Anti-obesity Pharmacotherapy and Inflammation

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756764
• Other study ID #: U24DK132740-5053
• Secondary ID: U24DK132740
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: March 20, 2025

Study information

• Verified date: March 2024
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: Maria D Sanchez-Pino, Ph.D.
• Phone: 5042102831
• Email: msanc2[@]lsuhsc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 20, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Semaglutide
Medication for weight loss
• Phentermine-Topiramate combination
Medication for weight loss
• Phentermine
Medication for weight loss
• Tirzepatide
Medication for weight loss
• Topiramate
Medication for weight loss
• Diethylpropion
Medication for weight loss
• Naltrexone/Bupropion
Medication for weight loss
• Liraglutide
Medication for weight loss

Locations

Country	Name	City	State
United States	LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO	New Orleans	Louisiana
United States	Ochsner Health System - Biospecimen	New Orleans	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans	Ochsner Health System, Pennington Biomedical Research Center, Tulane University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100)	baseline and 24 weeks
Primary	MDSC in peripheral blood	Changes in number of MDSC in blood	baseline and 24 weeks
Primary	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	Systemic inflammation measured by C-reactive protein levels	Changes in concentration (mg/L) of C-reactive protein in serum	baseline and 24 weeks
Secondary	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