NCT05746650

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Feb 2023Sep 2027

First Submitted

Initial submission to the registry

January 24, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 24, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

4.3 years

First QC Date

January 24, 2023

Last Update Submit

September 19, 2025

Conditions

Muscle Injury

Outcome Measures

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

    2 years

Secondary Outcomes (8)

  • Difference in muscle protein synthesis in regenerating muscle, myotendinous junction tissue with or without growth hormone

    2 years

  • Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue

    2 years

  • Single protein synthesis in regenerating muscle and myotendinous junction tissue with or without growth hormone

    2 years

  • Tendon tissue synthesis from injured muscle vs. control muscle

    2 years

  • Difference in muscle protein synthesis in regenerating muscle, myotendinous junction, and tendon tissue with or without growth hormone

    2 years

  • +3 more secondary outcomes

Study Arms (4)

1) Electrical stimulation + growth hormone

EXPERIMENTAL

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 stimulationDrug: Growth hormone (somatropin)

2) Electrical stimulation

EXPERIMENTAL

One bout of electrical stimulation with 200 eccentric contractions

Procedure: Electrical stimulation

3) Growth hormone

ACTIVE COMPARATOR

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)

4) Control

PLACEBO COMPARATOR

No intervention

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

Interventions

Electrical stimulationPROCEDURE

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

1) Electrical stimulation + growth hormone2) Electrical stimulation
Growth hormone (somatropin)DRUG

Daily injection of growth hormone

1) Electrical stimulation + growth hormone3) Growth hormone
Control (No electrical stimulation, nor growth hormone)OTHER

No electrical stimulation, nor growth hormone

4) Control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women scheduled to undergo reconstructive knee surgery
  • BMI 18-35

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

RECRUITING

MeSH Terms

Interventions

Electric StimulationGrowth HormoneHuman Growth Hormone

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative TechniquesPituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Grith Højfeldt, PhD

    Institute of Sports Medicine, Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grith Stougaard Højfeldt, PhD

CONTACT

+45 61651061grith.stougaard.hoejfeldt@regionh.dk

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

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 28, 2023

Study Start

February 24, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations

DK(1)