Aspiration Therapy in Asian Patients

May 9, 2018 updated by: Dr. Michele Yuen, The University of Hong Kong

Weight Reduction by Aspiration Therapy in Asian Patients With Morbid Obesity

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.

Study Overview

Detailed Description

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

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment

Intervention:

  1. 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.

  2. Behavioral: Lifestyle Therapy Lifestyle therapy is a behavioral, diet and physical activity education program Other Name: Lifestyle Behavioral Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
Other Names:
  • Lifestyle Behavioral Therapy
Use of the AspireAssist device in aspiration therapy
Other Names:
  • AspireAssist® Aspiration Therapy System
ACTIVE_COMPARATOR: 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.

Lifestyle therapy is a behavioral, diet and physical activity education program
Other Names:
  • Lifestyle Behavioral Therapy
Use of the AspireAssist device in aspiration therapy
Other Names:
  • AspireAssist® Aspiration Therapy System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood pressure
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
Using the control of eating questionnaire
2 years
Change in depressive symptoms
Time Frame: 2 years
Patient Health Questionnaire
2 years
Change in anxiety symptoms
Time Frame: 2 years
State-Trait Anxiety Inventory (STAI)
2 years
Change in eating behavior
Time Frame: 2 years
Eating Disorder Examination (EDE-Q)
2 years
Change in psychosocial functioning
Time Frame: 2 years
Obesity Related Psychological Problem Scale (OP Scale)
2 years
Electrolyte disturbances
Time Frame: 2 years
Number of treatment group subjects with hypokalemia, hypokalemia requiring oral replacement therapy and hypokalemia requiring in-patient care
2 years
Micronutrient disturbances
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 1 year
Mean weight gain during the first year after removal of the A-tube in the AT group
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (ESTIMATE)

August 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • UW 16-244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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