Background: Microalbuminuria is an early sign of kidney disease in diabetes and indicates cardiovascular risk. We tested if a prespecified urinary proteomic risk classifier (CKD273) was associated with development of microalbuminuria and if progression to microalbuminuria could be prevented with the mineralocorticoid receptor antagonist spironolactone. Methods: Prospective multicentre study in people with type 2 diabetes, normal urinary albumin excretion and preserved renal function in 15 European specialist centres. High-risk individuals determined by CKD273 were randomised 1:1 (interactive web response system) in a double-blind randomised controlled trial comparing spironolactone 25 mg o.d. to placebo. Primary endpoint was development of confirmed microalbuminuria in all individuals with available data. Secondary endpoints included reduction in incidence of microalbuminuria with spironolactone and association between CKD273 and impaired renal function defined as a glomerular filtration rate < 60 ml/min per 1•73 m 2. This study is registered with ClinicalTrials.gov: NCT02040441 and is completed. Findings: From March 25, 2014 to September 30, 2018 we followed 1775 participants, 12% (n=216) had high-risk urinary proteomic pattern of which 209 were included in the trial and assigned spironolactone (n=102) or placebo (n=107). Median follow-up time was 2•51 years (IQR 2•0-3•0). Progression to microalbuminuria was seen in 28•2% of high-risk and 8•9% of low-risk people (P< 0•001) (hazard ratio (HR), 2•48; 95% confidence interval [CI], 1•80 to 3•42 P<0•001, independent of baseline clinical characteristics). A 30% decline in eGFR from baseline was seen in 42 (19•4 %) high-risk participants compared to 62 (3•9 %) low-risk participants, HR 5•15; 95 % CI (3•41 to 7•76; p<0.0001). Development of microalbuminuria was seen in 35 (33%) randomised to placebo and 26 (25%) randomised to spironolactone treatment (HR 0•81, 95% CI, 0•49 to 1•34, P=0•41). Harms: hyperkalaemia was seen in 13 versus 4, and gynaecomastia in 3 versus 0 subjects on spironolactone and placebo, respectively. Interpretation: In people with type 2 diabetes and normoalbuminuria, the urinary proteomic classifier CKD273 was associated with a 2•5 times increased risk for progression to microalbuminuria over a median of 2•5 years, independent of clinical characteristics. Spironolactone did not prevent progression to microalbuminuria in high-risk subjects.

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Abnormal uterine bleeding is a complex gynecological problem, especially in the perimenopausal and postmenopausal period. Etiology may be organic (endometrial polyp, hyperplasia, myoma, endometrial atrophy, carcinoma) or non-organic (dysfunctional uterine bleeding).To analyze the histopathological findings of samples of fractionated explorative curettage in patients with abnormal uterine bleeding and to investigate certain risk factors for their occurrence (age, obesity, hypertension, diabetes).This was a prospective study comprising a total of 104 subjects. They were divided into two groups: 54 women in postmenopausal age and 50 in premenopausal age. The data were collected by interviewing and analyzing the findings from histopathological analyses of samples obtained by fractional explorative curettage. The following anamnestic data were analyzed: age, history of hypertension and diabetes. The study was performed in the Special Hospital for Gynecology and Obstetrics "Mother Theresa" -Chair.The most common pathological finding in both groups was endometrial polyp (in 39.5% of postmenopausal and 46.9% of premenopausal women). In 4 participants (5.7% of the total), endometrial adenocarcinoma was diagnosed. The mean age of patients was 57 years in the postmenopausal group and 43 years in the premenopausal group. The average BMI (Body Mass Index) was 33 in the postmenopausal group and 25 in the premenopausal group. Hypertension was detected in 64.8% of postmenopausal women and in 34% of premenopausal women. 13% of postmenopausal women were diagnosed with diabetes. It was detected in 12% of premenopausal women.Fractional explorative curettage is an important diagnostic procedure for prompt and timely diagnosis of premalignant and malignant changes of the female genital tract. We detected endometrial adenocarcinoma in 7,4% of the postmenopausal patients and in 4% of premenopausal patients with abnormal uterine bleeding. It is especially important to highlight obesity and hypertension as risk factors for abnormal uterine bleeding and endometrial pathology.

Our study shows improved glucose control in long-term CSII users. A reduction of HbA1c levels by -1.1% was maintained during the study period.

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