Genistein supplementation and cardiac function in postmenopausal women with metabolic syndrome: Results from a pilot strain-echo study

Genistein, a soy-derived isoflavone,may improve cardiovascular risk profile in postmenopausal women with metabolic syndrome (MetS), but few literature data on its cardiac effects in humans are available. The aim of this sub-study of a randomized double-blind case-control study was to analyze the effect on cardiac function of one-year genistein dietary supplementation in 22 post-menopausal patients with MetS. Participants received 54 mg/day of genistein (n = 11) or placebo (n = 11) in combination with a Mediterranean-style diet and regular exercise. Left ventricular (LV) systolic function was assessed as the primary endpoint, according to conventional and strain-echocardiography measurements. Also, left atrial (LA) morphofunctional indices were investigated at baseline and at the final visit. Results were expressed as median with interquartile range (IQ). A significant improvement of LV ejection fraction (20.3 (IQ 12.5) vs. -1.67 (IQ 24.8); p = 0.040)), and LA area fractional change (11.1 (IQ 22.6) vs. 2.8 (9.5); p = 0.034)) were observed in genistein patients compared to the controls, following 12 months of treatment. In addition, body surface area indexed LA systolic volume and peak LA longitudinal strain significantly changed from basal to the end of the study in genistein-treated patients. One-year supplementation with 54 mg/day of pure genistein improved both LV ejection fraction and LA remodeling and function in postmenopausal women with MetS

Association of kidney disease measures with risk of renal function worsening in patients with type 1 diabetes

Background: Albuminuria has been classically considered a marker of kidney damage progression in diabetic patients and it is routinely assessed to monitor kidney function. However, the role of a mild GFR reduction on the development of stage 653 CKD has been less explored in type 1 diabetes mellitus (T1DM) patients. Aim of the present study was to evaluate the prognostic role of kidney disease measures, namely albuminuria and reduced GFR, on the development of stage 653 CKD in a large cohort of patients affected by T1DM. Methods: A total of 4284 patients affected by T1DM followed-up at 76 diabetes centers participating to the Italian Association of Clinical Diabetologists (Associazione Medici Diabetologi, AMD) initiative constitutes the study population. Urinary albumin excretion (ACR) and estimated GFR (eGFR) were retrieved and analyzed. The incidence of stage 653 CKD (eGFR < 60 mL/min/1.73 m2) or eGFR reduction > 30% from baseline was evaluated. Results: The mean estimated GFR was 98 \ub1 17 mL/min/1.73m2 and the proportion of patients with albuminuria was 15.3% (n = 654) at baseline. About 8% (n = 337) of patients developed one of the two renal endpoints during the 4-year follow-up period. Age, albuminuria (micro or macro) and baseline eGFR < 90 ml/min/m2 were independent risk factors for stage 653 CKD and renal function worsening. When compared to patients with eGFR > 90 ml/min/1.73m2 and normoalbuminuria, those with albuminuria at baseline had a 1.69 greater risk of reaching stage 3 CKD, while patients with mild eGFR reduction (i.e. eGFR between 90 and 60 mL/min/1.73 m2) show a 3.81 greater risk that rose to 8.24 for those patients with albuminuria and mild eGFR reduction at baseline. Conclusions: Albuminuria and eGFR reduction represent independent risk factors for incident stage 653 CKD in T1DM patients. The simultaneous occurrence of reduced eGFR and albuminuria have a synergistic effect on renal function worsening

Cardiac Diastolic Evaluation in Pregnant Women with Abnormal Glucose Tolerance: An Opportunity to Detect the Early and Subclinical Alterations and Prevent Cardiovascular Diseases

