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临床试验/NCT03785470
NCT03785470已完成不适用

Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Change in Insulin-stimulated leg blood flow

研究概览

简要总结

The purpose of this study is to determine if short-term adoption of a Westernized lifestyle characterized by physical inactivity and increased consumption of fructose will result in metabolic and vascular dysfunction. Healthy individuals aged 18-45 years old will undergo an acute period of physical inactivity (10 days) coupled with increased fructose consumption. Augmented fructose consumption will be achieved via commercially available soda beverages which are high in fructose. Vascular and metabolic function measures will be performed before and after the 10-day intervention.

详细描述

Men and women who regularly engage in >10,000 steps per day, age 18-45 years, body mass index < 30 kg/m2, and with no history of chronic disease will be recruited. Subjects who are eligible will undergo an acute period of physical inactivity (10 days) coupled with increased fructose consumption (6 cans/day). Physical activity levels will be assessed via a pedometer to quantify if individuals achieve <5000 steps/day. Vascular and metabolic function measures will be performed before and after the 10-day intervention.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women who regularly engage in >10,000 steps per day
  • Age 18-45 years
  • Body mass index < 30 kg/m2
  • No history of chronic disease

排除标准

  • Known cardiovascular disease including hypertension, heart failure, coronary artery disease, and stroke
  • Renal or hepatic diseases
  • Active cancer
  • Autoimmune diseases
  • Current use of immunosuppressant therapy
  • Excessive alcohol consumption (> 14 drinks/week for men and >7 drinks/week for women)
  • Current tobacco use
  • Current pregnancy
  • Diagnosis of type 2 diabetes
  • Regular consumption of >2 non-diet sodas/day

结局指标

主要结局

Change in Insulin-stimulated leg blood flow

时间窗: this will be assessed at baseline and at the final visit (10 days)

Subjects will be instrumented with EKG for contrast-enhanced ultrasound (CEU) measurements. We will perform a hyperinsulinemic euglycemic clamp to evaluate microvascular perfusion of skeletal muscle via CEU. Insulin will be infused at a constant rate to mimic postprandial insulin concentrations and glucose maintained at fasting values via a variable 20% dextrose infusion. At baseline and in the steady state phase of the insulin clamp, we will assess microvascular perfusion in the vastus lateralis muscle using CEU (IE-33, Philips Ultrasound), via infusion of perflutren lipid microspheres. Microvascular perfusion will be assessed as an A-value. A is the video intensity plateau after complete replenishment reflecting relative microvascular blood volume (MBV).

次要结局

  • Change in Brachial artery flow mediated dilation (FMD)(this will be assessed at baseline and at the final visit (10 days))
  • Change in carotid femoral pulse wave velocity (cfPWV)(this will be assessed at baseline and at the final visit (10 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Camila Manrique

Associate Professor, Endocrinology

University of Missouri-Columbia

研究点 (2)

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