Fachklinik Bad Heilbrunn

Bad Heilbrunn, Germany

Fachklinik Bad Heilbrunn

Bad Heilbrunn, Germany

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Aronson R.,LMC Diabetes & Endocrinology | Cohen O.,Institute of Endocrinology | Cohen O.,Chaim Sheba Medical Center | Conget I.,University of Barcelona | And 38 more authors.
Diabetes Technology and Therapeutics | Year: 2014

Background: In insulin-requiring type 2 diabetes patients, current insulin therapy approaches such as basal-alone or basal-bolus multiple daily injections (MDI) have not consistently provided achievement of optimal glycemic control. Previous studies have suggested a potential benefit of continuous subcutaneous insulin infusion (CSII) in these patients. The OpT2mise study is a multicenter, randomized, trial comparing CSII with MDI in a large cohort of subjects with evidence of persistent hyperglycemia despite previous MDI therapy. Subjects and Methods: Subjects were enrolled into a run-in period for optimization of their MDI insulin regimen. Subjects showing persistent hyperglycemia (glycated hemoglobin [HbA1c] ≥8% and ≤12%) were then randomly assigned to CSII or continuing an MDI regimen for a 6-month phase followed by a single crossover of the MDI arm, switching to CSII. The primary end point is the between-group difference in mean change in HbA1c from baseline to 6 months. Secondary end points include change in mean 24-h glucose values, area under the curve and time spent in hypoglycemia and hyperglycemia, measures of glycemic excursions, change in postprandial hyperglycemia, and evaluation of treatment satisfaction. Safety end points include hypoglycemia, hospital admissions, and emergency room visits. Results: When subject enrollment was completed in May 2013, 495 subjects had been enrolled in the study. The study completion for the primary end point is expected in January 2014. Conclusions: OpT2mise will represent the largest studied homogeneous cohort of type 2 diabetes patients with persistent hyperglycemia despite optimized MDI therapy. OpT2mise will help define the role of CSII in insulin intensification and define its safety, rate of hypoglycemia, patient adherence, and patient satisfaction. © Copyright 2014, Mary Ann Liebert, Inc. 2014.


Conget I.,University of Barcelona | Castaneda J.,Medtronic | Petrovski G.,University of Macedonia | Guerci B.,Nancy University Hospital Center | And 39 more authors.
Diabetes Technology and Therapeutics | Year: 2016

Background: The OpT2mise randomized trial was designed to compare the effects of continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI) on glucose profiles in patients with type 2 diabetes. Research Design and Methods: Patients with glycated hemoglobin (HbA1c) levels of ≥8% (64 mmol/mol) and ≤12% (108 mmol/mol) despite insulin doses of 0.7-1.8 U/kg/day via MDI were randomized to CSII (n=168) or continued MDI (n=163). Changes in glucose profiles were evaluated using continuous glucose monitoring data collected over 6-day periods before and 6 months after randomization. Results: After 6 months, reductions in HbA1c levels were significantly greater with CSII (-1.1±1.2% [-12.0±13.1 mmol/mol]) than with MDI (-0.4±1.1% [-4.4±12.0 mmol/mol]) (P<0.001). Similarly, compared with patients receiving MDI, those receiving CSII showed significantly greater reductions in 24-h mean sensor glucose (SG) (treatment difference, -17.1 mg/dL; P=0.0023), less exposure to SG >180 mg/dL (-12.4%; P=0.0004) and SG >250 mg/dL (-5.5%; P=0.0153), and more time in the SG range of 70-180 mg/dL (12.3%; P=0.0002), with no differences in exposure to SG<70 mg/dL or in glucose variability. Changes in postprandial (4-h) glucose area under the curve >180 mg/dL were significantly greater with CSII than with MDI after breakfast (-775.9±1,441.2 mg/dL/min vs. -160.7±1,074.1 mg/dL/min; P=0.0015) and after dinner (-731.4±1,580.7 mg/dL/min vs. -71.1±1,083.5 mg/dL/min; P=0.0014). Conclusions: In patients with suboptimally controlled type 2 diabetes, CSII significantly improves selected glucometrics, compared with MDI, without increasing the risk of hypoglycemia. © Ignacio Conget, et al., 2016; Published by Mary Ann Liebert, Inc. 2016.