Objectives of this study were to assess diastolic function in pregnant women with abnormal glucose tolerance (AGT), compared with normal glucose tolerance (NGT) women, and to evaluate the insulin resistance status and its association with Doppler-echocardiographic indexes. Echocardiograms of 108 consecutive Caucasian women with singleton pregnancies were performed. Insulin resistance status was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI). All the studied women showed normal diastolic patterns. Patients with AGT (50.9%), as compared with NGT women, had higher HOMA-IR (1.70±1.30 versus 1.01±0.81, P=0.003), lower QUICKI (0.36±0.005 versus 0.40±0.06, P=0.004), higher lateral mitral annulus late diastolic velocity (13.6±4.9 versus 11.9±4.9, P=0.03), and higher A-wave velocity, the wave responsible for the active atrial contraction component (75.2±14.2 versus 67.7±16.2, P=0.01). At multivariate regression analysis HOMA-IR was the only parameter associated with A-wave velocity. In conclusion, women with AGT had an increased subclinical diastolic active participation, which is associated with higher levels of insulin resistance. For the increased risk of deterioration of cardiac diastolic function, earlier and more seriously than normal pregnancy, AGT women may have a careful followup to detect the early signs of cardiac alteration and to prevent cardiovascular diseases

Genistein in the metabolic syndrome: Results of a randomized clinical trial

Context: This study was performed to evaluate the effects of genistein on metabolic and cardiovascular risk factors in Caucasian postmenopausal subjects with metabolic syndrome (MetS). Objective: Our objective was to assess the effects of genistein on surrogate endpoints associated with diabetes and cardiovascular disease. Design and Setting: This was a randomized, double-blind, placebo-controlled trial at 3 university medical centers in Italy. Patients: Patients included 120 postmenopausal women with MetS according to modified Third Report of the National Cholesterol Education Program (NCEP), Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) criteria. Intervention: After a 4-week stabilization period, postmenopausal women with MetS were randomly assigned to receive placebo (n = 60) or 54 mg genistein daily (n = 60) for 1 year. Main Outcome Measures: The primary outcome was homeostasis model assessment for insulin resistance (HOMA-IR) at 1 year. Secondary outcomes were fasting glucose, fasting insulin, total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, visfatin, adiponectin, and homocysteine levels. Data on adverse events were also recorded. Results: At 1 year in genistein recipients, fasting glucose, fasting insulin, and HOMA-IR (mean from 4.5 to 2.7; P < .001) decreased and were unchanged in placebo recipients. Genistein statistically increased HDL-C (mean from 46.4 to 56.8 mg/dL) and adiponectin and decreased total cholesterol, LDL-C (mean from 108.8 to 78.7 mg/dL), triglycerides, visfatin, and homocysteine (mean from 14.3 to 11.7 mu mol/L) blood levels. Systolic and diastolic blood pressure was also reduced in genistein recipients. Genistein recipients neither experienced more side adverse effects than placebo nor discontinued the study. Conclusion: One year of treatment with genistein improves surrogate endpoints associated with risk for diabetes and cardiovascular disease in postmenopausal women with MetS.Context: This study was performed to evaluate the effects of genistein on metabolic and cardiovascular risk factors in Caucasian postmenopausal subjects with metabolic syndrome (MetS). Objective: Our objective was to assess the effects of genistein on surrogate endpoints associated with diabetes and cardiovascular disease. Design and Setting: This was a randomized, double-blind, placebo-controlled trial at 3 university medical centers in Italy. Patients: Patients included 120 postmenopausal women with MetS according to modified Third Report of the National Cholesterol Education Program (NCEP), Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) criteria. Intervention: After a 4-week stabilization period, postmenopausal women with MetS were randomly assigned to receive placebo (n = 60) or 54 mg genistein daily (n = 60) for 1 year. Main Outcome Measures: The primary outcome was homeostasis model assessment for insulin resistance (HOMA-IR) at 1 year. Secondary outcomes were fasting glucose, fasting insulin, total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, visfatin, adiponectin, and homocysteine levels. Data on adverse events were also recorded. Results: At 1 year in genistein recipients, fasting glucose, fasting insulin, and HOMA-IR (mean from 4.5 to 2.7; P<.001) decreased and were unchanged in placebo recipients. Genistein statistically increased HDL-C (mean from 46.4 to 56.8 mg/dL) and adiponectin and decreased total cholesterol, LDL-C (mean from 108.8 to 78.7 mg/dL), triglycerides, visfatin, and homocysteine (mean from 14.3 to 11.7 μmol/L) blood levels. Systolic and diastolic blood pressure was also reduced in genistein recipients. Genistein recipients neither experienced more side adverse effects than placebo nor discontinued the study. Conclusion: One year of treatment with genistein improves surrogate endpoints associated with risk for diabetes and cardiovascular disease in postmenopausal women with MetS. Copyright © 2013 by The Endocrine Society

