Nina Riedel1, Katharina Laubner2, Anne Lautenbach3, Gerhard Schön4, Matthias Schlensak5, Rainer Stengel6, Thomas Eberl7, Frank Dederichs8, Jens Aberle3, Jochen Seufert2. 1. Department for Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. Electronic address: ninasauer@ymail.com. 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, Hamburg, Germany. 4. Institute of Medical Biometry and Epidemiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 5. Schön Klinik Düsseldorf SE & Co. KG, Department of Surgery, Düsseldorf, Germany. 6. Diakonissenanstalt Emmaus, Niesky, Germany. 7. Donau-Ries-Klinik, Donauwörth, Germany. 8. Department of Internal Medicine/Gastroenterology, Marien Hospital Gelsenkirchen, Gelsenkirchen, Germany; Department of Internal Medicine/Gastroenterology, Kath. Kliniken Hagen, Hagen, Germany.
Abstract
BACKGROUND: The endoscopic duodenal-jejunal bypass liner (DJBL) represents a novel temporary endoscopic approach for treatment of obesity-associated type 2 diabetes. Recent results from the German DJBL registry confirmed substantial positive metabolic effects of the DJBL in type 2 diabetes. However, the last Food and Drug Administration trial was stopped due to a high occurrence of hepatic abscesses (3.5%). OBJECTIVES: Here, we analyzed time courses of development of co-morbidities, nutritive changes, and occurrence of adverse events during the 1-year treatment phase with the DJBL in the German DJBL registry. METHODS: Sixty-six patients from the registry were analyzed for efficacy, safety, and nutritional status. Patient data sets were analyzed at implantation, 3 and 6 months after implantation, and at explantation visits. RESULTS: Weight, body mass index, glycated hemoglobin, and low-density lipoprotein cholesterol primarily declined during the first 3 months after implantation, whereas systolic and diastolic blood pressure were predominantly reduced during the second half of the treatment phase. Severe DJBL-associated side effects were mainly documented at the explantation visit (intestinal obstruction [1.7%], dislocation [1.7%], and liver abscess [1.7%]). Measurements of serum concentrations of ferritin, albumin, vitamin B12, folic acid, 25-hydroxyvitamin D3 (25 OH-Vit-D3), and calcium provided suggestive evidence of a possible decrease of nutritional absorption of vitamins and trace elements by the DJBL. CONCLUSIONS: The DJBL demonstrates high efficacy with substantial improvement of all parameters of the metabolic syndrome and the potential for reduction of comedications in overweight patients with type 2 diabetes. These registry results are important to optimize recommendations for adaptation of concomitant medication, surveillance of adverse events, nutritional status and supplementation, and adaptation of the implantation period of the DJBL.
BACKGROUND: The endoscopic duodenal-jejunal bypass liner (DJBL) represents a novel temporary endoscopic approach for treatment of obesity-associated type 2 diabetes. Recent results from the German DJBL registry confirmed substantial positive metabolic effects of the DJBL in type 2 diabetes. However, the last Food and Drug Administration trial was stopped due to a high occurrence of hepatic abscesses (3.5%). OBJECTIVES: Here, we analyzed time courses of development of co-morbidities, nutritive changes, and occurrence of adverse events during the 1-year treatment phase with the DJBL in the German DJBL registry. METHODS: Sixty-six patients from the registry were analyzed for efficacy, safety, and nutritional status. Patient data sets were analyzed at implantation, 3 and 6 months after implantation, and at explantation visits. RESULTS: Weight, body mass index, glycated hemoglobin, and low-density lipoprotein cholesterol primarily declined during the first 3 months after implantation, whereas systolic and diastolic blood pressure were predominantly reduced during the second half of the treatment phase. Severe DJBL-associated side effects were mainly documented at the explantation visit (intestinal obstruction [1.7%], dislocation [1.7%], and liver abscess [1.7%]). Measurements of serum concentrations of ferritin, albumin, vitamin B12, folic acid, 25-hydroxyvitamin D3 (25 OH-Vit-D3), and calcium provided suggestive evidence of a possible decrease of nutritional absorption of vitamins and trace elements by the DJBL. CONCLUSIONS: The DJBL demonstrates high efficacy with substantial improvement of all parameters of the metabolic syndrome and the potential for reduction of comedications in overweight patients with type 2 diabetes. These registry results are important to optimize recommendations for adaptation of concomitant medication, surveillance of adverse events, nutritional status and supplementation, and adaptation of the implantation period of the DJBL.