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Background: Cardiovascular diseases are the leading cause of death worldwide. Subclinical alterations of the cardiovascular system, such as increased exercise blood pressure or an endothelial dysfunction confer a higher risk of manifest cardiovascular diseases and incident events. Detecting associations between circulating markers of the endocrine-metabolic system and the subclinical cardiovascular phenotypes could be useful to better understand cardiovascular disease progression and to improve risk prediction for manifest cardiovascular diseases. Methods: The associations between (a) serum thyroid-stimulating hormone and increased exercise blood pressure, (b) serum hemoglobin A1c and endothelial dysfunction as well as (c) serum insulin-like growth factor I and endothelial dysfunction were studied using cross-sectional data from around 1400 subjects aged 25 to 85 years collected during the 5-year follow-up of the population-based Study of Health in Pomerania (SHIP-1). Increased exercise blood pressure was defined as a value above the sex- and age-specific 80th percentile measured at the 100 W stage of a symptom-limited bicycle ergometry test. Endothelial dysfunction was defined as an impaired flow-mediated dilation measured as a continuous decrease or below the median of sex-specific distribution. Non-fasting blood samples were drawn from the cubital vein in the supine position. Results: The odds for increased systolic exercise blood pressure (odds ratio 1.24, 95% confidence interval 0.88; 1.76) and diastolic exercise blood pressure (odds ratio 0.98, 95% confidence interval 0.70; 1.39) as well as for exercise-induced increase of systolic and diastolic blood pressure were not significantly different between subjects with high and low serum thyroid-stimulating hormone levels within the reference range. In women without current use of antihypertensive medication, increasing serum hemoglobin A1c levels were associated with decreasing flow-mediated dilation levels (ß = -1.17, 95% confidence interval -2.03; -0.30). Such an association was not found in men. In men, logistic regression analysis revealed an odds ratio of 1.27 (95% confidence interval 1.07; 1.51) for decreased flow-mediated dilation for each decrement of serum insulin-like growth factor I standard deviation. In women, no significant association between serum insulin-like growth factor I levels and flow-mediated dilation was observed (odds ratio 0.88, 95% confidence interval 0.74; 1.05). Conclusions: Based on the presented results it is concluded that (a) serum thyroid-stimulating hormone levels are not associated with exercise blood pressure in the general population, (b) higher serum hemoglobin A1c levels in non-diabetic subjects are inversely associated with flow-mediated dilation in women without antihypertensive medication, but not in men, and (c) lower serum insulin-like growth factor I levels are associated with impaired endothelial function in men, but not in women. Therefore the metabolic marker hemoglobin A1c and the endocrine marker insulin-like growth factor I might be markers facilitating the identification of subjects at high risk of subclinical cardiovascular alterations.
Background: Alcohol consumption accounts for a high burden of disease. The general population of West Pomerania has been characterized as a population at risk with a high prevalence of behavioural risk factors such as alcohol risk drinking. This is reflected by the high proportion of patients being admitted to general hospitals due to alcohol-attributable diseases. The aims of the present dissertation were (a) to analyze dose-response relations between volume of alcohol drinking and the risk of diseases with different alcohol-attributable fractions (AAF) in general hospital inpatients (study 1); (b) to assess motivation to change drinking behaviour and motivation to seek help for alcohol problems during their hospital stay as well as changes in motivation to change drinking behaviour, motivation to seek help and changes in daily alcohol consumption across time according to diseases with different AAFs (study 2); and (c) to investigate the association of fatty liver disease (FLD) with blood pressure and hypertension in a general population sample and to test for the specific contribution of alcohol consumption to this association (study 3). Methods: For studies 1 and 2, data from 'Early Intervention at General Hospitals', a randomized controlled trial to test the effectiveness of brief intervention for alcohol problem drinking in general hospitals, were used. Study 1 comprised data from 846 inpatients, study 2 comprised data from 294 inpatients aged 18 to 64 years with alcohol problem drinking and alcohol-attributable diseases from four general hospitals in West