Aspiration Therapy in Asian Patients
Weight Reduction by Aspiration Therapy in Asian Patients With Morbid Obesity
1 other identifier
interventional
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Aug 2016
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 12, 2016
CompletedFirst Posted
Study publicly available on registry
August 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 15, 2018
May 1, 2018
2.3 years
August 12, 2016
May 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (23)
Change in blood pressure
2 years
Change in Serum Lipids
2 years
Change in Mean Hemoglobin A1c
2 years
Change in serum leptin
2 years
Change in serum ghrelin
2 years
- +18 more secondary outcomes
Study Arms (2)
Treatment
EXPERIMENTALIntervention: 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
Control
ACTIVE COMPARATORIntervention: (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.
Interventions
Use of the AspireAssist device in aspiration therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
Eligibility Criteria
You may qualify if:
- Measured body mass index (BMI) of 27.5-55.0 kg/m2 at time of screening.
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Aspire Bariatrics, Inc.collaborator
Study Sites (1)
The University of Hong Kong
Hong Kong, Hong Kong
Related Publications (11)
Dupont WD, Plummer WD Jr. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998 Dec;19(6):589-601. doi: 10.1016/s0197-2456(98)00037-3.
PMID: 9875838BACKGROUNDKo GT. The cost of obesity in Hong Kong. Obes Rev. 2008 Mar;9 Suppl 1:74-7. doi: 10.1111/j.1467-789X.2007.00442.x.
PMID: 18307703BACKGROUNDSpitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
PMID: 10568646BACKGROUNDMond JM, Hay PJ, Rodgers B, Owen C, Beumont PJ. Validity of the Eating Disorder Examination Questionnaire (EDE-Q) in screening for eating disorders in community samples. Behav Res Ther. 2004 May;42(5):551-67. doi: 10.1016/S0005-7967(03)00161-X.
PMID: 15033501BACKGROUNDBeumont PJ, Kopec-Schrader EM, Talbot P, Touyz SW. Measuring the specific psychopathology of eating disorder patients. Aust N Z J Psychiatry. 1993 Sep;27(3):506-11. doi: 10.3109/00048679309075810.
PMID: 8250797BACKGROUNDKarlsson J, Taft C, Sjostrom L, Torgerson JS, Sullivan M. Psychosocial functioning in the obese before and after weight reduction: construct validity and responsiveness of the Obesity-related Problems scale. Int J Obes Relat Metab Disord. 2003 May;27(5):617-30. doi: 10.1038/sj.ijo.0802272.
PMID: 12704406BACKGROUNDvan Hout GC, van Oudheusden I, van Heck GL. Psychological profile of the morbidly obese. Obes Surg. 2004 May;14(5):579-88. doi: 10.1381/096089204323093336.
PMID: 15186623BACKGROUNDHerpertz S, Kielmann R, Wolf AM, Langkafel M, Senf W, Hebebrand J. Does obesity surgery improve psychosocial functioning? A systematic review. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1300-14. doi: 10.1038/sj.ijo.0802410.
PMID: 14574339BACKGROUNDAbiles V, Rodriguez-Ruiz S, Abiles J, Mellado C, Garcia A, Perez de la Cruz A, Fernandez-Santaella MC. Psychological characteristics of morbidly obese candidates for bariatric surgery. Obes Surg. 2010 Feb;20(2):161-7. doi: 10.1007/s11695-008-9726-1. Epub 2008 Oct 29.
PMID: 18958537BACKGROUNDSullivan S, Stein R, Jonnalagadda S, Mullady D, Edmundowicz S. Aspiration therapy leads to weight loss in obese subjects: a pilot study. Gastroenterology. 2013 Dec;145(6):1245-52.e1-5. doi: 10.1053/j.gastro.2013.08.056. Epub 2013 Sep 6.
PMID: 24012983RESULTPekkarinen T, Kaukua J, Mustajoki P. Long-term weight maintenance after a 17-week weight loss intervention with or without a one-year maintenance program: a randomized controlled trial. J Obes. 2015;2015:651460. doi: 10.1155/2015/651460. Epub 2015 Mar 30.
PMID: 25918644RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist in Endocrinology & Metabolism, Honorary Clinical Assistant Professor
Study Record Dates
First Submitted
August 12, 2016
First Posted
August 29, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
May 15, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share