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

Bispebjerg Hospital

Status: Enrolling

Conditions: Muscle Injury

Treatments: Drug: Growth hormone (somatropin); Procedure: Electrical stimulation; Other: Control (No electrical stimulation, nor growth hormone)

Study type: Interventional

Funder types: Other

Identifiers

NCT05746650

BBH158

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

1) Electrical stimulation + growth hormone

Experimental group

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.

Treatment:

Procedure: Electrical stimulation

Drug: Growth hormone (somatropin)

2) Electrical stimulation

Experimental group

Description:

One bout of electrical stimulation with 200 eccentric contractions

Treatment:

Procedure: Electrical stimulation

3) Growth hormone

Active Comparator group

Description:

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

Treatment:

Drug: Growth hormone (somatropin)

4) Control

Placebo Comparator group

Description:

No intervention

Treatment:

Other: Control (No electrical stimulation, nor growth hormone)