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Aspiration Therapy for Obese Adolescents

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ClinicalTrials.gov Identifier: NCT03598920
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : August 1, 2019
Sponsor:
Collaborators:
University of Ostrava
Vítkovice Hospital Ostrava, Czech Republic
Information provided by (Responsible Party):
University Hospital Ostrava

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.


Condition or disease Intervention/treatment
Obesity, Morbid Device: AsspireAssist Other: Nutritional consulting

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Safety and Efficacy Assessment of Aspiration Therapy for Morbidly Obese Adolescents
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort Intervention/treatment
AspireAssist
Patients undergoing the endoscopic bariatric procedure using the AsspireAssist device
Device: AsspireAssist
Endoscopic bariatric procedure using the AsspireAssist device

Nutritional consulting
Patients undergoing nutritional consulting
Other: Nutritional consulting
Nutritional consulting provided by a specialized consultant.




Primary Outcome Measures :
  1. Long-term weight reduction assessment in kgs [ Time Frame: 12 months ]
    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).

  2. Long-term changes of nutritional status [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Changes in serum levels of adipose tissue hormones [ Time Frame: 12 months ]
    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.

  2. Changes in serum levels of lipids [ Time Frame: 12 months ]
    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.

  3. Changes in serum levels GI hormones and saccharide metabolism [ Time Frame: 12 months ]
    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.

  4. IWQOL Questionnaire evaluation [ Time Frame: 12 months ]
    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.

  5. SF-36 Questionnaire evaluation [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolescents with malignant obesity (BMI> 40) in range BMI 30-50 kg/m2.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598920


Contacts
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Contact: Petr Vávra, Ass.Prof.,MD,Ph.D. 0042059737 ext 2544 petr.vavra@fno.cz
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz

Locations
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Czechia
Ostrava University Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 70103
Contact: Marek Bužga, Ass.Prof.,MSc.,Ph.D.    0042055346 ext 1770    marek.buzga@osu.cz   
Principal Investigator: Marek Bužga, Ass.Prof.,MSc.,Ph.D.         
Vítkovice Hospital Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 703 00
Contact: Jan Boženský, MD    0042059563 ext 3530    jan.bozensky@vtn.agel.cz   
Principal Investigator: Jan Boženský, MD         
University Hospital Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 708 52
Contact: Petr Vávra, Ass.Prof.,MD,Ph.D.    0042059737 ext 2544    petr.vavra@fno.cz   
Contact: Jiří Hynčica    0042059737 ext 2587    jiri.hyncica@fno.cz   
Principal Investigator: Evžen Machytka, MD,Ph.D.         
Sub-Investigator: Christian Kufa, MD         
Sponsors and Collaborators
University Hospital Ostrava
University of Ostrava
Vítkovice Hospital Ostrava, Czech Republic
Investigators
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Principal Investigator: Evžen Machytka, MD,Ph.D. University Hospital Ostrava

Publications:

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03598920     History of Changes
Other Study ID Numbers: FNO-IK-Aspiration
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators have not decided to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Ostrava:
obesity
bariatric medicine
endoscopy treatment
body composition
Adipokines
Ghrelin
Quality of Life
nutrition status
vitamins
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms