NCT06059651RecruitingAccepts Healthy Volunteers
The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology
Pennington Biomedical Research Center
Start Date
1/1/2024
Completion Date
12/31/2026
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
Age Range: 35 years to 60 years
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
Interventions
PROCEDURE
Metabolic & Bariatric Surgery
Conditions
Obesity
Locations
Pennington Biomedical Resarch Center
Baton Rouge, Louisiana 70808
United States