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Biomedical subjects

I Mühlhauser

Publications and source records attributed to I Mühlhauser.

At least 37 records · Page 2Linked to original sources
PubMed1999

Effects of intensified antihypertensive treatment in diabetic nephropathy: mortality and morbidity results of a prospective controlled 10-year study.

OBJECTIVE: The aim of this study was to describe the effect of intensified antihypertensive therapy based on a structured teaching and treatment programme on the prognosis of hypertensive type 1 (insulin-dependent) diabetic patients with kidney disease. DESIGN: The study was a controlled, prospective, parallel, 10-year follow-up trial. PATIENTS AND INTERVENTIONS: A sequential sample of 91 hypertensive type 1 diabetic patients with overt diabetic nephropathy was prospectively followed for 10 years. Forty-five patients (intensified antihypertensive therapy; IT group) participated in an intensified antihypertensive therapy programme and 46 patients received routine antihypertensive treatment as provided by family physicians, consultants and local hospitals (routine antihypertensive therapy; RT group). OUTCOME MEASURES: The main endpoint was death; secondary endpoints were renal replacement therapy, blindness and amputation. RESULTS: Blood pressure was reduced in the IT group and increased in the RT group. During the follow-up period, 29 patients died, seven in the IT group and 22 in the RT group. The survival curves were significantly different (P = 0.0008). The main causes of death were cardiac. In a multiple Cox proportional hazards model, allocation to the IT group reduced the mortality risk [relative risk (RR) = 0.213; 95% confidence interval 0.089-0.509, P = 0.00051, while age (P = 0.0039) and mean blood pressure (P= 0.0113) increased this risk. In multiple Cox or multiple logistic regression models, the risks of dialysis (RR = 0.269, 95% confidence interval 0.110-0.656, P = 0.0039), blindness (odds ratio = 0.158, 95% confidence interval 0.037-0.684, P= 0.0136), and amputation (RR = 0.181, 95% confidence interval 0.047-0.703, P= 0.0135) were significantly lower in the IT group compared with the RT group (log rank P = 0.0008). CONCLUSION: We conclude that intensified antihypertensive treatment, based on a hypertension teaching and treatment programme, reduces long-term morbidity and mortality in patients with diabetic nephropathy.

Adult↗
PubMed1999

Intensified treatment and education of type 1 diabetes as clinical routine. A nationwide quality-circle experience in Germany. ASD (the Working Group on Structured Diabetes Therapy of the German Diabetes Association).

This contribution describes the nationwide implementation of an intensive treatment and education program for type 1 diabetic patients in the clinical routine of the German health care system. Based on the formation of a working group (Arbeitsgemeinschaft Strukturierte Diabetestherapie [ASD]) of presently 57 general internal medicine departments, mainly from secondary and tertiary care levels in city and country hospitals throughout the country, a peer-review quality circle was formed as an official working group of the German Diabetes Association. The participating institutions performed a structured program of intensive treatment and education in all type 1 diabetic patients referred to them on a routine basis. The program includes multiple daily insulin injections or continuous subcutaneous insulin infusion, several times daily blood glucose self-monitoring and self-adaptation of insulin dosages and other aspects of treatment by the patients, and a far-reaching liberalization of the nutrition regimen. The group has attempted to document and to improve the quality of the structure and process of type 1 diabetes care in its participating institutions by a system of peer supervision. Furthermore, all member institutions volunteered to collect outcome data based on systematic 1-1.3 years' follow-up examinations of consecutive type 1 diabetic patients. For the 1997 evaluation of 1,103 type 1 diabetic patients, significant decreases of GHb levels and of incidence rates of severe hypoglycemia (from 0.35 to 0.16 cases per patient-year) and ketoacidosis (from 0.08 to 0.02 cases per patient-year) are presented. The ASD quality circle represents a model to improve principal aspects of type 1 diabetes care on a nationwide basis.

Cohort Studies↗
PubMed1999

Rationale for the use of insulin therapy alone as the pharmacological treatment of type 2 diabetes.

