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临床试验/NCT01765894
NCT01765894已完成不适用

Influence of Moderate Exercise on Blood Glucose in Type 2 Diabetics and Healthy Controls.

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年10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
24
试验地点
1
主要终点
Glucose homeostasis in controls, type 2 diabetics without medication and type 2 diabetics in metformin treatment.

研究概览

简要总结

Project description

Research project title:

Influence of moderate exercise on blood glucose in type 2 diabetics and healthy controls.

Project description and objective

Obesity is so widespread in Denmark that 47% of the population is classed as overweight (BMI>=25) and around 13% of the population is classed as obese (BMI>=30).

The strong correlation between obesity and type 2 diabetes (at least 2/3 of type 2 diabetics are overweight) has led to many studies which look at different forms of exercise for this group, because weight loss may improve the diabetes and even defer the onset of the disorder and in doing so lower complications and increase long term survival.

For people who do not have type 2 diabetes, the work-induced increased sympathetic activity will lead to suppressed insulin secretion and increased glucagon secretion. This increases the endogenous glucose production from the liver and thus maintains a normal concentration of blood sugar in a physical training situation where the demand for glucose has increased.

The theory behind the project is that the mechanisms that help to increase glucose production in the liver during physical activity are weaker in type 2 diabetics, which can cause hypoglycaemia during and after physical exercise. In other words, we want to study the liver's sensitivity to stimulus from physical work by patients with type 2 diabetes and in relevant healthy control subjects.

Previous studies have indicated that this type of mechanism is not intact in type 2 diabetics; because the level of insulin does not fall as expected during or after physical training. However, there are no existing studies that measure the liver's glucose secretion using stable isotopes during prolonged moderate physical work. Measuring this will help to clarify our understanding of glucose homeostasis in type 2 diabetics.

This study is very relevant, because it may be expected that the preferred form of physical exercise of an overweight type 2 diabetic can be of moderate intensity and previous studies also show that this form of physical exercise delivers health gains in terms of an improvement in insulin sensitivity and a reduction in the level of insulin.

The objective of this study is to determine if the level of blood glucose stays constant before, during and after physical training and to examine the liver's ability to secret glucose accordingly.

详细描述

Design

A group of 20 people with type 2 diabetes and 10 control subjects are twice invited to the laboratory, respectively.

The type 2 diabetes group consist of 10 individuals being treated with metformin and 10 individuals who are not being treated with Metformin. The latter group may be diet-treated diabetics or diabetics who have stopped taking their oral antidiabetic agent for 72 hours before the day of the experiment.

On the first visit, the following is carried out:

  • DXA scan, blood pressure measurement, determination of ECG and VO2-max on a cycleergometer
  • Blood sample
  • Questionnaire about everyday physical activity (I-PAQ)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age between 30 and 60 years old
  • Maximum oxygen consumption between 20 and 50 ml/kg/minute
  • BMI between 25 and 35 kg/m2
  • Normal ECG
  • Must have a stable weight throughout the last three months and have a normal balanced diet
  • Can cycle for 45 minutes

排除标准

  • For patients with type 2 diabetes: insulin treatment
  • ECG that indicates cardiovascular disease
  • Illness or medicine that may affect the results
  • On-going weight loss diet

结局指标

主要结局

Glucose homeostasis in controls, type 2 diabetics without medication and type 2 diabetics in metformin treatment.

时间窗: Observational study. Glucose homeostasis is tested one day only (in our Lab). Samples are taken 2,5 hours before, during and untill 1 hour after 45 minutes of exercise. Samples are taken every 5 minutes.

Glucose, hormones, substrates, metabolites and glucose-isotopes as mentioned in the protocol. These end points will be measured on test day 2 only. Hormones and metabolites will be measured as AUC and total concentrations.

次要结局

  • DXA-values(one measurement each subject (test day 1))
  • MAP during moderate exercise(45 min of moderate exercise (test day 2).)
  • vo2max(one measurement each subject (test day 1))
  • IL-6 and incretins(Observational study. Each test subject is tested for IL-6 and incretins one day only (in our Lab), where blood samples are taken continously during the test day every 5 minutes before, during and after exercise (test day 2).)

研究者

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

Merethe Hansen

PhD student Merethe Hansen

University of Copenhagen

研究点 (1)

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