Ehlers-Danlos Syndrome, Classic Clinical Trial
Official title:
IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients
The investigators want to inject insulin-like growth factor-I (IGF-I) into the patella
tendon of Ehlers-Danlos patients and healthy controls to evaluate the response in collagen
synthesis. Furthermore collagen synthesis is measured in muscle connective tissue and in
skin.
The hypothesis is that the connective tissue in Ehlers-Danlos patients is more compliant and
poorer in collagen than healthy controls, but that collagen synthesis can be stimulated by
IGF-I.
IGF-I will be injected with ultrasound guidance to one patella tendon and the other one will
be injected with saline as control. Injections will be performed double blinded and timed 24
hours and 6 hours before tissue sampling.
Collagen synthesis will be measured as fractional synthesis rate based on stabile isotope
technique using labelled proline.
10 patients diagnosed with Classical form of Ehlers-Danlos syndrome will be included and
matched with 10 healthy controls based on age, gender, BMI and activity level.
The muscle biopsy will be taken from vastus lateralis muscle and the skin biopsy from the
buttocks. The biopsies will if the size permits it also be used for histology and mRNA
analyses.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science