Metabolic SyndromeSPHINGONCT02851602
Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome
A study testing Blood sample in people with Metabolic Syndrome, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
HDL in obese non-diabetic patients show major alterations in their function and thus their cardio-protective effects. These alterations could be explained by the quantitative and qualitative anomalies in the phospholipids and sphingolipids in the HDL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Blood sample
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2013to 14 Nov 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged > 18 years
- fasting glycaemia < 1.10 g/l
- waist circumference > 102 cm for men and 88 cm for women (criteria NCEP/ATP III)
- 2 criteria among the following 3 (NCEP/ATP III criteria for metabolic syndrome):
- triglyceridaemia ≥ 1.50 g/l
- HDL cholesterol < 0.40 g/l for men and 0.50 g/l for women
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- arterial blood pressure ≥ 130/85 mmHg or treatment for arterial hypertension
- patients who have provided written consent INCLUSION CRITERIA FOR HEALTHY SUBJECTS
- age > 18 years
- fasting glycaemia < 1.10 g/l
- waist circumference < 102 cm for men and 88 cm for women
- triglyceridaemia < 1.50 g/l
- HDL cholesterol ≥ 0.40 g/l for men and 0.50 g/l for women
- Healthy subjects who have provided written consent
Who cannot join
- Persons without national health insurance cover
- Diabetes
- Diseases that interfere with lipoprotein metabolism (dysthyroidism not controlled with the treatment, kidney or liver disease)
- Treatments that interfere with lipoprotein metabolism (lipid-lowering agents, oestrogens, corticoids, retinoids, antiretroviral agents)
- Pregnancy/breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
HDL in obese non-diabetic patients show major alterations in their function and thus their cardio-protective effects. These alterations could be explained by the quantitative and qualitative anomalies in the phospholipids and sphingolipids in the HDL. These molecules play a major role in HDL function and probably present early modifications in obesity, even before the onset of glycaemia deregulation.
The aim of this study is to show the presence of qualitative and quantitative modifications of phospholipids and sphingolipids in HDL from obese patients compared with HDL from non-obese controls.
- Conditions
- Metabolic Syndrome
- Being tested
- Blood sample
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
| Study group | Role | What they receive |
|---|---|---|
| Obese | Experimental | Not described Receives: Biological: Blood sample |
| control | Placebo comparator | Not described Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the mass percentages of total phospholipids + sphingolipids compared with the total HDL mass
in patients with abdominal obesity without hyperglycaemia compared with healthy controls
Measured: At inclusion
Secondary outcomes (2)
Difference in the percentage of each family of phospholipids or sphingolipids compared with total phospholipids + sphingolipids
in patients with abdominal obesity but without hyperglycaemia compared with healthy controls
Measured: At inclusion
Difference in the percentage of each sub-family according to the nature of the fatty acids for phosphatidylcholines on the one hand and sphingomyelins on the other in patients
with abdominal obesity but without hyperglycaemia compared with healthy control
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start18 Nov 2013
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851602
- Sponsor's protocol ID
- VERGES 2013
- Acronym
- SPHINGO
- Status last verified
- Jan 2019
- First submitted
- 28 Jul 2016
- Last updated
- 10 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02851602
- Acronym / sponsor ID
- SPHINGO / VERGES 2013
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 18 Nov 2013 (actual)
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 1 Aug 2016 (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.
HDL in obese non-diabetic patients show major alterations in their function and thus their cardio-protective effects. These alterations could be explained by the quantitative and qualitative anomalies in the phospholipids and sphingolipids in the HDL. These molecules play a major role in HDL function and probably present early modifications in obesity, even before the onset of glycaemia deregulation.
The aim of this study is to show the presence of qualitative and quantitative modifications of phospholipids and sphingolipids in HDL from obese patients compared with HDL from non-obese controls.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | Experimental | Biological: Blood sample |
| control | Placebo comparator | Biological: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- aged > 18 years
- fasting glycaemia < 1.10 g/l
- waist circumference > 102 cm for men and 88 cm for women (criteria NCEP/ATP III)
- 2 criteria among the following 3 (NCEP/ATP III criteria for metabolic syndrome):
- triglyceridaemia ≥ 1.50 g/l
Key exclusion criteria (5 listed)
- Persons without national health insurance cover
- Diabetes
- Diseases that interfere with lipoprotein metabolism (dysthyroidism not controlled with the treatment, kidney or liver disease)
- Treatments that interfere with lipoprotein metabolism (lipid-lowering agents, oestrogens, corticoids, retinoids, antiretroviral agents)
- Pregnancy/breast feeding
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 sample | Biological | Obese, control |
Primary outcome
Difference in the mass percentages of total phospholipids + sphingolipids compared with the total HDL mass
Time frame: At inclusion
in patients with abdominal obesity without hyperglycaemia compared with healthy controls
2 secondary outcomes
Difference in the percentage of each family of phospholipids or sphingolipids compared with total phospholipids + sphingolipids
Time frame: At inclusion
Difference in the percentage of each sub-family according to the nature of the fatty acids for phosphatidylcholines on the one hand and sphingomyelins on the other in patients
Time frame: At inclusion
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 10 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Metabolic Syndrome, run by Centre Hospitalier Universitaire Dijon 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 14 inclusion and 5 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 10 Jan 2019. 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. 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?
Difference in the mass percentages of total phospholipids + sphingolipids compared with the total HDL mass (time frame: At inclusion). 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 10 Jan 2019.