Role of Eosinophils in Human Adipose Tissue Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- AT-EOS content
研究概览
简要总结
The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils (EOS), and adipose tissue (AT) in human health and in disease states such as obesity and insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity (BMI>30 kg/m2).
- •Evidence of insulin resistance as defined by hemoglobin A1c > 5.7%.
- •Mayo Clinic patients evaluated by Dr. Rahul Pannala.
- •Pursue an endoscopic gastroplasty at Mayo Clinic Arizona in the Gastroenterology department.
- •Equal distribution of gender.
- •18 yo older of age.
- •BMI>30 kg/m
- •Nonsmoker.
- •Taking no medication affecting glucose or lipid metabolism.
- •No more than 5% change in body weight in the previous 6 months.
- •Mostly sedentary (engaging in strenuous exercise (> 70% max HR) less than 3 times a week).
- •Not be receiving corticosteroid therapy.
- •Have no history of asthma, COPD or atopic syndrome, or autoimmune disease (Ulcerative colitis, Chron's disease, eosinophilic esophagitis, any rheumatologic disease such as lupus, rheumatoid arthritis, Sjogren syndrome).
排除标准
- •<17 years of age.
- •BMI <30 kg/m
- •Taking medication affecting glucose or lipid metabolism.
- •Greater than 5% change in body weight within the previous six months.
- •Engage in strenuous exercise (>70% max HR) less than 3 times a week.
- •Receiving corticosteroid therapy.
- •Have a history of asthma.
- •History of COPD or atopic syndrome.
- •History of autoimmune disease (Ulcerative colitis, Chron's disease, eosinophilic esophagitis, any rheumatologic disease such as lupus, rheumatoid arthritis, Sjogren syndrome).
研究组 & 干预措施
Subjects with Obesity
Subjects will be recruited to undergo endoscopic sleeve gastroplasty. The subjects will be studied at baseline, 30, 60, 90 days after procedure
干预措施: endoscopy sleeve gastroplasty (Procedure)
结局指标
主要结局
AT-EOS content
时间窗: at 90 days post-intervention
subcutaneous fat biopsy will be processed to extract stromal vascular fraction (SVF) which will contain eosinophils. The SVF will be run trough flow cytometry to get an estimated count to be reported as a ratio over the total number of cells
weight loss
时间窗: at 90 days post-intervention
total body weight
fat mass
时间窗: at 90 days post-intervention
% fat mass will be estimated by bioimpedence
weight loss
时间窗: at 30 days post-intervention
total body weight
weight loss
时间窗: at 60 days post-intervention
total body weight
fat mass
时间窗: at 30 days post-intervention
% fat mass will be estimated by bioimpedence
fat mass
时间窗: at 60 days post-intervention
% fat mass will be estimated by bioimpedence
AT-EOS content
时间窗: at baseline
subcutaneous fat biopsy will be processed to extract stromal vascular fraction (SVF) which will contain eosinophils. The SVF will be run trough flow cytometry to get an estimated count to be reported as a ratio over the total number of cells
次要结局
- insulin sensitivity(at baseline and 90 days post-intervention)
- inflammation(at 90 days post-intervention)
- adipose tissue inflammation(at 90 days post-intervention)
- inflammation(at 30 days post-intervention)
- inflammation(at 60 days post-intervention)
- adipose tissue inflammation(at baseline)
研究者
Elena Anna (Eleanna) De Filippis, M.D., Ph.D.
Principal Investigator
Mayo Clinic