injury vs. control (no injury) with or without 14 days treatment with somatropin.
Time Frame
28 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grith S Højfeldt, PhD
Phone
+45 61651061
Email
grith.stougaard.hoejfeldt@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Damgaard, MD
Phone
+4522278320
Email
ann.damgaard.02@regionh.dk
Facility Information:
Facility Name
Institute of Sports Medicine Copenhagen
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grith Højfeldt, M.Sc.
Phone
+45 386 35366
Email
grith.westergaard.hoejfeldt.01@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IPD will be made available upon individual request once the study is finalised and published.

Learn more about this trial

Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain

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