Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
详细描述
The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band system in the morbidly obese adolescent population in the United States. We also propose to take advantage of the opportunity for liver biopsy and the data collected for the FDA study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the course of the NAFLD disease in adolescents who have undergone weight loss, including the progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What are the factors implicated in this progression and 4) Is there a link between the excess visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 14 through 17
- •BMI greater than 40
- •BMI 35 to 40 and also having an obesity related comorbidity
- •Have a history of working in a multidisciplinary weight loss program utilizing nutritional training, behavior modification, and activity training
排除标准
- •Subject history of congenital or acquired anomalies fo the gastrointestinal tract
- •Severe cardiopulmonary or other serious organic disease
- •Severe coagulopathy
- •Hepatic insufficiency or cirrhosis
- •History of bariatric gastric or esophageal surgery
- •History of intestinal obstruction or adhesive peritonitis
- •History of esophageal motility disorders
- •Type I diabetes
结局指标
主要结局
Weight loss
时间窗: Every six months
次要结局
- Resolution of comorbidities(every six months)
- Assess the status of comorbidities and changes in quality of life scores from baseline.(every six months)
研究者
Bob Kanard
Visiting Assistant Professor/MD
University of Illinois at Chicago