Before any treatment of type 2 diabetes in accordance with the principles of evidence-based medicine can be generally recommended, the considerable disease heterogeneity must be taken into account, and randomized controlled intervention trials directed to cardiovascular and microangiopathic organ damage end points must be performed for the various subgroups of patients. Until then, it appears prudent to treat the typical Caucasian type 2 diabetic patient primarily by nondrug therapies, and if they fail to achieve the patient's individual treatment goals, then insulin treatment should be initiated. Treatment of type 2 diabetic patients with insulin alone, aimed at the patient's individual therapeutic goals, is effective and safe when conducted as an integral part of specific and structured treatment and teaching programs. Insulin treatment can be safely used to achieve near-normal HbA1c levels (< 7.0-7.5%) if prevention of diabetic microangiopathy is indicated, or to maintain HbA1c levels < 8.5-9.0% if catabolic symptoms due to insulin deficiency are to be prevented.

Demography↗
PubMed1999

[Amputations and mortality in elderly insulin-treated patients with type 2 diabetes].

The diabetic foot syndrome has a strong impact on the morbidity of elderly patients with type 2 diabetes, since diabetics have a 22-fold higher amputation rate. The aim of this study was to conduct a prospective evaluation of elderly insulin-treated patients with type 2 diabetes, giving special consideration to the diabetic foot syndrome. 94 consecutively admitted patients (mean age 68 years; mean diabetes duration 13 years) were re-evaluated 2, 5 and 10 years after participation in a 5-day insulin treatment and teaching programme for patients with type 2 diabetes. During the 10-year follow-up period 60 (64%) patients had died. Of the remaining 34 patients 33 were evaluated personally or by phone. All patients still alive had no acute foot complications and no amputations during the 10-year follow-up period. In these patients an acceptable level of metabolic control and acute metabolic decompensations was found. However, in 55 deceased patients (no data were available for 5 patients) 20 above-knee amputations (1 patient on both legs) and 2 fore-foot amputations were performed. This shows that severe complications as amputations associated with high mortality will be grossly underestimated, unless deceased patients are included in follow-up studies. An improved care for the feet of elderly insulin-treated patients is needed.

Aged↗
PubMed1998

Social status and the quality of care for adult people with type I (insulin-dependent) diabetes mellitus--a population-based study.

UNLABELLED: The objective of this study was to assess the degree of diabetes care and education achieved for Type I (insulin-dependent) diabetes mellitus at the community level in relation to social status and to elucidate potential pathways that mediate any social class gradient. A population-based sample of 684 adults with Type I diabetes (41% women, mean +/- SD age 36 +/- 11, diabetes duration 18 +/- 11 years) in the district of North-Rhine (9.5 million inhabitants), Germany, were examined in their homes using a mobile ambulance. RESULTS: HbA1c (normal 4.3-6.1%) 8.0 +/- 1.5%, incidence of severe hypoglycaemia (injection of glucose or glucagon) 0.21 cases per patient-year; 62% of patients had participated in a structured group treatment and teaching programme for intensification of insulin therapy; 70% used 3 or more insulin injections per day, 9% were on continuous subcutaneous insulin infusion; 91% reported to have had measurements of HbA1c during the preceding year, and 80% to have had an examination of the retina by an ophthalmologist. Care was insufficient with respect to the quality of blood pressure control (70% of patients on antihypertensive drugs had blood pressure values > or = 160/95 mmHg), patient awareness of proteinuria/albuminuria (27% of patients had not heard about it) and prevention of foot complications (only 42% with a diabetes duration over 10 years had remembered to have a foot examination during the preceding 12 months). There was a pronounced social gradient with respect to micro- and macrovascular complications (prevalence of overt nephropathy 7 vs 20% for highest vs lowest quintiles of social class [OR 3.5, 95% CI 1.6-7.5, p = 0.002]) and diabetes-specific quality of life. HbA1c, blood pressure and smoking accounted for part of the association between social class and microvascular complications. The social class gradient was not due to inequality to access to health services, but to lower acceptance among low social class patients of preventive and health maintaining behaviour. In conclusion, achieved standards of care are high with respect to the implementation of intensified treatment regimens, the level of patient education achieved, treatment control and eye care, whereas areas for improvement are blood pressure control and preventive measures for foot care. A substantial social gradient in diabetes care persists despite equal access of patients to health services.

Adolescent↗
PubMed1998

Risk factors of severe hypoglycaemia in adult patients with Type I diabetes--a prospective population based study.

