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B Haastert

Publications and source records attributed to B Haastert.

At least 37 records · Page 2Linked to original sources

Prevalence of functional bowel disorders and related health care seeking: a population-based study.

OBJECTIVES: There are few population-based studies on prevalence of functional bowel disorders (FBD) and related health care seeking. The aim of the present study was to evaluate the prevalence of FBD in a population-based sample and to assess FBD-related health care seeking and medication in Germany. MATERIAL: Cross-sectional study, based on an age- and sex-stratified random sample of 2,400 subjects aged 21-80 years in Düsseldorf, Germany (about 500,000 population). Assessment was performed using a postal written questionnaire. METHODS: Prevalence of gastrointestinal pain or discomfort in the past 12 months was assessed, in particular, lower abdominal pain and irritable bowel syndrome (IBS). Furthermore, health care seeking and medication (prescribed and over-the-counter) due to FBD was assessed. Multiple logistic regression (survey estimated) was performed to evaluate associations of FBD with age, sex, and the socioeconomic status (SES). RESULTS: 1,281 subjects (53.4 %) were analyzed. Standardized prevalences were 22.6 % (95 %-CI: 20.3 - 25.1 %) for lower abdominal pain and 12.5 % (10.7-14.5 %) for IBS. Both lower abdominal pain and IBS were significantly less frequent in the older population compared to younger subjects. No significant differences were found for gender and SES. Among subjects with lower abdominal pain and IBS, 55.1 % and 49.3 % reported health care seeking due to their GI disorders, and 63.9 % and 56.2 % reported use of medication, respectively. CONCLUSIONS: A high prevalence of functional bowel disorders was found in this population-based study in Germany. Only about half of the subjects reported health care seeking due to their bowel disorders. Self-medication with over-the-counter agents was frequently performed.

Adult↗

Health-related quality of life in subjects with functional bowel disorders in Germany.

OBJECTIVES: A low health-related quality of life (HRQL) was reported in subjects with functional bowel disorders (FBD). The aim of the present study was to investigate the association between HRQL and FBD within a three year period in a population-based sample in Germany. DESIGN: A panel-study based on an age- and sex-stratified random sample of subjects aged 21 - 80 years in Düsseldorf, Germany (about 500,000 population). METHODS: The presence of FBD, in particular lower abdominal pain, was assessed annually over a three year period using a postal questionnaire. With the last questionning, HRQL was assessed using the Medical Outcome Short Form (SF36) in 305 subjects responding all three questionnaires (49 % males, mean age (SD) 54 (15) years). HRQL was analyzed based on SF36 scores and component summary scores, adjusted for age and sex using regression models. RESULTS: Twenty-eight percent (28 %; 95 % confidence interval 23 - 33 %) of the respondents reported FBD in at least one year of the study period. HRQL was significantly lower in study subjects with FBD in all scores compared to subjects without any FBD during observation time and compared to the German general population. No significant differences between subjects with persistent and those with intermittent FBD could be evaluated. CONCLUSIONS: Subjects with FBD within a three-year period had impaired HRQL compared to subjects without FBD and the general population in Germany. HRQL seemed to be less impaired than in subjects with IBS from the UK and the US.

Abdominal Pain↗

Hospitalization among diabetic children and adolescents and non-diabetic control subjects: a prospective population-based study.

AIM/HYPOTHESIS: Data comparing the hospitalization of diabetic paediatric patients with the non-diabetic population is scarce. We undertook a population-based incidence study to compare hospitalization in a cohort of Type I diabetic children and adolescents. in Germany, in the first course of treatment after diabetes onset, with hospitalization in non-diabetic control subjects matched for age, sex, and region. METHODS: A total of 373 subjects with newly diagnosed diabetes (onset between 1 and under 15 (<15) years of age in 1996 and 1997; 54% male, mean age at diagnosis 7.6 +/- 3.8 years) and 783 non-diabetic control subjects matched for age, sex, and region were followed for 1 year on average. Hospital admissions and the length of stay (days) were assessed by written questionnaires. Incidence rates of hospitalization and the expected number of hospital days per person-year were estimated for both cohorts. Using Poisson regression, we estimated ratios of hospitalization incidence rates (IRRs) and of expected numbers of hospital days (DRRs) in the diabetic cohort compared to the non-diabetic cohort, adjusting for age, sex and social status. RESULTS: Hospitalization incidence rates and hospital days, expressed per person-year (95%-CI). were 0.34 (0.29-0.39) and 2.36 (2.22-2.50) in the diabetic cohort and 0.07 (0.05-0.09) and 0.29 (0.26-0.33) in the non-diabetic cohort, respectively. Among diabetic subjects, both parameters were associated with higher age and female sex. IRR and DRR (95%-CI) were 4.7 (3.5-6.5) and 7.7 (6.7-8.9). CONCLUSION/INTERPRETATION: In the first year after onset, children and adolescents with diabetes had a 4.7 times higher hospitalization risk and spent 7.7 times more days in hospital than non-diabetic subjects. The ratios were smaller than those in Finland and Denmark in the 1980s, most likely due to differences between health care systems and time trends.

