Bariatric Surgery in Children. (BASIC)
The BASIC Trial. Morbid Obesity in Children and Adolescents: a Prospective Randomised Trial of Conservative Treatment Versus Surgery
Rationale:
In the Western world overweight and obesity is an increasing problem both in adults and in children. In youth, it is associated with early death and a number of co-morbidities including metabolic and endocrine changes, increased inflammatory status, cardiovascular abnormalities, nonalcoholic fatty liver disease, and impaired quality of life.
The standard treatment for morbid obesity in children is by combined life style interventions. However, the medium and long term effects of dietetic interventions, behaviour therapy and medication is relatively poor. In adults bariatric surgery shows good results with up to 30% weight reduction in 3 years. The preliminary results in youth are similar, but surgery in this age group is relatively uncommon. In the Netherlands surgery in this age group is only allowed in clinical trials, until the benefits and risks have been established. (National Health Authorities)
Objective:
To determine if surgery gives a superior weight and body mass index (BMI) reduction than combined life style interventions in adolescents with morbid obesity and to assess its effect on obesity associated co-morbidity.
Study design:
Prospective randomised interventional study.
Study population:
Morbidly obese children, aged 14 - 16 years, with sex and age adjusted BMI >40 kg/m2 or >35 kg/m2 with co-morbidity.
Intervention:
Bariatric surgery by laparoscopic adjustable gastric band (LAGB) or combined life style interventions
Main study parameters/endpoints:
Primary endpoints: weight loss, loss of excess weight, loss of excess BMI. Secondary endpoints: Body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, brain development, quality of life, and behaviour changes. The potential complications of surgery are monitored.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Limburg
-
Maastricht、Limburg、荷兰、6202ZA
- Maastricht University Medical Center
-
-
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
Inclusion Criteria:
- Aged 14 to 16
Age and sex adjusted BMI >40 kg/m2 or >35 kg/m2 with associated co-morbidity.
* Associated co-morbidity includes: glucose intolerance, type 2 diabetes, hypertension, pseudotumor cerebri, acanthosis nigricans, obstructive sleep apnoea syndrome, depression, arthropathies, non-alcoholic steatohepatitis and dyslipidemia.
- > 1 year multidisciplinary organized weight reducing attempts with less than 5% weight loss
- Demonstrate decisional capacity
Exclusion Criteria:
- Psychologically not suitable
- Pre-menarche or bone age <15 years in boys
- Obesity associated to other disorders such as hypothyroidism
- Syndromal disorders such as Prader-Willi syndrome
- Severe cardiorespiratory impairment (ASA class 3 or higher)
- Insufficiently fluid in the Dutch language
- Unwillingness to adhere to follow-up programmes
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 |
---|---|
有源比较器:控制组
|
Control group will receive standard therapy consisting of combined lifestyle interventions.
|
实验性的:Laparoscopic adjustable gastric band
|
Laparoscopic gastric band placement.
Combined lifestyle interventions will continue after surgery.
Control group will receive standard therapy consisting of combined lifestyle interventions.
|
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 |
---|---|---|
Weight
大体时间:6 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
6 months
|
Weight
大体时间:12 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
12 months
|
Weight
大体时间:24 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
24 months
|
Weight
大体时间:36 months
|
Weight loss, excess weight loss and loss of excess BMI.
|
36 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Body composition
大体时间:12 months
|
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
|
12 months
|
Pubertal development
大体时间:6 months
|
Follow-up of hormonal status and Tanner stages.
|
6 months
|
Metabolic and endocrine changes
大体时间:6 months
|
6 months
|
|
Inflammatory status
大体时间:6 months
|
Measurement of serum inflammatory markers.
|
6 months
|
Cardiovascular abnormalities
大体时间:6 months
|
6 months
|
|
Non-alcoholic fatty liver disease
大体时间:6 months
|
Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured.