The objective of this study was to identify possible risk factors of severe hypoglycaemia (SH) in a prospective population based study of adult Type I (insulin-dependent) diabetic patients. A representative sample of 684 patients (41% women, mean +/- SD age 36 +/- 11, diabetes duration 18 +/- 11 years), living in the district of Northrhine (9.5 million inhabitants), Germany, were examined in their homes using a mobile ambulance. A comprehensive baseline assessment of possible predictors of SH included sociodemographic and disease related variables, hypoglycaemia awareness, diabetes management, and attitudes and behavioural aspects as expressed by the patients. After a mean of 19 +/- 6 months 669 (98%) patients were interviewed about events of SH since the baseline examination. Using the multiple Cox proportional hazards model, five risk factors of SH were identified: SH during the preceding year [hazard ratio (HR) 2.7, 95% confidence intervals (CI) 1.8-4.2], any history of SH (HR 1.9, CI 1.1-3.4), C-peptide negativity (HR 4.0, CI 1.2-12.7), social status (HR 0.8 for a difference of 5 units for a value range of 0-24, CI 0.6-0.9), and patients' determination to reach normoglycaemia (HR 0.7 for a difference of 1 unit for a value range of 1-6, CI 0.5-0.9), indicating that the lower the social status and the higher the patients' determination to reach normoglycaemia, the higher the risk of SH. After eliminating the history of hypoglycaemia from the model, impaired hypoglycaemia awareness and patients' inappropriate denial of SH as their particular problem became additional significant risk factors of SH. In conclusion, in this population based study of adult Type I diabetic patients, C-peptide negativity, a previous event of SH, patients' determination to reach normoglycaemia and social class were risk factors of SH.

Adult↗
PubMed1998

Validation of a diabetes-specific quality-of-life scale for patients with type 1 diabetes.

OBJECTIVE: To validate a diabetes-specific quality-of-life scale and to assess its psychometric properties in a large sample of patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: To assess the quality of diabetes care in a population-based study, a representative sample of 684 patients with type 1 diabetes was examined. A total of 657 patients (42% female; mean age 36 years; mean diabetes duration 18 years) completed the diabetes-specific quality-of-life scale (DSQOLS), which comprised 64 items on individual treatment goals (10 items), satisfaction with treatment success (10 items), and diabetes-related distress (44 items). Statistical examinations covered factor analysis, internal consistency of subscales, and construct and discriminant validity. RESULTS: Factor analysis of the 44 items on diabetes-specific burdens revealed six reliable components (Cronbach's alpha): social relations (0.88), physical complaints (0.84), worries about future (0.84), leisure time flexibility (0.85), diet restrictions (0.71), and daily hassles (0.70). All six subscales were significantly correlated with a validated well-being scale (r = -0.35 to -0.53, P < 0.001) and treatment satisfaction (r = 0.28 to 0.43, P < 0.001). Physical complaints (r = 0.24) and worries about future (r = 0.17) showed the highest correlations with HbA1c (P < 0.001). A flexible insulin therapy, a liberalized diet, the absence of late complications, and a higher social status were significantly associated with more favorable scores in different domains. CONCLUSIONS: The DSQOLS is a reliable and valid measure of diabetes-specific quality of life. The scale is able to distinguish between patients with different treatment and dietary regimens and to detect social inequities. Use of the DSQOLS for assessment of individual treatment goals as defined by the patients may be helpful to identify motivational deficits and to tailor individual treatment strategies.

Adult↗
PubMed1997

Intensified insulin therapy and the risk of severe hypoglycaemia.

