- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04061018
The Genetic, Protein, and Lipid Basis of Variation in Cholesterol Efflux
Study Overview
Status
Conditions
Detailed Description
The mechanisms that underlie variation in cholesterol efflux are unknown. There is a critical need to identify factors that regulate cholesterol efflux to effectively advance the clinical development of cholesterol efflux as both a risk prediction marker and as a target of therapy. The investigator's long-term goal is to determine whether modulating cholesterol efflux prevents or reverses cardiovascular disease. The overall objective of this study is to systematically create a family pedigree and biobank repository of blood and DNA from participants from the Dallas Heart Study with extreme low or high cholesterol efflux, with the specific aims of : 1) determining the heritability of and genomic factors associated with cholesterol efflux, and 2) identifying the protein and lipid signature of extreme low and high cholesterol efflux in a sex- and ethnicity-specific manner. The investigator's central hypothesis is that a combination of genetic variation in lipid transporters as well as proteins and lipids will be most strongly correlated with variation in efflux.
DHS probands and their relatives (parents, siblings, adult children, grandparents, aunts/uncles, cousins) with extreme low or high cholesterol efflux will be recruited to establish a prospective family pedigree cohort and understand the heritability of extreme cholesterol efflux. Investigators will collect the following information from all participants: demographics, health history, lifestyle measures, and medications. Blood will be collected on-site by venipuncture and plasma, serum, and cells will be stored at -80o Celsius. All efflux measurements will be completed in the investigator's laboratory.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Participants from the Dallas Heart Study (DHS) with extreme low or high cholesterol efflux will be recruited in this study. DHS is a multi-ethnic, population based probability sample of Dallas County designed to define the social and the biological variables contributing to ethnic differences in cardiovascular health at the community level.
https://www.utsouthwestern.edu/edumedia/edufiles/research/center_translational_medicine/dallas_heart_study/dhs-study-overview.pdf
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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High Cholesterol Efflux
Dallas Heart Study participants who are above the sex and ethnicity specific 90th % of cholesterol efflux
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Low Cholesterol Efflux
Dallas Heart Study participants who are below the sex and ethnicity specific 10th % of cholesterol efflux
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contribution of genetic factors to variability in cholesterol efflux
Time Frame: Anticipated completion date - November 2022
|
The expected outcome is establishing the degree of heritability of the extreme low or high cholesterol efflux phenotype, specific for sex and ethnicity and the contribution of common and rare genetic variants to cholesterol efflux.
This will establish for the first time to what degree inherited verses environmental factors associate with variation in cholesterol efflux.
|
Anticipated completion date - November 2022
|
Circulating metabolites and proteins linked to variation cholesterol efflux
Time Frame: Anticipated completion date - November 2022
|
The investigators will measure circulating metabolites and proteins and identify the most relevant to the high/low cholesterol efflux phenotype, offering the potential to focus future studies targeting metabolic regulators of efflux.
|
Anticipated completion date - November 2022
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anand Rohatgi, MD, UT Southwetsern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 042016-020
- 1R01HL136724-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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