Impact of an Exercise Training Program on Bone Development and Cardiovascular Disease Risk Factors in Children With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Bone mineral density and content
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •List of inclusion criteria for Type 1 diabetes patients:
- •disease for at least 1 year.
- •List of inclusion criteria for healthy subjects:
- •good general health and normal growth.
排除标准
- •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.
研究组 & 干预措施
Control Diabetic
干预措施: Exercise training program (Behavioral)
Control Healthy
干预措施: Exercise training program (Behavioral)
Exercise Diabetic
干预措施: Exercise training program (Behavioral)
Exercise Healthy
干预措施: Exercise training program (Behavioral)
结局指标
主要结局
Bone mineral density and content
时间窗: at 9 months
Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.
Bone mineral density and content
时间窗: Baseline
Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.
次要结局
- Anthropometrics(at 9 months)
- Blood lipids levels(at 9 months)
- Physical activity(at 9 months)
- Nutrition(at 9 months)
- Circulating bone biomarkers levels(at 9 months)
- Glycated Haemoglobin(at 9 months)
- Systemic blood pressure(at 9 months)
- Body composition(at 9 months)
- Anthropometrics(Baseline)
- Blood lipids levels(Baseline)
- Physical activity(Baseline)
- Nutrition(Baseline)
- Circulating bone biomarkers levels(Baseline)
- Glycated Haemoglobin(Baseline)
- Systemic blood pressure(Baseline)
- Body composition(Baseline)
- Glycated Haemoglobin(at 3 months)
- Glycated Haemoglobin(at 6 months)