Spatial characteristics of non-communicable diseases and their associations to social conditions in a large urban cohort in Germany-Results from the Hamburg City Health Study.

BACKGROUND: Non-communicable diseases (NCDs) are responsible for many deaths. They are associated with several modifiable and metabolic risk factors and are therefore prone to significant regional variations on different scales. However, only few intra-urban studies examined spatial variation in NCDs and its association with social circumstances, especially in Germany. Thus, the present study aimed to identify associations of personal risk factors and local social conditions with NCDs in a large German city. METHODS: This study is based on a population-based cohort of the Hamburg City Health Study including 10,000 probands. Six NCDs were analyzed (chronic obstructive pulmonary disease [COPD], coronary heart disease [CHD], diabetes mellitus, heart failure, depression, and hypertension) in 68 city district clusters. As risk factors, we considered socio-demographic variables (age, sex, education) and risk behaviour variables (smoking, alcohol consumption). Logistic regression analyses identified associations between the district clusters and the prevalence rates for each NCD. Regional variation was detected by Gini coefficients and spatial cluster analyses. Local social condition indexes were correlated with prevalence rates of NCDs on city district level and hot-spot analyses were performed for significant high or low values. RESULTS: The analyses included 7,308 participants with a mean age of 63.1 years (51.5% female). The prevalence of hypertension (67.6%) was the highest. Risk factor associations were identified between smoking, alcohol consumption and education and the prevalence of NCDs (hypertension, diabetes, and COPD). Significant regional variations were detected and persisted after adjusting for personal risk factors. Correlations for prevalence rates with the local social conditions were significant for hypertension (r = 0.294, p < 0.02), diabetes (r = 0.259, p = 0.03), and COPD (r = 0.360, p < 0.01). CONCLUSIONS: The study shows that regional differences in NCD prevalence persist even after adjusting for personal risk factors. This highlights the central role of both personal socio-economic status and behaviors such as alcohol and tobacco consumption. It also highlights the importance of other potential regional factors (e.g. the environment) in shaping NCD prevalence. This knowledge helps policy- and decision-makers to develop intervention strategies.

Obesity management: sex-specific considerations.

Obesity is a global health issue that has grown to epidemic proportions. According to World Health Organisation (WHO), overweight and obesity are responsible for more than 1.2 million deaths in Europe each year, representing > 13% of the region's total mortality. Highly processed, calorie-dense foods and reduced physical activity are considered as primary drivers of obesity, but genetic predisposition also plays a significant role. Notably, obesity is more prevalent in women than in men in most countries, and several obesity-related comorbidities exhibit sex-specific pathways. Treatment indication depends on BMI (body mass index), as well as existing comorbidities and risk factors. To reduce obesity-associated comorbidities, a permanent reduction in body weight of (at least) 5-10% is recommended. Treatment guidelines suggest an escalating stepwise approach including lifestyle intervention, pharmacotherapy, and bariatric-metabolic surgery. As cumulative evidence suggests differences in weight loss outcomes, there is growing interest in sex-specific considerations in obesity management. However, most trials do not report weight loss or changes in body composition separately for women and men. Here, we discuss state-of-the-art obesity management and focus on current data about the impact of sex on weight loss outcomes.

["Treatment of obesity - State of the art"]. / "State of the Art in der Therapie der Adipositas".

According to WHO, overweight and obesity are responsible for more than 1,2 million deaths in Europe each year, representing >13% of the Region's total mortality. According to the 2022 Obesity Report, it will take significant effort to get people to adopt healthier lifestyles and be more physically active. Therapeutic measures in the context of an escalating stepwise approach should include strategies for a targeted weight reduction and long-term weight maintenance. An important health policy goal should be better access to these therapy options with an additional focus on primary prevention.

Sustained weight loss with semaglutide once weekly in patients without type 2 diabetes and post-bariatric treatment failure.

