The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156997
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : April 16, 2024
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Anand Rohatgi, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date October 10, 2019
First Posted Date November 8, 2019
Last Update Posted Date April 16, 2024
Actual Study Start Date May 10, 2019
Estimated Primary Completion Date May 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2019)
  • 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
  • Data collection for repository [ Time Frame: Day 1 ]
    Demographic information, clinical history and lipid related bio-marker information will be collected from participants
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Extreme Lipids Repository
Official Title Extreme Lipids Repository
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Retention:   Samples With DNA
Description:
Plasma, Serum, DNA, Cells
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.
Condition Lipoprotein Disorder
Intervention Other: No intervention is involved in this study
No intervention is involved in this study
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Other: No intervention is involved in this study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 5, 2019)		 250
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2029
Estimated Primary Completion Date May 2029   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Shailesh Jaiswal 214-645-2049 Shailesh.Jaiswal@UTSouthwestern.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04156997
Other Study ID Numbers STU-2018-0429
1K24HL146838-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Current Responsible Party Anand Rohatgi, University of Texas Southwestern Medical Center
Original Responsible Party University of Texas Southwestern Medical Center
Current Study Sponsor University of Texas Southwestern Medical Center
Original Study Sponsor Same as current
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Anand Rohatgi, MD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date April 2024