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

NCT06059651 | Completed Results

• 1 other identifier: PBRC 2023-026
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

obesity; bariatric surgery; lipid metabolism; adipose tissue

Outcome Measures

Primary Outcomes (1)

• Plasma Fatty Acid Concentration in Circulation After Bariatric Surgery and Bariatric Surgery

  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 Outcomes (1)

• Metabolic, Inflammatory, and Immunologic Adaptations

  Pre Bariatric surgery (Cohort 1), 1 year Post Bariatric surgery (Cohort 2)

Other Outcomes (1)

• Adipose Tissue-derived Conditioned Media

  Pre bariatric surgery (cohort 1) and post Bariatric surgery (cohort 2)

Study Arms (2)

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

Procedure: Metabolic & Bariatric Surgery

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.

Procedure: Metabolic & Bariatric Surgery

Interventions

Metabolic & Bariatric Surgery PROCEDURE

Metabolic and Bariatric surgery such as Roux-en-Y gastric bypass and Sleeve gastrectomy

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 35 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Pennington Biomedical Resarch Center

Baton Rouge, Louisiana, 70808, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

MeSH Terms

Conditions

Obesity

Interventions

Metabolic Networks and Pathways; Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metabolism; Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Zubaidah nor Hanipah
• Organization: Pennington Biomedical Research Center

Zubaidah.NorHanipah@pbrc.edu

2257632831

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: January 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 15, 2026
• Results First Posted: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)