Adolescent↗

Incidence of blindness in southern Germany between 1990 and 1998.

AIMS/HYPOTHESIS: A reduction of diabetes-related blindness by at least one third was declared a primary objective for Europe in 1989 (St. Vincent Declaration). To ascertain a potential change of incidence rates, we collected data on blindness in a German district (population: about 5 million) over 9 years. METHODS: We obtained complete lists of newly registered blindness-allowance recipients between 1990 and 1998 and population data on Württemberg-Hohenzollern, Germany. We estimated incidence rates of blindness in the general population and the diabetic population. To ascertain any time trend, we applied Poisson regression models. RESULTS: There were 6371 newly registered blindness allowance recipients (1990-1998). Of these 67% were women and 27 % had diabetes. Mean age was 71.7 years. Standardised results in the diabetic population (incidence rates per 100,000 person-years; standard: diabetic population; 95 % CI): 1990: 72 (61;82); 1991: 88 (76;100); 1992: 77 (67;88); 1993: 82 (71;93); 1994: 62 (53;72); 1995: 82 (71;93); 1996: 70 (60;80); 1997: 69 (59;79); 1998: 59 (49;68). The Poisson model estimated a 3 % decrease of incident blindness in the diabetic population for each year (Relative risk per year 0.97; CI: 0.95; 0.99). No significant change could be observed in the non-diabetic population (Relative risk: 0.99; CI: 0.98; 1.00). Relative risks for each year varied between sub-groups according to sex, diabetic status and cause of blindness between 0.94 and 1.01. CONCLUSION/INTERPRETATION: A slight reduction of incident blindness could be shown but a reduction by one third has not been reached. Several possible sources of bias in the data have to be considered.

Adult↗

Pertussis in Germany: regional differences in management and vaccination status of hospitalized cases.

The incidence of pertussis requiring hospitalization in children younger than 16 years was estimated by the use of an active surveillance-system. Of special interest were differences between West and East Germany following different vaccination strategies before reunification. In 1997 and 1998, 754 pertussis cases required a total of 11,151 hospital inpatient days. The incidence of hospitalized pertussis was 2.68/100,000 person years and this was significantly higher in East than in West Germany. In East Germany an unusually high percentage of hospitalized cases was found in children aged 6-15 years (45% versus 13% in West Germany). The difference between the regions may be due either to a different perception of the disease or to an increased immunity induced by prior disease or vaccination. In East Germany, pertussis was rare until reunification but it has increased significantly since then. Older children may thus represent a population at risk of pertussis having not had previous exposure to pertussis antigens.

Adolescent↗

Undiagnosed diabetes mellitus and metabolic control assessed by HbA(1c) among residents of nursing homes.

