DiabetesECLIPSENCT00932087
Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange
An observational study of Diabetes and Metabolic Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12 metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls Read more about this study
- Who is it for?
- Ages 30 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Metabolic Syndrome
- What is being tested?
- Blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Jan 2010
- 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 30 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: group 1: type 2 diabetics with metabolic syndrome group 2: metabolic syndrome without diabetes group 3: subjects with type 1 diabetes group 4: controls
Who may be able to join
- statin and fibrate Wash out for one week
- HbA1c>7% and <12% (Arms 1 and 3)
- HbA1c<6% (Arms 2 and 4)
- Metabolic sd according NCEP III (3 out 4 criteria) (Arms 1 and 2)
Who cannot join
- secondary CV prevention
Trial locations and contacts
1 site in 1 country.
France1 site
Fédération d'Endocrinologie-Diabétologie-Maladies métaboliques-Nutrition - Hôpital Cardiovasculaire et Pneumologique
Lyon, 69394
About this study
Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12 metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls
- Conditions
- Diabetes, Metabolic Syndrome
- Being tested
- Blood sample
- Keywords
- Platelet function, diabetes, metabolic syndrome
- Medical subject headings
- Diabetes Mellitus, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
Blood sample for lipidomic study
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetics with metabolic syndrome | Not described Receives: Procedure: Blood sample | |
| metabolic syndrome without diabetes | Not described Receives: Procedure: Blood sample | |
| type 1 diabetes | Not described Receives: Procedure: Blood sample | |
| control | Not described Receives: Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of plasma isoprostane and lipoperoxides
Measured: at baseline
Secondary outcomes (1)
TXA2 and PF4 levels after platelet activation of control platelet exposed to LDL
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Philippe MOULIN, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932087
- Sponsor's protocol ID
- 2008.516
- Acronym
- ECLIPSE
- Status last verified
- Apr 2010
- First submitted
- 22 Jun 2009
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Colas R, Sassolas A, Guichardant M, Cugnet-Anceau C, Moret M, Moulin P, Lagarde M, Calzada C. LDL from obese patients with the metabolic syndrome show increased lipid peroxidation and activate platelets. Diabetologia. 2011 Nov;54(11):2931-40. doi: 10.1007/s00125-011-2272-8. Epub 2011 Aug 17.
PubMed 21847583
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange
- ClinicalTrials.gov ID
- NCT00932087
- Acronym / sponsor ID
- ECLIPSE / 2008.516
- Conditions
- Diabetes, Metabolic Syndrome
- Keywords
- Platelet function, diabetes, metabolic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 2 Jul 2009 (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.
Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12 metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetics with metabolic syndrome | – | Procedure: Blood sample |
| metabolic syndrome without diabetes | – | Procedure: Blood sample |
| type 1 diabetes | – | Procedure: Blood sample |
| control | – | Procedure: Blood sample |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- group 1: type 2 diabetics with metabolic syndrome group 2: metabolic syndrome without diabetes group 3: subjects with type 1 diabetes group 4: controls
Key inclusion criteria (4 listed)
- statin and fibrate Wash out for one week
- HbA1c>7% and <12% (Arms 1 and 3)
- HbA1c<6% (Arms 2 and 4)
- Metabolic sd according NCEP III (3 out 4 criteria) (Arms 1 and 2)
Key exclusion criteria (1 listed)
- secondary CV prevention
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 |
|---|---|---|
| Blood sampleBlood sample for lipidomic study | Procedure or surgery | control, metabolic syndrome without diabetes, type 1 diabetes, type 2 diabetics with metabolic syndrome |
Primary outcome
Level of plasma isoprostane and lipoperoxides
Time frame: at baseline
1 secondary outcome
TXA2 and PF4 levels after platelet activation of control platelet exposed to LDL
Time frame: 2 hours
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 13 Apr 2010.
- Derived from this study: PubMed 21847583Colas R, Sassolas A, Guichardant M, Cugnet-Anceau C, Moret M, Moulin P, Lagarde M, Calzada C. LDL from obese patients with the metabolic syndrome show increased lipid peroxidation and activate platelets. Diabetologia. 2011 Nov;54(11):2931-40. doi: 10.1007/s00125-011-2272-8. Epub 2011 Aug 17.
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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, MD, PhD 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 Diabetes and Metabolic Syndrome, 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 4 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 13 Apr 2010. 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?
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?
Level of plasma isoprostane and lipoperoxides (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00932087, which also lists 1 linked publication.
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 13 Apr 2010.