Clinical trial NCT05756764: Anti-obesity Pharmacotherapy and Inflammation
Official title: Pilot Study of the Effect of Weight Loss by Pharmacotherapy on Chronic Pro-tumor Inflammatory Cells
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Keywords: Inflammation
Dyslipidemia
Metabolic syndrome
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: Tulane University
name: Pennington Biomedical Research Center
name: Ochsner Health System
First posted: 2023-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: weight loss
timeFrame: baseline and 24 weeks
measure: MDSC in peripheral blood
timeFrame: baseline and 24 weeks
measure: Levels of lipids in circulation
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: Systemic inflammation measured by C-reactive protein levels
timeFrame: baseline and 24 weeks
measure: Systemic inflammation measured by adipokines levels in circulation
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health System - Biospecimen
state: Louisiana
Study officials:
affiliation: LSU-Health Sciences Center
name: Maria D Sanchez-Pino, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: