Weight Reduction by Aspiration Therapy in Asian Patients With Morbid Obesity
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Weight reduction by aspiration therapy after 1 year of treatment
研究概览
简要总结
This research project will provide insight into the efficacy and safety of aspiration therapy in the management of obesity and its comorbidities in the Asian population, and will determine if there is a role for this novel endoscopic device in the treatment algorithm of obesity in the investigators' local regions.
详细描述
Obesity is a major global health problem and Asians are equally affected. According to the latest Behavioural Risk Factor Survey in 2014, 20.8% of adults in Hong Kong have body mass index (BMI) belonging to the obese category. Obesity is associated with a multitude of medical and psychological comorbidities that could cumulate in increased healthcare costs and impaired quality of life. As such, an effective treatment strategy for obesity is imperative.
Sustainable weight reduction by lifestyle measures alone is often difficult if not impossible. Pharmacotherapy can provide additional weight reduction when used as an adjunct to lifestyle intervention but the efficacy is modest. The most effective method for weight reduction to date is bariatric surgery but this is limited by its invasiveness and irreversibility. The limitations of current obesity treatment has led to an increased interest in endoscopic treatment, which may be more effective than pharmacotherapy and less invasive and more reversible than bariatric surgery.
The AspireAssist® Aspiration Therapy System is a novel endoscopic therapy developed by Aspire Bariatrics Inc. (King of Prussia, United States) for treatment of obesity. The system takes advantage of percutaneous endoscopic gastrostomy (PEG) tube technology to induce weight reduction by aspirating a portion of ingested meals from the stomach. In a pilot study involving 18 Caucasian obese subjects randomly assigned in a 2:1 ratio to aspiration therapy group and lifestyle therapy only group, the weight reduction was 18.6% +/- 2.3% and 5.9% +/- 5.0% respectively. The present study aims to investigate the effectiveness and safety of this device in Asian subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Measured body mass index (BMI) of 27.5-55.0 kg/m2 at time of screening.
- •21- 65 years of age (inclusive) at time of screening.
- •Failed attempt for a duration equal to 3-months at weight loss by alternative approaches (e.g. supervised or unsupervised diets, exercise, behavioral modification programs)
- •Stable weight (<3% change in self-reported weight) over the previous 3 months at time of screening.
- •Women of childbearing potential who agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, intrauterine device (IUD), condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit
- •Willing and able to provide informed consent and comply with the protocol.
排除标准
- •Evidence of an eating disorder or major depression
- •History of gastrointestinal disease or previous gastric surgery that would increase the risk of the AspireAssist® Tube (A-Tube) placement
- •Severe co-existing medical diseases or malignancies
- •Bleeding tendency (low platelet, coagulopathy including being on anti-coagulants)
- •Pregnant/lactating
研究组 & 干预措施
Treatment
Intervention:
- Device: Aspiration Therapy (AspireAssist)
- Subjects randomized to the treatment group will undergo an endoscopic procedure to have the experimental device (i.e. the A-tube) inserted. This will be followed by regular follow up visits and lifestyle therapy matched to the control group. The device will be removed at the end of one year and this group will be observed for one year more to determine if there is any legacy effect.
- Behavioral: Lifestyle Therapy Lifestyle therapy is a behavioral, diet and physical activity education program Other Name: Lifestyle Behavioral Therapy
干预措施: Aspiration Therapy (AspireAssist®) (Device)
Treatment
Intervention:
- Device: Aspiration Therapy (AspireAssist)
- Subjects randomized to the treatment group will undergo an endoscopic procedure to have the experimental device (i.e. the A-tube) inserted. This will be followed by regular follow up visits and lifestyle therapy matched to the control group. The device will be removed at the end of one year and this group will be observed for one year more to determine if there is any legacy effect.
- Behavioral: Lifestyle Therapy Lifestyle therapy is a behavioral, diet and physical activity education program Other Name: Lifestyle Behavioral Therapy
干预措施: Lifestyle Therapy (Behavioral)
Control
Intervention:
(1) Behavioral: Lifestyle Therapy Lifestyle therapy is a behavioral, diet and physical activity education program Other Name: Lifestyle Behavioral Therapy
- Subjects randomized to the control group will receive lifestyle management matched to the treatment group in the first year. At the end of one year, they will be crossed over to treatment and the A-tube will be inserted. They will then follow up the same follow up schedule of the treatment group during the first year.
干预措施: Aspiration Therapy (AspireAssist®) (Device)
Control
Intervention:
(1) Behavioral: Lifestyle Therapy Lifestyle therapy is a behavioral, diet and physical activity education program Other Name: Lifestyle Behavioral Therapy
- Subjects randomized to the control group will receive lifestyle management matched to the treatment group in the first year. At the end of one year, they will be crossed over to treatment and the A-tube will be inserted. They will then follow up the same follow up schedule of the treatment group during the first year.
干预措施: Lifestyle Therapy (Behavioral)
结局指标
主要结局
Weight reduction by aspiration therapy after 1 year of treatment
时间窗: 1 year
Aspiration therapy using the AspireAssist® Aspiration Therapy System (Aspire Bariatrics Inc., King of Prussia, United States) for weight reduction in Asian subjects with obesity over a 12-month treatment period.
次要结局
- Change in Serum Lipids(2 years)
- Change in Mean Hemoglobin A1c(2 years)
- Change in serum ghrelin(2 years)
- Change in depressive symptoms(2 years)
- Change in serum leptin(2 years)
- Change in serum glucagon-like peptide 1(2 years)
- Change in serum C-peptide(2 years)
- Change in eating behavior(2 years)
- Electrolyte disturbances(2 years)
- Change in psychosocial functioning(2 years)
- Adverse events(2 years)
- Change in anxiety symptoms(2 years)
- Change in blood pressure(2 years)
- Change in serum insulin(2 years)
- Micronutrient disturbances(2 years)
- Change in serum fibroblast growth factor 19(2 years)
- Sustainability of weight reduction (if any) with removal of the A-tube after the treatment period(1 year)
- Change in serum peptide YY(2 years)
- Change in serum gastric inhibitory polypeptide(2 years)
- Change in serum amylin(2 years)
- Change in serum pancreatic polypeptide(2 years)
- Change in serum cholecystokinin(2 years)
- Change in perceived appetite / satiety(2 years)
研究者
Dr. Michele Yuen
Specialist in Endocrinology & Metabolism, Honorary Clinical Assistant Professor
The University of Hong Kong