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Trial record 3 of 12 for:    ehlers-danlos
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IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rie Harboe Nielsen, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01446783
First received: September 27, 2011
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  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.


Condition Intervention
Ehlers-Danlos Syndrome, Classic
 Drug: mecasermin
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Fractional synthesis rate of collagen in tendon, muscle and skin [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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:
  • Electron microscopy [ Designated as safety issue: No ]
    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.

  • mRNA [ Designated as safety issue: No ]
    From the muscle biopsy a piece will be stored for mRNA analysis if possible. Targets will be collagen types and IGF-I isoforms.


Enrollment: 15
Study Start Date: September 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446783

Locations
Denmark
Institute of Sportsmedicine Copenhagen
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Study Director: Michael Kjaer, Professor Institute of Sportsmedicine Copenhagen
  More Information

No publications provided

Responsible Party: Rie Harboe Nielsen, Principal Investigator, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01446783     History of Changes
Other Study ID Numbers: H-1-2011-010
Study First Received: September 27, 2011
Last Updated: November 19, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by Bispebjerg Hospital:
COL5A1
Collagen disorders
IGF-I
Collagen synthesis

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on June 18, 2013