AIMS/HYPOTHESIS: Diabetes prevalence and diabetes care in residents of nursing homes is a neglected area of research although the growing number of elderly people with diabetes represents a growing challenge for health care in most countries. In this study, we used HbA(1c) measurement to estimate the percentage of residents with undiagnosed diabetes and the quality of metabolic control of subjects with known diabetes in nursing homes. METHODS: All 41 nursing homes in the county of Heinsberg in Northrhine-Westfalia were asked to complete a structured questionnaire on the prevalence of known diabetes among all residents. In addition, all residents were offered measurement of glycated haemoglobin A1c (HbA(1c)) from a capillary blood sample. Undiagnosed diabetes was defined by a HbA(1c) level greater than 6.0%. RESULTS: 39 nursing homes participated in the study comprising 99.6% of all residents. Among the 1936 residents 507 (26.2%) were known to suffer from diabetes. Among the latter 37.0% were under insulin treatment. Blood samples for the determination of HbA(1c) were obtained from 979 subjects from 20 nursing homes. Among those 60 years old or above (n = 843) the mean level of HbA(1c) in those with known diabetes was 7.3 +/- 1.5% and in those without 6.1 +/- 0.9%. Only 16.7% of the subjects with known diabetes had a HbA(1c) greater than 8.5% indicating poor metabolic control. Among the residents previously not known to have diabetes 47.2% had a HbA(1c) equal to or greater than 6.1%, but among those only 8.5% had a HbA(1c) greater than 7.0%. CONCLUSIONS/INTERPRETATION: Although the prevalence of undiagnosed diabetes mellitus defined by HbA(1c) above the normal range in elderly nursing home residents is high, only few may require treatment. The quality of metabolic control among those with known diabetes mellitus is better than expected.

Aged↗

Low fecal elastase-1 in type I diabetes mellitus.

BACKGROUND: Previous studies suggested impaired pancreatic exocrine function in type I diabetes patients, but have been limited by small or highly selected samples. Fecal elastase-1 has facilitated evaluation of pancreatic dysfunction in population-based studies. METHODS: 112 type I diabetic patients (age +/- SD: 37 +/- 11 years; 47 % males; diabetes duration: 12.5 +/- 10.5 years) were consecutively selected from main regional diabetes centers in Essen, West-Germany. 116 non-diabetic control subjects, similar with respect to age and sex, were recruited from the same geographical region. Elastase-1 measurement was performed centrally by ELISA (ScheboTech, Germany). RESULTS: Elastase-1 concentrations in type I diabetic patients were significantly lower than in control subjects (median; inter-quartile range: diabetic patients: 227, 98-386 microgram/g stool; non-diabetic subjects: 544, 377-702 microgram/g stool) (p < 0.01). Elastase-1 < 100 microgram/g stool (E1 < 100) was found in 25.9 % of diabetic and 5.2 % of non-diabetic subjects, yielding an age-sex-adjusted prevalence Odds ratio (POR; 95 % CI) for diabetes and E1 < 100 of 6.9 (2.8-19.6). After adjusting for potential confounders (history of gastrointestinal diseases, smoking, alcohol consumption) the strong association remained (POR: 6.7; 2.7-19.2). Among patients with diabetes, E1 < 100 was associated with quality of glycemic control (HbA1c, change per 1 %: POR 1.5; 1.1-2.0), diabetes duration (per year: POR 1.1; 1.03-1.2), and age at diabetes onset (per age year: POR 1.1; 1.02-1.1). No association was found with history of gastrointestinal diseases, smoking, or alcohol consumption (current, life-time). CONCLUSIONS: Fecal elastase-1 concentrations were lower in type I diabetes patients compared to control subjects, indicating impaired pancreatic exocrine function. Low elastase-1 was associated with poor metabolic control and longer diabetes duration.

Adult↗

Low faecal elastase 1 concentrations in type 2 diabetes mellitus.

BACKGROUND: Previous studies have suggested an association between impaired pancreatic exocrine function and diabetes, but the evidence is weak because the invasive nature of the tests used to define exocrine function has led to small studies on selected patients. The availability of faecal elastase 1 as a non-invasive test has aided the detection of impaired exocrine function in population studies. We describe the association between levels of faecal elastase 1 and Type 2 diabetes. METHODS: 544 Type 2 diabetic patients (age: 63 +/- 8 years) were randomly selected from local diabetes registers in Cambridgeshire, UK and individually matched for age, sex and practice to 544 controls in whom diabetes was excluded by HbA1c measurement. RESULTS: Faecal elastase 1 concentrations were significantly lower in cases than controls (median: cases 308 microg/g; controls 418 microg/g; P < 0.01). Low levels of faecal elastase 1 (< 100 microg/g) were found in 11.9% of cases and 3.7% of controls (age-sex-adjusted odds ratio; 95% CI: 3.6; 2.2-6.2). After adjustment for potential confounding factors, the OR was 4.5 (2.6-8.3). Among patients with diabetes, poor glycaemic control (HbA1c > or = 7%) was associated with a higher risk of low elastase 1 level (OR 5.6; 1.5-37). No significant association was found with diabetes duration, peripheral neuropathy, alcohol intake, or prior gastrointestinal diseases. CONCLUSIONS: Faecal elastase 1 concentrations are lower in Type 2 diabetic patients than in non-diabetic controls, suggesting the co-existence of diabetes and impaired pancreatic exocrine function. Among the diabetic patients, the risk of having low elastase 1 levels was associated with glycaemic control.

