Extreme Lipids Repository

Recruiting

• Conditions: Lipoprotein Disorder
• Interventions: Other: No intervention is involved in this study

• Registration Number: NCT04156997
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-05-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-16
• Primary Completion: 2029-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

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Exclusion Criteria

• Anyone under 18 years of age will be excluded from the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	No intervention is involved in this study	Healthy adult volunteers with normal lipid metabolism will be recruited for the purpose of comparison
Patients with extreme lipid phenotypes	No intervention is involved in this study	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

Primary Outcome Measures

Name	Time	Method
Data collection for repository	Day 1	Demographic information, clinical history and lipid related bio-marker information will be collected from participants
Biological sample collection for repository	Day 1	Blood samples will be collected for preparation of plasma and serum, extraction of DNA and isolation of circulating cells. Future analysis include genomic, proteomic and metabolomic analysis

Trial Locations

Locations (2)

University of Texas Southwestern Medical Center - Ambulatory Clinic; 🇺🇸 Dallas, Texas, United States

Parkland Health Hospital System; 🇺🇸 Dallas, Texas, United States