Clinical trial NCT02881684: Aspiration Therapy in Asian Patients
Official title: Weight Reduction by Aspiration Therapy in Asian Patients With Morbid Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Aspire Bariatrics, Inc.
First posted: 2016-08-29
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight reduction by aspiration therapy after 1 year of treatment
timeFrame: 1 year
Secondary outcomes:
measure: Change in blood pressure
timeFrame: 2 years
measure: Change in Serum Lipids
timeFrame: 2 years
measure: Change in Mean Hemoglobin A1c
timeFrame: 2 years
measure: Change in serum leptin
timeFrame: 2 years
measure: Change in serum ghrelin
timeFrame: 2 years
measure: Change in serum peptide YY
timeFrame: 2 years
measure: Change in serum gastric inhibitory polypeptide
timeFrame: 2 years
measure: Change in serum glucagon-like peptide 1
timeFrame: 2 years
measure: Change in serum amylin
timeFrame: 2 years
measure: Change in serum pancreatic polypeptide
timeFrame: 2 years
measure: Change in serum cholecystokinin
timeFrame: 2 years
measure: Change in serum insulin
timeFrame: 2 years
measure: Change in serum C-peptide
timeFrame: 2 years
measure: Change in serum fibroblast growth factor 19
timeFrame: 2 years
measure: Change in perceived appetite / satiety
timeFrame: 2 years
measure: Change in depressive symptoms
timeFrame: 2 years
measure: Change in anxiety symptoms
timeFrame: 2 years
measure: Change in eating behavior
timeFrame: 2 years
measure: Change in psychosocial functioning
timeFrame: 2 years
measure: Electrolyte disturbances
timeFrame: 2 years
measure: Micronutrient disturbances
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
measure: Sustainability of weight reduction (if any) with removal of the A-tube after the treatment period
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References:
citation: 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.
citation: Ko 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.
citation: Spitzer 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.
citation: Mond 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.
citation: Beumont 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.
citation: Karlsson 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.
citation: van 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.
citation: Herpertz 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.
citation: Abiles 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.
citation: Sullivan 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.
citation: Pekkarinen 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.