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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Procedure: Metabolic & Bariatric Surgery

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Zubaidah Nor Hanipah, M.D.; Phone Number: 2257632831; Email: Zubaidah.NorHanipah@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Pennington Biomedical Resarch Center
      • Contact: Justin Brown

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; 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; Roux-en-Y metabolic and bariatric surgery
Cohort 2; 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; Roux-en-Y metabolic and bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Justin Brown, Ph.D., Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PBRC 2023-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No