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NCT05746650 Clinical Trial

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

Muscle Injury Clinical Trial

— GH-MTJ  

Official title:
Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05746650
Other study ID # BBH158
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 24, 2023
Est. completion date March 1, 2025

Study information
Verified date March 2023
Source Bispebjerg Hospital
Contact Grith Stougaard Højfeldt, PhD
Phone +45 61651061
Email grith.stougaard.hoejfeldt@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date March 1, 2025
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Electrical stimulation
Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles
Drug:
• Growth hormone (somatropin)
Daily injection of growth hormone
Other:
• Control (No electrical stimulation, nor growth hormone)
No electrical stimulation, nor growth hormone

Locations
Country Name City State
Denmark Bispebjerg Hospital Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 years
Secondary 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 2 years
Secondary 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 2 years
Secondary 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 2 years
Secondary Tendon tissue synthesis from injured muscle vs. control muscle FSR based on D2O intake and D-alanine label in tissue 2 years
Secondary 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 2 years
Secondary 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 2 years
Secondary Number of satellite cells, fibroblasts and immune cells in renereting vs. control tissue, with and without growth hormone Histochemical staining of muscle cross sections 2 years
Secondary Mechanical properties of tissue with and without growth hormone Ex vivo mechanical stress test 2 years
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