Aged↗

Unchanged incidence of lower-limb amputations in a German City, 1990-1998.

OBJECTIVE: A reduction of diabetes-related amputations by at least one-half within 5 years was declared a primary objective for Europe (St. Vincent Declaration, 1989). We collected data about incidence rates of amputations in one German city (Leverkusen, with a population of approximately 160,000 inhabitants) between 1990 and 1998 to ascertain a potential change in rates of incidence. RESEARCH DESIGN AND METHODS: From all three hospitals in Leverkusen, we obtained complete lists of lower-limb amputations. From each patient record, diabetic status was determined. Only the first observed amputation was counted for the analysis. We estimated incidence rates of amputations in the entire population, the diabetic population, and the nondiabetic population. To test for time trend, we fitted Poisson regression models, adjusting for age and sex. RESULTS: During, the defined period (the years 1990, 1991, and 1994-1998), 339 patients (all residents of Leverkusen) without previous amputations had nontraumatic lower-limb amputations. Of all subjects. 46% were female. Moreover, 76% of the subjects were known to have diabetes. Mean age was 71.3 years. Incidence rates in the diabetic population (standardized to the estimated German diabetic population, per 100,000 person-years) were as follows: 1990, 549; 1991, 356; 1994, 544; 1995, 386; 1996, 426; 1997, 433; and 1998, 463. The Poisson models showed no significant change of incident amputations over time in the diabetic population or in the nondiabetic population. CONCLUSIONS: Beyond random variation, no change of incidence rates could be observed over the past 9 years. More specific interventions are needed to achieve a substantial reduction of diabetes-related amputations.

Adolescent↗

[Management of diabetic patients in inpatient nursing care facilities in the Heinsberg district].

BACKGROUND AND OBJECTIVE: Little information is available on the diabetes management of elderly people under institutional care. It was therefore aim of this study to assess the quality of diabetes care in this patient group. PATIENTS AND METHODS: In the county of Heinsberg, North Rhine-Westphalia, after agreement in the local public health conference, all 41 nursing homes were addressed and asked to fill out a structured, detailed questionnaire. Thirty-nine institutions participated in the study representing 99.6% of all patients under such care. RESULTS: Out of the 1936 residents 507 had known diabetes mellitus (prevalence 26.2%) with an age-dependent decrease. 37.0% of the diabetic subjects were treated with insulin, 46.7% received oral hypoglycemic agents. Advanced late complications were reported in a minority of patients (3.4% amputations, 13.6% blindness or severe visual impairment, 1.0% hemodialysis). In the majority of patients, the metabolic control was assessed by blood glucose measurement, but only in low frequency. Eye examination within the previous 12 months was reported for only 50.0% of the diabetic subjects. Although the diabetics were frequently seen by their doctors (48.1% > 2 consultations/month, 48.7% with 1 to 2 consultations/month), 30.8% had at least 1 hospital stay during the previous 12 months. Among the 834 nurses with the full dataset only 4 had a special training in diabetology. CONCLUSION: The results of this study indicate that the diabetes management of patients living in nursing homes only partially fulfills the current requirements for diabetes care. There appears to be a particular need to improve the nurses training in diabetes as well as the communication between nursing homes and doctors.

Aged↗

[Care of elderly diabetics by ambulatory nursing in the Heinsberg region].