About 20%-25% of patients experience weight regain (WR) or insufficient weight loss (IWL) following bariatric surgery (BS). Therefore, we aimed to retrospectively assess the effectiveness of adjunct treatment with semaglutide in patients without type 2 diabetes (T2D) with post-bariatric treatment failure over a 12 months period. Post-bariatric patients without T2D with WR or IWL (n = 29) were included in the analysis. The primary endpoint was weight loss 12 months after initiation of adjunct treatment. Secondary endpoints included change in body mass index, HbA1c, lipid profile, high sensitive C-reactive protein and liver enzymes. Total weight loss during semaglutide treatment added up to 14.7% ± 8.9% (mean ± SD, p < .001) after 12 months. Categorical weight loss was >5% in 89.7% of patients, >10% in 62.1% of patients, >15% in 34.5% of patients, >20% in 24.1% of patients and > 25% in 17.2% of patients. Adjunct treatment with semaglutide resulted in sustained weight loss regardless of sex, WR or IWL and type of surgery. Among patients with prediabetes (n = 6), 12 months treatment led to normoglycemia in all patients (p < .05). Treatment options to manage post-bariatric treatment failure are scarce. Our results imply a clear benefit of adjunct treatment with semaglutide in post-bariatric patients over a 12 months follow-up period.

Fatty acid-binding protein-4 (FABP4) and matrix metalloproteinase-9 (MMP9) as predictive values for nonalcoholic steatohepatitis (NASH).

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD), especially nonalcoholic steatohepatitis (NASH) increases the risk for liver cirrhosis. Noninvasive tests for NAFLD/NASH exist, but they are unreliable and thus liver biopsy remains the standard for diagnosis and new noninvasive diagnostic approaches are of great interest. The aim of this study was to test whether the serum levels of fatty acid-binding protein-4 (FABP4) and matrix metalloproteinase-9 (MMP9) could be used as a diagnostic tool for NASH. METHODS: Patients who underwent bariatric surgery and simultaneous liver biopsy were identified. Biopsies were assigned a NAFLD activity score (NAS). MMP9- and FABP4- Enzyme-linked Immunosorbent Assays (ELISAs) on serum samples were performed. The serum levels of FABP4/MMP9 were compared and different models to predict NASH were developed. RESULTS: A total of 84 patients were included, 28 patients (33.3%) were diagnosed with NASH. Higher concentrations of MMP9 in NASH patients (p < 0.01) were detected. FABP4 concentrations were not significantly increased. A moderate correlation between the NAS and MMP9 concentrations (r = 0.32, P < 0.01) was observed. The neural network model fit best with the dataset, with an area under the curve (AUC) of 83% and an accuracy of 88%. CONCLUSION: Serum MMP9 levels are increased in patients with NASH and should routinely be measured in patients with obesity, but further investigations are needed to improve noninvasive NASH diagnosis.

Low-Grade Hepatic Steatosis Is Associated with Long-term Remission of Type 2 Diabetes Independent of Type of Bariatric-Metabolic Surgery.

BACKGROUND: Bariatric-metabolic surgery (BS) decreases the grade of steatosis, hepatic inflammation, and fibrosis in patients with severe obesity and non-alcoholic fatty liver disease (NAFLD). Mechanisms include substantial weight loss, but also simultaneous effects on glucose homeostasis. Therefore, we aimed to investigate the association between NAFLD and remission of type 2 diabetes (T2D) up to 8 years following different types of BS. METHODS: In a retrospective cohort study including 107 patients with obesity and T2D at baseline, the association between biopsy-proven NAFLD defined as steatosis in > 5% of hepatocytes at the time of surgery and T2D remission up to 8 years following different surgical procedures was investigated. Univariate regression analysis was used to examine the association between NAFLD and remission of T2D. RESULTS: Long-term remission of T2D was present in 56% of patients (n = 60). The presence of low-grade liver steatosis (grade 1) was associated with remission of T2D. Patients with a liver steatosis score ≥ 2 showed higher HbA1c levels at baseline. There were no significant differences in preoperative presence of lobular inflammation, hepatocyte ballooning, or fibrosis between patients who achieved T2D remission compared with those with no remission. Type of surgery did not affect remission of T2D. CONCLUSION: Our results suggest that the presence of low-grade liver steatosis is associated with remission of T2D following sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB). Therefore, BS should be considered at an early NAFLD stage in patients with T2D.

The Potential of Semaglutide Once-Weekly in Patients Without Type 2 Diabetes with Weight Regain or Insufficient Weight Loss After Bariatric Surgery-a Retrospective Analysis.