La terapia insulinica sottocutanea continua (CSII) in Italia. Terza indagine nazionale [Subcutaneous insulin infusion (CSII) in italy: The third national survey]

Continuous subcutaneous insulin infusion (CSII) is increasingly being used worldwide, mostly thanks to technical improvements. This study examined the current status of CSII in Italy. Physicians in charge of 272 diabetes centers caring for patients using CSII were sent a questionnaire investigating clinical features, pump technology and management of these patients; a large proportion (217 centers, 79.8%) joined the study. By end-April 2013, data had been collected on 10152 patients treated with CSII; 98.2% had type 1 diabetes, 82.4% were adults, 57% female. Only just over half the centers (59%) managed more than 20 CSII patients each. The distribution of patients varied widely both among and within different regions. The main indication for CSII was the de- sire to improve glycemic control. Dropouts (8.65%) were mainly due to difficulties with pump wearability or non-optimal glycemic control. Among CSII patients 61% used a traditional pump, 39% a sensor augmented pump. Only 68% used the CSII advanced functions and glucose sensors were used twelve days per month on average. Round-the-clock assistance was guaranteed in 81% of centers; a full diabetes team followed patients in only 40% of adult-care centers and 50% of pediatric units. CSII is increasingly used in Italy, by adults and pediatric patients. However, further work is needed to unify treatment strategies throughout the country and to encourage optimal pump use and applications.La diffusione della terapia insulinica sottocutanea continua con microinfusore (CSII) è in continuo aumento nel mondo, grazie anche al miglioramento della tecnologia degli strumenti. Scopo di questo lavoro è stato quello di valutare lo stato attuale della CSII in Italia. A tal fine ai responsabili di 272 strutture diabetologiche che seguono pazienti in terapia con microinfusore è stato inviato un questionario che indagava aspetti clinici, tecnici e organizzativi della terapia con microinfusore. Duecentodiciassette strutture (79,8%) hanno partecipato all’indagine. Dai dati raccolti è emerso che a fine aprile 2013 in tali strutture vi erano 10.152 pazienti in terapia con microinfusore, quasi tutti (98,2%) affetti da diabete di tipo 1, prevalentemente adulti (82,4%) e di sesso femminile (57%). La diffusione della CSII risultava molto disomogenea tra le diverse Regioni e anche tra le diverse strutture diabetologiche di una stessa Regione: solo il 59% delle strutture seguiva più di 20 pazienti ciascuna. Motivo principale per iniziare la CSII era la ricerca del buon controllo glicemico. Il drop-out (8,65% dei casi), avveniva soprattutto per problemi legati alla portabilità della pompa o al mancato raggiungimento del target glicemico. La maggior parte dei pazienti (61%) utilizzava un microinfusore tradizionale, il 39% un microinfusore integrato (32%) o associato (7%) a un dispositivo per il monitoraggio in continuo della glicemia. Le funzioni avanzate del microinfusore venivano mediamente utilizzate solo dal 68% dei pazienti e il sensore era utilizzato mediamente solo per 12 giorni al mese. L’81% delle strutture garantiva una reperibilità 24 ore su 24. Solo nel 40% delle strutture per adulti e nel 50% di quelle pediatriche i pazienti venivano seguiti da un team completo. In conclusione, la CSII si sta sempre più diffondendo in Italia, sia tra i pazienti adulti sia tra quelli pediatrici. È auspicabile una maggiore uniformità tra le diverse Regioni e un uso più adeguato della tecnologia stessa.Continuous subcutaneous insulin infusion (CSII) is increasingly being used worldwide, mostly thanks to technical improvements. This study examined the current status of CSII in Italy. Physicians in charge of 272 diabetes centers caring for patients using CSII were sent a questionnaire investigating clinical features, pump technology and management of these patients; a large proportion (217 centers, 79.8%) joined the study. By end-April 2013, data had been collected on 10152 patients treated with CSII; 98.2% had type 1 diabetes, 82.4% were adults, 57% female. Only just over half the centers (59%) managed more than 20 CSII patients each. The distribution of patients varied widely both among and within different regions. The main indication for CSII was the de- sire to improve glycemic control. Dropouts (8.65%) were mainly due to difficulties with pump wearability or non-optimal glycemic control. Among CSII patients 61% used a traditional pump, 39% a sensor augmented pump. Only 68% used the CSII advanced functions and glucose sensors were used twelve days per month on average. Round-the-clock assistance was guaranteed in 81% of centers; a full diabetes team followed patients in only 40% of adult-care centers and 50% of pediatric units. CSII is increasingly used in Italy, by adults and pediatric patients. However, further work is needed to unify treatment strategies throughout the country and to encourage optimal pump use and applications

