Pilot Study of the Effect of Weight Loss by Pharmacotherapy on Chronic Pro-tumor Inflammatory Cells
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- MDSC in peripheral blood
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI): over 30 kg/m2
- •Age: 35 to 60 years old
排除标准
- •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
- •Pregnancy or breastfeeding women
研究组 & 干预措施
Patients with obesity on pharmacotherapy
Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
干预措施: Semaglutide (Drug)
Patients with obesity on pharmacotherapy
Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
干预措施: Phentermine-Topiramate combination (Drug)
Patients with obesity on pharmacotherapy
Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
干预措施: Phentermine (Drug)
Patients with obesity on pharmacotherapy
Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
干预措施: Tirzepatide (Drug)
Patients with obesity on pharmacotherapy
Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
干预措施: Topiramate (Drug)
Patients with obesity on pharmacotherapy
Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
干预措施: Diethylpropion (Drug)
Patients with obesity on pharmacotherapy
Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
干预措施: Naltrexone/Bupropion (Drug)
Patients with obesity on pharmacotherapy
Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
干预措施: Liraglutide (Drug)
结局指标
主要结局
MDSC in peripheral blood
时间窗: baseline and 24 weeks
Changes in number of MDSC in blood
weight loss
时间窗: baseline and 24 weeks
Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100)
Levels of lipids in circulation
时间窗: baseline and 24 weeks
Changes in concentration (mg/dL) of each type of lipids: LDL-Cholesterol, triglycerides, and free fatty acids
次要结局
- Systemic inflammation measured by C-reactive protein levels(baseline and 24 weeks)
- Systemic inflammation measured by adipokines levels in circulation(baseline and 24 weeks)
研究者
Maria Sanchez-Pino, Ph.D.
Assistant Professor
Louisiana State University Health Sciences Center in New Orleans