Clinical trial NCT06059651: The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology
Official title: The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include women with class III obesity who plan to undergo or have completed treatment with metabolic and bariatric surgery.

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

Primary outcomes:
measure: Change in insulin-inhibited adipose tissue lipolysis
timeFrame: Baseline, week 52
measure: Change in the number of circulating myeloid-derived suppressor cells
timeFrame: Baseline, week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Resarch Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Justin Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: