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临床试验/NCT05357534
NCT05357534Unknown不适用

Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients

Université de Reims Champagne-Ardenne0 个研究点目标入组 30 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Feeling lucidity

研究概览

简要总结

Type 1 diabetes is an autoimmune disease with absence of insulin secretion. Blood sugar is a physiological variable that reflets for blood glucose concentration. Blood sugar level fluctuates, especially during physical activity.

Sports activity would increase insulin sensitivity, improve lifestyle and, by extension, promote glycemic balance. However, glycemic balance will be disturbed by physical activity with higher risk of hypoglycemia and hyperglycemia.

Moreover, hypoglycemia and hyperglycemia will impact body functions. Perceptions of blood sugar variations during physical exercise and their influences on sports performance have not been studied, whether in type 1 diabetes patients or healthy subjects.

详细描述

The aim of the study is to evaluate the perception of blood sugar variations in healthy subjects and type 1 diabetes patients during physical activity

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Type 1 diabetics diagnosed more than 3 years ago and controlled (an HbA1c of less than 8%) for "type 1 diabetes" group
  • without diabetes for "healkthy" group
  • Aged 18 to 65
  • Body Mass Index less than 30 kg/m2
  • regular running (at least 30 minutes per week and at least one 10-km run per year for the previous 2 years)
  • Agreeing to participate in the study

排除标准

  • Physical injury
  • beta blockers treatment

结局指标

主要结局

Feeling lucidity

时间窗: Day 0

Lucidity, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "not at all lucid" to "completely lucid"

Feeling fatigue

时间窗: Day 0

hydratation, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of dehydration" to "dehydrated"

blood sugar

时间窗: Day 0

Blood sugar evaluated in g/L via continuous blood glucose measurement

total running time

时间窗: Day 0

Sports performance evaluated by total running time of the 10 km run on a treadmill

average running speed

时间窗: Day 0

Sports performance evaluated by average running speed of the 10 km run on a treadmill

average speed per kilometer Sports performance

时间窗: Day 0

Sports performance evaluated by average speed per kilometer of the 10 km run on a treadmill

feeling hungry

时间窗: Day 0

hungry, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of hunger" to "hungry"

次要结局

未报告次要终点

研究者

发起方
Université de Reims Champagne-Ardenne
申办方类型
Other
责任方
Sponsor

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