An observational study in Obesity, sponsored by Louisiana State University Health Sciences Center in New Orleans. Active, not recruiting at 2 sites in United States. Open to participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Observational
This study evaluates the relationship between weight loss, circulating inflammatory markers and lipids from 24 patients before and after 6 months of pharmacotherapy as a standard of care for anti-obesity treatment
This study aims to determine if weight loss by pharmacotherapy with liraglutide, semaglutide, or phentermine-topiramate promotes the reduction of pro-tumoral inflammatory cells Myeloid-derived suppressor cells (MDSC), simultaneously to the improvement of lipid profile (LDL-Cholesterol, HDL-Cholesterol, triglycerides, and free fatty acids) and concentration in the blood.
Liraglutide, semaglutide, and phentermine-topiramate are FDA-approved medications to treat obesity and obesity-associated comorbidities.
Twenty-four patients undergoing standard of care for anti-obesity treatment at VA Medical Center, and Tulane Center for Clinical Research (TCCR) will be recruited before initiation of pharmacotherapy as part of their standard of care and followed up to 6 months to compare the primary study variables.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 30 is below the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 70 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with obesity, defined as having a body mass index (BMI) > 30, from New Orleans and its surroundings, scheduled for initiating the anti-obesity treatment with drugs for weight loss as part of their standard-of-care for anti-obesity treatment at Clinics from New Orleans and its surroundings; therefore, the research trial team will not provide the medications. Expect to recruit 50% African American (6 women, 6 men), and 50% White American (6 women, 6 men), as a representative majority of the New Orleans population.
Exclusion Criteria:
Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
Drug: Semaglutide · Drug: Phentermine-Topiramate combination · Drug: Phentermine · Drug: Tirzepatide · Drug: Topiramate · Drug: Diethylpropion · Drug: Naltrexone/Bupropion · Drug: Liraglutide
Medication for weight loss
Also known as: Glucagon-like peptide-1 receptor (GLP1-R) agonist, Wegovy
Medication for weight loss
Also known as: Qsymia
Medication for weight loss
Also known as: Lomaira, Adipex-P
Medication for weight loss
Also known as: Mounjaro, Zepbound, GIP/GLP-1 RA
Medication for weight loss
Also known as: Topamax, Trokendi XR, Qudexy XR
Medication for weight loss
Also known as: Tenuate, Diethylcathinone
Medication for weight loss
Also known as: Contrave
Medication for weight loss
Also known as: Saxenda, Victoza, Glucagon-like peptide-1 receptor (GLP1-R) agonist
weight loss
Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100)
Time frame: baseline and 24 weeks
MDSC in peripheral blood
Changes in number of MDSC in blood
Time frame: baseline and 24 weeks
Levels of lipids in circulation
Changes in concentration (mg/dL) of each type of lipids: LDL-Cholesterol, triglycerides, and free fatty acids
Time frame: baseline and 24 weeks
Systemic inflammation measured by C-reactive protein levels
Changes in concentration (mg/L) of C-reactive protein in serum
Time frame: baseline and 24 weeks
Systemic inflammation measured by adipokines levels in circulation
Changes in concentration (pg/mL) of interleukin 6 (IL-6), tumor-necrosis factor alpha (TNFa) and leptin in plasma
Time frame: baseline and 24 weeks
Plan to share: Yes — The investigators will adhere to the NIH Grants Policy on Sharing of Unique Research Resources, including the Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (NOT-OD-21-013). Data dictionaries, statistical analysis code, and de-identified data may be deposited for sharing. Data may include demographic, clinical, anthropometric, outcome measures, and other relevant variables, as allowed by the data-owning organization, consistent with applicable laws and regulations.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Louisiana State University Health Sciences Center in New Orleans