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| ID | Type | Description | Link |
|---|---|---|---|
| 1K24HL146838-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Healthy volunteers | Healthy adult volunteers with normal lipid metabolism will be recruited for the purpose of comparison |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention is involved in this study | Other | No intervention is involved in this study |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Data collection for repository | Demographic information, clinical history and lipid related bio-marker information will be collected from participants | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with lipid and metabolism disorders and up to 50 healthy volunteers (age 18 years or older) with a normal lipid metabolism.
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| Name | Affiliation | Role |
|---|---|---|
| Anand Rohatgi, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Health Hospital System | Dallas | Texas | 75390 | United States | ||
| University of Texas Southwestern Medical Center - Ambulatory Clinic |
Deidentified demographics, risk factors, clinical history, and research-based measures will be shared with other researchers with appropriate approval.
Data will become available after completed enrollment of any participant. The data will be available for the duration of the registry.
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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Plasma, Serum, DNA, Cells
| Dallas |
| Texas |
| 75390 |
| United States |