PURPOSE: About 20-25% of patients experience weight regain (WR) or insufficient weight loss (IWL) after bariatric metabolic surgery (BS). Therefore, we aimed to retrospectively assess the effectiveness of adjunct treatment with the GLP-1 receptor agonist semaglutide in non-diabetic patients with WR or IWL after BS. MATERIALS AND METHODS: Post-bariatric patients without type 2 diabetes (T2D) with WR or IWL (n = 44) were included in the analysis. The primary endpoint was weight loss 3 and 6 months after initiation of adjunct treatment. Secondary endpoints included change in BMI, HbA1c, lipid profile, hs-CRP, and liver enzymes. RESULTS: Patients started semaglutide 64.7 ± 47.6 months (mean ± SD) after BS. At initiation of semaglutide, WR after post-bariatric weight nadir was 12.3 ± 14.4% (mean ± SD). Total weight loss during semaglutide treatment was - 6.0 ± 4.3% (mean ± SD, p < 0.001) after 3 months (3.2 months, IQR 3.0-3.5, n = 38) and - 10.3 ± 5.5% (mean ± SD, p < 0.001) after 6 months (5.8 months, IQR 5.8-6.4, n = 20). At 3 months, categorical weight loss was > 5% in 61% of patients, > 10% in 16% of patients, and > 15% in 2% of patients. Triglycerides (OR = 0.99; p < 0.05), ALT (OR = 0.87; p = 0.05), and AST (OR = 0.89; p < 0.05) at baseline were negatively associated with weight loss of at least 5% at 3 months' follow-up (p < 0.05). CONCLUSION: Treatment options to manage post-bariatric excess weight (regain) are scarce. Our results imply a clear benefit of adjunct treatment with semaglutide in post-bariatric patients. However, these results need to be confirmed in a prospective randomized controlled trial to close the gap between lifestyle intervention and revision surgery in patients with IWL or WR after BS.

[Obesity - a chronic disease requiring treatment]. / Adipositas ­ eine behandlungsbedürftige chronische Erkrankung.

The globally increasing prevalence of obesity represents a key medical and socioeconomic challenge. Due to related comorbidities and complications such as arterial hypertension, diabetes mellitus, fatty liver disease, and arteriosclerosis, obesity leads to a significant statistical reduction in lifespan. Currently, bariatric surgery is the most effective approach to manage body weight and comorbidities while lifestyle intervention as basic obesity therapy and medical treatment often do not lead to sufficient and sustainable weight loss. However, recent medical approaches show now promising effects on weight control and might close the gap towards bariatric surgical procedures. For instance, semaglutide has been approved by EMA in January 2022 for medical treatment of obesity concomitant to basic lifestyle therapy in adults with a BMI of ≥ 30 kg/m2 or ≥ 27 kg/m2 and weight-related comorbidity. Apart from weight control, improvement in cardiometabolic risk factors can be achieved with this treatment. Moreover, other drugs, mostly based on incretin mono- or multiagonism, are currently developed and may open further effective treatment options for obesity and its complications in the near future.On a health political level, first steps for the development of a structured treatment program (DMP) for obesity are in progress to enable early guideline-based and structured treatment of obesity, and to prevent the obesity associated complications.

Thyroid-stimulating hormone levels in euthyroid patients 8 years following bariatric surgery.

BACKGROUND: Bariatric surgery (BS) was shown to promote a decline in thyroid-stimulating hormone (TSH) in euthyroid patients with severe obesity in the short-term. Aim of the present study was to assess the effect of weight loss on thyroid function in euthyroid patients in the long-term following different bariatric procedures. METHODS: In a retrospective cohort study including 135 patients at baseline, thyroid function was assessed at six time points up to 8 years after surgery. Patients were stratified by TSH levels at baseline and divided into two groups to compare the change in TSH at long-time. We used log-linear regression to assess the relation between thyroid hormones and TSH and linear regression analyses to identify variables that were thought to determine TSH and fT3/fT4-ratio as well as their change long-term. RESULTS: Over a mean follow-up of 8 years, TSH and fT3/fT4-ratio declined (both p < 0.001). Patients with high-normal TSH showed a greater decline in TSH than those with normal TSH compared to baseline. Thyroid hormones and TSH displayed a negative log-linear correlation at long-term follow-up. Change in TSH at long-time showed a negative correlation with TSH at baseline (B = -0.55; p < 0.001). With regard to type of surgery, there were no significant differences in TSH. CONCLUSION: BS promotes a decline of TSH in euthyroid patients up to 8 years after intervention despite weight regain. The greatest change in TSH was seen among patients with high-normal baseline-TSH. Results of log-linear regression suggest recovery of the pituitary-thyroid axis. Type of surgery did not affect the change in TSH levels over time.

