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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04156997
Other study ID # STU-2018-0429
Secondary ID 1K24HL146838-01
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT05496790 - Role of LipoprotEin(a) in CardiovascuLar Diseases and Premature Acute Coronary Syndromes - (RELACS) Study
Not yet recruiting NCT05081440 - A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center