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

 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 first data harvest was in 2011 and the second in 2016. The master database is
 housed at The Johns Hopkins Hospital in Baltimore, Maryland, and maintained by Drs. Jones and
 Martin. 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.

 DATABASE ORGANIZATION:

 In the current database, each record represents a unique patient. The 1st available VAP test
 for each patient is included. To meet the needs of a variety of research questions, we are
 prospectively planning to organize harvest 2 data into 3-year interval datasets (i.e., VLDL
 2006-2008, 2009-2011, VLDL 2012-2014, etc), a summation dataset (first VAP test for each
 patient), serial lab dataset (patients who have had repeated testing), and ancillary datasets
 (subsets of patients with coexisting data on other measures such as apolipoproteins, vitamin
 D, etc).

 INDIVIDUAL STUDIES:

 Individual VLDL studies are based on a priori hypotheses or aims with statistical analysis
 plans (SAPs) peer-reviewed prior to execution. In the expandable "Detailed Description"
 section below, the VLDL investigators will periodically register individual studies and
 update their status here.
REGISTRATION & STATUS OF VLDL STUDIES

 -  VLDL-1A: Friedewald Estimated versus Directly Measured Low-Density Lipoprotein
 Cholesterol and Treatment Implications (abstract presented; manuscript published;
 citation provided below)

 -  VLDL-1B: Comparison of a Novel Method vs the Friedewald Equation for Estimating
 Low-Density Lipoprotein Cholesterol Levels from the Standard Lipid Profile (manuscript
 published; citation provided below)

 -  VLDL-1C: Low-Density Lipoprotein Cholesterol Estimation at Very Low Levels and Clinical
 Implications (abstract presented; manuscript published; citation provided below)

 -  VLDL-1D: Fasting vs non-fasting impact on low-density lipoprotein-cholesterol accuracy
 (abstract presented; manuscript published; citation provided below)

 -  VLDL-2A: Non-High-Density Lipoprotein Cholesterol, Guideline Targets, and Population
 Percentiles for Secondary Prevention (abstract presented; manuscript published; citation
 provided below)

 -  VLDL-2B: Patient-Level Discordance in Population Percentiles of the Total Cholesterol to
 High-Density Lipoprotein Cholesterol Ratio in Comparison With Low-Density Lipoprotein
 Cholesterol and Non-High-Density Lipoprotein Cholesterol (abstract presented; manuscript
 published; citation provided below)

 -  VLDL-3: Deficient Serum 25-Hydroxy Vitamin D is Associated with an Atherogenic Lipid
 Profile (abstract presented; manuscript published; citation provided below)

 -  VLDL-4: Relationship of the Triglyceride to High-Density Lipoprotein Cholesterol
 (TG/HDL-C) Ratio to the Remainder of the Lipid Profile (abstract presented; manuscript
 published; citation provided below)

 -  VLDL-5: Ratio of Dense to Buoyant LDL Subclass and LDL Density Phenotype (abstract
 presented; manuscript published; citation provided below)

 -  VLDL-6: Characterization of Fredrickson-Levy Dyslipidemia Classes without Chylomicrons
 (IIa, IIb, III,IV) (abstract presented; manuscript in preparation)

 -  VLDL-7: Characterization of Fredrickson-Levy Dyslipidemia Classes with Chylomicrons
 (I,V) (abstract presented; manuscript in preparation)

 -  VLDL-8: Continuum of Non-Chylomicron Dyslipidemia Phenotype not Classifiable by
 Fredrickson-Levy Criteria (abstract presented; manuscript in preparation)

 -  VLDL-9: Lipid Phenotypes at the Extremes of High-Density Lipoprotein Cholesterol
 (abstract presented; manuscript published; citation provided below)

 -  VLDL-10A: Atherogenic Lipid Levels in 662,711 Elderly Persons: The Very Large Database
 of Lipids 10A (abstract presented; manuscript in preparation)

 -  VLDL-10B: Narrowing Sex Differences in Lipoprotein Cholesterol Subclasses Following
 Mid-Life (abstract presented; manuscript published; citation provided below)

 -  VLDL-11: Exploration of individuals with American Heart Association (AHA) ideal total
 cholesterol (<200 mg/dL) (statistical analysis plan in development)

 -  VLDL-12: Extremely low LDL-C, non-HDL-C phenotype (statistical analysis plan in
 development)

 -  VLDL-13: Thyroid function vs. lipids (abstract presented; manuscript in preparation)

 -  VLDL-14: Seasonal variation in lipids and biomarkers (abstract presented; manuscript in
 preparation)

 -  VLDL-15: Lipids, hsCRP, Lp(a), Lp-PLA2: phenotypes, lipid oxidation, inflammation
 (statistical analysis plan in development)

 -  VLDL-16: Secular trends in metabolic syndrome lipid criteria, remnant lipoprotein
 cholesterol (statistical analysis plan in development)

 -  VLDL-17: Screening for familial hypercholesterolemia (abstract presented; manuscript
 published; citation provided below)

 -  VLDL-18: Remnant Lipoprotein Cholesterol definitions (statistical analysis plan in
 development)

 -  VLDL-19: Lipoprotein(a) in familial hypercholesterolemia (statistical analysis plan in
 development)

 -  VLDL-20: Lipoprotein subfractions and uric acid (abstract in preparation)

 -  VLDL-21: Lipoprotein subfractions and homocysteine (abstract presented; manuscript
 published; citation provided below)

 -  VLDL-22: Lipoprotein(a), HDL-C, and TG (abstract presented; manuscript in preparation)

 -  VLDL-23: Dual LDL-C and hs-CRP target attainment (abstract presented; manuscript in
 preparation)
Patients with age and lipid data are included in the master database. Eligibility criteria
 are specific to each individual study.