Trial Outcomes & Findings for The Genetic, Protein, and Lipid Basis of Variation in Cholesterol Efflux (NCT NCT04061018)
NCT ID: NCT04061018
Last Updated: 2026-03-20
Results Overview
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: \[(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)\]. Cholesterol efflux capacity is inversely correlated with incidence of cardiovascular events (i.e. higher cholesterol efflux capacity is better for patients).
COMPLETED
86 participants
Baseline
2026-03-20
Participant Flow
Though both Dallas Heart Study (DHS) patients with High/ Low Cholesterol Efflux and their family members were both enrolled in this study, the study population only included random set of 57 subjects from DHS that were below 10th or above 90th percentile of cholesterol efflux distribution. Though 29 family members were enrolled, they were not assigned to any of the below Arms/ Groups and didn't start on this study and therefore no data was collected on them.
Participant milestones
| Measure |
High Cholesterol Efflux
Dallas Heart Study participants who are above the sex and ethnicity specific 90th % of cholesterol efflux
|
Low Cholesterol Efflux
Dallas Heart Study participants who are below the sex and ethnicity specific 10th % of cholesterol efflux
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
27
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Genetic, Protein, and Lipid Basis of Variation in Cholesterol Efflux
Baseline characteristics by cohort
| Measure |
High Cholesterol Efflux
n=19 Participants
Dallas Heart Study participants who are above the sex and ethnicity specific 90th % of cholesterol efflux
|
Low Cholesterol Efflux
n=17 Participants
Dallas Heart Study participants who are below the sex and ethnicity specific 10th % of cholesterol efflux
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=154 Participants
|
4 Participants
n=151 Participants
|
17 Participants
n=305 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=154 Participants
|
13 Participants
n=151 Participants
|
19 Participants
n=305 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=154 Participants
|
12 Participants
n=151 Participants
|
25 Participants
n=305 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=154 Participants
|
5 Participants
n=151 Participants
|
11 Participants
n=305 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=154 Participants
|
10 Participants
n=151 Participants
|
22 Participants
n=305 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=154 Participants
|
9 Participants
n=151 Participants
|
18 Participants
n=305 Participants
|
|
Number of Participants with Hypercholesterolemia
|
9 Participants
n=154 Participants
|
9 Participants
n=151 Participants
|
18 Participants
n=305 Participants
|
|
Number of Participants with Diabetes
|
6 Participants
n=154 Participants
|
4 Participants
n=151 Participants
|
10 Participants
n=305 Participants
|
|
Number of Participants with Heart Disease
|
2 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
2 Participants
n=305 Participants
|
|
Number of Participants with Hypertension
|
8 Participants
n=154 Participants
|
12 Participants
n=151 Participants
|
20 Participants
n=305 Participants
|
|
Number of Participants Menopausal
|
11 Participants
n=154 Participants
|
11 Participants
n=151 Participants
|
22 Participants
n=305 Participants
|
|
Number of Participants who are Current Smokers
|
4 Participants
n=154 Participants
|
1 Participants
n=151 Participants
|
5 Participants
n=305 Participants
|
|
Number of Participants who drink Alcohol
|
13 Participants
n=154 Participants
|
12 Participants
n=151 Participants
|
25 Participants
n=305 Participants
|
|
Number of Participants who take Blood pressure medication
|
9 Participants
n=154 Participants
|
11 Participants
n=151 Participants
|
20 Participants
n=305 Participants
|
|
Number of Participants who take Glucose medication
|
5 Participants
n=154 Participants
|
4 Participants
n=151 Participants
|
9 Participants
n=305 Participants
|
|
Number of Participants who take Lipid medication
|
8 Participants
n=154 Participants
|
6 Participants
n=151 Participants
|
14 Participants
n=305 Participants
|
PRIMARY outcome
Timeframe: BaselineCholesterol 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: \[(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)\]. Cholesterol efflux capacity is inversely correlated with incidence of cardiovascular events (i.e. higher cholesterol efflux capacity is better for patients).
Outcome measures
| Measure |
High Cholesterol Efflux
n=19 Participants
Dallas Heart Study participants who are above the sex and ethnicity specific 90th % of cholesterol efflux
|
Low Cholesterol Efflux
n=17 Participants
Dallas Heart Study participants who are below the sex and ethnicity specific 10th % of cholesterol efflux
|
|---|---|---|
|
Cholesterol Efflux Capacity (CEC)
|
1.30 Ratio
Interval 1.2 to 1.42
|
0.65 Ratio
Interval 0.38 to 0.75
|
PRIMARY outcome
Timeframe: BaselineThe investigators will measure circulating metabolite (glucose) and identify the most relevant to the high/low cholesterol efflux phenotype, offering the potential to focus future studies targeting metabolic regulators of efflux.
Outcome measures
| Measure |
High Cholesterol Efflux
n=19 Participants
Dallas Heart Study participants who are above the sex and ethnicity specific 90th % of cholesterol efflux
|
Low Cholesterol Efflux
n=17 Participants
Dallas Heart Study participants who are below the sex and ethnicity specific 10th % of cholesterol efflux
|
|---|---|---|
|
Circulating Metabolite (Glucose) Linked to Variation Cholesterol Efflux
|
5.72 mmol/L
Interval 4.94 to 6.94
|
5.27 mmol/L
Interval 4.99 to 5.77
|
PRIMARY outcome
Timeframe: BaselineThe investigators will measure circulating metabolite (creatinine) and identify the most relevant to the high/low cholesterol efflux phenotype, offering the potential to focus future studies targeting metabolic regulators of efflux.
Outcome measures
| Measure |
High Cholesterol Efflux
n=19 Participants
Dallas Heart Study participants who are above the sex and ethnicity specific 90th % of cholesterol efflux
|
Low Cholesterol Efflux
n=17 Participants
Dallas Heart Study participants who are below the sex and ethnicity specific 10th % of cholesterol efflux
|
|---|---|---|
|
Circulating Metabolite (Creatinine) Linked to Variation Cholesterol Efflux
|
77.79 umol/L
Interval 61.88 to 86.63
|
71.60 umol/L
Interval 51.27 to 81.33
|
PRIMARY outcome
Timeframe: BaselineThe investigators will measure circulating proteins (apolipoprotein A-I, Albumin, Hemoglobin) and identify the most relevant to the high/low cholesterol efflux phenotype, offering the potential to focus future studies targeting metabolic regulators of efflux.
Outcome measures
| Measure |
High Cholesterol Efflux
n=19 Participants
Dallas Heart Study participants who are above the sex and ethnicity specific 90th % of cholesterol efflux
|
Low Cholesterol Efflux
n=17 Participants
Dallas Heart Study participants who are below the sex and ethnicity specific 10th % of cholesterol efflux
|
|---|---|---|
|
Circulating Proteins Linked to Variation Cholesterol Efflux
Albumin
|
44 G/L
Interval 42.0 to 45.0
|
45 G/L
Interval 41.0 to 46.0
|
|
Circulating Proteins Linked to Variation Cholesterol Efflux
Apolipoprotein A-I
|
1.54 G/L
Interval 1.48 to 1.82
|
1.55 G/L
Interval 1.49 to 1.71
|
|
Circulating Proteins Linked to Variation Cholesterol Efflux
Hemoglobin
|
136 G/L
Interval 129.0 to 149.0
|
137 G/L
Interval 130.0 to 143.0
|
Adverse Events
High Cholesterol Efflux
Low Cholesterol Efflux
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place