Health TrialsbyHealthPanel

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

ConditionMuscle Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorBispebjerg Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy men and women scheduled to undergo reconstructive knee surgery

BMI 18-35

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electrical stimulation

    Procedure/Surgery

    Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles

  • Growth hormone (somatropin)

    Drug

    Daily injection of growth hormone

  • Control (No electrical stimulation, nor growth hormone)

    Other intervention

    No electrical stimulation, nor growth hormone

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: 1) Electrical stimulation + growth hormoneExperimental treatment 2 interventions
Group B: 2) Electrical stimulationExperimental treatment 1 intervention
Group C: 3) Growth hormoneActive comparator 1 intervention
Group D: 4) ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
2 years

Secondary outcomes

1

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

Time frame
2 years
2

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

Time frame
2 years
3

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

Time frame
2 years
4

Tendon tissue synthesis from injured muscle vs. control muscle

FSR based on D2O intake and D-alanine label in tissue

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bispebjerg Hospital

Lead sponsor

Source ClinicalTrials.gov
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