Extreme Lipids Repository

NCT ID: NCT04156997

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-10

Study Completion Date

2029-05-31

Brief Summary

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This is a prospective, observational study to establish a repository of samples from patients with extreme lipid phenotypes including but not limited to hyperlipidemia, dyslipidemia, hyperlipoproteinemia, extreme low/high HDL levels and deranged lipoprotein metabolism. The investigators plan to conduct sophisticated composition and functional analyses as well as genetic analysis to better understand the determinants of extreme lipid derangements.

Detailed Description

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Participants will be recruited from clinical encounters within the University of Texas (UT) Southwestern Medical Center and Parkland Hospital by screening the Electronic Medical Record (EMR) for those with lipid labs and values that satisfy criteria for extreme values. Identified participants will be recruited to provide health information via survey, permission to extract clinical information from the EMR, and blood collection for future analyses. Measurements will span direct measurement of circulating species, genetic analyses, and analysis of circulating cells. The blood specimens will be stored for future studies and collaborations and thus, will constitute a blood-based repository. All study procedures are experimental but do not involve an actual intervention.

Conditions

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Lipoprotein Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with extreme lipid phenotypes

Adult patients (age 18 years or older) diagnosed with any lipid or metabolic disorder including hyperlipidemia, dyslipidemia, hyperlipoproteinemia, low HDL levels and deranged lipoprotein metabolism

No intervention is involved in this study

Intervention Type OTHER

No intervention is involved in this study

Healthy volunteers

Healthy adult volunteers with normal lipid metabolism will be recruited for the purpose of comparison

No intervention is involved in this study

Intervention Type OTHER

No intervention is involved in this study

Interventions

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No intervention is involved in this study

No intervention is involved in this study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adult patients (age 18 years or older) diagnosed with any lipid or metabolic disorder including hyperlipidemia, dyslipidemia, hyperlipoproteinemia, low HDL levels and deranged lipoprotein metabolism

Exclusion Criteria

* Anyone under 18 years of age will be excluded from the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Anand Rohatgi

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anand Rohatgi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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Parkland Health Hospital System

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center - Ambulatory Clinic

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1K24HL146838-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU-2018-0429

Identifier Type: -

Identifier Source: org_study_id

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