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The Very Large Database of Lipids (VLDL) (VLDL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01698489
Recruitment Status : Active, not recruiting
First Posted : October 3, 2012
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
VAP Diagnostics Lab
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief Summary:

Closer examination of granular lipid data in a large population offers numerous opportunities to generate new knowledge, ranging from studies examining concordance between commonly used lipid parameters to phenotypic characterization of rare or extreme disorders of lipid metabolism, opening possibilities to better personalize future treatment of abnormal blood lipids.

STUDY POPULATION:

The Very Large Database of Lipids (VLDL) includes adults and children who were clinically referred for a Vertical Auto Profile (VAP). Patient samples originated predominantly from outpatient primary care clinics in the U.S. (85%), along with specialty clinics and inpatient settings.

LIPID MEASUREMENTS:

The VAP test (VAP Diagnostics Lab, Birmingham, Alabama, USA) directly measures cholesterol concentrations of low density lipoprotein, very low density lipoprotein, intermediate density lipoprotein, high density lipoprotein, their subfractions, and lipoprotein(a). Triglycerides in the database are directly measured using the Abbott ARCHITECT C-8000 system (Abbott Park, Illinois, USA). Lipid distributions in the database closely match those from the population-representative National Health and Nutrition Examination Survey (NHANES).

STUDY PROCEDURES:

This database was investigator-initiated. Only de-identified data reach the investigational site. The master database is housed at The Johns Hopkins Hospital in Baltimore, Maryland, and maintained by Drs. Jones and Martin. The current database (2nd harvest) includes 5,051,467 patients whose laboratory samples were collected from October 1, 2015 and June 30, 2019. Only electronic data, and not blood samples, are sent to Hopkins. The academic investigators have unrestricted access to study data, take responsibility for the accuracy of analyses, and have authority over manuscript preparation and submission.

VARIABLES:

The variables currently in the VLDL database are testing date, age, sex, fasting/nonfasting, and components of the VAP test. From these primary variables, many additional variables were derived for inclusion in the master database. Other analytes measured by validated assays in subsets of the VLDL database include apolipoprotein B (apoB), apolipoprotein A1 (apoAI), high-sensitivity C-reactive protein (hsCRP), homocysteine, uric acid, insulin, hemoglobin A1c, 25-hydroxy vitamin D, cystatin C, lipoprotein-associated phosphatase (Lp-PLA2), thyroid stimulating hormone (TSH), free T3 and T4, pro-brain natriuretic peptide (pBNP), direct bilirubin, creatine phosphokinase (CPK), creatinine and other components of the comprehensive metabolic panel, magnesium, and phosphate.


Condition or disease
Lipid Disorders and Lipid Measurement

Study Design
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Study Type : Observational
Actual Enrollment : 5051467 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Very Large Database of Lipids (VLDL): A Clinical Laboratory Big Data Project
Actual Study Start Date : April 2006
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Low-density lipoprotein cholesterol level [ Time Frame: 4 years ]
    Low-density lipoprotein cholesterol levels measured in milligrams per deciliter.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients clinically referred for VAP density gradient ultracentrifugation.
Criteria
Patients with age and lipid data are included in the master database. Eligibility criteria are specific to each individual study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698489


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
VAP Diagnostics Lab
Investigators
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Study Director: Steven R Jones, MD Johns Hopkins University
Principal Investigator: Seth S Martin, MD, MHS Johns Hopkins University
More Information
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Publications of Results:
Ahmed, HM, Elshazly MB, Martin SS, Blaha MJ, Kulkarni KR, Jones SR. Ratio of Dense to Buoyant LDL Subclass is Associated with LDL Density Phenotype (VLDL-5). The Open Chemical and Biomedical Methods Journal 2013. 6:1-5.

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01698489    
Other Study ID Numbers: NA_00074308
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases