Ehlers-Danlos Syndrome, ClassicNCT01446783
IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients
A study testing mecasermin and Saline in people with Ehlers-Danlos Syndrome, Classic, run by Bispebjerg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ehlers-Danlos Syndrome, Classic
- What is being tested?
- mecasermin and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Classic form of Ehlers-Danlos syndrome OR healthy matched control
Who cannot join
- Malignity, cardiac diseases, diabetes, tendinopathy in patella tendons
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ehlers-Danlos Syndrome, Classic
- Being tested
- mecasermin, Saline
- Keywords
- COL5A1, Collagen disorders, IGF-I, Collagen synthesis
- Medical subject headings
- Ehlers-Danlos Syndrome, Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mecaserminDrug
Also called Increlex (mecasermin), Ipsen
0,1 ml mecasermin (10 mg/ml) is injected intratendinous into the patella tendon with ultrasound guidance.
SalineDrug
0,1 ml saline is injected intratendinous into the patella tendon with ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| mecasermin + Ehlers-Danlos | Active comparator | Not described Receives: Drug: mecasermin |
| Saline + Ehlers-Danlos | Placebo comparator | Not described Receives: Drug: Saline |
| Mecasamin + healthy control | Active comparator | Not described Receives: Drug: mecasermin |
| Saline + healthy control | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Secondary outcomes (2)
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.
mRNA
From the muscle biopsy a piece will be stored for mRNA analysis if possible. Targets will be collagen types and IGF-I isoforms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos Syndrome, ClassicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rie Harboe Nielsen, Bispebjerg Hospital
- Investigators
- Michael Kjaer, Professor, Study director, Institute of Sportsmedicine Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446783
- Sponsor's protocol ID
- H-1-2011-010
- Status last verified
- Nov 2012
- First submitted
- 27 Sep 2011
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients
- ClinicalTrials.gov ID
- NCT01446783
- Acronym / sponsor ID
- H-1-2011-010
- Conditions
- Ehlers-Danlos Syndrome, Classic
- Keywords
- COL5A1, Collagen disorders, IGF-I, Collagen synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Classic form of Ehlers-Danlos syndrome OR healthy matched control
Key exclusion criteria (1 listed)
- Malignity, cardiac diseases, diabetes, tendinopathy in patella tendons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mecaserminAlso: Increlex (mecasermin), Ipsen0,1 ml mecasermin (10 mg/ml) is injected intratendinous into the patella tendon with ultrasound guidance. | Drug | Mecasamin + healthy control, mecasermin + Ehlers-Danlos |
| Saline0,1 ml saline is injected intratendinous into the patella tendon with ultrasound guidance. | Drug | Saline + Ehlers-Danlos, Saline + healthy control |
Primary outcome
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.
2 secondary outcomes
Electron microscopy
mRNA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kjaer, Professor study director
Institute of Sportsmedicine Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mecasermin and Saline in people with Ehlers-Danlos Syndrome, Classic, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional synthesis rate of collagen in tendon, muscle and skin (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.