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Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Tripolt, NJ; Aberer, F; Url, J; Högenauer, C; Schreiber, F; Eherer, A; Sourij, C; Obermayer, AM; Stadlbauer, V; Svehlikova, E; Brunner, M; Kojzar, H; Pferschy, PN; Pieber, TR; Sourij, H.
Impact of Duodeno-Jejunal Bypass Liner (EndoBarrierTM) Implantation on Insulin Sensitivity in Patients with Type 2 Diabetes Mellitus (T2DM): A Study Protocol for a Pilot Trial.
Diabetes Ther. 2019; 10(1):299-309
Doi: 10.1007/s13300-018-0540-z
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- Leading authors Med Uni Graz
- Sourij Harald
- Tripolt Norbert
- Co-authors Med Uni Graz
- Aberer Felix
- Brunner Markus
- Brunner Martina
- Eherer Andreas
- Hoegenauer Christoph
- Kojzar Harald
- Pferschy Peter
- Pieber Thomas
- Ramirez-Obermayer Anna Maria Antonia
- Schreiber Florian
- Sourij Caren
- Stadlbauer-Köllner Vanessa
- Svehlikova Eva
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- Abstract:
- INTRODUCTION: A 60-cm endoscopically implantable duodenal-jejunal bypass liner (Endobarrier™, GI Dynamics, Lexington, MA, USA) has been introduced as a therapeutic option to support weight loss for a selected group of obese subjects with type 2 diabetes mellitus (T2DM). The sleeve prevents contact between chyme and the intestinal mucosa of the upper gastrointestinal tract. The primary aim of this study is to elucidate the changes in insulin sensitivity and beta-cell function after EndoBarrier™ implantation in obese patients with T2DM; changes in gut permeability and gut microbiome are also to be examined. METHODS: This is an open, single-center, prospective trial in which ten obese subjects with T2DM and suboptimal glycemic control (glycosylated hemoglobin A1c (HbA1c) level > 48 mmol/mol) are investigated with regards to EndoBarrier™ implantation. The Endobarrier™ is implanted shortly after baseline and left in situ for a period of 36 weeks. Dual-energy X-ray absorptiometry measurement, assessment of beta-cell function and insulin sensitivity as measured by a Botnia clamp procedure, and a mixed-meal tolerance test are performed prior to implantation and at 4, 36, and 64 weeks after implantation. The composition of the gut microbiota is characterized from stool using 454 pyrosequencing of 16S rRNA genes. Gut permeability is assessed by a differential sugar absorption method. PLANNED OUTCOME: This study will give mechanistic insights in particulr into changes of insulin sensitivity, beta-cell function or microbiome changes over time in subjects implanted with an EndobarrierTM device. TRIAL REGISTRATION: NCT02769728, Registered 12 May 2016. Current Protocol Date/Version: 04 September 2017/Version 1.9.
- Find related publications in this database (Keywords)
- Beta-cell function
- Botnia clamp
- Duodenal-jejunal bypass liner
- EndoBarrier
- Insulin sensitivity
- Type 2 diabetes mellitus