NCT06059651 The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology
| NCT ID | NCT06059651 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pennington Biomedical Research Center |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Justin Brown, Ph.D.
PRINCIPAL INVESTIGATOR
Pennington Biomedical Research Center
Frequently Asked Questions
Who can join the NCT06059651 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 60 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06059651 currently recruiting?
Yes, NCT06059651 is actively recruiting participants. Contact the research team at Zubaidah.NorHanipah@pbrc.edu for enrollment information.
Where is the NCT06059651 trial being conducted?
This trial is being conducted at Baton Rouge, United States.
Who is sponsoring the NCT06059651 clinical trial?
NCT06059651 is sponsored by Pennington Biomedical Research Center. The principal investigator is Justin Brown, Ph.D. at Pennington Biomedical Research Center. The trial plans to enroll 20 participants.
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