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

Launched by PENNINGTON BIOMEDICAL RESEARCH CENTER · Sep 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how metabolic and bariatric surgery can affect fat metabolism and certain immune cells in women with obesity. The researchers are particularly interested in understanding the changes that happen in the body after surgery, especially regarding fat levels in the blood and the behavior of immune cells that may suppress the body's ability to fight cancer. The goal is to learn more about the connections between these factors, which could help improve treatment options for people with obesity.

To participate in this study, you need to be a biological female between the ages of 35 and 60 who has a body mass index (BMI) of 40 or higher, indicating obesity. You should also have high levels of fats in your blood, known as hyperlipidemia, and not be on certain medications for obesity or have any serious health issues like diabetes or cancer. If you join the study, you'll be asked to give consent for researchers to collect some of your blood and tissue samples for future analysis. This trial is currently recruiting participants, and it's a great opportunity to contribute to important research that could lead to better health outcomes for many people.

Gender

FEMALE

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