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

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ClinicalTrials.gov Identifier: NCT01446783
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):
Rie Harboe Nielsen, Bispebjerg Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ehlers-Danlos Syndrome, Classic Drug: mecasermin Drug: Saline Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients
Study Start Date : September 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: mecasermin + Ehlers-Danlos Drug: mecasermin
0,1 ml mecasermin (10 mg/ml) is injected intratendinous into the patella tendon with ultrasound guidance.
Other Name: Increlex (mecasermin), Ipsen
Placebo Comparator: Saline + Ehlers-Danlos Drug: Saline
0,1 ml saline is injected intratendinous into the patella tendon with ultrasound guidance.
Active Comparator: Mecasamin + healthy control Drug: mecasermin
0,1 ml mecasermin (10 mg/ml) is injected intratendinous into the patella tendon with ultrasound guidance.
Other Name: Increlex (mecasermin), Ipsen
Placebo Comparator: Saline + healthy control Drug: Saline
0,1 ml saline is injected intratendinous into the patella tendon with ultrasound guidance.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Malignity, cardiac diseases, diabetes, tendinopathy in patella tendons
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446783


Locations
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Denmark
Institute of Sportsmedicine Copenhagen
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Study Director: Michael Kjaer, Professor Institute of Sportsmedicine Copenhagen
More Information
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Responsible Party: Rie Harboe Nielsen, Principal Investigator, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01446783    
Other Study ID Numbers: H-1-2011-010
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: November 20, 2012
Last Verified: November 2012
Keywords provided by Rie Harboe Nielsen, Bispebjerg Hospital:
COL5A1
Collagen disorders
IGF-I
Collagen synthesis
Additional relevant MeSH terms:
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Ehlers-Danlos Syndrome
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases
Mecasermin
Growth Substances
Physiological Effects of Drugs