ClinicalTrials.gov
History of Changes for Study: NCT04156997
Extreme Lipids Repository
Latest version (submitted April 12, 2024) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 November 5, 2019 None (earliest Version on record)
2 May 12, 2020 Recruitment Status, Study Status and Contacts/Locations
3 April 14, 2021 Recruitment Status, Study Status and Contacts/Locations
4 April 11, 2022 Sponsor/Collaborators and Study Status
5 April 30, 2023 Contacts/Locations, Study Status and Study Description
6 April 12, 2024 Contacts/Locations and Study Status
Comparison Format:
Scroll up to access the controls
Study NCT04156997
Submitted Date:  November 5, 2019 (v1)
Open or close this module Study Identification
Unique Protocol ID: STU-2018-0429
Brief Title: Extreme Lipids Repository
Official Title: Extreme Lipids Repository
Secondary IDs: 1K24HL146838-01 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: November 2019
Overall Status: Recruiting
Study Start: May 10, 2019
Primary Completion: May 2029 [Anticipated]
Study Completion: May 2029 [Anticipated]
First Submitted: October 10, 2019
First Submitted that
Met QC Criteria:		 November 5, 2019
First Posted: November 8, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:		 November 5, 2019
Last Update Posted: November 8, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Texas Southwestern Medical Center
Responsible Party: Sponsor
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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, 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.
Open or close this module Conditions
Conditions: Lipoprotein Disorder
Keywords: Lipoproteins
Cholesterol
High Density Lipoproteins
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Cross-Sectional
Biospecimen Retention: Samples With DNA
Biospecimen Description: Plasma, Serum, DNA, Cells
Enrollment: 250 [Anticipated]
Number of Groups/Cohorts 2
Target Follow-Up Duration: 1 Day
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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
 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
 No intervention is involved in this study
No intervention is involved in this study
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Study Population: Subjects with lipid and metabolism disorders and up to 50 healthy volunteers (age 18 years or older) with a normal lipid metabolism.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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.
Open or close this module Contacts/Locations
Central Contact Person: Sneha Deodhar
Telephone: 214-648-2872
Email: Sneha.Deodhar@UTSouthwestern.edu
Study Officials: Anand Rohatgi, MD
Principal Investigator
University of Texas Southwestern Medical Center
Locations: United States, Texas
Texas Health Resources
[Recruiting]
Dallas, Texas, United States, 75231
Contact:Contact: Sneha Deodhar 214-648-2872 Sneha.Deodhar@UTSouthwestern.edu
Parkland Health Hospital System
[Recruiting]
Dallas, Texas, United States, 75390
Contact:Contact: Sneha Deodhar 214-648-2872 Sneha.Deodhar@UTSouthwestern.edu
University of Texas Southwestern Medical Center - Ambulatory Clinic
[Recruiting]
Dallas, Texas, United States, 75390
Contact:Contact: Sneha Deodha 214-648-2872 Sneha.Deodhar@UTSouthwestern.edu
Open or close this module IPDSharing
Plan to Share IPD: Yes
Deidentified demographics, risk factors, clinical history, and research-based measures will be shared with other researchers with appropriate approval.
Supporting Information:
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.
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:
Scroll up to access the controls Scroll to the Study top
U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services