Liebl A.,Fachklinik Bad Heilbrunn | Prusty V.,Novo Nordisk AS | Valensi P.,Paris Nord University | Kawamori R.,Juntendo University | And 5 more authors.
Drugs | Year: 2012

Biphasic insulin aspart 30 (BIAsp 30) includes 30 soluble rapid-acting insulin aspart (IAsp) along with an intermediate-acting 70 protaminated IAsp that provides coverage of prandial and basal insulin in a single injection. As BIAsp 30 has been available internationally for 10 years, this review provides a comprehensive overview of the discovery of BIAsp 30, its pharmacokinetic and pharmacodynamic profile, safety and efficacy outcomes from the clinical trial programme, 'real-life' clinical insights provided by observational study data, and cost effectiveness and quality-of-life information. These studies have demonstrated that BIAsp 30 once or twice daily is an appropriate option for insulin initiation. BIAsp 30 also provides a switch option in patients on biphasic human insulin (BHI). Switching from BHI to BIAsp 30 is associated with improved postprandial glucose (PPG) and reduced nocturnal and major hypoglycaemia, although daytime hypoglycaemia is higher with BIAsp 30. Intensification of BIAsp 30 can be achieved by increasing the number of daily doses up to three times daily with meals. Therefore, BIAsp 30 provides an intensification option for individuals who are not achieving control with basal insulin and would prefer the simplicity of a single biphasic insulin instead of progressing to a basal-bolus approach. BIAsp 30 has a simple dose-titration algorithm, which enables patients to effectively self-titrate their insulin dose. Cost-effectiveness analyses have demonstrated that BIAsp 30 is cost effective or dominant compared with BHI 30 or insulin glargine in a number of healthcare settings. In conclusion, BIAsp 30 offers a simple and flexible option for insulin initiation and intensification that provides coverage of both fasting and prandial glucose. Adis © 2012 Springer International Publishing AG. All rights reserved.


Bottger S.,Stadtisches Klinikum Munich GmbH | Haberl R.,Stadtisches Klinikum Munich GmbH | Prosiegel M.,Fachklinik Bad Heilbrunn | Audebert H.,Charité - Medical University of Berlin | And 3 more authors.
Brain Research | Year: 2010

Aims: There is behavioral evidence of increased spontaneous recruitment of visual attention to ancestral evolved categories, such as animals, compared with expertise-derived categories, such as a computer. In order to investigate the association between visual perception and spontaneous visual attention, a study was performed to determine if brain activation whilst viewing moving animals was increased compared with optokinetic computer stimuli. Methods: Functional MRI was performed in 12 healthy volunteers using a standard block-design paradigm, consisting of three consecutive experiments. Subjects viewed the following images: Experiment one - optokinetic computer stimuli alternating with static computer stimuli; Experiment two - moving animals alternating with non-moving animals; Experiment three - moving animals alternating with optokinetic computer stimuli. Results: Moving animals evoked motion-dependent activation bilaterally in the middle and superior temporal gyri, right inferior temporal gyrus, left occipital gyrus, right supramarginal gyrus, and left straight gyrus. Integrated object-and-motion-dependent activation was found bilateral in inferior and middle temporal gyri, right superior temporal gyrus, right superior parietal lobule, left dorsal putamen, and right amygdala. Conclusions: These results suggest that there is increased cerebral activity in the visuo-attentional network whilst viewing moving animals compared with optokinetic computer stimuli. © 2010 Elsevier B.V. All rights reserved.


Liebl A.,Fachklinik Bad Heilbrunn | Henrichs H.R.,Arbeitsgemeinschaft Diabetologische Technology e.V. | Heinemann L.,Science and Co. | Freckmann G.,Institute For Diabetes Technology | And 2 more authors.
Diabetes, Stoffwechsel und Herz | Year: 2012

Continuous glucose monitoring (CGM) has become an increasingly important part of modern diabetes therapy. Recent randomized controlled studies have provided evidence that sufficiently frequent CGM can improve HbA 1c results in patients with type 1 diabetes and elevated baseline HbA 1c levels, while lowering the rate and duration of hypoglycaemic events in patients with good baseline HbA 1c levels. The CGM group in German Diabetes Association (DDG)'s diabetes technology working group (AGDT) has defined evidence-based indications for the clinical CGM application in a consensus statement; these indications are hypoglycaemia (frequent, severe, or nocturnal) and hypoglycaemia unawareness, insufficient metabolic control despite full use of every possible therapeutic option and good patient compliance, pregnancy with unsatisfactory blood glucose results, and the need for more than ten blood glucose measurements per day. Contraindications and defined preconditions for the successful use of CGM should be considered.


Liebl R.,Internistisch nephrologische Gemeinschaftspraxis | Feucht H.E.,Fachklinik Bad Heilbrunn | Fischereder M.,Ludwig Maximilians University of Munich
Nieren- und Hochdruckkrankheiten | Year: 2012

A 73-year-old woman with autosomal polycystic kidney disease and CKD stage 5 had a kidney transplant in1986. Twenty-four years later mammography showed a nodule that could not be exactly differentiated by cytological examination. Histological examination then revealed a clear cell carcinoma. Following computed tomography, she underwent nephrectomy that confirmed the presence of a clear cell carcinoma in the polycystic kidney. No more metastases were found. In the literature only 15 cases of metastatic spread of a renal cell carcinoma to the breast are published. The clinical outcome after switching the immunosuppressive therapy from a cyclosporine-based to an everolimus-based scheme is discussed. © 2012 Dustri-Verlag Dr. Karl Feistle.


