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临床试验/NCT01407627
NCT01407627已完成不适用

Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans

University of Calgary2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2011年7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
64
试验地点
2
主要终点
Change in filtration fraction

研究概览

简要总结

Fructose is an ingredient that is added to many of our foods. It is a cheaper, sweeter additive that can be found in everything from soda pop to yogurt to granola bars. In the last few years a significant number of studies have been published linking consumption of fructose with obesity, hypertension and more recently, kidney and cardiovascular disease.

Animal studies show a strong link between excessive ingestion of fructose and the development of kidney and cardiovascular disease mediated by the renin angiotensin system, a hormonal system whose activation is detrimental to both the kidney and the heart. There has been very little research done on the potentially pathophysiological relationship between a high fructose diet and kidney and cardiovascular disease in humans.

The investigators hypothesize that ingestion of fructose will result in upregulation of the renin angiotensin system in humans.

Cardiovascular disease in women is a significant risk factor. By having women participate who are on the birth control pill and as well as women who use non oral forms of birth control or no birth control, kidney function and cardiovascular health can be examined as it relates to in the influence oral hormones might play. How the kidney responds to the influence of sugar and fructose while a woman is on an oral birth control pill, may reveal mechanisms that could help us understand cardiovascular disease in women.

详细描述

PRIMARY AIM: To examine whether the physiologic and molecular responses to Angiotensin II (AngII) challenge differ in response to fructose intake as assessed by two independent means:

  1. The renal and mean arterial pressure (MAP) response to an AngII challenge.
  2. Reactive changes in circulating levels of renin and aldosterone with graded AngII challenge.

PRIMARY HYPOTHESES: Ingestion of fructose in healthy subjects will result in:

  1. A decrease in renal and systemic sensitivity to infused AngII.
  2. A decrease in the reactive changes in renin and aldosterone with graded AngII challenge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • age≥18 years,
  • able to comprehend study and comply with high-salt diet
  • kidney disease (on the approval of their nephrologist)
  • on an oral birth control pill and non oral birth control and those not on birth control

排除标准

  • cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
  • cerebrovascular disease (transient ischemic attacks or stroke)
  • hypertension (BP>140/90 or use of antihypertensive medications)
  • diabetes mellitus (defined by history, use of hypoglycemic agents or a fasting glucose >7mmol/L)
  • hyperlipidemia (LDL >4.5mmol/L or use of lipid-lowering agents)
  • pregnancy

结局指标

主要结局

Change in filtration fraction

时间窗: after 2 weeks of ingestion of fructose compared to baseline value

To examine whether the physiologic and molecular responses to an Angiotensin II challenge differ in response to fructose intake as assessed by reactive changes in circulating levels of renin and aldosterone with a graded Angiotensin II challenge.

次要结局

  • change in blood pressure in response to angiotensin II challenge(change after 2 weeks of fructose ingestion)

研究者

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

Sofia Ahmed

Dr. Sofia Ahmed

University of Calgary

研究点 (2)

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