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

Bispebjerg Hospital

Status: Completed

Conditions: Ehlers-Danlos Syndrome, Classic

Treatments: Drug: mecasermin; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01446783

H-1-2011-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Classic form of Ehlers-Danlos syndrome OR healthy matched control

Exclusion criteria

• Malignity, cardiac diseases, diabetes, tendinopathy in patella tendons

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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15 participants in 4 patient groups, including a placebo group

mecasermin + Ehlers-Danlos

Active Comparator group

Treatment:

Drug: mecasermin

Saline + Ehlers-Danlos

Placebo Comparator group

Treatment:

Drug: Saline

Mecasamin + healthy control

Active Comparator group

Treatment:

Drug: mecasermin

Saline + healthy control

Placebo Comparator group

Treatment:

Drug: Saline