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Recruiting NCT06059651

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

— Observational Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metabolic & Bariatric Surgery.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 35 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Procedure Metabolic & Bariatric Surgery
    Roux-en-Y metabolic and bariatric surgery

Primary outcome measures

  • Change in insulin-inhibited adipose tissue lipolysis [Time frame: Baseline, week 52]
  • Change in the number of circulating myeloid-derived suppressor cells [Time frame: Baseline, week 52]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Pennington Biomedical Resarch Center — Baton Rouge

Identifiers

NCT: NCT06059651 · PBRC 2023-026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