Comparison of Anti-factor Xa Levels in Female and Male Patients with Obesity After Enoxaparin Application for Thromboprophylaxis.

PURPOSE: Venous thromboembolic events (VTEs) are common complications after bariatric surgery, and enoxaparin is commonly used to prevent VTEs. The risk for VTEs is sex-specific. Whether enoxaparin application results in similar anti-factor Xa activities (aFXa) in males and females with obesity remains to be determined. We investigated whether our dosage regimen of enoxaparin resulted in similar serum aFXa levels in female and male patients undergoing bariatric surgery. MATERIALS AND METHODS: We administered enoxaparin twice daily in patients undergoing bariatric surgery. Patients with a body mass index (BMI) > 60 kg/m2 (n = 11) received 60 mg enoxaparin (group 2), and patients with lower BMI (n = 86) received 40 mg per dose (group 1). Peak aFXa levels were measured 3 days after surgery. The primary outcome was the aFXa level. As a secondary outcome, we detected VTEs and major bleeding events and explored the possible influencing factors of aFXa. RESULTS: Women had higher aFXa than men, but after matching for anthropometric values, the two groups were similar (females: 0.17 ± 0.08 U/ml; males: 0.18 ± 0.08 U/ml). Linear regression revealed a moderate relationship between weight and aFXa levels. The 3-month follow-up was attended by 94.9%, at which one patient had pulmonary embolism. CONCLUSION: Individual enoxaparin dosage regimens for men and women do not seem to be required. Weight-based dosing regimen seems to be a more reasonable choice.

Prevalence and risk factors of undiagnosed diabetes mellitus among gastroenterological patients: a HbA1c-based single center experience - Prevalence of undiagnosed diabetes in gastroenterological patients.

BACKGROUND: Diabetes mellitus is a major risk factor for microvascular disease, leading to chronic kidney injury or cardiovascular disease, but there is a tremendous proportion of patients worldwide who suffer from undiagnosed diabetes. Until now, little is known about the prevalence of undiagnosed diabetes in gastroenterology inpatients. OBJECTIVE: To improve detection of undiagnosed diabetes, a routine screening procedure for gastroenterology inpatients, based on hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) measurement, was established. METHODS: We conducted a retrospective analysis of the implemented diabetes screening. Diabetes mellitus was diagnosed according to the guideline of the German Diabetes Association in patients with an HbA1c of ≥6.5% anld/or fasting plasma glucose (FPG) ≥126 mg/dL. Univariate and multivariate analyses were performed to identify independent risk factors for undiagnosed diabetes. RESULTS: Within a 3-month period, 606 patients were eligible for a diabetes screening. Pre-existing diabetes was documented in 120 patients (19.8 %), undiagnosed diabetes was found in 24 (3.9%), and 162 patients (26.7%) met the definition for prediabetes. Steroid medication use, age, and liver cirrhosis due to primary sclerosing cholangitis (PSC) were identified as risk factors for undiagnosed diabetes. CONCLUSION: The prevalence of undiagnosed diabetes in gastroenterology inpatients is markedly elevated in comparison to the general population, and a substantial number of inpatients are in a prediabetic status, underlining the need for diabetes screening. In addition to previously described risk factors of patient age and steroid medication use, we identified PSC-related liver cirrhosis (but not liver cirrhosis due to another etiology) as an independent risk factor for undiagnosed diabetes.

Long-Term Improvement of Chronic Low-Grade Inflammation After Bariatric Surgery.

PURPOSE: Bariatric surgery (BS) was shown to improve inflammatory markers in previous short-term follow-up studies. The aim of the present study was to assess the long-term effects of BS on chronic low-grade inflammation markers related to severe obesity. Moreover, the meaning of the type of BS procedure as well as the remission of type 2 diabetes (T2D) for inflammatory status up to 4 years after BS was analyzed. MATERIALS AND METHODS: In a retrospective cohort study including 163 patients at baseline, inflammatory and metabolic parameters were assessed at 4 time points: before surgery (baseline), 6 months after surgery (visit 1), 2 years after surgery (visit 2), and 4 years after surgery (visit 3). Univariate regression analysis was used to identify variables that were thought to determine change in inflammatory parameters. RESULTS: CRP, hs-CRP, leucocytes, and ferritin significantly declined in the mid- and long-term according to the U-shaped curve of weight loss (p<0.001). Change in body mass index (BMI) at long-time follow-up showed a significant linear effect on change in leucocytes (B=0.082; p<0.001) and change in hs-CRP (B=0.03; p<0.05). There was a strong, positive correlation between T2D and hs-CRP at visit 2 (rs=0.195; p<0.05) and visit 3 (rs=0.36; p=0.001). With regard to type of surgery and gender, there were no significant differences in inflammatory parameters. CONCLUSION: BS is able to reduce obesity-related chronic low-grade inflammation up to 4 years after surgical intervention. The improvement in metaflammation is related to the change in BMI and remission of T2D in the long-term.

