DyslipidemiasLDL FORMULANCT05598216
Assessment of Different Equations to Accurately Calculate LDL Cholesterol
An observational study of Dyslipidemias and Lipid Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Purpose The LDL-C is a very important marker of the lipid panel which allows the introduction of a treatment and then the follow-up to prevent the cardiovascular risk. Friedewald et al have established the most widely used equation at the present time. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Lipid Disorder
- How many people
- 160,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2014to Dec 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: lipid profile performed in the lab during the recruitment period
Who may be able to join
- lipid profile performed in the location 1 during the recruitment period
Who cannot join
- Results outside the first and 99th percentile for TG parameters
- Samples slightly opalescent
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est
Bron, 69677
About this study
Official title: LDL Cholesterol: Friedewald, Always the Best Option to Evaluate LDL cholesteRol Concentration in norMal and Dyslipidemic sUbjects, in Fasting and Pot-prandiaL State?
Purpose The LDL-C is a very important marker of the lipid panel which allows the introduction of a treatment and then the follow-up to prevent the cardiovascular risk. Friedewald et al have established the most widely used equation at the present time. However, it has many well-known limitations, as being false in postprandial period.
New equations have been developed recently. Our work consisted in the assessment of the accuracy of Friedewald, Sampson and Martin-Hopkins equations and evaluated the consequences in terms of misclassification. Given that European recommendations allow the realization of lipid profiles in postprandial period, we studied the accuracy of these equations in non-fasting state .
Read more
Method The LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins). Results will be compared between equations and between calculated and measured concentrations determined using an ultracentrifugation method. The study is conducted out according to The Code of Ethics of the World Medical Association (Declaration of Helsinki) and obtained the agreement of the Scientific and Ethics Committee of the Hospices Civils de Lyon (LDL EQUATION CNIL 21_488) Hypothesis
To evaluate the most accurate equation in different conditions:
- Fasting and non-fasting state
- In subjects with normal or dyslipidemic lipid profile To evaluate the clinical impact on risk re-classification and lipid treatment goals if LDL-c is calculated using the best equation instead of the Friedewald's.
- Conditions
- Dyslipidemias, Lipid Disorder
- Being tested
- no intervention, Serum LDL cholesterol calculation
- Keywords
- LDL cholesterol, equation, postprandial, Dyslipidemia
- Medical subject headings
- Dyslipidemias, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, Serum LDL cholesterol calculationDiagnostic test
The serum LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins)
| Study group | Role | What they receive |
|---|---|---|
| Fasting state | based on the sampling time and the serum's aspect Receives: Diagnostic Test: no intervention, Serum LDL cholesterol calculation | |
| non-fasting state | based on the sampling time and the serum's aspect Receives: Diagnostic Test: no intervention, Serum LDL cholesterol calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the most accurate equation to calculate LDL cholesterol (mmo/L or g/L)
The outcome measure is LDL cholesterol concentration (mmol/l or g/L) determined using different equations (Friedwald, Martin Hopkins, Sampson equations, …) and measured.
Measured: The outcome measure will be assessed through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Nov 2014
- Primary completion30 Dec 2021
- Study completionDec 2025 (estimated)
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 DyslipidemiasStudies 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
- Retrospective
- Enrolment
- 160,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598216
- Sponsor's protocol ID
- 488
- Acronym
- LDL FORMULA
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vasse J, Lassartesse A, Marmontel O, Charriere S, Bouveyron C, Marrie N, Moulin P, Di Filippo M. Assessment of three equations to calculate plasma LDL cholesterol concentration in fasting and non-fasting hypertriglyceridemic patients. Clin Chem Lab Med. 2023 Sep 8;62(2):270-279. doi: 10.1515/cclm-2023-0360. Print 2024 Jan 26.
PubMed 37678263
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LDL Cholesterol: Friedewald, Always the Best Option to Evaluate LDL cholesteRol Concentration in norMal and Dyslipidemic sUbjects, in Fasting and Pot-prandiaL State?
- ClinicalTrials.gov ID
- NCT05598216
- Acronym / sponsor ID
- LDL FORMULA / 488
- Conditions
- Dyslipidemias, Lipid Disorder
- Keywords
- LDL cholesterol, equation, postprandial, Dyslipidemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160,000 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Oct 2022 (actual)
- 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.
Purpose The LDL-C is a very important marker of the lipid panel which allows the introduction of a treatment and then the follow-up to prevent the cardiovascular risk. Friedewald et al have established the most widely used equation at the present time. However, it has many well-known limitations, as being false in postprandial period.
New equations have been developed recently. Our work consisted in the assessment of the accuracy of Friedewald, Sampson and Martin-Hopkins equations and evaluated the consequences in terms of misclassification. Given that European recommendations allow the realization of lipid profiles in postprandial period, we studied the accuracy of these equations in non-fasting state .
Method The LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins). Results will be compared between equations and between calculated and measured concentrations determined using an ultracentrifugation method. The study is conducted out according to The Code of Ethics of the World Medical Association (Declaration of Helsinki) and obtained the agreement of the Scientific and Ethics Committee of the Hospices Civils de Lyon (LDL EQUATION CNIL 21_488) Hypothesis
To evaluate the most accurate equation in different conditions:
- Fasting and non-fasting state
- In subjects with normal or dyslipidemic lipid profile To evaluate the clinical impact on risk re-classification and lipid treatment goals if LDL-c is calculated using the best equation instead of the Friedewald's.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting state | – | Diagnostic Test: no intervention, Serum LDL cholesterol calculationbased on the sampling time and the serum's aspect |
| non-fasting state | – | Diagnostic Test: no intervention, Serum LDL cholesterol calculationbased on the sampling time and the serum's aspect |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- lipid profile performed in the lab during the recruitment period
Key inclusion criteria (1 listed)
- lipid profile performed in the location 1 during the recruitment period
Key exclusion criteria (2 listed)
- Results outside the first and 99th percentile for TG parameters
- Samples slightly opalescent
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 |
|---|---|---|
| no intervention, Serum LDL cholesterol calculationThe serum LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins) | Diagnostic test | Fasting state, non-fasting state |
Primary outcome
Evaluation of the most accurate equation to calculate LDL cholesterol (mmo/L or g/L)
Time frame: The outcome measure will be assessed through study completion, an average of 1 year
The outcome measure is LDL cholesterol concentration (mmol/l or g/L) determined using different equations (Friedwald, Martin Hopkins, Sampson equations, …) and measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Derived from this study: PubMed 37678263Vasse J, Lassartesse A, Marmontel O, Charriere S, Bouveyron C, Marrie N, Moulin P, Di Filippo M. Assessment of three equations to calculate plasma LDL cholesterol concentration in fasting and non-fasting hypertriglyceridemic patients. Clin Chem Lab Med. 2023 Sep 8;62(2):270-279. doi: 10.1515/cclm-2023-0360. Print 2024 Jan 26.
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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?
An observational study of Dyslipidemias and Lipid Disorder, 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 Oct 2022. 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?
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?
Evaluation of the most accurate equation to calculate LDL cholesterol (mmo/L or g/L) (time frame: The outcome measure will be assessed through study completion, an average of 1 year). 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 NCT05598216, 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 28 Oct 2022.