Bariatric surgery versus conservative treatment in morbidly obese childre

Recruiting

• Conditions: morbide obesitas; obesity; overweight; 10003018; 10017998

• Registration Number: NL-OMON47066
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Age 14 * 16 years (16 years inclusive)
- Sex and age adjusted BMI > 40 kg/m2 or > 35 kg/m2 with co-morbidity
- > 1 year organized weight reduction reducing attempts with sex and age adjusted weight loss less than 5%
- Written informed consent of the patient and parents
- Demonstrate decisional capacity

Exclusion Criteria

- Psychologically not suitable
- Pre menarche
- Bone age < 15 years in boys
- Secondary causes of obesity such as hypothyroidism
- Syndromal causes of obesity such as Prader-Willi syndrome
- Severe cardiorespiratory impairment (ASA class 3 or higher)
- Inability to speak Dutch
- Unwillingness to adhere to follow-up programmes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Weight loss, excess weight loss, loss excess BMI</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Glucose tolerance<br /><br>- Fat distribution / body composition<br /><br>- Inflammatory status<br /><br>- Bloodpressure<br /><br>- Atherosclerosis and arterial stiffness<br /><br>- Microvascular function<br /><br>- Endothelial function<br /><br>- Myocardial funtion<br /><br>- Nonalcoholic steatohepatitis<br /><br>- Quality of life<br /><br>- Physical activity<br /><br>- Responsiveness to food</p><br>