Bohmig G.A.,Medical University of Vienna | Kikic Z.,Medical University of Vienna | Wahrmann M.,Medical University of Vienna | Eskandary F.,Medical University of Vienna | And 4 more authors.
Clinical Biochemistry | Year: 2015

Objective: Antibody-mediated rejection (ABMR) is an important cause of kidney allograft injury. In the last two decades, detection of complement split product C4d along transplant capillaries, a footprint of antibody-mediated classical complement activation, has evolved as a useful diagnostic marker of ABMR. While it was recognized that ABMR may occur also in the absence of C4d, numerous studies have shown that C4d deposition may indicate a more severe rejection phenotype associated with poor graft survival. Such studies suggest a possible diagnostic benefit of ex vivo monitoring the complement-activating capability of circulating alloantibodies. Design and methods: We reviewed the literature between 1993 and 2015, focusing on in vivo (biopsy work-up) and in vitro detection (modified bead array technology) of HLA antibody-triggered classical complement activation in kidney transplantation. Results: Precise HLA antibody detection methods, in particular Luminex-based single antigen bead (SAB) assays, have provided a valuable basis for the design of techniques for in vitro detection of HLA antibody-triggered complement activation reflected by C1q, C4 or C3 split product deposition to the bead surface. Establishing such assays it was recognized that deposition of complement products to SAB, which critically depends on antibody binding strength, may be a cardinal trigger of the prozone effect, a troublesome in vitro artifact caused by a steric interference with IgG detection reagents. False-low IgG results, especially on SAB with extensive antibody binding, have to be considered when interpreting studies analyzing the diagnostic value of complement in relation to standard IgG detection. Levels of complement-fixing donor-specific antibodies (DSA) were shown to correlate with the results of standard crossmatch tests, suggesting potential application for crossmatch prediction. Moreover, while the utility of pre-transplant complement detection, at least in crossmatch-negative transplant recipients, is controversially discussed, a series of studies have shown that the appearance of post-transplant complement-fixing DSA may be associated with C4d deposition in transplant capillaries and a particular risk of graft failure. Conclusions: The independent value of modified single antigen bead assays, as compared to a careful analysis of standard IgG detection, which may be affected considerably by complement dependent artifacts, needs to be clarified. Whether they have the potential to improve the predictive accuracy of our current diagnostic repertoire warrants further study. © 2015.


PubMed | Fachklinik Bad Heilbrunn and Medical University of Vienna
Type: Journal Article | Journal: Clinical biochemistry | Year: 2016

Antibody-mediated rejection (ABMR) is an important cause of kidney allograft injury. In the last two decades, detection of complement split product C4d along transplant capillaries, a footprint of antibody-mediated classical complement activation, has evolved as a useful diagnostic marker of ABMR. While it was recognized that ABMR may occur also in the absence of C4d, numerous studies have shown that C4d deposition may indicate a more severe rejection phenotype associated with poor graft survival. Such studies suggest a possible diagnostic benefit of ex vivo monitoring the complement-activating capability of circulating alloantibodies.We reviewed the literature between 1993 and 2015, focusing on in vivo (biopsy work-up) and in vitro detection (modified bead array technology) of HLA antibody-triggered classical complement activation in kidney transplantation.Precise HLA antibody detection methods, in particular Luminex-based single antigen bead (SAB) assays, have provided a valuable basis for the design of techniques for in vitro detection of HLA antibody-triggered complement activation reflected by C1q, C4 or C3 split product deposition to the bead surface. Establishing such assays it was recognized that deposition of complement products to SAB, which critically depends on antibody binding strength, may be a cardinal trigger of the prozone effect, a troublesome in vitro artifact caused by a steric interference with IgG detection reagents. False-low IgG results, especially on SAB with extensive antibody binding, have to be considered when interpreting studies analyzing the diagnostic value of complement in relation to standard IgG detection. Levels of complement-fixing donor-specific antibodies (DSA) were shown to correlate with the results of standard crossmatch tests, suggesting potential application for crossmatch prediction. Moreover, while the utility of pre-transplant complement detection, at least in crossmatch-negative transplant recipients, is controversially discussed, a series of studies have shown that the appearance of post-transplant complement-fixing DSA may be associated with C4d deposition in transplant capillaries and a particular risk of graft failure.The independent value of modified single antigen bead assays, as compared to a careful analysis of standard IgG detection, which may be affected considerably by complement dependent artifacts, needs to be clarified. Whether they have the potential to improve the predictive accuracy of our current diagnostic repertoire warrants further study.

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