Protein Turnover in Healthy and Overuse-diseased Tendon
1 other identifier
interventional
36
1 country
1
Brief Summary
The goal of this clinical trial is to examine the regional protein turnover in tendon tissue from patients with chronic patellar tendinopathy and comparing this to healthy controls. Further we will examine the effect of resistance training on protein turnover in healthy individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
1 active site
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
First Submitted
Initial submission to the registry
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
May 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedJune 3, 2024
May 1, 2024
12 months
March 3, 2023
May 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Protein turnover in tendon tissue from patients with chronic tendinopathy compared to healthy controls
Fractional synthesis rate (FSR) measured in % pr. day in the trypsin-soluble and trypsin-insoluble fraction
8 days
Secondary Outcomes (9)
Tracer incorporation in isolated fractions of the tendon
8 days
Tracer incorporation in isolated fractions of the tendon
8 days
Anterior-posterior dimensions of patella tendon
8 days
Doppler flow in patella tendon
8 days
Subjective pain in patella tendon
8 days
- +4 more secondary outcomes
Study Arms (2)
Chronic tendinopathy patients
EXPERIMENTALHealthy controls
EXPERIMENTALInterventions
Only the control group: 3 exercise bouts within the study period. Comparison between exercised and non-exercised leg.
Comparison of primary and secondary outcomes.
Eligibility Criteria
You may qualify if:
- Physical active men and women
- Body mass index 18,5 - 30 kg/m2
- Subjective activity related pain in patella tendon.
- Clinical symptoms of patella tendinopathy.
- Ultrasound verification of at least 1 in three of the following: Enchanced anterior-posterior diameter, increased Doppler signal and/or a hypoechoic area in the diseased part of the tendon.
You may not qualify if:
- Former knee surgery or injuries to the patella tendon.
- Local injection of corticosteroids within 12 months.
- Medication that affects protein synthesis in tendon tissue.
- Former/current use of anabolic steroids or growth hormone.
- Smoking
- Known rheumatoid disease or diabetes.
- Former participation in trials using deuterated water and 15N tracers.
- Treatment for patella tendinopathy within 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Sports Medicine Copenhagen
Copenhagen, Capital Region, 2400, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Kjær, Professor
Institute of Sports Medicine, Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
March 3, 2023
First Posted
March 20, 2023
Study Start
May 10, 2023
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
June 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
Data will be shared with other researchers upon request.