Status:
RECRUITING
The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology
Lead Sponsor:
Pennington Biomedical Research Center
Conditions:
Obesity
Eligibility:
FEMALE
35-60 years
Brief Summary
This study aims to determine the relationship between lipid kinetics changes and blood immunosuppressive cells by metabolic surgery in two patient cohorts.
Eligibility Criteria
Inclusion
- For an eligible subject, all the following must be answered "yes":
- Biological female sex
- Age \>=35 and \<=60 years (including pre- and postmenopausal)
- Self-reported white or black race
- The study will enroll approximately 50% white and 50% black subjects
- Body mass index \>/=40 kg/m2
- Have a diagnosis of hyperlipidemia (high triglycerides and LDL-cholesterol) or in treatment with any medication for hyperlipidemia at enrollment
- Ability to provide written informed consent
- Allow the collection and storage of biospecimens and data for future use
- Not having yet started the pre-op liquid diet before the bariatric surgery
- For an eligible subject, all the following must be answered "no":
- Have type one or type two diabetes
- Use of anti-inflammatory medications, such as glucocorticoids or non-steroidal anti-inflammatory medications, within the past 15 days
- Use of medication approved for obesity management, including, but not limited to, phentermine-topiramate (Qsymia), orlistat (Xenical), naltrexone-bupropion (Contrave), liraglutide (Saxenda), and semaglutide (Wegovy)
- History of cancer of any type
- History of chronic conditions known to cause inflammation, such as tuberculosis, autoimmune disease, and human immunodeficiency virus
- An acute history (within the past 60 days) or confirmed or suspected SARS-CoV-2 (COVID-19) infection
- Currently pregnant, breastfeeding, or planning to become pregnant within the next 52 weeks
- Currently participating in another study with competing outcomes
- Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06059651
Start Date
January 1 2024
End Date
December 31 2026
Last Update
February 17 2025
Active Locations (1)
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1
Pennington Biomedical Resarch Center
Baton Rouge, Louisiana, United States, 70808