Pomerania. Hospital diagnoses were classified according to their AAF: (1) diseases wholly attributable to alcohol consumption by definition (AAF=1), (2) diseases partially attributable to alcohol consumption (AAF<1), and (3) diseases with no relation to alcohol consumption or where alcohol consumption has been found to be a protective factor (AAF=0). Study 3 encompassed data from the 'Study of Health in Pomerania', a general population sample of 3191 adults aged 20-79 years. FLD was defined using ultrasound in combination with increased serum alanine aminotransferase levels. Results: Analyses showed that 46.8% of the general hospital inpatients had a disease attributable to alcohol consumption. There was a dose-response relationship between volume of alcohol drinking and the risk of diseases with different AAFs. Inpatients consuming >120 g and inpatients consuming 61-120 g of pure alcohol per day revealed significantly higher odds for diseases with AAF=1 compared to inpatients consuming 31-60 g of pure alcohol per day with odds ratios (OR) of 6.3 (95% CI 3.6-11.3) and 2.9 (95% CI 1.6-5.1), respectively. Regarding diseases with AAF<1, inpatients consuming >120 g of pure alcohol per day had significantly higher odds compared to inpatients consuming 31-60 g of pure alcohol per day (OR 2.0, CI 1.2-3.4). Analyses on motivation to change drinking behaviour and on motivation to seek help at hospitalization revealed that motivation to change drinking behaviour was higher among inpatients with alcohol-attributable diseases than among inpatients without alcohol-attributable diseases (p<.001). Among inpatients with AAF=1, motivation to seek help was higher than among inpatients with AAF<1 and AAF=0 (p<.001). While motivation to change drinking behaviour remained stable within one year after hospitalization in all three AAF groups, motivation to seek help decreased in this time period. The volume of alcohol consumed decreased in all three AAF groups within one year after hospitalization. Data from the general population study revealed that FLD was associated with blood pressure and hypertension at baseline and at five-year examination follow-up. For example, the chance of hypertension at both time points was threefold higher in individuals with FLD (OR 2.8, CI 1.3-6.2; OR 3.1, CI 1.7-5.8, respectively) compared to individuals without FLD. Analyses further revealed that the association of FLD with blood pressure and hypertension was independent of alcohol consumption. Conclusion: The results of the present dissertation provide relevant implications for public health. In view of the high proportion of general hospital inpatients with alcohol-attributable diseases, a screening procedure for problem drinking is needed. Furthermore, appropriate interventions considering the inpatient’s motivational level have to be implemented. The concept of AAFs to classify disease conditions according to their causal relationship with alcohol consumption might be a tool to detect inpatients with problem drinking. The results regarding FLD and its association with blood pressure and hypertension demonstrate that it is important to pay attention to alcohol-attributable diseases in the general population and that alcohol-attributable diseases are associated with subsequent serious sequelae. The results of the present work further indicate that the concept to distinguish between alcoholic and non-alcoholic origin of FLD might be obsolete and should be replaced by a concept that regards FLD as a multifactorial disease condition.
Background: It has not been investigated whether there are associations between urinary iodine (UI) excretion measurements some years apart, nor whether such an association remains after adjustment for nutritional habits. The aim of the present study was to investigate the relation between iodine-creatinine ratio (ICR) at two measuring points 5 years apart. Methods: Data from 2,659 individuals from the Study of Health in Pomerania were analyzed. Analysis of covariance and Poisson regressions were used to associate baseline with follow-up ICR. Results: Baseline ICR was associated with follow-up ICR. Particularly, baseline ICR >300 µg/g was related to an ICR >300 µg/g at follow-up (relative risk, RR: 2.20; p < 0.001). The association was stronger in males (RR: 2.64; p < 0.001) than in females (RR: 1.64; p = 0.007). In contrast, baseline ICR <100 µg/g was only associated with an ICR <100 µg/g at follow-up in males when considering unadjusted ICR. Conclusions: We detected only a weak correlation with respect to low ICR. Studies assessing iodine status in a population should take into account that an individual with a low UI excretion in one measurement is not necessarily permanently iodine deficient. On the other hand, current high ICR could have been predicted by high ICR 5 years ago.