The objectives of the present analyses were to assess the association between HbA1c levels and severe hypoglycaemia (SH, treatment with glucose i.v. or glucagon injection) and to identify predictors of SH in a prospective multicentre trial. The study population consisted of 636 insulin-dependent diabetic patients who had participated in a structured 5-day in-patient group treatment and teaching programme for intensification of insulin therapy (ITTP) in one of 10 hospitals and who were re-examined after 1, 2, 3, and 6 years including assessment of demographic, disease and treatment related parameters, diabetes-related knowledge, behaviour, and emotional coping. At baseline, age (mean +/- SD) was 27 +/- 7 years, diabetes duration 9 +/- 7 years and HbA1c 8.3 +/- 1.9 %. During the 6-year follow-up, the mean HbA1c value improved to 7.6%, and in patients with a diabetes duration of more than 1 year at entry into the study (n = 538) the incidence of SH decreased from 0.28 cases/patient/year during the year preceding the ITTP to 0.17 cases/patient/year. The patient group was divided into decile groups according to mean follow-up HbA1c values. In each group more than 230 patient years could be analysed. Groups with mean HbA1c values of 5.7, 7.0, 7.4, 7.7 and 8.9% had comparable risks of SH (0.15-0.19 cases/patient/year). In a logistic regression analysis, mean HbA1c during follow-up, a history of SH during the year preceding the ITTP, C-peptide level, emotional coping, carrying emergency carbohydrates (as assessed at the 1-year follow-up), and age at onset of diabetes were significant independent predictors of SH. The incidence of SH between centres varied between 0.05 and 0.27 cases/patient/year. In conclusion, in the present analyses no linear or exponential relationship between HbA1c and severe hypoglycaemia could be identified by using simple group comparisons. Applying complex regression analyses, various patient-related predictors of severe hypoglycaemia were identified.

Adult↗
PubMed1996

Cigarette smoking and progression of retinopathy and nephropathy in type 1 diabetes.

The objective of the present study was to analyse the association between cigarette smoking and progression of retinopathy and nephropathy, respectively, in a prospective multicentre study including 636 people with Type 1 diabetes: 81% of the original cohort of consecutively referred patients, aged 15 to 40 years and free of severe late diabetic complications. At baseline, all patients had participated in a 5-day in-patient group treatment and teaching programme for intensification of insulin therapy. Patients were examined at recruitment, and after 1, 2, 3 and 6 years including assessment of smoking status, blood pressure, metabolic control, and degree of nephropathy. Degree of retinopathy was assessed by ophthalmoscopy or fundus photography at baseline and after 6 years. Several logistic regression analyses were performed by describing the responses retinopathy and nephropathy, respectively, either as progression yes/no or as actual status at the 6-year follow-up and by using different measures for smoking. Adjustments for important covariables were made. While significant associations between smoking, and retinopathy and nephropathy respectively, were found, the relations were variable depending on the statistical model used. The results show that the real associations between smoking and retinopathy and nephropathy are complex and that more emphasis should be put on the complete description of the response variables and the statistical models used in clinical and epidemiological research.

Adult↗
PubMed1996

Effects of dietary sodium on blood pressure in IDDM patients with nephropathy.

The objectives of the study were to assess the effects of moderate sodium restriction on blood pressure in insulin-dependent diabetic (IDDM) patients with nephropathy and high normal or mildly hypertensive blood pressure (primary objective), and to document possible associated changes of exchangeable body sodium, body volumes, components of the renin-angiotensin-aldosterone system, atrial natriuretic peptide, and catecholamines (secondary objective). Sixteen patients with untreated systolic blood pressure > or = 140 < 160 mmHg and/or diastolic blood pressure > or = 85 < 100 mmHg were included in a double-blind, randomized, placebo-controlled trial. After a 4-week run-in period on their usual diet and a 2-week dietary training period to reduce sodium intake to about 90 mmol/day, eight patients received 100 mmol/day sodium supplement (group 2) and eight patients a matching placebo (group 1) for 4 weeks while continuing on the reduced-sodium diet. Patients were examined at weekly intervals. Main response variables were mean values of supine and sitting systolic and diastolic blood pressure as measured in the clinic and by the patients at home. The differences in blood pressure between the beginning and the end of the blinded 4-week study period were calculated and the differences in changes between the two patient groups were regarded as the main outcome parameters. During the blinded 4-week study period, average urinary sodium excretion was 92 +/- 33 (mean +/- SD) mmol/day in group 1 and 199 +/- 52 mmol/day in group 2 (p = 0.0002). The differences in blood pressure changes between the two patient groups were 3.9(-1.2 to 9) mmHg [mean (95% confidence intervals)] for systolic home blood pressure, 0.9(-3.7 to 5.5) mmHg for diastolic home blood pressure, 4.9(-3.3 to 13.1) mmHg for clinic systolic blood pressure and 5.3(1 to 9.7 mmHg, p = 0.02) for clinic diastolic blood pressure. Combining all patients, there were relevant associations between changes of urinary sodium excretion and blood volume (Spearman correlation coefficient r = 0.57), blood pressure and angiotensin II (diastolic: r = -0.7; systolic: r = -0.48), and exchangeable body sodium and renin activity (r = -0.5). In conclusion, in this study of IDDM patients with nephropathy and high normal or mildly hypertensive blood pressure, a difference in sodium intake of about 100 mmol/day for a period of 4 weeks led to a slight reduction of clinic diastolic blood pressure. Studies including larger numbers of patients with various stages of nephropathy and hypertension are needed to definitely clarify the effects of sodium restriction in IDDM.