Bariatric Surgery Is Protective Against Renal Function Decline in Severely Obese Patients in the Long-Term.

PURPOSE: This study aims to assess the long-term renal effects of bariatric surgery (BS) in severely obese patients over a follow-up period of up to 11 years. MATERIALS AND METHODS: In a retrospective cohort study including 102 patients, patients were stratified by eGFR at baseline and divided into three groups: (1) reduced, (2) normal, and (3) increased filtration rate. Adjustments for age- and sex-related decline in eGFR were performed. We used uni- and multivariate regression analysis to identify variables that were thought to determine change in eGFR. RESULTS: Over a median follow-up of 8.5 years (interquartile range 2.7), eGFR declined from 96.1 ± 20.7 to 84.9 ± 21.0 ml/min (p < 0.001). Among patients with (1), eGFR remained stable (69.1 ± 19.3 ml/min). Among patients with (2), eGFR declined from 99.7 ± 13.3 ml/min to 88.7 ± 19.4 ml/min (p < 0.001). Among patients with (3), eGFR decreased to normal levels (94.2 ± 17.7 ml/min, p < 0.001). Age- and sex-adjusted eGFR increased (6.4 ± 14.4 ml/min; p < 0.05) among patients with reduced filtration rate. Among patients with normal filtration rate, adjusted eGFR remained stable during follow-up (-1.3 ± 15.2 ml/min; n.s.). Among patients with increased filtration rate, adjusted eGFR decreased and remained within the normal range (-13.2 ± 12.2 ml/min; p < 0.001). Change in eGFR showed a negative correlation with eGFR at baseline (B = -0.31; p < 0.001), change in LDL-cholesterol (B = -0.09; p < 0.05), and a negative correlation with treatment requiring hypertension (B = -9.36; p = 0.001). CONCLUSION: BS is protective against renal function decline in severely obese patients in the long term.

Screening and management of postoperative hypoparathyroidism-induced hypocalcemia in thyroidectomized patients in the endocrine ward compared with the surgical ward.

Transient hypoparathyroid-associated hypocalcemia is a common side effect after thyroidectomy. Not only may it be life-threatening, but it also can distinctly affect length of hospital stay and treatment costs. Screening and treatment practices are suspected to differ between clinicians in endocrine and surgical wards. We therefore compared discipline-related differences in screening and treatment of hypocalcemia as well as the length of hospital stay of patients after thyroidectomy. Data from 170 patients treated with total thyroidectomy in the Department of Otolaryngology (n = 29), General Surgery (n = 49) and Endocrinology (n = 92) were analyzed, and measurements of postoperative calcium and parathyroid hormone, calcium at time of discharge, percentage of discharge with a calcium level <1.9 mmol/L (defined as severe hypocalcemia), treatment of hypocalcemia, and duration of hospitalization were compared between disciplines. Postoperative calcium levels were measured in 97.8% of patients in endocrine wards compared with 83.3% in surgical departments (p = 0.001), and discharge with a calcium level <1.9 mmol/L was statistically more frequent in surgical vs. endocrine wards. Additional to calcium supplementation, active vitamin D was administered in 95% of patients treated in endocrine wards vs. 35% in surgical wards. Length of hospitalization was 8.12 (±6.62) days (endocrinology) to 10.55 (±9.39) days (surgical wards) (p = 0.05). Monitoring of calcium levels is an important indicator of the quality of postoperative care after thyroidectomy. To prevent postoperative hypocalcemia-induced complications and to reduce the length of hospital stay, an interdisciplinary approach for the management of hypocalcemia after thyroidectomy might be a promising model for future treatment concepts.

Longitudinal evaluation of efficacy, safety and nutritional status during one-year treatment with the duodenal-jejunal bypass liner.

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.

Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes mellitus: A case control study.

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.

Trends in BMI, Glycemic Control and Obesity-Associated Comorbidities After Explantation of the Duodenal-Jejunal Bypass Liner (DJBL).

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.