Effectiveness of Varenicline as an Aid to Smoking Cessation in Primary Care: An Observational Study
(2012)
Aims: Although varenicline is commonly prescribed in primary care, information on smoking-related comorbidities and the effectiveness of varenicline in this context in Germany is scarce. This study assessed the efficacy and safety of varenicline in a large sample of patients seeking smoking cessation treatment through their general practitioners. The frequency of comorbidities was also evaluated. Methods: This was a 12-week, prospective, observational, non-comparative phase IV trial conducted in Germany. Abstinence rates at week 12 were evaluated by verbal reporting using the nicotine use inventory. Results: Overall, 1,391 subjects were enrolled; 1,177 received study medication and were evaluated for effectiveness and safety. At the end of the study, 71.1% (95% confidence interval 68.5–73.7) of subjects were abstinent. There were a total of 205 all-causality adverse events; 2.2% were classified as serious or severe. There were no fatal adverse events. At inclusion, 66.7% of participants had at least 1 concurrent comorbidity, with chronic obstructive pulmonary disease (35.5%), hypertension (29.6%) and depression (10.4%) being the most commonly reported. Conclusion: These real-world data indicate that varenicline is an effective and well-tolerated smoking cessation treatment when used in the primary care setting including patients with smoking-related comorbidities.
SummaryBackground: According to the literature, ductoscopy is gaining increasing importance in the diagnosis of intraductal anomalies in cases of pathologic nipple discharge. In a multicenter study, the impact of this method was assessed in comparison with that of standard diagnostics. Patients and Methods: Between 09/2006 and 05/2009, a total of 214 patients from 7 German breast centers were included. All patients underwent elective ductoscopy and subsequent ductal excision because of pathologic nipple discharge. Ductoscopy was compared with the following standard diagnostics: breast sonography, mammography, magnetic resonance imaging (MRI), galactography, cytologic nipple swab, and ductal lavage cytology. The histological and imaging results were compared and contrasted to the results obtained from the nipple swab and cytologic assessment. Results: Sonography had the highest (82.9%) sensitivity, followed by MRI (82.5%), galactography (81.3%), ductoscopy (71.2%), lavage cytology (57.8%), mammography (57.1%), and nipple swab (22.8%). Nipple swabs had the highest (85.5%) specificity, followed by lavage cytology (85.2%), ductoscopy (49.4%), galactography (44.4%), mammography (33.3%), sonography (17.9%), and MRI (11.8%). Conclusion: Currently, ductoscopy provides a direct intraoperative visualization of intraductal lesions. Sensitivity and specificity are similar to those of standard diagnostics. The technique supports selective duct excision, in contrast to the unselective technique according to Urban. Therefore, ductoscopy extends the interventional/diagnostic armamentarium.
Prostate volume estimation in MR images for epidemiological and clinical studies – new methods
(2014)
Benign prostatic hyperplasia (BPH) is one of the most widespread diseases among men older than 50 years. The literature provides various cut-off values for pathological enlargement of the prostate. Prostate volume (PV) measurement in large population-based studies would allow deriving more objective reference values and a more valid early BPH diagnosis. A fully automated method is therefore required. In the clinical context, the measurement of the PV is important for treatment response monitoring in the clinical applications for BPH management research, and an accurate method for PV is essential. Magnetic Resonance Imaging was used for PV estimation. Two methods based on the Support Vector Machines (SVM) were developed: the binary Support Vector Machines (C SVM)-based method for epidemiological studies and the single-class Support Vector Machines (S SVM)-based method for clinical studies. The second method was additionally compared to the ellipsoid formula for PV estimation, which is widespread in the clinic. The comparison between volume measurement of the C SVM-based method and manual delineation of observers A and B yielded a strong correlation (Spearmans rank correlation coefficients ñ of 0.936 [p < 0.001] and 0.859 [p < 0.001], respectively). Comparing the C SVM-based method and the two manual delineations by observers A and B shows an agreement with a mean difference of 3.0 ml (95% confidence interval of -3.1 to +9.2 ml) and 1.9 ml (95% confidence interval of −7.1 to +10.8 ml), respectively. The S SVM-based method and the reference PV (manual delineation of observer A) show excellent correlation (Spearmans rank correlation coefficient ñ = 0.965, p < 0.001), while the ellipsoid formula is less well correlated with the reference PV (Spearmans rank correlation coefficient ñ = 0.873, p < 0.001). The mean difference between S SVM and the reference PV was −0.05 ml (95% confidence interval of −3.8 to +3.7 ml); on the other hand, the mean difference between the ellipsoid formula and the reference PV was much greater, with 8.6 ml (95% confidence interval of +1 to +16.2 ml). The C SVM-based method has considerable potential for integration in epidemiological studies. The prostate volumes obtained by the S SVM-based method agreed excellently with the reference and would be clinically useful for urologists in prostate volumetric analysis.
