跳至主要内容
临床试验/NCT03868592
NCT03868592招募中不适用

Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019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
招募中
发起方
Mayo Clinic
入组人数
30
试验地点
1
主要终点
insulin regulation of lipolysis (IC50)

研究概览

简要总结

It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these questions.

详细描述

The purpose of this study is to determine whether the adipose inflammatory cell and cytokine content in Class III obesity is related to lipolysis insulin resistance and, if so, whether sustained, substantial weight loss one year following bariatric surgery reduces inflammation in parallel with improved insulin regulation of lipolysis

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 40 - 50 kg/m
  • Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery

排除标准

  • Type 1 or Type 2 Diabetes diagnosis or fasting plasma glucose ≥126 mg/dL
  • Active coronary artery disease
  • Participation in structured exercise (>2 times per week for 30 minutes or longer)
  • Medications known to affect adipose tissue metabolism (e.g., beta blockers, corticosteroids)
  • Renal insufficiency (serum creatinine > 1.5mg/dl)
  • Chronic active liver disease (Bilirubin > 17mmol/L, AST > 144 IU/L, or ALT>165IU/L)
  • Pregnancy or breastfeeding.

研究组 & 干预措施

Gastric sleeve surgery

Experimental

before and after weight loss from bariatric surgery

干预措施: Gastric sleeve/bariatric surgery (Procedure)

结局指标

主要结局

insulin regulation of lipolysis (IC50)

时间窗: Before bariatric surgery and approximately 1 year after surgery

The ability of insulin to suppress FFA palmitate release will be assessed using a 2-step insulin clamp and isotope dilution techniques for palmitate kinetics

adipose macrophage content, adipose IL-6 and TNF gene expression

时间窗: Before bariatric surgery and approximately 1 year after surgery

Adipose tissue macrophage content as assessed by immunohistochemistry using stains for CD36, CD14 and CD206 will be done. mRNA expression for IL-6 and TNF will be measured

次要结局

  • adipocyte perilipin 1 and HSL and ATGL(Before bariatric surgery and approximately 1 year after surgery)

研究者

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

Michael D. Jensen

Principal Investigator

Mayo Clinic

研究点 (1)

Loading locations...

相似试验