OBJECTIVE: The number of elderly people with chronic diseases receiving ambulant nursing care in the German population is continually increasing. However, little information is available on the quality of care of elderly diabetic patients. The aim of this study was to investigate the pattern of care provided for this group by such ambulatory nursing services. PATIENTS AND METHODS: All ambulant nursing services in the county of Heinsberg, North-Rhine-Westphalia, were contacted and asked to answer a standardized questionnaire. 23 of the 24 services participated in the study and provided suitable answers. The study was conducted between October 1998 and March 1999. RESULTS: All services together took care of 337 persons with known diabetes mellitus, of whom 79.6% were female and 20.4% were male. The total diabetes prevalence among all patients was 27.2%. 231 diabetic persons (68.5%) were treated with insulin. Nurses administered insulin to 84.8% of the patients. As expected many diabetics had severe late complications (7.4% amputation, 20.8% blindness, 4.2% renal failure). In the majority of patients, blood glucose was monitored, but only occasionally, whereas urinary glucose was checked in only a few cases. Foot inspection and care were provided regularly. 115 diabetics (34.1%) had at least one hospital stay during the previous 12-months period. CONCLUSION: The results of this study indicate that ambulatory nursing services care mainly for insulin-treated diabetic patients in late stages of the disease. The current organisational structure not meet the requirements of modern diabetes management.

Aged↗

[Drug prescriptions and costs in diabetic polyneuropathy].

BACKGROUND AND OBJECTIVE: Numerous medications are used in the treatment of diabetic polyneuropathy (PNP) without evidence of their efficacy. This study was undertaken to obtain the costs of drugs prescribed to patients with PNP throughout the Federal Republic of Germany in primary-care practices. PATIENTS AND METHODS: Data (stored in the Medi-Plus data bank of the Institute for Medical Statistics, Frankfurt) from 400 primary-care practices were analysed for the year 1996 with regard to diagnoses and prescriptions for 40,112 diabetics over the age of > or = 20 years. A polyneuropathy (PNP) had been diagnosed in 3548 patients (8.8%) (age: 68 +/- 12 years, 56% women). The cost of medications listed for the treatment of PNP was identified and extrapolated to the total prescription cost for treated diabetic PNP in the whole of Germany. In addition the proportion of costs for drugs with unproven efficacy was calculated. RESULTS: Antidepressives were prescribed for 13%, carbamazepine for 4%, and lipoic (thioctic) acid for 41% of diabetics with PNP. Annual costs per patient (mean value) were DM 203 for lipoic acid, DM 53 for vasoactive drugs and DM 42 for analgesics. Projection for the estimated total number of diabetic patients with PNP treated in primary care practices (n = 361,400) gave a total cost of DM 116 million (95% confidence limit: DM 109-123), of which DM 41 million (35%) was for medications of unproven efficacy. CONCLUSION: In Germany one third of drug costs for diabetic patients with PNP in primary care is for medications of unproven efficacy. Cost-effective guidelines for the treatment of diabetic PNP are urgently required.

Aged↗

Venous incompetence in erectile dysfunction: evaluation with color-coded duplex sonography and cavernosometry/-graphy.

The purpose of this study was to assess the accuracy of multi-parameter measurements with color-coded duplex sonography (CCDS) for the diagnosis of venous leakage in patients with erectile dysfunction. Sixty patients with repeated unsatisfactory reactions after intracavernous injection of vasoactive substances underwent CCDS. Following intracavernous injection of prostaglandin E1, peak systolic velocity (PSV), enddiastolic velocity (EDV), time averaged velocity (TAV), resistance index (RI), and pulsatility index (PI) were measured in the cavernous arteries over 30 min (one measurement per minute). The results were compared with independent measurements based on dynamic pharmaco-cavernosometry/cavernosography (DPCC). Dynamic pharmaco-cavernosometry/cavernosography revealed venous leakage in 33 patients. Of 48 patients with normal PSV ( > 25 cm/s), 25 had veno-occlusive dysfunction and the remainder presented normal venous function. No statistically significant differences between these groups were found in EDV, RI, and PI measurements. In contrast, differences in TAV were significant between patients with (mean 9.4 +/- 4.6 cm/s) and without venous leakage (mean 5.5 +/- 2.2 cm/s; p = 0.001). Analysis of relative frequencies revealed a broad overlap of EDV, TAV, RI, and PI measurements between both groups. Sensitivities and specificities determined from receiver-operating-characteristic curves were > 80 % and > 50% for a TAV threshold of 5 cm/s, and an RI threshold of 1.0. Measurements of EDV, TAV, RI, and PI in patients with repeated unsatisfactory reactions on intracavernous prostaglandin injection are poor predictors of venous leakage and should not replace DPCC in the investigation of vasculogenic impotence.

