The Very Large Database of Lipids (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: September 5, 2013
Last verified: September 2013
  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:


Further study details as provided by Johns Hopkins University:

Enrollment: 2859333
Study Start Date: April 2011
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: Derivation and Validation of a Novel Method for More Accurate Estimation of Low-Density Lipoprotein Cholesterol from the Standard Lipid Profile (manuscript under review)
  • VLDL-2: Non-HDL-C, TC/HDL-C, and LDL-C Population Percentiles and Discordance (abstract presented; manuscript published; citation provided below)
  • VLDL-3: Vitamin D Levels and Lipids (abstract presented; manuscript in preparation)
  • VLDL-4: Correlates of the TG/HDL-C Ratio (abstract submitted; manuscript in preparation)
  • 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: Characterization of Those with Extremely Low or High HDL-C Concentrations (abstract submitted; manuscript in preparation)
  • VLDL-10A: Atherogenic Lipid Levels in 662,711 Elderly Persons: The Very Large Database of Lipids 10A (abstract submitted; manuscript in preparation)
  • VLDL-10B: Narrowing Sex Differences in Lipoprotein Cholesterol Subclasses Following Menopause: Insights from the Very Large Database of Lipids (abstract submitted; manuscript in preparation)
  • VLDL-11: Triglyceride-Rich Remnant Lipoprotein Cholesterol Concentrations in AIM-HIGH-Like Patients (abstract submitted; manuscript in preparation)
  • VLDL-12: Complementary Information in Common Lipid Classifications (abstract in preparation)
  • VLDL-13: The Relationship between Thyroid dysfunction and Advanced Lipoprotein Cholesterol Subfractions in a Contemporary Sample of US Adults (abstract submitted; manuscript in preparation)
  • VLDL-14: Seasonal Differences in Lipid Profiles of 2.8 Million Consecutive, Unique US Adults: The Very Large Database of Lipids Seasonal Substudy (abstract submitted; manuscript in preparation)
  Eligibility

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:
Publications:
Additional 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: September 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sphingolipidoses
Lipid Metabolism Disorders
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014