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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 : January 13, 2020
Sponsor:
Collaborator:
VAP Diagnostics Lab
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date October 1, 2012
First Posted Date October 3, 2012
Last Update Posted Date January 13, 2020
Actual Study Start Date April 2006
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2015)
all-cause mortality [ Time Frame: up to 9 years from time of baseline lipid profile ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Very Large Database of Lipids (VLDL)
Official Title The Very Large Database of Lipids (VLDL): A Clinical Laboratory Big Data Project
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).

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.

Detailed Description

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)
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients clinically referred for VAP density gradient ultracentrifugation.
Condition Lipid Disorders and Lipid Measurement
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 20, 2013)
2859333
Original Estimated Enrollment
 (submitted: October 2, 2012)
1361009
Estimated Study Completion Date April 2026
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria Patients with age and lipid data are included in the master database. Eligibility criteria are specific to each individual study.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01698489
Other Study ID Numbers NA_00074308
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators VAP Diagnostics Lab
Investigators
Study Director: Steven R Jones, MD Johns Hopkins University
Principal Investigator: Seth S Martin, MD, MHS Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date January 2020