Adolescent↗
PubMed1996

Effects of smoking on blood pressure and proteinuria in patients with diabetic nephropathy.

OBJECTIVES: To investigate the effects of smoking on blood pressure and proteinuria in hypertensive diabetic patients with nephropathy. DESIGN: Controlled, randomized, cross-over study. SETTING: Tertiary care centre, University Hospital of Düsseldorf, Germany. SUBJECTS: A total of 25 subjects were recruited, each of whom smoked at least 20 cigarettes a day: 10 normotensive healthy volunteers and 15 hypertensive type 1 (insulin-dependent) diabetic outpatients with diabetic retinopathy and persistent micro- or macroalbuminuria; 10 diabetic patients had normal autonomic function test, whilst five patients showed signs of autonomic neuropathy. INTERVENTIONS: Controlled smoking or nonsmoking over a period of 8 h on separate days. MAIN OUTCOME MEASURES: Blood pressure was measured every 10 min with an automatic device and urine samples were collected every 3 h. RESULTS: Systolic blood pressure increased during smoking in controls (mean) (11.5 mmHg, P = 0.0001) and in diabetic patients without autonomic neuropathy (7.9 mmHg; P = 0.018), but not in patients with autonomic neuropathy (-2.4 mmHg; P = 0.792). Diastolic blood pressure increased during smoking in controls (6.2 mmHg; P = 0.019) but not in diabetic patients (2.5 mmHg; P = 0.204. 0.2 mmHg; P = 0.956). During smoking, median proteinuria and albuminuria increased in diabetic patients without autonomic neuropathy (8.1 mg mmol-1 creatinine, P = 0.002; and 2.6 mg mmol creatinine, P = 0.084). No significant changes in albuminuria or proteinuria occurred in the other two groups. CONCLUSIONS: Smoking increases blood pressure values in healthy subjects and in hypertensive patients with diabetic nephropathy and without autonomic neuropathy. This effect of smoking may be partly responsible for the faster progression of diabetic nephropathy in smoking diabetic patients.

Adult↗
PubMed1995

Intensified antihypertensive therapy is associated with improved survival in type 1 diabetic patients with nephropathy.

OBJECTIVE: To determine the prognosis of treated hypertensive type 1 (insulin-dependent) diabetic patients with overt nephropathy. DESIGN: A controlled, prospective, parallel, 5-year follow-up trial. SETTING: The tertiary care centre of the Heinrich Heine University Hospital in Dusseldorf, Germany. PATIENTS AND INTERVENTIONS: A sequential sample of 91 hypertensive patients with overt diabetic nephropathy participated in a diabetes treatment programme. Thereafter 45 patients received intensified antihypertensive therapy including blood pressure self-monitoring and self-adjustment of antihypertensive drug treatment with the goal of permanent normalization of blood pressure values below 140/90 mmHg. The remaining 46 patients were administered routine antihypertensive therapy and formed the control group. At baseline both groups were comparable in age, sex, metabolic control and renal function. The groups differed at baseline in their duration of diabetes and blood pressure values, which were higher in the intensified antihypertensive therapy group. OUTCOME MEASURES: Total mortality and the need for renal replacement therapy. MAIN RESULTS: Blood pressure control was significantly improved in patients who were subjected to intensified antihypertensive therapy, whereas it deteriorated in the group of patients who received routine antihypertensive therapy. At follow-up, primary end points of the study occurred in five (11%) patients of the intensified therapy group and in 19 (41%) patients of the routine therapy group. According to life table analysis, intensified antihypertensive therapy was associated with less frequent primary end points (P = 0.0058) and longer survival (P = 0.01). The differences between the groups remained significant after adjustment for covariates in the proportional hazards model. CONCLUSION: Participation in a treatment programme aimed at intensification of antihypertensive therapy is associated with a reduction of mortality in hypertensive type 1 diabetic patients with overt nephropathy.

