IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients | oneedsvoice

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completed

IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients

study id #: NCT01446783

condition: Ehlers-Danlos Syndrome, Classic

status: completed

purpose:

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.

intervention: Drug: mecasermin
0,1 ml mecasermin (10 mg/ml) is injected intratendinous into the patella tendon with ultrasound guidance.
Other Name: Increlex (mecasermin), Ipsen
Drug: Saline
0,1 ml saline is injected intratendinous into the patella tendon with ultrasound guidance.

start date: September 2011

estimated completion: November 2012

last updated: November 20, 2012

phase of development: N/A

size / enrollment: 15

study design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

study description: 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.

primary outcomes:

  • Fractional synthesis rate of collagen in tendon [ Time Frame:6 hours ] A flood primed infusion of proline labelled with a stable isotope is used to calculate fractional synthesis rate of collagen in the 3 types of tissues. The infusion continues for 6 hours and tissue sampling is performed afterwards.

secondary outcomes:

  • Electron microscopy If there is additional tissue in the biopsies a piece will be stored for electron microscopy. In skin and tendon a transverse slice will be evaluated on collagen ill be stfibril diameter, form and density. In muscle the amount and appearance of connective tissue will be studied.
  • mRNA From the muscle biopsy a piece wored for mRNA analysis if possible. Targets will be collagen types and IGF-I isoforms.

inclusion criteria: - Classic form of Ehlers-Danlos syndrome OR healthy matched control

exclusion criteria: - Malignity, cardiac diseases, diabetes, tendinopathy in patella tendons

sponsor: Bispebjerg Hospital

investigators: Michael Kjaer, Professor Institute of Sportsmedicine Copenhagen

locations: Denmark