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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Atherotech Diagnostics Lab
Information provided by (Responsible Party):
Seth S. Martin, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01698489
First received: October 1, 2012
Last updated: October 14, 2015
Last verified: October 2015
History of Changes
  Purpose

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 (Atherotech, 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) 2007-2008.

STUDY PROCEDURES:

This database was investigator-initiated. Only de-identified data reach the investigational site. The first data harvest was in 2011, and encompassed 1,350,908 samples. The second harvest is underway; thus far, an updated database suited to assess seasonal variation has been established with 2,859,333 samples. 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 biospecimens, 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, low density lipoprotein, very low density lipoprotein, intermediate density lipoprotein, high density lipoprotein, their subfractions, lipoprotein(a), and LDL pattern. From these primary variables, many additional variables were derived for inclusion in the master database (e.g., non-HDL-C, Friedewald LDL-C, TC/HDL-C, etc.). Other analytes measured by validated assays in subsets of the VLDL database include apoB, apoA1, hsCRP, homocysteine, uric acid, insulin, hemoglobin A1c, 25-hydroxy vitamin D, cystatin C, Lp-PLA2, TSH, free T3 and T4, pro-BNP, direct bilirubin, 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, hs-CRP, TSH/T4, etc).

INDIVIDUAL STUDIES:

Individual VLDL studies will be 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 on clinicaltrials.gov.


Condition
Lipid Disorders and Lipid Measurement

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • all-cause mortality [ Time Frame: up to 9 years from time of baseline lipid profile ] [ Designated as safety issue: No ]
Enrollment: 2859333
Study Start Date: April 2011
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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 accepted for presentation; manuscript in preparation)
  • 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 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), LpPLA2: phenotypes, lipid oxidation, inflammation (statistical analysis plan in development)
  • VLDL-16: Secular trends in MetSyn lipid criteria, RLP-C (statistical analysis plan in development)
  • VLDL-17: Screening for familial hypercholesterolemia (abstract presented; manuscript published; citation provided below)
  • VLDL-18: RLP-C 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 in preparation)
  • VLDL-22: Lipoprotein(a), HDL-C, and TG (abstract in preparation)
  • VLDL-23: Dual LDL-C and hs-CRP target attainment (statistical analysis plan in development)
  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698489

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
Sponsors and Collaborators
Johns Hopkins University
Atherotech Diagnostics Lab
Investigators
Study Director: Steven R Jones, MD Johns Hopkins University
  More Information

Additional Information:
Ratio of Dense to Buoyant LDL Subclass is Associated with LDL Density  This link exits the ClinicalTrials.gov site
Deficient serum 25-hydroxy vitamin D is associated with an atherogenic lipid profile: The Very Large Database of Lipids (VLDL-3) Study  This link exits the ClinicalTrials.gov site

Publications:
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.

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

Responsible Party: Seth S. Martin, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01698489     History of Changes
Other Study ID Numbers: NA_00074308 
Study First Received: October 1, 2012
Last Updated: October 14, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 26, 2016