Aspiration Therapy for Obese Adolescents

NCT03598920 | Completed

• 1 other identifier: FNO-IK-Aspiration
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Obesity, Morbid

Keywords

obesity; bariatric medicine; endoscopy treatment; body composition; Adipokines; Ghrelin; Quality of Life; nutrition status; vitamins

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Changes in serum levels of adipose tissue hormones

  12 months

• Changes in serum levels of lipids

  12 months

• Changes in serum levels GI hormones and saccharide metabolism

  12 months

• IWQOL Questionnaire evaluation

  12 months

• SF-36 Questionnaire evaluation

  12 months

Study Arms (2)

AspireAssist

Patients undergoing the endoscopic bariatric procedure using the AsspireAssist device

Device: AsspireAssist

Nutritional consulting

Patients undergoing nutritional consulting

Other: Nutritional consulting

Interventions

AsspireAssist DEVICE

Endoscopic bariatric procedure using the AsspireAssist device

AspireAssist

Nutritional consulting OTHER

Nutritional consulting provided by a specialized consultant.

Nutritional consulting

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with malignant obesity (BMI\> 40) in range BMI 30-50 kg/m2.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University of Ostrava: collaborator
• Vítkovice Hospital Ostrava, Czech Republic: collaborator

Study Sites (3)

Ostrava University

Ostrava, Moravian-Silesian Region, 70103, Czechia

Location

Vítkovice Hospital Ostrava

Ostrava, Moravian-Silesian Region, 703 00, Czechia

Location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Related Publications (10)

• 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.

  PMID: 29388050 BACKGROUND

• 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.

  PMID: 28192103 BACKGROUND

• 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.

  PMID: 28147221 BACKGROUND

• 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.

  PMID: 28740414 BACKGROUND

• 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.

  PMID: 28292406 BACKGROUND

• 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.

  PMID: 28270668 BACKGROUND

• 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.

  PMID: 25828245 BACKGROUND

• 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.

  PMID: 24409479 BACKGROUND

• 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.

  PMID: 24012983 BACKGROUND

• 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.

  PMID: 25268305 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evžen Machytka, MD,Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 26, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

CZ (3)