Clinical trial NCT02731859: EndoBarrier Register Deutschland-Safety and Efficacy of the Endoscopic Duodenal-Jejunal Bypass Sleeve
Official title: EndoBarrier Register Deutschland
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Diabetes Mellitus
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Morphic Medical Inc.
First posted: 2016-04-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with either Obesity and/or Diabetes mellitus who are treated with the EndoBarrier

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.

Eligibility criteria: Inclusion Criteria:

* clinical decision for treatment with EndoBarrier
* informed consent for registry participation

Exclusion Criteria:

* Patients not meeting the inclusion criteria
* age \< 18

Primary outcomes:
measure: Reduction of HbA1C
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of Antidiabetic Medication
timeFrame: From Implantation to at least 2 years follow up
measure: Excess weight loss
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of BMI
timeFrame: From Implantation to at least 2 years follow up
measure: Weight reduction
timeFrame: From Implantation to at least 2 years follow up
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: From Implantation to at least 2 years follow up
measure: Improvement of subjective Arthropathia
timeFrame: From Implantation to at least 2 years follow up
measure: Smoking Status
timeFrame: From Implantation to at least 2 years follow up
measure: Time of implantation and explantation
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of fasting glucose
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of fasting insulin
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of fasting C-Peptide
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of systolic blood pressure
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of diastolic blood pressure
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of antihypertensive medication
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of total cholesterol
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of LDL-cholesterol
timeFrame: From Implantation to at least 2 years follow up
measure: Increase of HDL-cholesterol
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of fasting triglycerides
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of antihyperlipidemic medication
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of 25OHD3
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of Calcium
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of Ferritin
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of Hemoglobin
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of Vitamin B12
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of Albumin
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of Folic acid
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of Vitamin B1
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of Vitamin B6
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of CK
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of AST
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of ALT
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of hsCRP
timeFrame: From Implantation to at least 2 years follow up
measure: Duration of implantation process of the EndoBarrier in minutes
timeFrame: From Implantation to at least 2 years follow up
measure: Duration of ithe explantation process of the EndoBarrier in minutes
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of waist circumference
timeFrame: From Implantation to at least 2 years follow up
measure: Reduction of daily caloric intake
timeFrame: From Implantation to at least 2 years follow up
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Donauwörth
country: Germany
facility: Donau-Ries Klinik Donauwörth
city: Düsseldorf
country: Germany
facility: St. Martinus Krankenhaus Düsseldorf
city: Forchheim
country: Germany
facility: Klinikum Forchheim
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg- Abt. Innere Medizin II
city: Gelsenkirchen
country: Germany
facility: Marienhospital Gelsenkirchen
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Köln-Weyertal
city: Niesky
country: Germany
facility: Krankenhaus Emmaus-Niesky
city: Schmalkalden
country: Germany
facility: Elisabeth Klinikum Schmalkalde
city: Wuppertal
country: Germany
facility: Petrus Krankenhaus Wuppertal
Study officials:
affiliation: University hospital Hamburg, Endokrinology
name: Jens Aberle
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riedel N, Laubner K, Lautenbach A, Schon G, Schlensak M, Stengel R, Eberl T, Dederichs F, Aberle J, Seufert J. Trends in BMI, Glycemic Control and Obesity-Associated Comorbidities After Explantation of the Duodenal-Jejunal Bypass Liner (DJBL). Obes Surg. 2018 Aug;28(8):2187-2196. doi: 10.1007/s11695-018-3144-9.