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Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury (GH-MTJ)

Primary Purpose

Muscle Injury

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Electrical stimulation
Growth hormone (somatropin)
Control (No electrical stimulation, nor growth hormone)
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle Injury

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bispebjerg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

1) Electrical stimulation + growth hormone

2) Electrical stimulation

3) Growth hormone

4) Control

Arm Description

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.

One bout of electrical stimulation with 200 eccentric contractions

Daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.

No intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 24, 2023
Last Updated
March 10, 2023
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05746650
Brief Title
Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury
Acronym
GH-MTJ
Official Title
Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Injury

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1) Electrical stimulation + growth hormone
Arm Type
Experimental
Arm Description
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.
Arm Title
2) Electrical stimulation
Arm Type
Experimental
Arm Description
One bout of electrical stimulation with 200 eccentric contractions
Arm Title
3) Growth hormone
Arm Type
Active Comparator
Arm Description
Daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.
Arm Title
4) Control
Arm Type
Placebo Comparator
Arm Description
No intervention
Intervention Type
Procedure
Intervention Name(s)
Electrical stimulation
Intervention Description
Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles
Intervention Type
Drug
Intervention Name(s)
Growth hormone (somatropin)
Intervention Description
Daily injection of growth hormone
Intervention Type
Other
Intervention Name(s)
Control (No electrical stimulation, nor growth hormone)
Intervention Description
No electrical stimulation, nor growth hormone
Primary Outcome Measure Information:
Title
Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle
Description
Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Difference in muscle protein synthesis in regenerating muscle, myotendinous junction tissue with or without growth hormone
Description
Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue
Time Frame
2 years
Title
Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue
Description
Dynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins
Time Frame
2 years
Title
Single protein synthesis in regenerating muscle and myotendinous junction tissue with or without growth hormone
Description
Dynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins
Time Frame
2 years
Title
Tendon tissue synthesis from injured muscle vs. control muscle
Description
FSR based on D2O intake and D-alanine label in tissue
Time Frame
2 years
Title
Difference in muscle protein synthesis in regenerating muscle, myotendinous junction, and tendon tissue with or without growth hormone
Description
Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue
Time Frame
2 years
Title
Difference in muscle protein synthesis in regenerating vs. control muscle, myotendinous junction, and tendon tissue
Description
Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue
Time Frame
2 years
Title
Number of satellite cells, fibroblasts and immune cells in renereting vs. control tissue, with and without growth hormone
Description
Histochemical staining of muscle cross sections
Time Frame
2 years
Title
Mechanical properties of tissue with and without growth hormone
Description
Ex vivo mechanical stress test
Time Frame
2 years

10. Eligibility

Sex
All
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grith Stougaard Højfeldt, PhD
Phone
+45 61651061
Email
grith.stougaard.hoejfeldt@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grith Højfeldt, PhD
Organizational Affiliation
Institute of Sports Medicine, Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grith Stougaard Højfeldt, PhD
Phone
+4561651061
Email
grith.stougaard.hoejfeldt@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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