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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059651
• Other study ID #: PBRC 2023-026
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Pennington Biomedical Research Center
• Contact: Justin Brown, Ph.D.
• Phone: 2257632715
• Email: justin.brown[@]pbrc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Pennington Biomedical Resarch Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin-inhibited adipose tissue lipolysis		Baseline, week 52
Primary	Change in the number of circulating myeloid-derived suppressor cells		Baseline, week 52