Type 2 diabetes mellitus is one of the most challenging health problems for the next decades. The impact of type 2 diabetes mellitus on health care systems is largely driven by the increasing prevalence, the management of the disease and subsequent comorbidities, even in people with prediabetes or undiagnosed type 2 diabetes mellitus. An early detection of high risk groups is necessary to identify and modify risk factors such as obesity, physical inactivity or cigarette smoking which showed regional disparities in their distribution within a country. This leads to the assumption that there might be regional disparities regarding the prevalence and incidence of type 2 diabetes mellitus as well. For Germany as for other countries, comparable data on possible regional disparities in the prevalence and incidence of type 2 diabetes mellitus are missing. The aim of the present dissertation is to estimate the prevalence and incidence of type 2 diabetes mellitus on regional level within Germany, and to estimate the smoking prevalence as a modifiable risk factor in individuals with type 2 diabetes mellitus using data from the Diabetes Collaborative Research of Epidemiologic Studies consortium (DIAB CORE) within the Competence Net Diabetes in Germany. Well comparable data of five regional studies and one nationwide reference study are included: the Study of Health in Pomerania (SHIP); the Cardiovascular Disease, Living and Ageing in Halle Study (CARLA); the Dortmund Health Study (DHS); the Heinz Nixdorf Recall Study (HNR); the Cooperative Health Research in the Region of Augsburg Study (KORA); and the German National Health Interview and Examination Survey 1998 (GNHIES 98). First, the prevalence of type 2 diabetes mellitus was estimated. Data from five regional population-based studies and one nationwide study conducted between 1997 and 2006 with participants aged 45 to 74 years were analyzed. Type 2 diabetes mellitus prevalence estimates based on self-reports (standardized to the German population for the regional studies, reference date 2007/12/31) were compared. Of 11,688 participants of the regional studies, 1,008 had a known type 2 diabetes mellitus, corresponding to a prevalence of 8.6% (95% confidence interval [CI] 8.1% 9.1%). The standardized prevalence was highest in the East with 12.0% (95% CI 10.3% 13.7%) and lowest in the South of Germany with 5.8% (95% CI 4.9% 6.7%).Second, the incidence of type 2 diabetes mellitus was estimated. Data from participants (baseline age 45 to 74 years) from five regional population-based studies were included. The incidence rates per 1,000 person-years (95% CI) and the cumulative incidence (95% CI) from regional studies were directly standardized to the German population (reference date 2007/12/31) and weighted by inverse probability weights for losses to follow-up. Of 8,787 participants, 521 (5.9%) developed type 2 diabetes mellitus corresponding to an incidence rate of 11.8 per 1,000 person-years (95% CI 10.8 12.9). The incidence of known type 2 diabetes mellitus showed regional disparities within Germany. The incidence was highest in the East and lowest in the South of Germany with 16.9 (95% CI 13.3 21.8) vs. 9.0 (95% CI 7.4 11.1) per 1,000 person-years, respectively. Third, the smoking prevalence in participants aged 20 to 79 years with type 2 diabetes mellitus in the regional SHIP and the nationwide GNHIES 98 was estimated. Prevalence estimates of cigarette smoking were calculated using weights reflecting the European adult population (reference date 2005/12/31). The overall prevalence of current smoking was lower among participants with type 2 diabetes mellitus than among participants without type 2 diabetes mellitus (17.3% vs. 38.0% in SHIP and 24.7% vs. 32.1% in GNHIES 98). In both studies, the prevalence of current smoking was highest in men aged 20 to 39 years, in particular among men with type 2 diabetes mellitus. To conclude, considerable disparities in prevalence and incidence of type 2 diabetes mellitus indicate the need for interventions on the regional level within Germany. Former smoking was more prevalent among both men and women with type 2 diabetes mellitus in comparison to current and non-smoking. This finding probably reflects behavioural changes secondary to the disease onset and medical counselling. The finding that men aged 20 to 39 years with type 2 diabetes mellitus were more often current smokers than men without type 2 diabetes mellitus underpins the importance of smoking as one of the main modifiable risk factors for type 2 diabetes mellitus.
