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

Ehlers-Danlos Syndrome, Classic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446783
• Other study ID #: H-1-2011-010
• Status: Completed
• Phase: N/A
• First received: September 27, 2011
• Last updated: November 19, 2012
• Start date: September 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Ehlers-Danlos Syndrome, Classic

Intervention

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

Locations

Country	Name	City	State
Denmark	Institute of Sportsmedicine Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional synthesis rate of collagen in tendon, muscle and skin	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.	6 hours	No
Secondary	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.		No
Secondary	mRNA	From the muscle biopsy a piece will be stored for mRNA analysis if possible. Targets will be collagen types and IGF-I isoforms.		No