DysbetalipoproteinemiaDARKNCT01760265
DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk"
An observational study of Dysbetalipoproteinemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol and triglycerides. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Dysbetalipoproteinemia
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Jun 2013
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dysbetalipoproteinemia patients with APOE2/E2 or heterozygous mutation (negative dominance) and hypercholesterolemia, ratio CT VLDL/Tg VLDL >0.40
Who may be able to join
- apo E gene sequencing in CBE (Centre de Biologie Est / Hospices Civils de Lyon / France) laboratory in Lyon until December 2012
Who cannot join
- age < 40 years
- refused participation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon - Groupement Hospitalier Est
Bron, 69100
Philippe MOULIN, 4 72 68 13 04 ext. +33, Philippe.moulin@chu-lyon.fr
Philippe MOULIN, Pr
About this study
Official title: Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients
Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol and triglycerides.
As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia predispose to the premature development of atherosclerosis.
Read more
However among this population there is heterogeneity in development of cardiovascular complications and the determinants remain unclear actually.
The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis, and identify its determinants.
- Conditions
- Dysbetalipoproteinemia
- Keywords
- dysbetalipoproteinemia, artery calcium score, carotid intima media, ankle brachial index, dysbetalipoproteinemic patients
- Medical subject headings
- Hyperlipoproteinemia Type III
What is being measured
The primary outcome is the main question the study is designed to answer.
Computed tomographic measurements for coronary-artery calcium
Comparison with eventual previous examinations.
Measured: Day one : the coronary calcium score is assessed on the date of measurement
Secondary outcomes (2)
Measurement of carotid intima-media by ultrasonography
Comparison with eventual previous examinations.
Measured: Day one : on the date of measurement
Measurement of ankle brachial index
Comparison with eventual previous examinations
Measured: Day one : on the date of measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbetalipoproteinemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe MOULIN, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760265
- Sponsor's protocol ID
- 1
- Acronym
- DARK
- Status last verified
- Jan 2013
- First submitted
- 2 Jan 2013
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients
- ClinicalTrials.gov ID
- NCT01760265
- Acronym / sponsor ID
- DARK / 1
- Conditions
- Dysbetalipoproteinemia
- Keywords
- dysbetalipoproteinemia, artery calcium score, carotid intima media, ankle brachial index, dysbetalipoproteinemic patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 4 Jan 2013 (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.
Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol and triglycerides.
As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia predispose to the premature development of atherosclerosis.
However among this population there is heterogeneity in development of cardiovascular complications and the determinants remain unclear actually.
The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis, and identify its determinants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dysbetalipoproteinemia patients with APOE2/E2 or heterozygous mutation (negative dominance) and hypercholesterolemia, ratio CT VLDL/Tg VLDL >0.40
Key inclusion criteria (1 listed)
- apo E gene sequencing in CBE (Centre de Biologie Est / Hospices Civils de Lyon / France) laboratory in Lyon until December 2012
Key exclusion criteria (2 listed)
- age < 40 years
- refused participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Computed tomographic measurements for coronary-artery calcium
Time frame: Day one : the coronary calcium score is assessed on the date of measurement
Comparison with eventual previous examinations.
2 secondary outcomes
Measurement of carotid intima-media by ultrasonography
Time frame: Day one : on the date of measurement
Measurement of ankle brachial index
Time frame: Day one : on the date of measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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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.
Philippe MOULIN, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysbetalipoproteinemia, run by Hospices Civils de Lyon at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 28 Jan 2013. 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 France. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe MOULIN, Pr (4 72 68 13 04 ext. +33, philippe.moulin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computed tomographic measurements for coronary-artery calcium (time frame: Day one : the coronary calcium score is assessed on the date of measurement). 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 28 Jan 2013.