Diabetes Mellitus, Obesity
Conditions
Brief summary
The purpose of this study ist to determine long-term safety and efficacy in weight reduction and improvement of diabetes mellitus of the temporary, endoscopic duodenal-jejunal bypass-sleeve EndoBarrier® in a national registry.
Detailed description
Long-term data are collected by approximately 30 German centers. An electronic Case-Report-Form (eCRF) was designed to collect relevant pre-specified items by the Clinical Trial Center North (CTC). All German sites that have implanted EndoBarrier® since 2010 were invited to provide patient results. Data-acquisition is projected to a period of 5 years and a maximum of 1000 patients. An extension of data-acquisition is planned.
Interventions
DEVICEInsertion of EndoBarrier for approximately one year
Insertion of EndoBarrier for approximately one year then explantation and follow-up
Sponsors
Morphic Medical Inc.
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinical decision for treatment with EndoBarrier * informed consent for registry participation
Exclusion criteria
* Patients not meeting the inclusion criteria * age \< 18
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight reduction | From Implantation to at least 2 years follow up |
| Reduction of HbA1C | From Implantation to at least 2 years follow up |
| Reduction of Antidiabetic Medication | From Implantation to at least 2 years follow up |
| Excess weight loss | From Implantation to at least 2 years follow up |
| Reduction of BMI | From Implantation to at least 2 years follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of hsCRP | From Implantation to at least 2 years follow up | — |
| Duration of implantation process of the EndoBarrier in minutes | From Implantation to at least 2 years follow up | — |
| Number of participants with treatment-related adverse events | From Implantation to at least 2 years follow up | Adverse events associated to implantation, explantation or insertion of EndoBarrier such as bleeding, liver abscess, abdominal pain, nausea, vomiting, duodenal ulcers, duodenal perforation |
| Improvement of subjective Arthropathia | From Implantation to at least 2 years follow up | Qualitative Measurement of improvement of subjective Arthropathia, no scale is used |
| Smoking Status | From Implantation to at least 2 years follow up | — |
| Time of implantation and explantation | From Implantation to at least 2 years follow up | — |
| Reduction of fasting glucose | From Implantation to at least 2 years follow up | — |
| Reduction of fasting insulin | From Implantation to at least 2 years follow up | — |
| Reduction of fasting C-Peptide | From Implantation to at least 2 years follow up | — |
| Reduction of systolic blood pressure | From Implantation to at least 2 years follow up | — |
| Reduction of diastolic blood pressure | From Implantation to at least 2 years follow up | — |
| Reduction of antihypertensive medication | From Implantation to at least 2 years follow up | — |
| Reduction of total cholesterol | From Implantation to at least 2 years follow up | — |
| Reduction of waist circumference | From Implantation to at least 2 years follow up | — |
| Increase of HDL-cholesterol | From Implantation to at least 2 years follow up | — |
| Reduction of fasting triglycerides | From Implantation to at least 2 years follow up | — |
| Reduction of antihyperlipidemic medication | From Implantation to at least 2 years follow up | — |
| Reduction of 25OHD3 | From Implantation to at least 2 years follow up | — |
| Reduction of Calcium | From Implantation to at least 2 years follow up | — |
| Reduction of Ferritin | From Implantation to at least 2 years follow up | Ferritin will be measured |
| Reduction of Hemoglobin | From Implantation to at least 2 years follow up | — |
| Reduction of Vitamin B12 | From Implantation to at least 2 years follow up | — |
| Reduction of Albumin | From Implantation to at least 2 years follow up | — |
| Reduction of Folic acid | From Implantation to at least 2 years follow up | — |
| Reduction of Vitamin B1 | From Implantation to at least 2 years follow up | — |
| Reduction of Vitamin B6 | From Implantation to at least 2 years follow up | — |
| Reduction of daily caloric intake | From Implantation to at least 2 years follow up | — |
| Reduction of LDL-cholesterol | From Implantation to at least 2 years follow up | — |
| Duration of ithe explantation process of the EndoBarrier in minutes | From Implantation to at least 2 years follow up | — |
| Reduction of CK | From Implantation to at least 2 years follow up | — |
| Reduction of AST | From Implantation to at least 2 years follow up | — |
| Reduction of ALT | From Implantation to at least 2 years follow up | — |
Countries
Germany
Contacts
Primary ContactJulia Hinz
Backup ContactNina Sauer
Outcome results
None listed