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临床试验/NCT00653510
NCT00653510已完成不适用

The Effect of Acute Hyperglycemia on Cardiac Output, Amino Acid, Lipid and Glucose Metabolism in Patients With Type 2 Diabetes

University of Aarhus1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Metabolic changes

研究概览

简要总结

The purpose of the study is to characterize the changes in amino acid, lipid and glucose metabolism in patients with type 2 diabetes exposed to acute hyperglycemia. Moreover we wish to assess the effect of acute hyperglycemia on cardiac output.

详细描述

Cardiovascular disease is the main cause of death in modern Western societies. Obesity, diabetes and the metabolic syndrome are the main risk factors for cardiovascular disease. People with type 2 diabetes and no history of heart disease have a risk of myocardial infarction similar to the risk in non-diabetic patients with known heart disease.

However, the causal relationship between obesity, diabetes and cardiovascular disease is unclear. Insulin resistance leads to many metabolic abnormalities, including high circulating levels of free fatty acids (FFA). FFA induces insulin resistance and may lead to beta cell failure. In addition FFA may directly worsen the metabolic and electrochemical performance of the working heart. Moreover it is still unclear how acute hyperglycemia affects cardiac output.

In this study our purpose is to characterize the changes in amino acid, lipid and glucose metabolism in patients with type 2 diabetes exposed to acute hyperglycemia (blood glucose between 18 and 20 mmol/L) compared to the amino acid, lipid and glucose metabolism at a normal glucose level (blood glucose between 5 and 7 mmol/L). The results from the patients with type 2 diabetes will be compared with results from healthy controls examined in a fasting basal state. The patients must not suffer from any kind of serious heart disease and should be treated with insulin.

Moreover we wish to compare cardiac output at high and normal blood glucose levels, respectively. Cardiac output will primarily be assessed by doppler echocardiography.

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
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written consent
  • Age 40-75 years old
  • BMI between 22 and 35
  • Type 2 diabetes treated with insulin (< 60 IE/day)

排除标准

  • Severe disease
  • Severe cardiac disease

研究组 & 干预措施

Euglycemic

Experimental

The patients will be examined with a blood glucose at around 5-7 mmol/L.

干预措施: Actrapid (human insulin) (Drug)

Hyperglycemic

Experimental

The patients will be examined with a blood glucose at around 18-20 mmol/L

干预措施: Actrapid (human insulin) (Drug)

结局指标

主要结局

Metabolic changes

时间窗: 6 hours

次要结局

  • Left ventricular function(6 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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