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

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

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

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Metabolic & Bariatric Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>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. | Procedure: Metabolic & Bariatric Surgery<br>* Roux-en-Y metabolic and bariatric surgery<br>|
| Cohort 2<br>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. | Procedure: Metabolic & Bariatric Surgery<br>* Roux-en-Y metabolic and bariatric surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin-inhibited adipose tissue lipolysis |  | Baseline, week 52 | 
| Change in the number of circulating myeloid-derived suppressor cells |  | Baseline, week 52 |