Chemometric assessment of clinical data for diabetes mellitus 2 type patients using self-organizing maps.

The aim of this study was to offer an efficient and unsupervised strategy for medical data exploration to find relationships between clinical tests and major as well as concomitant syndromes of a specific disease. A large data set consisting of a group of 100 patients suffering diabetes mellitus type 2 disease characterized by more than 30 clinical parameters was explored using self-organizing maps (SOM) and classified by the use of non-hierarchical K-means algorithm implemented in the SOM. An attempt was made to correlate the classification results with the parameters of the metabolic syndrome. The classification result revealed 4 specific patterns of patients, each presented by respective discriminating parameters: (i) patients with well-controlled state of the disease, (ii) patients with disturbed kidney function, (iii) patients who do not keep the required medical treatment regime, and (iv) patients who neglect the disease. All patterns included respective number of patients with different clinical status and attitude to the health problem. Patients with a well-controlled state of the disease, although being chronic for a long period of time were characterized by very low density proteins and triglycerides levels as well as by the lowest levels for hemoglobin A(1c), total protein and creatine phosphokinase. Patients with disturbed kidney function were characterized by the highest averages of the uric acid, albumin, total protein and creatinine, and relatively low values for glucose. Patients who do not keep the required regime possessed the highest level of glucose along with maximal values for cholesterol and trombocytes. Patients who neglect the disease were characterized by high values of cholesterol and relatively high level of glucose, although the duration of the disease was the shortest as compared to the other groups of patients.

Effect of tibolone on sexual function in late postmenopausal women.

BACKGROUND: Sexual dysfunction may significantly affect quality of life and marital relations in the postmenopausal period. The aim of the study was to assess the effect of tibolone on climacteric symptoms and sexuality in late postmenopausal but still symptomatic women. PATIENTS AND METHODS: A six-month prospective study was conducted of two groups of clinically healthy postmenopausal women: a control group (n = 18; mean age 57.8 +/- 4.1 yrs; menopause at 49.7 +/- 2.5; years of amenorrhea 8.1 +/- 4.0 yrs) and a tibolone group (n = 22; mean age 57 +/- 4.5 yrs; menopause at 47.7 +/- 3.9; years of amenorrhea 9.2 +/- 4.6 yrs), who received 2.5 mg tibolone daily for six months. The Kupperman menopausal index (KI) was calculated for both groups at baseline and at six months. Sexual function was assessed by the Female Sexual Function Index (FSFI) questionnaire at the beginning and at the end of the study. The FSFI comprised five main domains: desire, arousal, lubrication, orgasm and pain. Satisfaction and a total score were also recorded. RESULTS: The results showed that during the observation period KI decreased significantly in the tibolone group (15.7 +/- 9.2 vs 11.3 +/- 6.8, p < 0.001), while in the control group no difference was observed. There was a significant improvement of sexual function in the tibolone group in all domains: desire -- from 2.6 +/- 1.0 to 3.1 +/- 1.0 (p < 0.001); arousal -- from 2.3 +/- 1.8 to 3.4 +/- 1.1 (p < 0.001); lubrication - 2.6 +/- 2.1 and 3.5 +/- 1.4 (p < 0.05). The ability to reach orgasm increased (p < 0.001) and pain and discomfort during and after sexual intercourse significantly decreased (p < 0.01). The overall satisfaction and the total score in the treated group changed favourably in a statistically significant manner, while these parameters did not change in the control group. CONCLUSIONS: Treatment with tibolone had a beneficial effect on the climacteric symptoms and sexual function of late postmenopausal women. Moreover, tibolone seems to have an advantage over conventional hormone replacement therapy (HRT) in improving desire and arousal.

Anticardiolipin antibodies during hormone replacement therapy in healthy postmenopausal women.

OBJECTIVE: The aim of the study was to investigate IgG and IgM anticardiolipin (aCL) antibodies in the course of hormone replacement therapy (HRT). SUBJECTS AND METHODS: Thirty clinically healthy postmenopausal women with no history of previous thrombotic events or autoimmune disease were divided in two groups: control group (n = 12, mean age 52.9 +/- 4.5 years, and 6.2 +/- 3.6 years duration of amenorrhea) and a second group (n = 18, mean age 53.6 +/- 3.5 years, and 5.7+/- 4.5 years of amenorrhea) who were allocated to HRT, containing 2 mg 17-beta estradiol plus 1mg norethisterone acetate daily for 6 months. ACL antibodies of IgG and IgM isotype were assessed using ELISA and the Kupperman menopausal index (KI) was calculated at baseline and after 3 and 6 months of treatment. RESULTS: HRT had a beneficial effect on climacteric symptoms, evaluated by KI (baseline versus 3rd month and 3rd month versus 6th month, P < 0.001 ). The KI did not change in the control group. The values of IgG at the three studied periods did not change significantly and were 14.1 +/- 4.2, 13.1 +/- 4.9 and 13.4 +/- 3.7 in the HRT group and 12.7 +/- 3.1, 13.7 +/-1.8 and 13.1 +/- 3.8 GPL, respectively, in the control group. IgM aCL antibodies increased during HRT and were as follows: 7.7 +/- 4.8 at baseline, 12.9 +/- 5.6 at 3rd month and 9.3 +/- 3.2 MPL at 6th month. In the control group, IgM were 8.0 +/- 2.8; 7.9 +/- 2.3 and 7.1 +/- 2.3 MPL, respectively. The differences between the two groups were significant at the third and the 6th month (P < 0.01 and P < 0.05 ). CONCLUSION: These data suggest that HRT is associated with elevation of IgM ACA in healthy postmenopausal women. As IgG aACA are considered more pathogenic, it seems unlikely that the early prothrombogenic effects of HRT can be assigned to ACA.

