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临床试验/NCT02378077
NCT02378077已完成不适用

Immunomodulatory Role of Eosinophils in Determining Inflammation and Insulin Sensitivity in Human Adipose Tissue- Aims 1&2

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
28
试验地点
1
主要终点
Eosinophil content in adipose tissue

研究概览

简要总结

This study is being done to better understand the relationship between inflammation and insulin resistance in your Adipose (fat) Tissue .

详细描述

This study is being done to determine whether eosinophils (a type of white blood cell) play an important role in human fat metabolism and inflammation.

This study is being done to determine if fish oil supplement could play a role in reducing inflammation and improving insulin sensitivity in your fat tissue.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Lean, healthy person with a body mass index (BMI) of 25 or less, or you are obese, BMI between 30 and 50, and non-diabetic.
  • •Lean healthy controls will not be on any medication and will be undergoing elective abdominal surgery excluding those involving acute inflammation (i.e. acute cholecystitis, bowel perforation, or diverticulitis).
  • •Obese, non-diabetic subjects will have a BMI between 30 and 50 and be taking no medications affecting glucose metabolism or lipid metabolism. These subjects will be identified from a pool of patients undergoing an elective abdominal surgical procedure such as inguinal hernia repair, laparoscopic Nissen fundoplication, planned cholecystectomy, but also bariatric surgery.
  • •Volunteers will not be taking corticosteroid therapy or have a history of asthma, COPD or atopic syndrome. All subjects will undergo a medical history intake and a physical examination followed by an OGTT to confirm normal glucose.

排除标准

  • 未提供

研究组 & 干预措施

Lean or Obese, Non-Diabetic

Experimental

To determine whether eosinophil content of adipose tissue is related to insulin sensitivity. We will use euglycemic clamps, fat biopsy (obtained during a scheduled abdominal surgery) and fat aspiration for analysis of subcutaneous (Sc) and omental (OM) adipose tissue from obese, insulin resistant and lean, insulin sensitive volunteers to test the hypothesis that, as in mice, eosinophil content in human subcutaneous and omental white adipose tissue, inversely correlates with body weight, with skeletal muscle and hepatic insulin sensitivity.

干预措施: Fat biopsy during scheduled abdominal surgery (Procedure)

Lean or Obese, Non-Diabetic

Experimental

To determine whether eosinophil content of adipose tissue is related to insulin sensitivity. We will use euglycemic clamps, fat biopsy (obtained during a scheduled abdominal surgery) and fat aspiration for analysis of subcutaneous (Sc) and omental (OM) adipose tissue from obese, insulin resistant and lean, insulin sensitive volunteers to test the hypothesis that, as in mice, eosinophil content in human subcutaneous and omental white adipose tissue, inversely correlates with body weight, with skeletal muscle and hepatic insulin sensitivity.

干预措施: Fat Aspiration (Procedure)

Fish oil supplementation

Experimental

Determine whether, in adipose tissue, levels of, anti-inflammatory molecules correlate with insulin sensitivity and whether these levels are altered by a treatment designed to promote resolution of inflammation. Volunteers will take a fish oil supplement for three months.

干预措施: Fat Aspiration (Procedure)

Fish oil supplementation

Experimental

Determine whether, in adipose tissue, levels of, anti-inflammatory molecules correlate with insulin sensitivity and whether these levels are altered by a treatment designed to promote resolution of inflammation. Volunteers will take a fish oil supplement for three months.

干预措施: Fish Oil Supplement (Dietary Supplement)

结局指标

主要结局

Eosinophil content in adipose tissue

时间窗: baseline

Eosinophils number will be measured by flow cytometry in subcutaneous and visceral fat of lean vs obese, non-diabetic volunteers

次要结局

  • Relationship between eosinophils content and body mass index (BMI)(baseline)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Anna (Eleanna) De Filippis, M.D., Ph.D.

Senior Consultant of Endocrinology and Metabolic Disease

Mayo Clinic

研究点 (1)

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