ObesityNCT06059651

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

An observational study of Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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 Read more about this study

Who is it for?: Ages 35 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Metabolic & Bariatric Surgery
Type of treatment: Surgery or procedure
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2024to 1 Apr 2026
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 60 years
Women only
Healthy volunteers accepted
Adult

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
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

Trial locations and contacts

1 site in 1 country.

United States1 site

Pennington Biomedical Resarch Center
Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Conditions: Obesity
Being tested: Metabolic & Bariatric Surgery
Keywords: obesity, bariatric surgery, lipid metabolism, adipose tissue
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06059651
Study group	Role	What they receive
Cohort 1		Cohort #1 (within-subject) will enroll up to 10 women with class III obesity who plan to undergo metabolic and bariatric surgery as a standard of obesity care. Subjects will complete study measures preoperatively Receives: 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 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. Receives: Procedure: Metabolic & Bariatric Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Fatty Acid Concentration in Circulation After Bariatric Surgery and Bariatric Surgery
Fatty acid concentration in serum plasma (mean and SD) before bariatric surgery (cohort 1) and 1-year post bariatric surgery (cohort 2) were measured.
Measured: Pre Bariatric surgery (Cohort 1), 1 year Post Bariatric surgery (Cohort 2)

Secondary outcomes (1)

Metabolic, Inflammatory, and Immunologic Adaptations
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)
Measured: Pre Bariatric surgery (Cohort 1), 1 year Post Bariatric surgery (Cohort 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20241 Apr 2026

First posted28 Sep 2023
Study start1 Jan 2024
Primary completion1 Mar 2026
Study completion1 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06059651
Sponsor's protocol ID: PBRC 2023-026
Status last verified: Sep 2026
First submitted: 22 Sep 2023
Last updated: 15 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
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Exercise Training and Vitamin D Metabolism
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Metabolic Health, Bones and Nuts During Weight Loss in Adults
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Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology
ClinicalTrials.gov ID: NCT06059651
Acronym / sponsor ID: PBRC 2023-026
Conditions: Obesity
Keywords: obesity, bariatric surgery, lipid metabolism, adipose tissue
Study type: Observational
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Collaborators: Louisiana State University Health Sciences Center in New Orleans
Study start: 1 Jan 2024 (actual)
Primary completion: 1 Mar 2026 (actual)
Study completion: 1 Apr 2026 (actual)
First posted: 28 Sep 2023 (actual)
Results: Posted 15 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Cohort 1	–	Procedure: Metabolic & Bariatric SurgeryCohort #1 (within-subject) will enroll up to 10 women with class III obesity who plan to undergo metabolic and bariatric surgery as a standard of obesity care. Subjects will complete study measures preoperatively
Cohort 2	–	Procedure: Metabolic & Bariatric SurgeryCohort #2 (between-subject) will enroll up to 10 women with a history of class III obesity who underwent 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.

Who may qualify

Ages: 35 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Metabolic & Bariatric SurgeryMetabolic and Bariatric surgery such as Roux-en-Y gastric bypass and Sleeve gastrectomy	Procedure or surgery	Cohort 1, Cohort 2

Primary outcome

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.

1 secondary outcome

Metabolic, Inflammatory, and Immunologic Adaptations
Time frame: Pre Bariatric surgery (Cohort 1), 1 year Post Bariatric surgery (Cohort 2)

Results and safety

Results posted to the registry on 15 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort #1	6	6
Cohort #2	5	5

Primary outcome: 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). Least squares mean (Standard Deviation). Unit: mmol/L

Measure	Cohort #1 n = 6	Cohort #2 n = 5
Value	0.76 (0.29)	0.60 (0.28)

Population analysed: Fatty acid levels before and after bariatric surgery

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 10 days after each study visits. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort #1	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Cohort #2	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06059651.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.