Anti-obesity Pharmacotherapy and Inflammation

Sponsor

Louisiana State University Health Sciences Center in New Orleans (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05756764

Collaborator

Tulane University (Other), Pennington Biomedical Research Center (Other)

Enrollment

Locations

10.1

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Liraglutide or Semaglutide Drug: Phentermine-Topiramate combination

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

24 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Jan 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with obesity on pharmacotherapy Before initiation of pharmacotherapy and 6-months after being under treatment with medication	Drug: Liraglutide or Semaglutide Medication for reducing obesity Other Names: Glucagon-like peptide-1 receptor (GLP1-R) agonists Wegovy Saxenda Drug: Phentermine-Topiramate combination Medication for reducing obesity Other Names: Qsymia

Arm

Intervention/Treatment

Patients with obesity on pharmacotherapy

Before initiation of pharmacotherapy and 6-months after being under treatment with medication

Drug: Liraglutide or Semaglutide

Medication for reducing obesity

Other Names:

Glucagon-like peptide-1 receptor (GLP1-R) agonists

Wegovy

Saxenda

Drug: Phentermine-Topiramate combination

Medication for reducing obesity

Other Names:

Qsymia

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

50% women (12) and 50% men (12)
Race: 50% African American (6 women, 6 men), 50% White American (6 women, 6 men)
Body mass index (BMI): over 30 kg/m2

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Louisiana Cancer Research Center (LCRC) - LSUHSC-NO	New Orleans	Louisiana	United States	70112
2	Tulane Center for Clinical Research (TCCR).	New Orleans	Louisiana	United States	70112