Effets du Rythme Circadien Sur la régulation glycémique Lors d'Exercices modérés Continus et Intermittents Intenses Chez Des Adolescents Vivant Avec le diabète de Type 1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Comparison of glycemic variation between the 4 conditions
研究概览
简要总结
Interventional research with minimal risks and constraints on the effects of circadian rhythm on glycemic regulation during intense moderate, continuous and intermittent exercise in adolescents living with type 1 diabetes
详细描述
Single-center, randomized, controlled study in adolescents living with type 1 diabetes. This study aims to evaluate the effect of exercise timing (morning vs. afternoon) and exercise type (continuous vs. intermittent) on blood glucose levels during and after exercise, as well as to assess the effect of exercise timing (morning vs. afternoon) and type of exercise (continuous vs. intermittent) on blood glucose during and after exercise
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
It is not possible to do a trial in blind or double blind because the moment of the day and the exercice modality can not be hidden, however the results analysis will be assessed in blind
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 10 to 16;
- •Living with type 1 diabetes for at least 1 year with HbA1c less than or equal to 12%;
- •Socially insured ;
- •Having given their written consent to participate in the research, as well as that of their legal guardians;
- •Willing to comply with all research procedures and duration.
排除标准
- •Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate less than 40 ml/min), neuropathy or severe proliferative retinopathy as assessed by the investigator;
- •Recent acute macrovascular event (< 3 months), e.g. acute coronary syndrome or cardiac surgery;
- •Abnormal blood picture and/or anemia;
- •Current pregnancy;
- •Other serious medical condition likely to interfere with study participation or ability to complete exercise periods in the judgment of the investigator (e.g., orthopedic limitation);
- •Inability to receive informed information;
- •Inability to participate in the entire study;
- •Lack of social security coverage;
- •Refusal to sign the consent form.
研究组 & 干预措施
Continuous - morning
Continuous exercise on ergocycle in the morning
Continuous - afternoon
Continuous exercise on ergocycle in the afternoon
干预措施: physical test (Other)
Intermittent - morning
Intermittent exercise on ergocycle in the morning
Intermittent - afternoon
Intermittent exercice on ergocycle in the afternoon
干预措施: physical test (Other)
结局指标
主要结局
Comparison of glycemic variation between the 4 conditions
时间窗: 1 year 10 months september 2026
Observation of time in target, time in hypoglycemia and time in hyperglycemia
次要结局
未报告次要终点