Effects of metabolic surgery on lipid metabolism and cancer biology

The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology

This study tests how metabolic surgery affects fat metabolism and immune cells in women with obesity to see if it can improve their health.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 35 Years to 60 Years
• Sex: Female
• Sponsor: Pennington Biomedical Research Center (Academic / other)
• Locations: 1 site (Baton Rouge, Louisiana)
• Trial ID: NCT06059651 on ClinicalTrials.gov

What this trial studies

This observational study investigates how metabolic and bariatric surgery influences lipid metabolism and the behavior of myeloid-derived suppressor cells in patients with obesity. It focuses on two cohorts of biological females aged 35 to 60 years, assessing changes in lipid kinetics and immunosuppressive cell profiles post-surgery. The study aims to enroll a balanced representation of white and black participants with a body mass index of 40 kg/m2 or higher and a diagnosis of hyperlipidemia. Participants will provide informed consent and allow for the collection of biospecimens for future research.

Who should consider this trial

Good fit: Ideal candidates are biological females aged 35 to 60 years with a body mass index of 40 kg/m2 or higher and a diagnosis of hyperlipidemia.

Not a fit: Patients with type one or type two diabetes or those currently using anti-inflammatory medications or obesity management drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how metabolic surgery impacts lipid metabolism and immune responses, potentially leading to improved treatment strategies for obesity-related conditions.

How similar studies have performed: While this study explores a specific relationship, similar studies have shown promising results in understanding metabolic surgery's effects on lipid metabolism and immune function.

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

Where this trial is running

Baton Rouge, Louisiana

• Pennington Biomedical Resarch Center — Baton Rouge, Louisiana, United States (Recruiting)

Study contacts

• Principal investigator: Justin Brown, Ph.D. — Pennington Biomedical Research Center
• Study coordinator: Zubaidah Nor Hanipah, M.D.

Conditions Obesity