Aspiration Therapy in Asian Patients

Obesity Clinical Trial

Official title:

Weight Reduction by Aspiration Therapy in Asian Patients With Morbid Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02881684
• Other study ID #: UW 16-244
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: The University of Hong Kong
• Contact: Michele MA Yuen, MBBS
• Phone: (852) 6073 2211
• Email: micheleyuen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Aspiration Therapy (AspireAssist®)
Use of the AspireAssist device in aspiration therapy

Behavioral:
• Lifestyle Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Aspire Bariatrics, Inc.

Country where clinical trial is conducted

Hong Kong, 

References & Publications (11)

Abilés V, Rodríguez-Ruiz S, Abilés J, Mellado C, García A, Pérez de la Cruz A, Fernández-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. — View 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. — View 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. — View 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. Review. — View Citation

Karlsson J, Taft C, Sjöström 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

van Hout GC, van Oudheusden I, van Heck GL. Psychological profile of the morbidly obese. Obes Surg. 2004 May;14(5):579-88. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in perceived appetite / satiety	Using the control of eating questionnaire	2 years
Secondary	Change in depressive symptoms	Patient Health Questionnaire	2 years
Secondary	Change in anxiety symptoms	State-Trait Anxiety Inventory (STAI)	2 years
Secondary	Change in eating behavior	Eating Disorder Examination (EDE-Q)	2 years
Secondary	Change in psychosocial functioning	Obesity Related Psychological Problem Scale (OP Scale)	2 years
Secondary	Electrolyte disturbances	Number of treatment group subjects with hypokalemia, hypokalemia requiring oral replacement therapy and hypokalemia requiring in-patient care	2 years
Secondary	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
Secondary	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
Secondary	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

External Links

•   Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.
•   Obesity. Centre for Health Protection, Department of Health, Government of Hong Kong, 2015.