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

NCT ID: NCT01446783

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ehlers-Danlos Syndrome, Classic

Keywords

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COL5A1 Collagen disorders IGF-I Collagen synthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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mecasermin + Ehlers-Danlos

Group Type ACTIVE_COMPARATOR

mecasermin

Intervention Type DRUG

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

Saline + Ehlers-Danlos

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Mecasamin + healthy control

Group Type ACTIVE_COMPARATOR

mecasermin

Intervention Type DRUG

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

Saline + healthy control

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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mecasermin

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Other Intervention Names

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Increlex (mecasermin), Ipsen

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Malignity, cardiac diseases, diabetes, tendinopathy in patella tendons
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rie Harboe Nielsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Kjaer, Professor

Role: STUDY_DIRECTOR

Institute of Sportsmedicine Copenhagen

Locations

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Institute of Sportsmedicine Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-1-2011-010

Identifier Type: -

Identifier Source: org_study_id