Extreme Lipids Repository

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.

Study Overview

• Status: Recruiting
• Conditions: Lipoprotein Disorder
• Intervention / Treatment: Other: No intervention is involved in this study

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Shailesh Jaiswal; Phone Number: 214-645-2049; Email: Shailesh.Jaiswal@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • Parkland Health Hospital System
      • Contact: Shailesh Jaiswal; Phone Number: 214-645-2049; Email: Shailesh.Jaiswal@UTSouthwestern.edu
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center - Ambulatory Clinic
      • Contact: Shailesh Jaiswal; Phone Number: 214-645-2049; Email: Shailesh.Jaiswal@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects with lipid and metabolism disorders and up to 50 healthy volunteers (age 18 years or older) with a normal lipid metabolism.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: No intervention is involved in this study; No intervention is involved in this study
Healthy volunteers; Healthy adult volunteers with normal lipid metabolism will be recruited for the purpose of comparison	Other: No intervention is involved in this study; No intervention is involved in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological sample collection for repository	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	Day 1
Data collection for repository	Demographic information, clinical history and lipid related bio-marker information will be collected from participants	Day 1

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Anand Rohatgi, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cholesterol; Lipoproteins; High Density Lipoproteins
• Other Study ID Numbers: STU-2018-0429; 1K24HL146838-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified demographics, risk factors, clinical history, and research-based measures will be shared with other researchers with appropriate approval.
• IPD Sharing Time Frame: Data will become available after completed enrollment of any participant. The data will be available for the duration of the registry.
• IPD Sharing Access Criteria: Researchers may request data from the PI, Dr. Anand Rohatgi. Once approval is given and appropriate regulatory approvals are in place, access may be granted and data shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No