Aspiration Therapy in Asian Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Weight Reduction by Aspiration Therapy in Asian Patients With Morbid Obesity

Conditions
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Obesity

Intervention / Treatment
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* Device: Aspiration Therapy (AspireAssist®)
* Behavioral: Lifestyle Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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 | Device: Aspiration Therapy (AspireAssist®)<br>* Use of the AspireAssist device in aspiration therapy<br>* Other names: AspireAssist® Aspiration Therapy System;Behavioral: Lifestyle Therapy<br>* Lifestyle therapy is a behavioral, diet and physical activity education program<br>* Other names: Lifestyle Behavioral Therapy;|
| Active Comparator: Control<br>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. | Device: Aspiration Therapy (AspireAssist®)<br>* Use of the AspireAssist device in aspiration therapy<br>* Other names: AspireAssist® Aspiration Therapy System;Behavioral: Lifestyle Therapy<br>* Lifestyle therapy is a behavioral, diet and physical activity education program<br>* Other names: Lifestyle Behavioral Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight reduction by aspiration therapy after 1 year of treatment | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | mean percent change in systolic and diastolic blood pressures during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in Serum Lipids | mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in Mean Hemoglobin A1c | change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline) during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum leptin | change in mean serum leptin levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum ghrelin | change in mean serum ghrelin levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum peptide YY | change in mean serum peptide YY levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum gastric inhibitory polypeptide | change in mean serum gastric inhibitory polypeptide levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum glucagon-like peptide 1 | change in mean serum glucagon-like peptide 1 levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum amylin | change in mean serum amylin levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum pancreatic polypeptide | change in mean serum pancreatic polypeptide levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum cholecystokinin | change in mean serum cholecystokinin levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum insulin | change in mean serum insulin levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum C-peptide | change in mean serum C-peptide levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in serum fibroblast growth factor 19 | change in mean serum fibroblast growth factor 19 levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group | 2 years | 
| Change in perceived appetite / satiety | Using the control of eating questionnaire | 2 years | 
| Change in depressive symptoms | Patient Health Questionnaire | 2 years | 
| Change in anxiety symptoms | State-Trait Anxiety Inventory (STAI) | 2 years | 
| Change in eating behavior | Eating Disorder Examination (EDE-Q) | 2 years | 
| Change in psychosocial functioning | Obesity Related Psychological Problem Scale (OP Scale) | 2 years | 
| Electrolyte disturbances | Number of treatment group subjects with hypokalemia, hypokalemia requiring oral replacement therapy and hypokalemia requiring in-patient care | 2 years | 
| Micronutrient disturbances | Number of treatment group subjects with iron / vitamin B12 / folate deficiencies, with iron / vitamin B12 / folate deficiencies requiring oral replacement therapy and with iron / vitamin B12 / folate deficiencies requiring in-patient care | 2 years | 
| Adverse events | The incidence of procedure-related, device-related, and therapy-related adverse events unrelated to electrolyte or micronutrient disturbances will be measured, as well as the incidence of device related, or unrelated, serious adverse events, including unanticipated adverse device effects. Also, the development of adverse eating behaviors will be assessed. | 2 years | 
| Sustainability of weight reduction (if any) with removal of the A-tube after the treatment period | Mean weight gain during the first year after removal of the A-tube in the AT group | 1 year |