The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology
September 14, 2026 updated by: Zubaidah Nor Hanipah, Pennington Biomedical Research Center
This study aims to determine the relationship between lipid metabolic alterations associated with insulin resistance changes, and blood immunosuppressive-type cells (MDSC) by metabolic and bariatric surgery in two patient cohorts matched on demographic and clinical factors
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
11
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Resarch Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
- Planned to have bariatric surgery or post-bariatric surgery
- 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 diabetes
- Use of anti-inflammatory medications, such as glucocorticoids or non-steroidal anti-inflammatory medications, within the past 15 days
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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 metabolic and bariatric surgery as a standard of obesity care.
Subjects will complete study measures preoperatively
|
Metabolic and Bariatric surgery such as Roux-en-Y gastric bypass and Sleeve gastrectomy
|
|
Cohort 2
Cohort #2 (between-subject) will enroll up to 10 women with a history of class III obesity who underwent 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.
|
Metabolic and Bariatric surgery such as Roux-en-Y gastric bypass and Sleeve gastrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma Fatty Acid Concentration in Circulation After Bariatric Surgery and Bariatric Surgery
Time Frame: Pre Bariatric surgery (Cohort 1), 1 year Post Bariatric surgery (Cohort 2)
|
Fatty acid concentration in serum plasma (mean and SD) before bariatric surgery (cohort 1) and 1-year post bariatric surgery (cohort 2) were measured.
|
Pre Bariatric surgery (Cohort 1), 1 year Post Bariatric surgery (Cohort 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic, Inflammatory, and Immunologic Adaptations
Time Frame: Pre Bariatric surgery (Cohort 1), 1 year Post Bariatric surgery (Cohort 2)
|
To characterize and compare systemic and tissue-specific metabolic, inflammatory, and immunologic adaptations associated with metabolic and bariatric surgery by assessing a range of physiologic and molecular endpoints in Cohort #1 (pre-surgery) versus Cohort #2 (post-surgery)
|
Pre Bariatric surgery (Cohort 1), 1 year Post Bariatric surgery (Cohort 2)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adipose Tissue-derived Conditioned Media
Time Frame: Pre bariatric surgery (cohort 1) and post Bariatric surgery (cohort 2)
|
Obtain an adipose tissue biopsy (subcutaneous and/or visceral) to generate adipose tissue-derived conditioned media with and without induction of lipolysis for in vitro experiments. Arm 1 (cohort 1) and Arm 2 (cohort 2) |
Pre bariatric surgery (cohort 1) and post Bariatric surgery (cohort 2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Justin Brown, Ph.D., Pennington Biomedical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
March 1, 2026
Study Completion (Actual)
April 1, 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)
September 15, 2026
Last Update Submitted That Met QC Criteria
September 14, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.