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

Pennington Biomedical Research Center

Status: Enrolling

Conditions: Obesity

Treatments: Procedure: Metabolic & Bariatric Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06059651

PBRC 2023-026

Details and patient eligibility

About

This study aims to determine the relationship between lipid kinetics changes and blood immunosuppressive cells by metabolic surgery in two patient cohorts.

Enrollment: 20 estimated patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

20 participants in 2 patient groups

Cohort 1

Description:

Cohort #1 (within-subject) will enroll up to 10 women with class III obesity who plan to undergo Roux-en-Y metabolic and bariatric surgery as a standard of obesity care. Subjects will complete study measures preoperatively and one year postoperatively.

Treatment:

Procedure: Metabolic & Bariatric Surgery

Cohort 2

Description:

Cohort #2 (between-subject) will enroll up to 10 women with a history of class III obesity who underwent Roux-en-Y metabolic and bariatric surgery as a standard of obesity care approximately one year before enrollment. Subjects in this cohort will be matched on demographic and clinical variables to those in Cohort #1.

Treatment:

Procedure: Metabolic & Bariatric Surgery