Randomized,Controlled,Open,Cross-Over Intervention Study for Evaluating the Role of Physical Activity in the Treatment of Children With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 入组人数
- 2,007
- 试验地点
- 2
- 主要终点
- HbA1C
研究概览
简要总结
Randomized, controlled, open, comparative intervention study in two groups, each consisting of 25 children with type 1 diabetes that will undergo twelve weeks of exercise program (intensive arm) and twelve weeks of regular activity (non intensive arm) separated by four week of washout period. The study will be conducted in a crossover manner: one group starting with the intensive arm followed by the non intensive arm and vice versa. Blood glucose, HbA1C, Fructosamine, 3 days continuous glucose monitoring system (CGMS), total daily insulin dose, fasting lipid profile, body impedance and BMR will be measured. Self esteem and quality of life questionnaires will be filled.
详细描述
Randomized, controlled, open, comparative, cross-over, intervention study in 50 children with type 1 diabetes.
objectives:
Primary objective To evaluate the efficacy and safety of physical activity for metabolic control in children with type I diabetes.
Secondary objectives
- To characterize the severity and pattern of occurrence of hypo and hyperglycemic episodes during and after exercise program in type I diabetic children.
- To evaluate changes in insulin sensitivity during and after periods of exercise in type I diabetic children.
- To evaluate the short term effect of exercise on BMI and body composition in type I diabetic children.
- To evaluate the short term effect of exercise on lipid profile in type I diabetic children.
- To evaluate differences in self esteem and quality of life between exercising and non exercising type I diabetic children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type I diabetic children
- •Tanner stage II-IV
- •Patients of the Schneider's national institute of childhood diabetes. Duration of diabetes
- •more than one year.
- •HbA1C between 8 and 12 at time
- •Mandatory 4 daily self blood glucose measurements and daily recording of adverse events.
- •A signed informed consent of the parents and child.
排除标准
- •Additional chronic significant disease such as cardiac, liver, renal disease .
- •Children who exercise regularly more than 180 min per week.
- •Cardiac symptoms: history of chest pain , syncope , palpitations or dyspnea during exercise.
- •Eating disorders.
- •Participation in a study during the past month.
结局指标
主要结局
HbA1C
时间窗: 0,3 monthes
fructosamine
时间窗: 0,3 monthes
次要结局
- Body composition & BMR(0,3 monthes)
- Self esteem & QOL questionnaires(o, 3 monthes)
- 3 days CGMS & SBGM profile(0,3 monthes)