Extreme Lipids Repository

Lipoprotein Disorder Clinical Trial

Official title:

Extreme Lipids Repository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04156997
• Other study ID #: STU-2018-0429
• Secondary ID: 1K24HL146838-01
• Status: Recruiting
• Start date: May 10, 2019
• Est. completion date: May 2029

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Shailesh Jaiswal
• Phone: 214-645-2049
• Email: Shailesh.Jaiswal[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 2029
• Est. primary completion date: May 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lipoprotein Disorder

Intervention

Other:
• No intervention is involved in this study
No intervention is involved in this study

Locations

Country	Name	City	State
United States	Parkland Health Hospital System	Dallas	Texas
United States	University of Texas Southwestern Medical Center - Ambulatory Clinic	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Data collection for repository	Demographic information, clinical history and lipid related bio-marker information will be collected from participants	Day 1