Adult↗

Cardiovascular drug prescriptions and risk of depression in diabetic patients.

Our aim was to investigate the association of calcium channel blocker (CCB), beta-blocker, and ACE inhibitor medications with the risk of depression in diabetic patients. A case-control study was performed using an automated database (MediPlus, IMS) of 400 primary care practices in Germany including 972 diabetic cases with newly diagnosed depression in 1996 (index date) and 972 diabetic controls, matched for age, sex, and index date. The odds ratios (95%-confidence intervals) for depression, adjusted for type of practice, number of visits and prescriptions, hospitalization, cardiovascular diagnoses, and renal failure, were 2.2 (95% CI: 1.2-4.2) for exposure to CCB 6 months prior to index date, 2.6 (95% CI: 1.1-7.0) for beta-blockers, and 1.3 (95% CI: 0.8-2.2) for ACE inhibitors, respectively. Adjusted odds ratio for CCB (4.3; 95% CI: 1.7-13.5) and beta-blockers (4.5; 95% CI: 1.2-29.5) were higher with daily dosages above the median. Prescriptions of CCB and beta-blockers among diabetic patients may increase the risk of depression. Because this association may alternatively be explained by cardiovascular comorbidity, further studies will be necessary to investigate the link between these cardiovascular medications and depression.

Adrenergic beta-Antagonists↗

Postmarketing surveillance of adverse drug reactions: a correlational study approach using multiple data sources.

The authors performed a correlational study on nationwide spontaneous adverse drug reaction (ADR) reports related to the antioxidant thioctic acid (Thioctacid; ASTA Medica) in Germany from April 1992 to March 1995. Thioctacid was predominantly utilized by general practitioners and internists for treatment of diabetic neuropathy. The total number of treated patients was estimated using a nationwide drug prescription database (MediPlus, IMS: 362 general practitioners and internists) and pharmacy drug sales data. All Thioctacid prescriptions in MediPlus were assessed and the mean cumulative dosage/patient/year was calculated. Then, the total number of Thioctacid patients in Germany was estimated: N=nationwide pharmacy sales (kg)/mean cumulative dosage/patient (kg). From April 1992 to March 1995, 78 patients with 112 ADRs were notified on spontaneous reports. There was a decreasing number of ADR reports per year (32 to 21 patients/year). In parallel, the estimated total numbers of treated patients/year also decreased from 426,658 to 304,155 (p<0.05). Poisson regression models were fitted including incident cases with ADR and the number of patients per year for each of the 3 years. No significant secular trend of ADR (p=0.91) and no impact of mean cumulative dosages was observed in the models. There were also no changes in the pattern of ADR (e.g. skin reactions, gastrointestinal complaints). This study suggests that a combination of spontaneous reporting systems with prescription drug databases and pharmacy sales data may be a useful tool to perform rapid postmarketing monitoring of ADR.

Journal Article↗

Plasma concentrations of soluble TNF-alpha receptors in obese subjects.

BACKGROUND: Recent studies show an increased adipose production of tumor necrosis factor-alpha (TNF-alpha) in human obesity. It was hypothesized from this finding and other data, that TNF-alpha may be a mediator of obesity-linked insulin resistance. OBJECTIVE: The aim of this study was to measure plasma concentrations of the two soluble TNF-alpha receptors, together with those of TNF-alpha in subjects with severe obesity with and without type 2 diabetes mellitus, in comparison to a lean control group, to examine whether plasma concentrations reflect an up-regulation of the TNF system in adipose tissue. PATIENTS AND METHODS: Plasma concentrations of the two soluble TNF-alpha receptors were measured in 49 obese subjects (mean body mass index (BMI): 44.9 kg/m2, 95% confidence intervals (CI) 42.3-47.5 kg/m2, including 19 type 2 diabetic individuals) and 28 lean controls, by using a highly sensitive enzyme-linked immunoassay (ELISA) technique. TNF-alpha concentrations were determined in 28 obese (10 with diabetes) and 23 lean subjects. RESULTS: The obese subjects showed significantly higher plasma concentrations of the soluble p60 and p80 TNF receptor, respectively, compared to the lean control group, independent of the presence of diabetes. Multiple regression analysis, with the p80 TNF receptor as dependent variable, revealed that BMI and log insulin significantly affected the plasma concentration of this soluble receptor subtype, explaining 46% of the variance, whereas for the p60 TNF receptor, only BMI turned out to influence plasma concentrations. TNF-alpha plasma concentrations were not different between the three groups (Kruskal-Wallis test: P=0.34), but due to the low power of the test, an effect of obesity on TNF-alpha is not excluded. CONCLUSION: These data indicate that plasma concentrations of both soluble TNF receptors are elevated in obesity and insulin resistance, possibly as a function of excess body fat. The reported adipose overexpression of TNF-alpha does not seem to be reflected by elevated plasma concentrations, suggesting a primarily local role of the cytokine.

