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OpenTrials
Completed

NCT Number: NCT06059651

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 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

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Key information

Age range

35 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Pennington Biomedical Resarch Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metabolic & Bariatric Surgery

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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