Aspiration Therapy for Obese Adolescents

Obesity, Morbid Clinical Trial

Official title:

Study of Safety and Efficacy Assessment of Aspiration Therapy for Morbidly Obese Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598920
• Other study ID #: FNO-IK-Aspiration
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Interventional studies devoted to adolescents are relatively rare in the world. This has several reasons. Treatment and research on obesity are centered on advanced forms of obesity in adults, bearing in mind that social and health problems make these patients cope with their condition. Studies on children tend to focus on epidemiology. On the other hand, effective long-term effective treatment is not just for young adults and adolescents. However, appropriate long-term weight reduction methods could help with chronic obesity at the onset of the disease. Here, the ideal scheme at the outset of the disease is to use less invasive endoscopic methods and then use invasive surgical methods at a later age.

The benefit of this study will certainly be to find out the reality of the use of this endoscopic method in young obese individuals, that is, population groups where, according to the WHO and CDC (Centers for Disease Control and Prevention), there has been a rapid increase in the incidence of obesity especially during the last 20 years.

Description:

The aim of the project is the testing and research of the impact on metabolism using the approved bariatric method AspireAssist, which is currently used in the adult population. The method has been approved by FDA since 2016. The method involves the introduction of percutaneous endoscopic gastrostomy (PEG) that allows the aspiration of a portion of the food and the control of the size and volume of the food received, even in the unmanaged size and volume of food intake.

Potential participants of the study will undergo an initial examination at the clinical department of pediatric medicine specializing in obesitology at the Vítkovice Hospital Ostrava a.s. In addition to a pediatric and internal examination, a potential patient will be examined by a clinical psychologist for the ability to participate in such a type of study on a long-term basis, and will further assess the degree of patient support and co-operation. Selected participants in the study or their family members will receive informed consent. A study participant is considered to be a participant in the study after consent to his / her inclusion in the study after the informed consent has been signed. The AspireAssist aspiration device is the definitive participation in the study.

Two parts will be monitored within the project. (1) Safety and efficacy will be assessed first in young obese patients for whom the use of bariatric methods is still a question of discussion, especially in surgical methods. (2) The second objective is to monitor the saccharide and lipid metabolism, GI hormones and also the impact of the AspireAssist method on the nutritional status of the adolescents studied.

The patients enrolled in the study are followed for the period of twelve months.

Timetable of the study procedures and controls:

Preoperative examination:

• Demographic data on age, sex, weight, height, smoking

• Assessment of body composition and sampling of blood

• Questionnaires for the quality of Life Examination 3 months postoperatively

• Assessment of body composition and sampling of blood

• Questionnaires for the quality of Life Examination 6 months after surgery

• Assessment of body composition and sampling of blood

• Questionnaires for the quality of Life Examination 12 months after surgery

• Assessment of body composition and sampling of blood

• Questionnaires for the quality of Life

Statistical data processing for statistical evaluation descriptive statistics is used (arithmetical average, standard deflection, frequency tables), X2 test, Fisher's exact test, analysis of variance (ANOVA), calculating of the OR (odds ratio) with 95 % confidence intervals, and logistic regression. Statistical tests are evaluated at the significance level of 5%. Statistical analysis is performed in the "Stata 10" programme. Program EpiData is used for data collection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 21 Years

Eligibility

Inclusion Criteria:

• history of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities)

Exclusion Criteria:

• Diabetes Type I.

• blood clotting disorder

• using of Insulin

• psychiatric disorders

• monogenic obesity (Prader-Willi syndrome, mutation of MC4R).

• thyroid disease

• diseases of the digestive system associated with disorders of intestinal absorption

• history of corticosteroid therapy in the past 12 months

• history of bulimia and other eating disorders

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Device:
• AsspireAssist
Endoscopic bariatric procedure using the AsspireAssist device

Other:
• Nutritional consulting
Nutritional consulting provided by a specialized consultant.

