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| ID | Type | Description | Link |
|---|---|---|---|
| U24DK132740 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Tulane University | OTHER |
| Pennington Biomedical Research Center | OTHER |
| Ochsner Health System | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with obesity on pharmacotherapy | Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Medication for weight loss |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Maria D Sanchez-Pino, Ph.D. | LSU-Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO | New Orleans | Louisiana | 70112 | United States | ||
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.
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.
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)
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007249 | Inflammation |
| D050171 | Dyslipidemias |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| C576188 | Qsymia |
| D010645 | Phentermine |
| D000098860 | Tirzepatide |
| D000077236 | Topiramate |
| D004053 | Diethylpropion |
| D009271 | Naltrexone |
| D016642 | Bupropion |
| C000591595 | bupropion hydrochloride, naltrexone hydrochoride drug combination |
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
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Whole blood will be obtained from participant subjects. Collection of serum, plasma, and isolation of leukocytes will be used for study aims and storage (-80 degrees).
| Phentermine-Topiramate combination | Drug | Medication for weight loss |
|
|
| Phentermine | Drug | Medication for weight loss |
|
|
| Tirzepatide | Drug | Medication for weight loss |
|
|
| Topiramate | Drug | Medication for weight loss |
|
|
| Diethylpropion | Drug | Medication for weight loss |
|
|
| Naltrexone/Bupropion | Drug | Medication for weight loss |
|
|
| Liraglutide | Drug | Medication for weight loss |
|
|
Changes in concentration (pg/mL) of interleukin 6 (IL-6), tumor-necrosis factor alpha (TNFa) and leptin in plasma
| baseline and 24 weeks |
| Ochsner Health System - Biospecimen |
| New Orleans |
| Louisiana |
| 70121 |
| United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |