NCT01446783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

1.2 years

First QC Date

September 27, 2011

Last Update Submit

November 19, 2012

Conditions

Ehlers-Danlos Syndrome, Classic

Keywords

COL5A1Collagen disordersIGF-ICollagen synthesis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Electron microscopy

  • mRNA

Study Arms (4)

mecasermin + Ehlers-Danlos

ACTIVE COMPARATOR
Drug: mecasermin

Saline + Ehlers-Danlos

PLACEBO COMPARATOR
Drug: Saline

Mecasamin + healthy control

ACTIVE COMPARATOR
Drug: mecasermin

Saline + healthy control

PLACEBO COMPARATOR
Drug: Saline

Interventions

mecaserminDRUG

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

Also known as: Increlex (mecasermin), Ipsen
Mecasamin + healthy controlmecasermin + Ehlers-Danlos
SalineDRUG

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

Saline + Ehlers-DanlosSaline + healthy control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sportsmedicine Copenhagen

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Ehlers-Danlos SyndromeCollagen Diseases

Interventions

mecaserminSodium Chloride

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Michael Kjaer, Professor

    Institute of Sportsmedicine Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2011

First Posted

October 5, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

DK(1)