Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for Cardiovascular Disease (CVD) Among Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Normalization of nocturnal blood pressure dipping
研究概览
简要总结
The objective is to, among obese adolescents, study impact of regular physical activity or metformin therapy on nocturnal blood pressure and related cardiovascular disease risk factors.
详细描述
Forty subjects will be assigned to the exercise intervention group, thirty to the metformin therapy group and thirty to the control group. Group I will be treated daily with metformin. Group II will perform exercise (endurance) three times/week with a personal coach and group III will serve as control. All participants will be examined at baseline, after 3 months of intervention, after 6 months of intervention and after one year of intervention. Examination includes anthropometric measures, measures of ambulatory 24-h blood pressure and insulin sensitivity, measures for function and structure of the heart and vessels, analysis of atherogenic factors in the blood, aerobic fitness testing and measurement of daily physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-19 years old at inclusion date
- •Obesity according to gender and age specific BMI (Cole 2000)
- •Reduced nocturnal systolic blood pressure fall (< 10%)
- •Signed informed consent by patient and parents
排除标准
- •Cardiovascular disease
- •Insulin dependent diabetes mellitus
- •Patient on medications that are contraindicated during Metformin treatment
- •Pregnancy
- •Mental or physical conditions limiting the ability to participate
研究组 & 干预措施
Metformin
干预措施: Metformin group (Drug)
Exercise
干预措施: Exercise (Behavioral)
结局指标
主要结局
Normalization of nocturnal blood pressure dipping
时间窗: Before and 3, 6 and 12 months of intervention
次要结局
- Normalization of insulin metabolism and cardiovascular structure and function(Before and 3, 6 and 12 months of intervention)
研究者
Maria Sandberg Westerstahl
PhD
Karolinska Institutet