Obesity
Conditions
Keywords
obesity, bariatric surgery, lipid metabolism, adipose tissue
Brief 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
Interventions
PROCEDUREMetabolic & Bariatric Surgery
Metabolic and Bariatric surgery such as Roux-en-Y gastric bypass and Sleeve gastrectomy
Sponsors
Pennington Biomedical Research Center
Louisiana State University Health Sciences Center in New Orleans
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Fatty Acid Concentration in Circulation After Bariatric Surgery and Bariatric Surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Metabolic, Inflammatory, and Immunologic Adaptations | 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) |
Countries
United States
Participant flow
Recruitment details
Metamor clinic from 2024-2025
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.09 years STANDARD_DEVIATION 6.33 |
| BMI | 40.92 kg/m2 STANDARD_DEVIATION 9.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
None listed