Trial Title:
Anti-obesity Pharmacotherapy and Inflammation
NCT ID:
NCT05756764
Condition:
Obesity
Conditions: Official terms:
Obesity
Semaglutide
Liraglutide
Topiramate
Phentermine
Diethylpropion
Naltrexone
Bupropion
Glucagon
Glucagon-Like Peptide 1
Tirzepatide
Conditions: Keywords:
Inflammation
Dyslipidemia
Metabolic syndrome
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Semaglutide
Description:
Medication for weight loss
Arm group label:
Patients with obesity on pharmacotherapy
Other name:
Glucagon-like peptide-1 receptor (GLP1-R) agonist
Other name:
Wegovy
Intervention type:
Drug
Intervention name:
Phentermine-Topiramate combination
Description:
Medication for weight loss
Arm group label:
Patients with obesity on pharmacotherapy
Other name:
Qsymia
Intervention type:
Drug
Intervention name:
Phentermine
Description:
Medication for weight loss
Arm group label:
Patients with obesity on pharmacotherapy
Other name:
Lomaira
Other name:
Adipex-P
Intervention type:
Drug
Intervention name:
Tirzepatide
Description:
Medication for weight loss
Arm group label:
Patients with obesity on pharmacotherapy
Other name:
Mounjaro
Other name:
Zepbound
Other name:
GIP/GLP-1 RA
Intervention type:
Drug
Intervention name:
Topiramate
Description:
Medication for weight loss
Arm group label:
Patients with obesity on pharmacotherapy
Other name:
Topamax
Other name:
Trokendi XR
Other name:
Qudexy XR
Intervention type:
Drug
Intervention name:
Diethylpropion
Description:
Medication for weight loss
Arm group label:
Patients with obesity on pharmacotherapy
Other name:
Tenuate
Other name:
Diethylcathinone
Intervention type:
Drug
Intervention name:
Naltrexone/Bupropion
Description:
Medication for weight loss
Arm group label:
Patients with obesity on pharmacotherapy
Other name:
Contrave
Intervention type:
Drug
Intervention name:
Liraglutide
Description:
Medication for weight loss
Arm group label:
Patients with obesity on pharmacotherapy
Other name:
Saxenda
Other name:
Victoza
Other name:
Glucagon-like peptide-1 receptor (GLP1-R) agonist
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
35 Years
Maximum age:
60 Years
Locations:
Facility:
Name:
LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maria D Sanchez-Pino, Ph.D.
Phone:
504-210-2831
Email:
msanc2@lsuhsc.edu
Investigator:
Last name:
Vivian Fonseca, MD
Email:
Sub-Investigator
Investigator:
Last name:
Justin Brown, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mary Meyaski-Schluter, Nurse
Email:
Sub-Investigator
Investigator:
Last name:
Maria D Sanchez-Pino, Ph.D.
Email:
Principal Investigator
Investigator:
Last name:
Virginia Garrison, Nurse
Email:
Sub-Investigator
Facility:
Name:
Ochsner Health System - Biospecimen
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melyssa Bratton, Ph.D.
Start date:
June 1, 2023
Completion date:
March 20, 2025
Lead sponsor:
Agency:
Louisiana State University Health Sciences Center in New Orleans
Agency class:
Other
Collaborator:
Agency:
Tulane University
Agency class:
Other
Collaborator:
Agency:
Pennington Biomedical Research Center
Agency class:
Other
Collaborator:
Agency:
Ochsner Health System
Agency class:
Other
Source:
Louisiana State University Health Sciences Center in New Orleans
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05756764