Randomized forced titration to different doses of technosphere insulin demonstrates reduction in postprandial glucose excursions and hemoglobin A1c in patients with type 2 diabetes.

BACKGROUND: Individuals with type 2 diabetes mellitus have impairments in early insulin release, resulting in increased postprandial glucose excursions and suboptimal glycemic control. Studies with Technosphere Insulin (TI) indicate that it has rapid systemic absorption and a short duration of glucose-lowering activity, making it well suited for controlling postprandial glucose levels. METHODS: The goal of this phase 2b, prospective, multicenter, double-blind, placebo-controlled study was to characterize the dose response of four different doses (equivalent to 3.6, 7.3, 10.9, and 14.6 U subcutaneous regular human insulin) of prandial TI or Technosphere powder alone administered before each of three meals daily, in combination with insulin glargine over an 11-week treatment period, in patients with type 2 diabetes and suboptimal glycemic control. RESULTS: The study enrolled 227 patients. In all dose groups, TI demonstrated statistically significant dose-dependent reductions in hemoglobin A1c (HbA1c) versus baseline (-0.4, -0.5, -0.5, and -0.6 for 3.6, 7.3, 10.9, and 14.6 U equivalents, respectively; p < 0.05 in all groups), as well as versus placebo or Technosphere powder alone (-0.40, -0.67, -0.70, and -0.78 for 3.6, 7.3, 10.9, and 14.6 U equivalents, respectively; p < 0.04 in all groups). It reduced the postprandial maximum glucose concentration within each treatment group (statistically significant in all but the TI 3.6 U-equivalent group) and reduced the postprandial area under the glucose curve (statistically significant for the TI 10.9 and 14.6 U-equivalent groups) versus placebo. There were no cases of severe hypoglycemia, while mild/moderate hypoglycemia was observed most frequently in the highest dosage groups, as expected. Rates of cough were low and comparable among all groups. No clinically relevant changes in pulmonary function tests, body weight, or high-resolution computerized axial tomography and magnetic resonance imaging were observed. CONCLUSIONS: This study demonstrated that, over 11 weeks, TI plus basal insulin glargine is well tolerated and results in dose-dependent reductions in postprandial glucose and HbA1c levels.

Renal Doppler ultrasound in patients with hypertension and metabolic syndrom.

Evaluation of the renal changes by conventional and Doppler ultrasound (US) was performed in patients with hypertension and obesity. 67 persons were examined and divided in 3 groups. Group I includes 27 patients--15 M and 12 F, average age 52+/-4.87 with well controlled diabetes mellitus type II and hypertension, Ccr.--139+/-1.31. Group II includes 20 patients--9 M and 11 F, average age 53+/-7 with well controlled hypertension without diabetes, with Ccr 128+/-7.8. Group III--20) pts. 8 F and 12 M, average age 54+/-5 with uncontrolled hypertension without diabetes, with Ccr 128+/-7.8. All examined pts. were with BMI>30 and hyperlipidemia--total cholesterol>6.5 mmol/l. Tests for microalbuminuria were negative in all 3 groups. In all three groups, using conventional US, the following parameters were detected by Aloca 4000 machine: renal (RV) and parenchyma (PV) volumes as well as Doppler parameters RI, PI, Vmax, Vmin, and Vmean. There were no significant differences between RV and PV of all examined groups: Group I--254+/-53, Group II--238+/-38, Group III--263+/-38, p=0.1. The strong correlation between renal volumes and BMI was found (Pearson's r 0.58). There were no significant differences between Vmax, Vmin, Vmean in all three groups. RI is normal <0.7 in all examined patients: Group I--0.63+/-0.06, Group II--0.61+/-0.02, Group III--0.66+/-0.03. RI in group III was significantly higher, p<0.05 compared to RI indices detected in other two groups but remains at normal levels. Intrarenal hemodynamics exhibited no difference in all examined groups. Analysis of the Doppler spectrum of the intrarenal arteries provides an accurate information about renal vascular changes but has no significant advantages in patients with hypertension and obesity with normal renal function and signs of hypertensive nephropathy "benign nephrosclerosis". Nevertheless Duplex Doppler Ultrasound is a noninvasive method which is an important part of the diagnostic algorithm in patients with diseases characterized by vascular involvement such as hypertension.