Adult↗
PubMed1995

Liberalized diet in patients with type 1 diabetes.

OBJECTIVE: To document that strict dietary regimen are not necessary in the context of intensified insulin therapy. DESIGN: German multicentre, prospective cohort study; 6 years follow-up. SETTING: Ambulatory examination using a mobile ambulance. SUBJECTS: A total of 636 type 1 diabetic patients (age 33 +/- 7 years, diabetes duration 15 +/- 7 years; mean +/- SD), who had participated in a structured, 5-day, in-patient, group treatment and teaching programme for intensification of insulin therapy and liberalization of the diabetes diet 6 years prior to follow-up. MAIN OUTCOME MEASURES: Relations between the extent to which patients practise a liberalized diet, the degree of metabolic control (HbA1c, severe hypoglycaemia, body mass index, cholesterol), and the patients' perceived burden through dietary treatment. RESULTS: In the total patient group, HbA1c was 7.9 +/- 1.6%, and the incidence of severe hypoglycaemia was 0.17 cases per patient during the preceding year; 31% patients injected insulin < or = 3 times per day, 58% 4-7 times per day, and 11% used insulin pump therapy. Only 11% patients reported following a meal plan, whereas 89% continually changed timing and amount of carbohydrate intake; only 5% had the same number of meals every day, whereas as many as 20% varied the number of meals per day by four or more; 53% skipped main meals; 85% habitually consumed sugar or sugar containing foods. Patients with a higher degree of diet liberalization injected insulin or used an insulin pump therapy more frequently, and perceived their dietary treatment to be less burdensome. No clinically significant associations were found between the extent of diet liberalization and metabolic control. CONCLUSIONS: Under the conditions where type 1 diabetic patients have the opportunity to participate in an intensified insulin treatment and teaching programme, liberalization of the diabetes diet is not associated with adverse effects on glycaemic control, but is associated with less perceived burden through dietary treatment.

Adult↗
PubMed1995

Mortality and morbidity in treated hypertensive type 2 diabetic patients with micro- or macroproteinuria.

In order to describe the natural history of high risk diabetic patients treated for hypertension we have followed a sequential sample of 100 hypertensive Type 2 diabetic patients with elevated urinary protein excretion ( > or = 60 mg 24 h-1) for a period of 1-7 years. Antihypertensive treatment was instituted in all patients and, in addition, the patients were offered the possibility of participation in an intensified antihypertensive therapy programme. After a mean follow-up of 4 years overall mortality was 13%. Nineteen percent of all patients experienced a cardiovascular event and 7% a cerebrovascular event. In conclusion, in this study the overall mortality was lower that previously reported in proteinuric Type 2 diabetic patients. Antihypertensive treatment may account for this outcome.

Age Factors↗
PubMed1995

Implementation of intensified insulin therapy: a European perspective.

The Diabetes Education Study Group (DESG) of the European Association for the Study of Diabetes (EASD) was founded in 1979 with its major goal to make effective patient training an integral part of any diabetes therapy. Within the DESG, a number of models for structured diabetes treatment and teaching programmes were developed. Concerning the care of persons with Type 1 diabetes, substantial emphasis was placed upon the 5-day in-patient treatment and teaching programme for groups of 6 to 10 patients as originally introduced at the University of Geneva and further developed for general use at the University of Düsseldorf. During the early 1980s, this programme was based upon intensified insulin therapy including a stepwise liberalization of previously rigid rules for nutrition and life schedules. In several European centres the programme was continuously evaluated and shown to be effective as documented by significant reductions of glycated haemoglobin values, episodes of ketoacidosis, hospitalizations, and sick-day leaves. In contrast to the Diabetes Control and Complications Trial (DCCT) the improvement of glycated haemoglobin values was not associated with an increased risk of severe hypoglycaemia. Possible reasons for this favourable outcome are discussed. During recent years the 5-day treatment and teaching programme for Type 1 diabetes has been translated into the general health care system of Germany without any loss of its efficacy. In addition, in various other European countries, model centres of diabetes care have implemented the 5-day programme, and for a number of these centres, its efficacy to improve the overall quality of diabetes care has been published or presented at meetings.

Albuminuria↗