Katharina Laubner1, Nina Riedel2, Katharina Fink3,4, Reinhard W Holl3,4, Reinhard Welp5, Hans-Peter Kempe6, Anne Lautenbach2, Matthias Schlensak7, Rainer Stengel8, Thomas Eberl9, Frank Dederichs10,11, Henning Schwacha12, Jochen Seufert1, Jens Aberle2. 1. Division of Endocrinology and Diabetology, Department of Medicine II, Medical Faculty, University Hospital of Freiburg, Freiburg, Germany. 2. Department of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 3. Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany. 4. German Center for Diabetes Research, Munich-Neuherberg, Germany. 5. Clinic for Internal Medicine, Knappschaftskrankenhaus Bottrop, Bottrop, Germany. 6. Diabetologikum Ludwigshafen, Ludwigshafen, Germany. 7. Department of Surgery, Schön Klinik Düsseldorf SE & Co. KG, Düsseldorf, Germany. 8. Diakonissenanstalt Emmaus, Niesky, Germany. 9. Donau-Ries-Klinik, Donauwörth, Germany. 10. Department of Internal Medicine/Gastroenterology, Marienhospital Gelsenkirchen, Gelsenkirchen, Germany. 11. Department of Internal Medicine/Gastroenterology, Kath. Kliniken Hagen, Hagen, Germany. 12. Department of Medicine II, Medical Center, University of Freiburg, Faculty of Medicine, Freiburg, Germany.
Abstract
AIMS: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device mimicking surgical duodenal-jejunal bypass, and is indicated for the treatment of obesity-associated type 2 diabetes mellitus. This analysis was conducted to evaluate the efficacy and safety of the DJBL in comparison to lifestyle changes and antidiabetic drugs. MATERIALS AND METHODS: To determine the efficacy and long-term safety of the DJBL, data concerning 235 obese patients with type 2 diabetes mellitus from the German DJBL registry were analysed. For comparison with standard treatment, propensity-score-matching with patients from the German DPV registry, including the matching parameters sex, age, diabetes duration, baseline BMI and baseline HbA1c, was applied. The final matched cohort consisted of 111 patients in the DJBL group and 222 matched control DPV patients. RESULTS: Mean treatment time with the DJBL was 47.5 ± 12.2 weeks, mean BMI reduction was 5.0 kg/m2 (P < .001) and mean HbA1c reduction was 1.3% (11.9 mmol/mol) (P < .001). Reduction of antidiabetic medications and improvements in other metabolic and cardiovascular risk parameters was observed. In comparison to the matched control group, mean reductions in HbA1c (-1.37% vs -0.51% [12.6 vs 3.2 mmol/mol]; P < .0001) and BMI (-3.02 kg/m2 vs -0.39 kg/m2 ; P < .0001) were significantly higher. Total cholesterol, LDL cholesterol and blood pressure were also significantly better. CONCLUSION: This study provides the largest, so far, hypothesis-generating evidence for a putative positive risk/benefit ratio for treatment of obese patients with type 2 diabetes mellitus with the DJBL as an alternative treatment option for this patient population.
AIMS: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device mimicking surgical duodenal-jejunal bypass, and is indicated for the treatment of obesity-associated type 2 diabetes mellitus. This analysis was conducted to evaluate the efficacy and safety of the DJBL in comparison to lifestyle changes and antidiabetic drugs. MATERIALS AND METHODS: To determine the efficacy and long-term safety of the DJBL, data concerning 235 obesepatients with type 2 diabetes mellitus from the German DJBL registry were analysed. For comparison with standard treatment, propensity-score-matching with patients from the German DPV registry, including the matching parameters sex, age, diabetes duration, baseline BMI and baseline HbA1c, was applied. The final matched cohort consisted of 111 patients in the DJBL group and 222 matched control DPVpatients. RESULTS: Mean treatment time with the DJBL was 47.5 ± 12.2 weeks, mean BMI reduction was 5.0 kg/m2 (P < .001) and mean HbA1c reduction was 1.3% (11.9 mmol/mol) (P < .001). Reduction of antidiabetic medications and improvements in other metabolic and cardiovascular risk parameters was observed. In comparison to the matched control group, mean reductions in HbA1c (-1.37% vs -0.51% [12.6 vs 3.2 mmol/mol]; P < .0001) and BMI (-3.02 kg/m2 vs -0.39 kg/m2 ; P < .0001) were significantly higher. Total cholesterol, LDL cholesterol and blood pressure were also significantly better. CONCLUSION: This study provides the largest, so far, hypothesis-generating evidence for a putative positive risk/benefit ratio for treatment of obesepatients with type 2 diabetes mellitus with the DJBL as an alternative treatment option for this patient population.
Authors: Thomas Karlas; David Petroff; Jürgen Feisthammel; Sebastian Beer; Matthias Blüher; Tatjana Schütz; Ralf Lichtinghagen; Albrecht Hoffmeister; Johannes Wiegand Journal: Obes Surg Date: 2022-06-17 Impact factor: 3.479
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