Exercise Training Intervention in Children With Type 1 Diabetes (Diabex)
Impact of an Exercise Training Program on Bone Development and Cardiovascular Disease Risk Factors in Children With Type 1 Diabetes Mellitus
Type 1 diabetes mellitus (T1DM) is associated with multiple co-morbidities, such as hypertension, dyslipidemia, coronary heart disease and osteoporosis. The foundation of these conditions lays in childhood. Exercise is known to have a positive influence on bone mineral density (BMD) and some impact on cardiovascular disease risk factors in healthy children, but little is known about these associations in children with T1DM.
The main purpose of this study is to assess the effects of a 9-month weight-bearing exercise training program on skeletal development in children with T1DM, compared to healthy subjects. The second aim is to evaluate whether the program influences also cardiovascular diseases risk factors.
This is a randomized controlled study incorporating 30 children with T1DM and 30 healthy children. Both groups are randomly divided (1:1) in an exercise or a control group: 1) exercise diabetic, 2) controls diabetic, 3) exercise healthy, 4) controls healthy.
Exercise groups participate to an identical weight-bearing exercise training program 2 x 90 minutes per week and controls are relatively inactive.
Main measures include: total body, lumbar spine and hip BMD by DXA, body fat and fat-free mass, bone biomarkers levels, resting and ambulatory blood pressure and fasting blood lipids.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Geneva、瑞士、1205
- University Hospital of Geneva
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
List of inclusion criteria for Type 1 diabetes patients:
1) disease for at least 1 year.
List of inclusion criteria for healthy subjects:
1) good general health and normal growth.
List of exclusion Criteria for all subjects:
- presence of other chronic disease, including thyroid disease;
- medications, hormones other than insulin, or calcium preparations taken in the preceding 6 months;
- presence of nephropathy;
- systemic disease or hospitalization for more than 2 weeks in the preceding year;
- less than 6 menstrual cycles in the past year for post-menarche girls;
- participation in competitive sport.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control Healthy
|
Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics. Control groups are relatively inactive. |
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无干预：Control Diabetic
|
Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics. Control groups are relatively inactive. |
|
实验性的：Exercise Diabetic
|
Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics. Control groups are relatively inactive. |
|
实验性的：Exercise Healthy
|
Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics. Control groups are relatively inactive. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Bone mineral density and content
大体时间：Baseline
|
Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.
|
Baseline
|
|
Bone mineral density and content
大体时间：at 9 months
|
Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.
|
at 9 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anthropometrics
大体时间：Baseline
|
Body weight, height, body mass index and pubertal stage
|
Baseline
|
|
Blood lipids levels
大体时间：Baseline
|
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
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Baseline
|
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Physical activity
大体时间：Baseline
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Physical activity level by questionnaire and accelerometer
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Baseline
|
|
Nutrition
大体时间：Baseline
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Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
Baseline
|
|
Circulating bone biomarkers levels
大体时间：Baseline
|
Serum levels of beta-CrossLaps (CTX), N-MID-Osteocalcin (OC), N-Terminal Propeptide of Type I Collagen (PINP) and 25-OH-vitamin D (25-OH-D)
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Baseline
|
|
Glycated Haemoglobin
大体时间：Baseline
|
capillary HbA1c levels
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Baseline
|
|
Systemic blood pressure
大体时间：Baseline
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Resting and 24-hour ambulatory systemic blood pressure monitoring
|
Baseline
|
|
Body composition
大体时间：Baseline
|
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
|
Baseline
|
|
Anthropometrics
大体时间：at 9 months
|
Body weight, height, body mass index and pubertal stage
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at 9 months
|
|
Blood lipids levels
大体时间：at 9 months
|
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
|
at 9 months
|
|
Physical activity
大体时间：at 9 months
|
Physical activity level by questionnaire and accelerometer
|
at 9 months
|
|
Nutrition
大体时间：at 9 months
|
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
at 9 months
|
|
Circulating bone biomarkers levels
大体时间：at 9 months
|
Serum levels of beta-CrossLaps (CTX), N-MID-Osteocalcin (OC), N-Terminal Propeptide of Type I Collagen (PINP) and 25-OH-vitamin D (25-OH-D)
|
at 9 months
|
|
Glycated Haemoglobin
大体时间：at 3 months
|
capillary HbA1c levels
|
at 3 months
|
|
Glycated Haemoglobin
大体时间：at 6 months
|
capillary HbA1c levels
|
at 6 months
|
|
Glycated Haemoglobin
大体时间：at 9 months
|
capillary HbA1c levels
|
at 9 months
|
|
Systemic blood pressure
大体时间：at 9 months
|
Resting and 24-hour ambulatory systemic blood pressure monitoring
|
at 9 months
|
|
Body composition
大体时间：at 9 months
|
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
|
at 9 months
|
合作者和调查者
调查人员
- 首席研究员：Farpour-Lambert Nathalie, PD、University Hospital, Geneva
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- snf n°63164
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