Anti-obesity Pharmacotherapy and Inflammation

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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Semaglutide; Drug: Phentermine-Topiramate combination; Drug: Phentermine; Drug: Tirzepatide; Drug: Topiramate; Drug: Diethylpropion; Drug: Naltrexone/Bupropion; Drug: Liraglutide

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 Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: Maria D Sanchez-Pino, Ph.D.; Phone Number: 5042102831; Email: msanc2@lsuhsc.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO
      • Contact: Maria D Sanchez-Pino, Ph.D.; Phone Number: 504-210-2831; Email: msanc2@lsuhsc.edu
      • Sub-Investigator: Vivian Fonseca, MD
      • Sub-Investigator: Justin Brown, Ph.D.
      • Principal Investigator: Maria D Sanchez-Pino, Ph.D.
      • Sub-Investigator: Mary Meyaski-Schluter, Nurse
      • Sub-Investigator: Virginia Garrison, Nurse
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Health System - Bioespecimen
      • Contact: Melyssa Bratton, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with obesity on pharmacotherapy; Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication

Drug: Semaglutide; Medication for weight loss; Other Names: Wegovy; Glucagon-like peptide-1 receptor (GLP1-R) agonist; Drug: Phentermine-Topiramate combination; Medication for weight loss; Other Names: Qsymia; Drug: Phentermine; Medication for weight loss; Other Names: Lomaira; Adipex-P; Drug: Tirzepatide; Medication for weight loss; Other Names: Mounjaro; Zepbound; GIP/GLP-1 RA; Drug: Topiramate; Medication for weight loss; Other Names: Topamax; Trokendi XR; Qudexy XR; Drug: Diethylpropion; Medication for weight loss; Other Names: Tenuate; Diethylcathinone; Drug: Naltrexone/Bupropion; Medication for weight loss; Other Names: Contrave; Drug: Liraglutide; Medication for weight loss; Other Names: Victoza; Saxenda; Glucagon-like peptide-1 receptor (GLP1-R) agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight loss	Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100)	baseline and 24 weeks
MDSC in peripheral blood	Changes in number of MDSC in blood	baseline and 24 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic inflammation measured by C-reactive protein levels	Changes in concentration (mg/L) of C-reactive protein in serum	baseline and 24 weeks
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

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Collaborators: Tulane University; Pennington Biomedical Research Center; Ochsner Health System
• Investigators: Principal Investigator: Maria D Sanchez-Pino, Ph.D., LSU-Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 20, 2025

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Metabolic syndrome; Dyslipidemia
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Hypoglycemic Agents; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Narcotic Antagonists; Cytochrome P-450 Enzyme Inhibitors; Anticonvulsants; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Appetite Depressants; Anti-Obesity Agents; Incretins; Alcohol Deterrents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Glucagon-Like Peptide-1 Receptor Agonists; Liraglutide; Naltrexone; Bupropion; Glucagon; Topiramate; Tirzepatide; Glucagon-Like Peptide 1; Phentermine; Diethylpropion; Semaglutide
• Other Study ID Numbers: U24DK132740-5053; U24DK132740 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The investigators will adhere to the NIH Grants Policy on Sharing of Unique Research Resources, including the Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (NOT-OD-21-013).

Data dictionaries, statistical analysis code, and de-identified data may be deposited for sharing. Data may include demographic, clinical, anthropometric, outcome measures, and other relevant variables, as allowed by the data-owning organization, consistent with applicable laws and regulations.

• IPD Sharing Time Frame: Data may be deposited into the repository no later than within one year of completing the study period for the award or upon acceptance of the data for publication or public disclosure of study results.
• IPD Sharing Access Criteria: Deidentified data and supporting information may be shared with investigators and research staff working under a Federal Wide Assurance (FWA) institution and could be used for secondary study purposes after approval of the local Institutional Review Board (IRB)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No