Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain

NCT05809947 | Completed

• 1 other identifier: BBH150
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a 5-week human study including 24 18-35 year old healthy men. Each participant will have muscle injury and tendon strain induced in one leg using neuromuscular electrical stimulation in conjunction with forced lengthening contractions. The investigators will monitor the recovery from injury/strain over a 4 week period, in which half of the subjects will receive growth hormone (somatropin) to stimulate the connective tissue synthesis.

Conditions

Muscle; Injury, Quadriceps (Thigh); Tendon Strain

Outcome Measures

Primary Outcomes (1)

• Effect of somatropin on muscle protein synthesis 14 days after injury

  The difference in fractional synthesis rate in muscle proteins 14 days after injury with or without 14 days treatment with somatropin. Measured using deuterated water

  14 days

Secondary Outcomes (14)

• Muscle protein synthesis 7 days after injury

  7 days

• Muscle protein synthesis 14 days after injury

  14 days

• Muscle protein breakdown 14 days after injury

  14 days

• Muscle protein breakdown 7 days after injury

  7 days

• Muscle protein breakdown 28 days after injury

  28 days

Study Arms (2)

Growth hormone/somatropin

EXPERIMENTAL

Somatropin over two weeks (33.3 ug/kg/day in the first week, 50 ug/kg/day in the second week)

Other: Neuromuscular electrical stimulation

Placebo

PLACEBO COMPARATOR

Injections of placebo/saline over two weeks

Other: Neuromuscular electrical stimulation

Interventions

Neuromuscular electrical stimulation OTHER

One bout of neuromuscular electrical stimulation in conjunction with forced lengthening contractions on one leg

Also known as: Neuromuscular electrical stimulation using Theta 4 channel stimulator from Chattanooga. Coupled with forced eccentric contractions.

Growth hormone/somatropin; Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men
• BMI between 18.5-30 kg/m\^2

You may not qualify if:

• Smoking
• Regular strength training within the last 3 months
• Current or former use of anabolic steroids or growth hormone
• Use of corticosteroids in the last 3 months
• Use of blood thinning medication
• Use of medication which can affect muscle protein synthesis
• Current or former drug og alcohol abuse
• Knee pain
• Previous participation in studies using deuterated water or alanine tracers

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Institute of Sports Medicine Copenhagen

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, postdoc

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 12, 2023
• Study Start: April 11, 2023
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)