Nina Riedel1, Katharina Laubner2, Anne Lautenbach3, Gerhard Schön4, Matthias Schlensak5, Rainer Stengel6, Thomas Eberl7, Frank Dederichs8,9, Jens Aberle3, Jochen Seufert2. 1. Department for Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. ni.sauer@uke.de. 2. Division of Endocrinology and Diabetology, Department of Medicine II, University Hospital of Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany. 3. Department for Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. 4. Institute of Medical Biometry and Epidemiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 5. Department of Surgery, Schön Klinik Düsseldorf SE & Co. KG, Düsseldorf, Germany. 6. Diakonissenanstalt Emmaus, Niesky, Germany. 7. Donau-Ries-Klinik, Donauwörth, Germany. 8. Department of Internal Medicine/Gastroenterology, Marienhospital Gelsenkirchen, Gelsenkirchen, Germany. 9. Department of Internal Medicine/Gastroenterology, Kath, Kliniken Hagen, Hagen, Germany.
Abstract
BACKGROUND: A novel-approach for treatment of obesity and diabetes mellitus type 2 (T2DM) is represented by the endoscopic duodenal-jejunal bypass liner (DJBL). Recent data from the German DJBL registry provide evidence for substantial efficacy of the DJBL during the implantation period in obese patients with T2DM. However, little is known about the trends of glycemic control, BMI, and comorbidities after explantation of the DJBL, which have been investigated in the registry in this report. METHODS: Patients were selected from the registry if they had a dataset at implantation, explantation, and at least one time point after explantation of the DJBL (n = 77). We also investigated a subgroup of patients with available data at least 1 year (-2 weeks) after explantation of the DJBL (n = 32). RESULTS: For a mean BMI at implantation and a mean follow-up period, an increase of BMI of 2.1 kg/m2 (CI 0.8-3.2; p = 0.013) had to be expected (for HbA1c 0.3% (CI - 0.0-0.7; p = n.s.), respectively). In the subgroup analysis, HbA1c and BMI increased after explantation of the DJBL but stayed significantly below baseline levels. Meanwhile, the mean number of antidiabetic drugs slightly increased. There was deterioration seen for blood pressure and LDL cholesterol over the postexplantation period to approximately baseline levels (or higher). CONCLUSION: With this data, we show that improvement of HbA1c and BMI can be partly maintained over a time of nearly 1-year postexplantation of the DJBL. However, for HbA1c, this may be biased by intensified medical treatment and effects deteriorated with time after explantation. These results suggest that implantation of the DJBL needs to be integrated in a long-term weight management program as most of other interventions in obese patients with T2DM. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02731859.
BACKGROUND: A novel-approach for treatment of obesity and diabetes mellitus type 2 (T2DM) is represented by the endoscopic duodenal-jejunal bypass liner (DJBL). Recent data from the German DJBL registry provide evidence for substantial efficacy of the DJBL during the implantation period in obesepatients with T2DM. However, little is known about the trends of glycemic control, BMI, and comorbidities after explantation of the DJBL, which have been investigated in the registry in this report. METHODS:Patients were selected from the registry if they had a dataset at implantation, explantation, and at least one time point after explantation of the DJBL (n = 77). We also investigated a subgroup of patients with available data at least 1 year (-2 weeks) after explantation of the DJBL (n = 32). RESULTS: For a mean BMI at implantation and a mean follow-up period, an increase of BMI of 2.1 kg/m2 (CI 0.8-3.2; p = 0.013) had to be expected (for HbA1c 0.3% (CI - 0.0-0.7; p = n.s.), respectively). In the subgroup analysis, HbA1c and BMI increased after explantation of the DJBL but stayed significantly below baseline levels. Meanwhile, the mean number of antidiabetic drugs slightly increased. There was deterioration seen for blood pressure and LDL cholesterol over the postexplantation period to approximately baseline levels (or higher). CONCLUSION: With this data, we show that improvement of HbA1c and BMI can be partly maintained over a time of nearly 1-year postexplantation of the DJBL. However, for HbA1c, this may be biased by intensified medical treatment and effects deteriorated with time after explantation. These results suggest that implantation of the DJBL needs to be integrated in a long-term weight management program as most of other interventions in obesepatients with T2DM. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02731859.
Entities:
Keywords:
DJBL; Diabetes mellitus type 2; Follow-up; Postexplantation
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