Locations

Country	Name	City	State
Czechia	Ostrava University	Ostrava	Moravian-Silesian Region
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region
Czechia	Vítkovice Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Ostrava	University of Ostrava, Vítkovice Hospital Ostrava, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (10)

Abu Dayyeh BK, Edmundowicz S, Thompson CC. Clinical Practice Update: Expert Review on Endoscopic Bariatric Therapies. Gastroenterology. 2017 Mar;152(4):716-729. doi: 10.1053/j.gastro.2017.01.035. Epub 2017 Jan 29. — View Citation

ASGE Bariatric Endoscopy Task Force; ASGE Technology Committee, Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, Banerjee S. Endoscopic bariatric therapies. Gastrointest Endosc. 2015 May;81(5):1073-86. doi: 10.1016/j.gie.2015.02.023. Epub 2015 Mar 28. No abstract available. — View Citation

Devault KR. Could aspiration therapy for obesity be an effective and safe alternative to traditional bariatric surgery? Gastroenterology. 2013 Dec;145(6):1188-90. doi: 10.1053/j.gastro.2013.10.038. No abstract available. — View Citation

Forssell H, Noren E. A novel endoscopic weight loss therapy using gastric aspiration: results after 6 months. Endoscopy. 2015 Jan;47(1):68-71. doi: 10.1055/s-0034-1378097. Epub 2014 Sep 30. — View Citation

Kumar N, Sullivan S, Thompson CC. The role of endoscopic therapy in obesity management: intragastric balloons and aspiration therapy. Diabetes Metab Syndr Obes. 2017 Jul 6;10:311-316. doi: 10.2147/DMSO.S95118. eCollection 2017. — View Citation

Kumbhari V, Okolo PI III. Editorial: Aspiration Therapy for Weight Loss: Is the Squeeze worth the Juice? Am J Gastroenterol. 2017 Mar;112(3):458-589. doi: 10.1038/ajg.2017.2. — View Citation

Nystrom M, Machytka E, Noren E, Testoni PA, Janssen I, Turro Homedes J, Espinos Perez JC, Turro Arau R. Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study. Obes Surg. 2018 Jul;28(7):1860-1868. doi: 10.1007/s11695-017-3096-5. — View Citation

Sullivan S, Edmundowicz SA, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: New and Emerging Technologies. Gastroenterology. 2017 May;152(7):1791-1801. doi: 10.1053/j.gastro.2017.01.044. Epub 2017 Feb 10. — 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

Sullivan S. Aspiration Therapy for Obesity. Gastrointest Endosc Clin N Am. 2017 Apr;27(2):277-288. doi: 10.1016/j.giec.2016.12.001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term weight reduction assessment in kgs	Evaluation of the success of treatment in terms of long-term weight reduction (difference in body weight in kilograms at the beginning vs. the end of the observation period of 12 months).	12 months
Primary	Long-term changes of nutritional status	Analysis of the dynamics of changes in nutrition status in adolescents after endoscopic bariatric treatment of obesity (BMI> 30) will be performed. In the study, serum concentrations of the following parameters will be measured: vitamins A, D, E, K, B1, B6, B12, Folic acid and plasma proteins such as albumin, pre albumin, creatinine. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L.	12 months
Secondary	Changes in serum levels of adipose tissue hormones	Analysis of the dynamics of changes in serum levels of adipose tissue hormones (Leptin, Adiponectin) in adolescents after endoscopic bariatric treatment of obesity (BMI> 30) will be performed. Points of measurements: before the planned intervention and then in intervals of 3, 6 and 12 months after procedure.	12 months
Secondary	Changes in serum levels of lipids	Analysis of the dynamics of changes in serum levels of lipids in adolescents after endoscopic bariatric treatment of obesity (BMI> 30) will be performed. In the study, serum concentrations of the following lipids will be measured: triacylglycerols, total cholesterol, high-density lipoprotein, low-density lipoprotein cholesterol, Apo D and Apo E, FGF 21, FGF19, FXR receptor, Omentin 1. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L.	12 months
Secondary	Changes in serum levels GI hormones and saccharide metabolism	Analysis of the dynamics of changes in serum levels of usual panel of GI hormones in adolescents after endoscopic bariatric treatment of malignant obesity (BMI> 35) will be performed. The following serum levels markers of bone resorption and formation will be assessed: fasting glycaemia, insulin and hemoglobin A1C, C-peptide, acylated ghrelin, GLP-1, GIP, PYY. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L.	12 months
Secondary	IWQOL Questionnaire evaluation	Evaluation of effects of endoscopic bariatric interventions on quality of life will be performed by using the IWQOL questionnaire. Improvement from baseline quality of life as measured by standardized IWQOL patient questionnaire (http://www.qualityoflifeconsulting.com/iwqol-lite.html) intended to measure the patient health status.	12 months
Secondary	SF-36 Questionnaire evaluation	Evaluation of effects of different types of bariatric interventions on the quality of life will be performed using the SF-36 questionnaire. Improvement from baseline quality of life as measured by standardized SF-36 patient questionnaire intended to measure the patient health status.	12 months