Context: 3,5-Diiodo-<smlcap>L</smlcap>-thyronine (3,5-T<sub>2</sub>) is a thyroid hormone metabolite which exhibited versatile effects in rodent models, including the prevention of insulin resistance or hepatic steatosis typically forced by a high-fat diet. With respect to euthyroid humans, we recently observed a putative link between serum 3,5-T<sub>2</sub> and glucose but not lipid metabolism. Objective: The aim of the present study was to widely screen the urine metabolome for associations with serum 3,5-T<sub>2</sub> concentrations in healthy individuals. Study Design and Methods: Urine metabolites of 715 euthyroid participants of the population-based Study of Health in Pomerania (SHIP-TREND) were analyzed by <sup>1</sup>H-NMR spectroscopy. Multinomial logistic and multivariate linear regression models were used to detect associations between urine metabolites and serum 3,5-T<sub>2</sub> concentrations. Results: Serum 3,5-T<sub>2</sub> concentrations were positively associated with urinary levels of trigonelline, pyroglutamate, acetone and hippurate. In detail, the odds for intermediate or suppressed serum 3,5-T<sub>2</sub> concentrations doubled owing to a 1-standard deviation (SD) decrease in urine trigonelline levels, or increased by 29-50% in relation to a 1-SD decrease in urine pyroglutamate, acetone and hippurate levels. Conclusion: Our findings in humans confirmed the metabolic effects of circulating 3,5-T<sub>2</sub> on glucose and lipid metabolism, oxidative stress and enhanced drug metabolism as postulated before based on interventional pharmacological studies in rodents. Of note, 3,5-T<sub>2</sub> exhibited a unique urinary metabolic profile distinct from previously published results for the classical thyroid hormones.
Previous studies on the antimicrobial activity of cold atmospheric pressure argon plasma showed varying effects against mecA<sup>+</sup> or mecA<sup>-</sup>Staphylococcus aureus strains. This observation may have important clinical and epidemiological implications. Here, the antibacterial activity of argon plasma was investigated against 78 genetically different S. aureus strains, stratified by mecA, luk-P, agr1-4, or the cell wall capsule polysaccharide types 5 and 8. kINPen09® served as the plasma source for all experiments. On agar plates, mecA<sup>+</sup>luk-P<sup>-</sup>S. aureus strains showed a decreased susceptibility against plasma compared to other S. aureus strains. This study underlines the high complexity of microbial defence against antimicrobial treatment and confirms a previously reported strain-dependent susceptibility of S. aureus to plasma treatment.
Background: The plasminogen activator system plays a key role in ovarian cancer (OC) tumor progression. The plasminogen activator inhibitor type 1 (PAI-1) and the recently identified PAI-1 RNA binding protein 1 (PAI-RBP1) are primary regulators of plasminogen activation and thus are putative biomarkers for OC progression. Methods: One hundred fifty six OC patients were analyzed to identify the presence of PAI-1 and PAI-RBP1 and subsequently correlated to clinicopathological parameters. Primary cells obtained from OC patient samples were applied in fluorescence microscopy analysis for examination of PAI-1 and PAI-RBP1 distribution. Results: PAI-1 and PAI-RBP1 have been found to be predictive markers for OC patients' outcome. PAI-1 levels significantly correlated with volume of ascites, FIGO staging, and lymph node status. PAI-RBP1 expression significantly correlated with age at first diagnosis, histological tumor type, presence of distant metastasis (pM), and recurrence. PAI-1 showed a trend toward association and PAI-RBP1 was significantly associated with progression-free survival. Notably, PAI-1 protein in recurrent OC tissues was exclusively localized in the nucleus. Conclusion: This study has shown that a combination of PAI-1 and PAI-RBP1 may represent novel prognostic factor for OC. Prospective trials are needed.