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Recruiting

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 kinetics changes and blood immunosuppressive cells by metabolic surgery in two patient cohorts.

Recruiting

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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

Location status: Recruiting

Location contact

Justin Brown

CONTACT

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
  • 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

Treatment and study plan

Metabolic & Bariatric Surgery

Procedure

Roux-en-Y metabolic and bariatric surgery

Primary outcomes

  1. Change in insulin-inhibited adipose tissue lipolysis

    Time frame: Baseline, week 52

  2. Change in the number of circulating myeloid-derived suppressor cells

    Time frame: Baseline, week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Zubaidah Nor Hanipah, M.D.

CONTACT

[email protected]

2257632831

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Feb 17, 2025

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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