Obesity
Conditions
Keywords
Inflammation, Dyslipidemia, Metabolic syndrome
Brief summary
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
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.
Interventions
DRUGLiraglutide
Medication for weight loss
DRUGSemaglutide
Medication for weight loss
DRUGPhentermine-Topiramate combination
Medication for weight loss
DRUGPhentermine
Medication for weight loss
DRUGTirzepatide
Medication for weight loss
DRUGTopiramate
Medication for weight loss
DRUGDiethylpropion
Medication for weight loss
Medication for weight loss
Sponsors
Tulane University
Pennington Biomedical Research Center
Ochsner Health System
Louisiana State University Health Sciences Center in New Orleans
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight loss | baseline and 24 weeks | Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100) |
| MDSC in peripheral blood | baseline and 24 weeks | Changes in number of MDSC in blood |
| Levels of lipids in circulation | baseline and 24 weeks | Changes in concentration (mg/dL) of each type of lipids: LDL-Cholesterol, triglycerides, and free fatty acids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic inflammation measured by C-reactive protein levels | baseline and 24 weeks | Changes in concentration (mg/L) of C-reactive protein in serum |
| Systemic inflammation measured by adipokines levels in circulation | baseline and 24 weeks | Changes in concentration (pg/mL) of interleukin 6 (IL-6), tumor-necrosis factor alpha (TNFa) and leptin in plasma |
Countries
United States
Outcome results
None listed