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临床试验/NCT00742456
NCT00742456已完成不适用

Insulin-induced Microvascular Dilatation During a Physiological Stimulus - Studies in Hypertension and Obesity.

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Functional recruitment of capillaries in the skin.

研究概览

简要总结

In this study we will examine if the insulin-induced microvascular effects will occur after a physiological stimulus (i.e. a oral glucose tolerance test). With that the physiological importance of the insulin-induced microvascular dilatation can be elucidated. In this study we hypothesize that oral glucose intake and consequently the endogenous induced hyperinsulinemia will lead to insulin-induced microvascular dilatation in healthy normotensive subjects. Furthermore, we suggest that the insulin-mediated microvascular dilatation, resulting from this physiological induced hyperinsulinemia, will be less in hypertensive and obese subjects compared to healthy controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy normotensive subjects:
  • 18-60 years
  • Blood pressure <140/90 mmHg
  • obese normotensive subjects:
  • 18-60 years
  • Blood pressure <140/90 mmHg
  • BMI 30-38kg/m2
  • hypertensive subjects:
  • 18-60 years
  • Untreated hypertension >140/90mmHg.
  • Exclusion Criteria for healthy normotensive and hypertensive subjects:
  • Obesity (BMI>27kg/m2)
  • Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
  • Diabetes mellitus according to the criteria of the ADA
  • Alcohol use >4U/day
  • Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)
  • Wearing contact lenses
  • for normotensive obese subjects:
  • Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
  • Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA
  • Alcohol use >4U/day
  • Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)
  • Wearing contact lenses

排除标准

  • 未提供

结局指标

主要结局

Functional recruitment of capillaries in the skin.

时间窗: January 2009 - January 2010

次要结局

  • Perfused capillary density in the nailfold.(January 2009 - January 2010)
  • Endothelium- (in)dependent vasodilatation of finger skin microcirculation(January 2009 - January 2010)
  • Density of arterioles, capillaries and venules in the bulbar conjunctiva.(January 2009 - January 2010)
  • Diameter of arterioles and venules in the bulbar conjunctiva.(January 2009 - January 2010)
  • Insulin sensitivity (HOMA-IR)(January 2009 - January 2010)

研究者

申办方类型
Other

研究点 (2)

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