Aspiration Therapy in Asian Patients

The University of Hong Kong15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Aspiration Therapy (AspireAssist®)DEVICE

Use of the AspireAssist device in aspiration therapy

Lifestyle TherapyBEHAVIORAL

Lifestyle therapy is a behavioral, diet and physical activity education program

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Measured body mass index (BMI) of 27.5-55.0 kg/m2 at time of screening. 2. 21- 65 years of age (inclusive) at time of screening. 3. 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) 4. Stable weight (\<3% change in self-reported weight) over the previous 3 months at time of screening. 5. 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 6. Willing and able to provide informed consent and comply with the protocol. Exclusion Criteria: 1. Evidence of an eating disorder or major depression 2. History of gastrointestinal disease or previous gastric surgery that would increase the risk of the AspireAssist® Tube (A-Tube) placement 3. Severe co-existing medical diseases or malignancies 4. Bleeding tendency (low platelet, coagulopathy including being on anti-coagulants) 5. Pregnant/lactating

Locations (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

Michele MA Yuen, MBBS

CONTACT

(852) 6073 2211 micheleyuen@hotmail.com

Carol HY Fong, MSc Stat

CONTACT

(852) 2255 3711 kalofong@gmail.com

Data from ClinicalTrials.gov

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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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 2 years

Change in perceived appetite / satiety

Using the control of eating questionnaire

Time frame: 2 years

Change in depressive symptoms

Patient Health Questionnaire

Time frame: 2 years

Change in anxiety symptoms

State-Trait Anxiety Inventory (STAI)

Time frame: 2 years

Change in eating behavior

Eating Disorder Examination (EDE-Q)

Time frame: 2 years

Change in psychosocial functioning

Obesity Related Psychological Problem Scale (OP Scale)

Time frame: 2 years

Electrolyte disturbances

Number of treatment group subjects with hypokalemia, hypokalemia requiring oral replacement therapy and hypokalemia requiring in-patient care

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 1 year