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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
VAP Diagnostics Lab
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01698489
First received: October 1, 2012
Last updated: August 16, 2017
Last verified: August 2017
  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 (VAP Diagnostis 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 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, fasting/nonfasting, and components of the VAP test. 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, Liproprotein-associated Phosphatase (Lp-PLA2), Thyroid Stimulating Hormone (TSH), free T3 and T4, pro- Brain Natiuretic Peptide (BNP), 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, hs-C-Reactive Protein (CRP), TSH/T4, 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 on clinicaltrials.gov.


Condition
Lipid Disorders and Lipid Measurement

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Very Large Database of Lipids (VLDL): A Clinical Laboratory Big Data Project

Resource links provided by NLM:


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 ]

Enrollment: 2859333
Actual Study Start Date: April 2006
Estimated Study Completion Date: April 2020
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
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, 21287
Sponsors and Collaborators
Johns Hopkins University
VAP Diagnostics Lab
Investigators
Study Director: Steven R Jones, MD Johns Hopkins University
Principal Investigator: Seth S Martin, MD, MHS Johns Hopkins University
  More Information

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: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01698489     History of Changes
Other Study ID Numbers: NA_00074308
Study First Received: October 1, 2012
Last Updated: August 16, 2017

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 20, 2017