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Extreme Lipids Repository

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156997
Recruitment Status : Suspended (The study is temporarily suspended due to covid-19 policy.)
First Posted : November 8, 2019
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Lipoprotein Disorder 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, Parkland Hospital, and overall Texas Health Resources health systems 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Extreme Lipids Repository
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : May 2029
Estimated Study Completion Date : May 2029

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




Primary Outcome Measures :
  1. Biological sample collection for repository [ Time Frame: 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

  2. Data collection for repository [ Time Frame: Day 1 ]
    Demographic information, clinical history and lipid related bio-marker information will be collected from participants


Biospecimen Retention:   Samples With DNA
Plasma, Serum, DNA, Cells


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156997


Locations
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United States, Texas
Texas Health Resources
Dallas, Texas, United States, 75231
Parkland Health Hospital System
Dallas, Texas, United States, 75390
University of Texas Southwestern Medical Center - Ambulatory Clinic
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Anand Rohatgi, MD University of Texas Southwestern Medical Center
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04156997    
Other Study ID Numbers: STU-2018-0429
1K24HL146838-01 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified demographics, risk factors, clinical history, and research-based measures will be shared with other researchers with appropriate approval.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Texas Southwestern Medical Center:
Lipoproteins
Cholesterol
High Density Lipoproteins