E66 E11
Conditions
Interventions
Group 1: endoscopically implanted duodenal-jejunal bypass liner (EndoBarrierTM) to reduce weight for 12 months
Group 2: intragastric balloon to reduce weight for 6 months
Group 3: Sham control with ga
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| successful weight loss 12 months after removal of the medical product (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
| Measure | Time frame |
|---|---|
| - Percentage weight loss 12 months after removal - successful weight loss (=10%) and percentage weight loss after 6 months - successful weight loss (=10%) and percentage weight loss at removal of medical product - remission and reduction of concomitant diseases at removal and 12 months after removal - change of the HbA1c-value at initial values >6,5% at removal and 12 months after removal - changes in quality of life (SF-36), physical activity (IPAQ) and body composition (BIA (Bioelectrical impedance analysis)) after 6, 12 and 24 months - complication rate of the endoscopic procedures in the periods 0-6 months or removal, 6-12 months or removal and time after removal - comparison of “success”12 months after removal (success is defined as excess weight loss of et least 25%) | — |
Countries
Germany
Contacts
Public ContactAlbrecht Hoffmeister
Klinik und Poliklinik für Gastroenterologie und Rheumatologie Universitätsklinikum Leipzig
Outcome results
None listed