CCL-2 is used as a surrogate marker to assess liver disease.
|
6 months
|
Quality of life changes
大体时间:6 months
|
6 months
|
|
Behaviour changes
大体时间:6 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
6 months
|
Operative complications
大体时间:up to 36 months
|
Early and late complications are being monitored
|
up to 36 months
|
Effects on sleep architecture
大体时间:6 months
|
6 months
|
|
Brain development
大体时间:6 months
|
If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.
|
6 months
|
Body composition
大体时间:24 months
|
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
|
24 months
|
Body composition
大体时间:36 months
|
Next to anthropometric measurements, bone mineral content, bone density, lean bodymass and fat percentage will be assessed.
|
36 months
|
Pubertal development
大体时间:12 months
|
Follow-up of hormonal status and Tanner stages.
|
12 months
|
Pubertal development
大体时间:24 months
|
Follow-up of hormonal status and Tanner stages.
|
24 months
|
Pubertal development
大体时间:36 months
|
Follow-up of hormonal status and Tanner stages.
|
36 months
|
Metabolic and endocrine changes
大体时间:12 months
|
12 months
|
|
Metabolic and endocrine changes
大体时间:24 months
|
24 months
|
|
Metabolic and endocrine changes
大体时间:36 months
|
36 months
|
|
Inflammatory status
大体时间:12 months
|
Measurement of serum inflammatory markers.
|
12 months
|
Inflammatory status
大体时间:24 months
|
Measurement of serum inflammatory markers.
|
24 months
|
Inflammatory status
大体时间:36 months
|
Measurement of serum inflammatory markers.
|
36 months
|
Cardiovascular abnormalities
大体时间:12 months
|
12 months
|
|
Cardiovascular abnormalities
大体时间:24 months
|
24 months
|
|
Cardiovascular abnormalities
大体时间:36 months
|
36 months
|
|
Non-alcoholic fatty liver disease
大体时间:12 months
|
Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured.
CCL-2 is used as a surrogate marker to assess liver disease.
|
12 months
|
Non-alcoholic fatty liver disease
大体时间:24 months
|
Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured.
CCL-2 is used as a surrogate marker to assess liver disease.
|
24 months
|
Non-alcoholic fatty liver disease
大体时间:36 months
|
Next to an ultrasound of the liver, serum levels of ALT, AST, ALP and GGT are measured.
CCL-2 is used as a surrogate marker to assess liver disease.
|
36 months
|
Quality of life changes
大体时间:12 months
|
12 months
|
|
Quality of life changes
大体时间:24 months
|
24 months
|
|
Quality of life changes
大体时间:36 months
|
36 months
|
|
Effects on sleep architecture
大体时间:12 months
|
12 months
|
|
Effects on sleep architecture
大体时间:24 months
|
24 months
|
|
Effects on sleep architecture
大体时间:36 months
|
36 months
|
|
Behaviour changes
大体时间:12 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
12 months
|
Behaviour changes
大体时间:24 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
24 months
|
Behaviour changes
大体时间:36 months
|
Measuring impulsivity and positive reward dominance with a computer task.
|
36 months
|
Brain development
大体时间:12 months
|
If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.
|
12 months
|
Brain development
大体时间:24 months
|
If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.
|
24 months
|
Brain development
大体时间:36 months
|
If extra sponsorship can be gained, we will use fMRI and MEG in a subgroup to measure blood oxygen level-dependent (BOLD) brain response to food stimuli.
|
36 months
|
Physical activity
大体时间:6 months
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
6 months
|
Physical activity
大体时间:12 months
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
12 months
|
Physical activity
大体时间:24
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
24
|
Physical activity
大体时间:36 months
|
Assessment of physical activity using a questionnaire and an accelerometer.
|
36 months
|
Behavior towards food
大体时间:6 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
6 months
|
Behavior towards food
大体时间:12 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
12 months
|
Behavior towards food
大体时间:24 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
24 months
|
Behavior towards food
大体时间:36 months
|
Behavior towards food is assessed by questionnaires and a computerized model for wanting and liking of food.
|
36 months
|
合作者和调查者
调查人员
- 首席研究员:LWE van Heurn, Professor、Maastricht University Medical Center
- 首席研究员:Yvonne Roebroek, PhD Student、Maastricht University Medical Center
- 首席研究员:Givan F Paulus, PhD Student、Spaarne Gasthuis, Haarlem
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 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.