Anti-obesity Pharmacotherapy and Inflammation

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Pilot Study of the Effect of Weight Loss by Pharmacotherapy on Chronic Pro-tumor Inflammatory Cells

Conditions
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Obesity

Intervention / Treatment
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* Drug: Liraglutide or Semaglutide
* Drug: Phentermine-Topiramate combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI): over 30 kg/m2 Age: 35 to 60 years old Exclusion Criteria: Taking medications with anti-inflammatory properties like glucocorticoids, prednisone, or non-steroidal anti-inflammatory medications, such as aspirin or Motrin Subjects on medications for long-term weight management such as phentermine-topiramate (Qsymia), orlistat (Xenical), naltrexone-bupropion (Contrave), and the glucagon-like peptide-1 receptor agonists such as liraglutide (Saxenda), and semaglutide (Wegovy). Prior history of cancer Having any clinical symptoms of systemic inflammation, acute infections such as Coronavirus disease 2019, or chronic diseases such as cancer, tuberculosis, autoimmune disease, and AIDS An adult unable to consent Prisoner Pregnancy or breastfeeding women

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with obesity on pharmacotherapy<br>Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication | Drug: Liraglutide or Semaglutide<br>* Medication for reducing obesity<br>* Other names: Saxenda;Drug: Phentermine-Topiramate combination<br>* Medication for reducing obesity<br>* Other names: Qsymia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100) | baseline and 24 weeks | 
| MDSC in peripheral blood | Changes in number of MDSC in blood | 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 | baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic inflammation measured by C-reactive protein levels | Changes in concentration (mg/L) of C-reactive protein in serum | 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 | baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Dyslipidemia, Metabolic syndrome