The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in the number of circulating myeloid-derived suppressor cells
研究概览
简要总结
This study aims to determine the relationship between lipid metabolic alterations associated with insulin resistance changes, and blood immunosuppressive-type cells (MDSC) by metabolic and bariatric surgery in two patient cohorts matched on demographic and clinical factors
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
- Female
- 接受健康志愿者
- 是
入选标准
- •For an eligible subject, all the following must be answered "yes":
- •Biological female sex
- •Age >=35 and <=60 years (including pre- and postmenopausal)
- •Self-reported white or black race
- •The study will enroll approximately 50% white and 50% black subjects
- •Body mass index >/=40 kg/m2
- •Planned to have bariatric surgery or post-bariatric surgery
- •Ability to provide written informed consent
- •Allow the collection and storage of biospecimens and data for future use
- •Not having yet started the pre-op liquid diet before the bariatric surgery
- •For an eligible subject, all the following must be answered "no":
- •Have type one diabetes
- •Use of anti-inflammatory medications, such as glucocorticoids or non-steroidal anti-inflammatory medications, within the past 15 days
- •History of cancer of any type
- •History of chronic conditions known to cause inflammation, such as tuberculosis, autoimmune disease, and human immunodeficiency virus
- •An acute history (within the past 60 days) or confirmed or suspected SARS-CoV-2 (COVID-19) infection
- •Currently pregnant, breastfeeding, or planning to become pregnant within the next 52 weeks
- •Currently participating in another study with competing outcomes
- •Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Cohort #1 (within-subject) will enroll up to 10 women with class III obesity who plan to undergo metabolic and bariatric surgery as a standard of obesity care. Subjects will complete study measures preoperatively
干预措施: Metabolic & Bariatric Surgery (Procedure)
Cohort 2
Cohort #2 (between-subject) will enroll up to 10 women with a history of class III obesity who underwent metabolic and bariatric surgery as a standard of obesity care approximately one year before enrollment. Subjects in this cohort will be matched on demographic and clinical variables to those in Cohort #1.
干预措施: Metabolic & Bariatric Surgery (Procedure)
结局指标
主要结局
Change in the number of circulating myeloid-derived suppressor cells
时间窗: Baseline, week 52
Change in insulin-inhibited adipose tissue lipolysis
时间窗: Baseline, week 52
Plasma Fatty Acid Concentration in Circulation After Bariatric Surgery and Bariatric Surgery
时间窗: Pre Bariatric surgery (Cohort 1), 1 year Post Bariatric surgery (Cohort 2)
Fatty acid concentration in serum plasma (mean and SD) before bariatric surgery (cohort 1) and 1-year post bariatric surgery (cohort 2) were measured.
次要结局
- Metabolic, Inflammatory, and Immunologic Adaptations(Pre Bariatric surgery (Cohort 1), 1 year Post Bariatric surgery (Cohort 2))
研究者
Zubaidah Nor Hanipah
Associate Professor
Pennington Biomedical Research Center