A study to evaluate the safety and efficacy of AspireAssist™ in morbidly obese adolescents

Completed

• Conditions: Adolescent obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN36495438
• Lead Sponsor: Vítkovicke Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-03
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 16 to 21 years at the time of selection for the study
2. Body mass index (BMI) 35 to 55 kg/ m2
3. Comorbidities such as hypertension and dyslipidemia treated by an appropriate specialist are permissible
4. Ability to comprehend the content of the informed consent form.
5. Cooperation of the subject's parents
6. Non-smoker

Exclusion Criteria

1. BMI below 35 or above 55
2. History of stomach and gallbladder surgeries
3. Previous technical difficulties with gastroduodenoscopy or a failure to carry out an endoscopy
4. Type 1 diabetes
5. Insulin therapy
6. History of gastrointestinal disease (acute gastritis, non-specific colitis)
7. Confirmed celiac disease
8. History of malignity
9. Previous endoscopic and surgical treatment of obesity (intragastric balloons, endoscopic or surgical gastric procedures, malabsorptive procedures of the GIT)
10. Specific genetic or hormonal disorders associated with obesity (Prader-Wili syndrome, MC4R mutation etc.)
11. Coagulation and hemopoiesis disorders
12. Both chronic and acute pancreatitis
13. Psychiatric disorders (endogenous depression, schizophrenia, suicidal tendencies, psychoses)
14. Uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg)
15. Autoimmune diseases or long-term use of systemic glucocorticoids or immunosuppressive therapy
16. Thyroid function disorders unresponsive to treatment
17. Kidney function disorders with GFR < 60 mL/min/1.73 m2 or albumin excretion > 1000 mg/day

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight reduction measured as % Total Body Weight loss will be evaluated at 3, 6 and 12 months of treatment.

Secondary Outcome Measures

Name	Time	Method
1. Waist circumference and BMI changes<br>2. Body composition changes – evaluation of fatty tissue volume reduction<br>3. Tolerance of the aspiration method by adolescents (to be measured with AspireAssist patient satisfaction survey)<br>4. Changes in food intake and dietary habits (to be measured with AspireAssist patient satisfaction survey)<br>5. Quality of life improvement assessed by means of IWQOL and SF-36.<br><br>These are all evaluated at 3, 6 and 12 months.