Extreme Lipids Repository
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ClinicalTrials.gov Identifier: NCT04156997 |
Recruitment Status :
Recruiting
First Posted : November 8, 2019
Last Update Posted : April 16, 2024
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Condition or disease | Intervention/treatment |
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Lipoprotein Disorder | Other: No intervention is involved in this study |
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
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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
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Other: No intervention is involved in this study
No intervention is involved in this study |
- 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
Biospecimen Retention: Samples With DNA
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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 |
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.
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
Contact: Shailesh Jaiswal | 214-645-2049 | Shailesh.Jaiswal@UTSouthwestern.edu |
United States, Texas | |
Parkland Health Hospital System | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Shailesh Jaiswal 214-645-2049 Shailesh.Jaiswal@UTSouthwestern.edu | |
University of Texas Southwestern Medical Center - Ambulatory Clinic | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Shailesh Jaiswal 214-645-2049 Shailesh.Jaiswal@UTSouthwestern.edu |
Principal Investigator: | Anand Rohatgi, MD | University of Texas Southwestern Medical Center |
Responsible Party: | Anand Rohatgi, Professor of Medicine, 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: | April 16, 2024 |
Last Verified: | April 2024 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lipoproteins Cholesterol High Density Lipoproteins |