Study of Safety and Efficacy Assessment of Aspiration Therapy for Morbidly Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Long-term changes of nutritional status
研究概览
简要总结
Interventional studies devoted to adolescents are relatively rare in the world. This has several reasons. Treatment and research on obesity are centered on advanced forms of obesity in adults, bearing in mind that social and health problems make these patients cope with their condition. Studies on children tend to focus on epidemiology. On the other hand, effective long-term effective treatment is not just for young adults and adolescents. However, appropriate long-term weight reduction methods could help with chronic obesity at the onset of the disease. Here, the ideal scheme at the outset of the disease is to use less invasive endoscopic methods and then use invasive surgical methods at a later age.
The benefit of this study will certainly be to find out the reality of the use of this endoscopic method in young obese individuals, that is, population groups where, according to the WHO and CDC (Centers for Disease Control and Prevention), there has been a rapid increase in the incidence of obesity especially during the last 20 years.
详细描述
The aim of the project is the testing and research of the impact on metabolism using the approved bariatric method AspireAssist, which is currently used in the adult population. The method has been approved by FDA since 2016. The method involves the introduction of percutaneous endoscopic gastrostomy (PEG) that allows the aspiration of a portion of the food and the control of the size and volume of the food received, even in the unmanaged size and volume of food intake.
Potential participants of the study will undergo an initial examination at the clinical department of pediatric medicine specializing in obesitology at the Vítkovice Hospital Ostrava a.s. In addition to a pediatric and internal examination, a potential patient will be examined by a clinical psychologist for the ability to participate in such a type of study on a long-term basis, and will further assess the degree of patient support and co-operation. Selected participants in the study or their family members will receive informed consent. A study participant is considered to be a participant in the study after consent to his / her inclusion in the study after the informed consent has been signed. The AspireAssist aspiration device is the definitive participation in the study.
Two parts will be monitored within the project. (1) Safety and efficacy will be assessed first in young obese patients for whom the use of bariatric methods is still a question of discussion, especially in surgical methods. (2) The second objective is to monitor the saccharide and lipid metabolism, GI hormones and also the impact of the AspireAssist method on the nutritional status of the adolescents studied.
The patients enrolled in the study are followed for the period of twelve months.
Timetable of the study procedures and controls:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities)
排除标准
- •Diabetes Type I.
- •blood clotting disorder
- •using of Insulin
- •psychiatric disorders
- •monogenic obesity (Prader-Willi syndrome, mutation of MC4R).
- •thyroid disease
- •diseases of the digestive system associated with disorders of intestinal absorption
- •history of corticosteroid therapy in the past 12 months
- •history of bulimia and other eating disorders
结局指标
主要结局
Long-term changes of nutritional status
时间窗: 12 months
Analysis of the dynamics of changes in nutrition status in adolescents after endoscopic bariatric treatment of obesity (BMI\> 30) will be performed. In the study, serum concentrations of the following parameters will be measured: vitamins A, D, E, K, B1, B6, B12, Folic acid and plasma proteins such as albumin, pre albumin, creatinine. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L.
Long-term weight reduction assessment in kgs
时间窗: 12 months
Evaluation of the success of treatment in terms of long-term weight reduction (difference in body weight in kilograms at the beginning vs. the end of the observation period of 12 months).
次要结局
- Changes in serum levels GI hormones and saccharide metabolism(12 months)
- Changes in serum levels of lipids(12 months)
- Changes in serum levels of adipose tissue hormones(12 months)
- IWQOL Questionnaire evaluation(12 months)
- SF-36 Questionnaire evaluation(12 months)