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

NCT06059651 | Recruiting

• 1 other identifier: PBRC 2023-026
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Change in insulin-inhibited adipose tissue lipolysis

  Baseline, week 52

• Change in the number of circulating myeloid-derived suppressor cells

  Baseline, week 52

Study Arms (2)

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

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

Interventions

Metabolic & Bariatric Surgery PROCEDURE

Roux-en-Y metabolic and bariatric surgery

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 * 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

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

Study Sites (1)

Pennington Biomedical Resarch Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

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

Study Officials

• Justin Brown, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zubaidah Nor Hanipah, M.D.

CONTACT

2257632831; Zubaidah.NorHanipah@pbrc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cancer Metabolism Program

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)