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Completed

NCT Number: NCT01446783

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.

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Key information

Conditions

Ehlers-Danlos Syndrome, Classic Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Ehlers-Danlos Syndrome Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sportsmedicine Copenhagen

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

mecasermin

Drug

0,1 ml mecasermin (10 mg/ml) is injected intratendinous into the patella tendon with ultrasound guidance.

Other names: Increlex (mecasermin), Ipsen

Saline

Drug

0,1 ml saline is injected intratendinous into the patella tendon with ultrasound guidance.

Primary outcomes

  1. Fractional synthesis rate of collagen in tendon, muscle and skin

    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

  1. 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 fibril diameter, form and density. In muscle the amount and appearance of connective tissue will be studied.

  2. mRNA

    From the muscle biopsy a piece will be stored for mRNA analysis if possible. Targets will be collagen types and IGF-I isoforms.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2011
Registry last updated
Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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