A multi-centred, randomized, controlled trial comparing weight loss in endoscopically implanted duodenal-jejunal bypass liners vs intragastric balloons vs a sham procedure
- Conditions
- E66E11ObesityType 2 diabetes mellitus
- Registration Number
- DRKS00011036
- Lead Sponsor
- niversität Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 33
Age = 18 years
- BMI = 35 or BMI = 30 kg/m² with obesity related co-morbidities such as diabetes
- Dietary consultation was received, but was ineffective
- written informed consent
- indication for long-tern PPI-therapy
- malignant disease
- peptic ulcer
- large hiatus hernia
- gastrointestinal disease
- previous gastric or bariatric surgery
- high risk of gastrointestinal bleeding
- symptomatic gallstones
- contraindication for general anaesthesia
- contraindication for devices according to manufacturer
- contraindication for proton pump inhibitors (PPIs)
- non controlled GERD (gastroesophageal reflux disease)
- suspected lack of compliance
- drug or alcohol abuse
- pregnant or nursing women
- fertile women without appropriate contraceptive measures while participating in the trial
- participation in other interventional trials
- psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire or follow dietary recommendations due to dementia, language difficulties)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method successful weight loss 12 months after removal of the medical product<br>(Note: The scheduled removal of the intragastric balloon is after 6 months, the EndoBarrier after 12 months. The primary EP is determined for the intragastric balloon and the sham-control after 18 months, and for the endo barrier after 24 months.)
- Secondary Outcome Measures
Name Time Method - Percentage weight loss 12 months after removal<br>- successful weight loss (=10%) and percentage weight loss after 6 months<br>- successful weight loss (=10%) and percentage weight loss at removal of medical product<br>- remission and reduction of concomitant diseases at removal and 12 months after removal<br>- change of the HbA1c-value at initial values >6,5% at removal and 12 months after removal<br>- changes in quality of life (SF-36), physical activity (IPAQ) and body composition (BIA (Bioelectrical impedance analysis)) after 6, 12 and 24 months<br>- complication rate of the endoscopic procedures in the periods 0-6 months or removal, 6-12 months or removal and time after removal<br>- comparison of success”12 months after removal (success is defined as excess weight loss of et least 25%)