N/A
N=57
The Genetic, Protein, and Lipid Basis of Variation in Cholesterol Efflux
Lipid Metabolism Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04061018 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Cholesterol Efflux Capacity (CEC) — 1.30; 0.65 Ratio
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cholesterol Efflux Capacity (CEC) |
1.30; 0.65 | — |
| PRIMARY Circulating Metabolite (Glucose) Linked to Variation Cholesterol Efflux |
5.72; 5.27 | — |
| PRIMARY Circulating Metabolite (Creatinine) Linked to Variation Cholesterol Efflux |
77.79; 71.60 | — |
| PRIMARY Circulating Proteins Linked to Variation Cholesterol Efflux |
1.54; 1.55; 44; 45; 136; 137 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Dallas Heart Study (DHS) Participants who are above or below the sex- and ethnicity-specific 10th and 90th% of cholesterol efflux.
- Family members of the DHS participants are also eligible
Exclusion Criteria
- HIV
- Cancer
- Autoimmune diseases
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT04061018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.