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

Sponsor

Bispebjerg Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05746650

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Injury	Procedure: Electrical stimulation Drug: Growth hormone (somatropin) Other: Control (No electrical stimulation, nor growth hormone)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1) Electrical stimulation + growth hormone 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.	Procedure: Electrical stimulation Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles Drug: Growth hormone (somatropin) Daily injection of growth hormone
Experimental: 2) Electrical stimulation One bout of electrical stimulation with 200 eccentric contractions	Procedure: Electrical stimulation Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles
Active Comparator: 3) Growth hormone Daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.	Drug: Growth hormone (somatropin) Daily injection of growth hormone
Placebo Comparator: 4) Control No intervention	Other: Control (No electrical stimulation, nor growth hormone) No electrical stimulation, nor growth hormone

Outcome Measures

Primary Outcome Measures

Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle [2 years]
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 [2 years]
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 [2 years]
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 [2 years]
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 [2 years]
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 [2 years]
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 [2 years]
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 [2 years]
Histochemical staining of muscle cross sections
Mechanical properties of tissue with and without growth hormone [2 years]
Ex vivo mechanical stress test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bispebjerg Hospital

Investigators

Principal Investigator: Grith Højfeldt, PhD, Institute of Sports Medicine, Bispebjerg Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Grith Højfeldt, Principal Investigator, Bispebjerg Hospital

ClinicalTrials.gov Identifier:

NCT05746650

Other Study ID Numbers:

BBH158

First Posted:

Feb 28, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wounds and Injuries

Hormones

Study Results

No Results Posted as of Mar 1, 2023