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NCT04061018 · ClinicalTrials.gov registry record
The Genetic, Protein, and Lipid Basis of Variation in Cholesterol Efflux
A clinical trial, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- 86
- Enrollment target
NCT04061018: Completed study, sponsored by University of Texas Southwestern Medical Center.
NCT04061018 is a clinical trial that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 86 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04061018 has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- 86 participants
- Enrollment target
Study Summary
The rationale of this research is that deep phenotyping of individuals at the extremes of cholesterol efflux will identify key determinants of efflux that are potential novel therapeutic targets to prevent or reverse Atherosclerotic Cardiovascular Disease (ASCVD). The investigators propose to carry out the objective by studying participants at extreme low and high cholesterol efflux identified from the investigator's study in the population-based Dallas Heart Study by accomplishing the following aims: 1) determine the heritability of and genomic factors associated with cholesterol efflux by establishing a family pedigree of extreme low and high efflux and sequencing candidate genes involved in HDL metabolism; and 2) identify the protein and lipid signature of extreme low and high cholesterol efflux in a sex- and ethnicity-specific manner using mass spectroscopy and ELISA in FPLC-derived fractions. The investigators expect to identify genetic variants and sex- and ethnicity-specific combinations of proteins and lipids in participants with extreme low and high efflux that may lead to novel ways to modulate efflux. This proposal leverages a well-phenotyped population-based study to characterize the gene-protein-lipid signature of 1) extremes of cholesterol efflux in a sex- and ethnicity-specific manner. Successful completion of these aims will have immediate and direct impact on the use of cholesterol efflux as a clinically relevant biomarker of therapeutic benefit and are necessary for the clinical development of appropriate new targets for manipulation of the key atheroprotective function of cholesterol efflux to reduce ASCVD.
Primary Outcome
Cholesterol efflux capacity (CEC) was determined by measuring the efflux of a fluorophore tagged cholesterol, BODIPY (Avanti polar lipids), from J774 murine macrophages (ATCC) to an appropriate acceptor. Efflux is calculated as a unitless measure by using the following formula: \[(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholestero
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2025-05-31 |
What the finished NCT04061018 record still lists
NCT04061018 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 86 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04061018 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04061018 about?
NCT04061018 is a clinical study titled "The Genetic, Protein, and Lipid Basis of Variation in Cholesterol Efflux". The rationale of this research is that deep phenotyping of individuals at the extremes of cholesterol efflux will identify key determinants of efflux that are potential novel therapeutic targets to prevent or reverse Atherosclerotic Cardiovascular Disease (ASCVD). The investigators propose to carry ...
What is the current status of trial NCT04061018?
This trial is currently completed. The enrollment target is 86 participants. The study started on 2017-12-01. Estimated completion is 2025-05-31.
Who is sponsoring clinical trial NCT04061018?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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