Adult↗

Long-term experience with an ultrapure individual dialysis fluid with a batch type machine.

BACKGROUND: This paper discusses long-term experience with a specific type of dialysis equipment which has been used more than 15 years without variation. The system was designed to allow easy individualization of dialysis fluid composition and to deliver dialysate of the highest hygienic quality. METHODS: Data from 399 patients covering the period from 1971 onwards were analysed retrospectively. Survival probabilities were estimated by the Kaplan-Meier method and the median number of days in hospital was calculated. Additional data collected from patient subgroups included serum albumin level, erythropoietin requirement and antihypertensive treatments. Kt/V and PCR from one subgroup were computed using the formulae of Daugirdas and Depner. RESULTS: The estimated survival probability after 5 years for all patients was 59.1% (95% CI: 52.6-65.6%). The main risk factors from the available covariables were age and IDDM. The cumulative incidence of carpal tunnel syndrome after 10 years of dialysis was estimated as 7% (95% CI: 0-14%). Data from the subgroups revealed that 82% of the patients had serum albumin levels >4.0 g/dl, 65% of the patients received no antihypertensive drugs and 39% received erythropoietin (37 +/- 28 units/kg bw/week) to correct dialysis anaemia (haemoglobin level = 98 +/- 8 g/l). Average Kt/V was 1.21 +/- 0.17, PCR was 1.10 +/- 0.22 g/kg/day. CONCLUSIONS: The setup described permits individualized therapy of high quality. The high serum albumin values and our very low incidence of carpal tunnel syndrome underline the importance of water and dialysate quality.

Adult↗

The Deutsche Nicotinamide Intervention Study: an attempt to prevent type 1 diabetes. DENIS Group.

On the basis of the positive outcome of animal experiments, several large placebo-controlled trials are underway and aiming for the first time at the prevention of an immune-mediated disease, type 1 diabetes. The first of these trials, The Deutsche Nicotinamide Intervention Study (DENIS), evaluated the clinical efficacy of high doses of nicotinamide in children at high risk for IDDM. Nicotinamide has been shown to protect beta-cells from inflammatory insults and to improve residual beta-cell function in patients after onset of IDDM. Individuals at high risk for developing IDDM within 3 years were identified by screening the siblings (age 3-12 years) of patients with IDDM for the presence of high titer (> or =20 Juvenile Diabetes Foundation [JDF] U) islet cell antibodies. Probands (n = 55) were randomized into placebo and nicotinamide (slow release, 1.2 g x m(-2) x day(-1)) receiving groups and followed prospectively in a controlled clinical trial using a sequential design. Rates of diabetes onset were similar in both groups throughout the observation period (maximum 3.8 years, median 2.1 years). This sequential design provides a 10% probability of a type II error against a reduction of the cumulative diabetes incidence at 3 years from 30 to 6% by nicotinamide. The trial was terminated when the second sequential interim analysis after the eleventh case of diabetes showed that the trial had failed to detect a reduction of the cumulative diabetes incidence at 3 years from 30 to 6% (P = 0.97). The group receiving nicotinamide exhibited decreased first-phase insulin secretion in response to intravenous glucose (P = 0.03). No other side effects were observed. We conclude that in this subgroup of diabetes-prone individuals at very high risk and with an assumed rapid disease progression, nicotinamide treatment did not cause a major decrease or delay of diabetes development. However, the data do not exclude the possibility of a less strong, but potentially meaningful, risk reduction in this cohort, or a major clinical effect of nicotinamide in individuals with less risk of progression to IDDM than studied here.

Austria↗