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临床试验/NCT04242524
NCT04242524已完成不适用

The Impact of Bariatric Surgery on Adipocyte Metabolism

University of Chicago1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2015年3月26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
入组人数
28
试验地点
1
主要终点
Change in insulin sensitivity

研究概览

简要总结

The purpose of this study is to understand how daily rhythms of behavior affect the expression of genes in fat cells, and how these daily cycles affect the way fat cells respond to insulin (a hormone that controls blood sugar levels) before and after bariatric surgery.

详细描述

Bariatric surgery as a means of weight loss has become increasingly popular over the last 10-15 years. In addition to promoting weight loss, bariatric surgery has become increasingly recognized for use in the management of diabetes. Recent studies have indicated that bariatric surgery can result in a marked improvement in insulin sensitivity before long term weight loss is attained. The goal of this project is to delineate the changes in the insulin responsiveness of subcutaneous adipocytes obtained by needle biopsy 2 weeks prior to surgery vs. 12 weeks after bariatric surgery, which could account for improvements in overall insulin sensitivity seen before any long-term sustained weight loss has occurred. The investigators will also examine gene expression in adipocytes (fat cells).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Obese Subjects
  • Inclusion Criteria:
  • 18-55 years old
  • BMI greater than 40 kg/m2
  • Scheduled for bariatric surgery at the Center for the Surgical Treatment of Obesity at the University of Chicago
  • Signed informed consent

排除标准

  • Diagnosed with a systemic illnesses, including heart, renal, liver, or malignant disease
  • Uncontrolled hypertension (blood pressure greater than 140 mmHg systolic and 90 mmHg diastolic without medication)
  • use of beta blockers
  • hemoglobin less than 11.5g/dL
  • known allergy to lidocaine
  • pregnancy
  • lactation
  • Subjects will not have undergone surgery, donated a unit of blood, or participated in another clinical study within the last 4 weeks prior to consent.
  • Post-menopausal
  • Non-Obese Subjects
  • Inclusion Criteria:
  • 18-55 years old
  • BMI less than 30 kg/m2
  • Signed informed consent
  • Exclusion Criteria:
  • Diagnosed with a systemic illnesses, including heart, renal, liver, or malignant disease
  • Uncontrolled hypertension (blood pressure greater than 140 mmHg systolic and 90 mmHg diastolic without medication)
  • use of beta blockers
  • hemoglobin less than 11.5g/dL
  • known allergy to lidocaine
  • pregnancy
  • lactation
  • Subjects will not have undergone surgery, donated a unit of blood, or participated in another clinical study within the last 4 weeks prior to consent.
  • Post-menopausal

研究组 & 干预措施

Circadian Clock Alignment - High BMI

Experimental

Subjects will come to the Sleep Lab three nights before their bariatric surgery procedure for an intervention that will align their central circadian clock. The intervention includes eating meals and snacks at fixed times and having lights off at a specific time at night and lights on at a specific time in the morning.

干预措施: Circadian Clock Alignment (Behavioral)

Circadian Clock Control - High BMI

Active Comparator

Subjects will not come to the Sleep Lab and will live normally at home with no changes to their meal, sleep or wake times.

干预措施: Circadian Clock Control (Behavioral)

Circadian Clock Control - Low BMI

Active Comparator

Subjects will not come to the Sleep Lab and will live normally at home with no changes to their meal, sleep or wake times.

干预措施: Circadian Clock Control (Behavioral)

结局指标

主要结局

Change in insulin sensitivity

时间窗: 12 weeks

Insulin sensitivity will be measured as the by the phosphorylation level of Akt in adipocytes (fat cells) at baseline and 12 weeks post bariatric surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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