Extreme Lipids Repository

NCT04156997 | Active Not Recruiting

• 2 other identifiers: STU-2018-04291K24HL146838-01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Lipoprotein Disorder

Keywords

Lipoproteins; Cholesterol; High Density Lipoproteins

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

No intervention is involved in this study OTHER

No intervention is involved in this study

Healthy volunteers; Patients with extreme lipid phenotypes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Parkland Health Hospital System

Dallas, Texas, 75390, United States

Location

University of Texas Southwestern Medical Center - Ambulatory Clinic

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, DNA, Cells

Study Officials

• Anand Rohatgi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: November 8, 2019
• Study Start: May 10, 2019
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will become available after completed enrollment of any participant. The data will be available for the duration of the registry.
• 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.

Locations

US (2)