Subcutaneous insulin infusion (CSII) in italy: The third national survey

Continuous subcutaneous insulin infusion (CSII) is increasingly being used worldwide, mostly thanks to technical improvements. This study examined the current status of CSII in Italy. Physicians in charge of 272 diabetes centers caring for patients using CSII were sent a questionnaire investigating clinical features, pump technology and management of these patients; a large proportion (217 centers, 79.8%) joined the study. By end-April 2013, data had been collected on 10152 patients treated with CSII; 98.2% had type 1 diabetes, 82.4% were adults, 57% female. Only just over half the centers (59%) managed more than 20 CSII patients each. The distribution of patients varied widely both among and within different regions. The main indication for CSII was the de- sire to improve glycemic control. Dropouts (8.65%) were mainly due to difficulties with pump wearability or non-optimal glycemic control. Among CSII patients 61% used a traditional pump, 39% a sensor augmented pump. Only 68% used the CSII advanced functions and glucose sensors were used twelve days per month on average. Round-the-clock assistance was guaranteed in 81% of centers; a full diabetes team followed patients in only 40% of adult-care centers and 50% of pediatric units. CSII is increasingly used in Italy, by adults and pediatric patients. However, further work is needed to unify treatment strategies throughout the country and to encourage optimal pump use and applications

La terapia insulinica sottocutanea continua (CSII) in Italia. Terza indagine nazionale

Continuous subcutaneous insulin infusion (CSII) is increasingly being used worldwide, mostly thanks to technical improvements. This study examined the current status of CSII in Italy. Physicians in charge of 272 diabetes centers caring for patients using CSII were sent a questionnaire investigating clinical features, pump technology and management of these patients; a large proportion (217 centers, 79.8%) joined the study. By end-April 2013, data had been collected on 10152 patients treated with CSII; 98.2% had type 1 diabetes, 82.4% were adults, 57% female. Only just over half the centers (59%) managed more than 20 CSII patients each. The distribution of patients varied widely both among and within different regions. The main indication for CSII was the de- sire to improve glycemic control. Dropouts (8.65%) were mainly due to difficulties with pump wearability or non-optimal glycemic control. Among CSII patients 61% used a traditional pump, 39% a sensor augmented pump. Only 68% used the CSII advanced functions and glucose sensors were used twelve days per month on average. Round-the-clock assistance was guaranteed in 81% of centers; a full diabetes team followed patients in only 40% of adult-care centers and 50% of pediatric units. CSII is increasingly used in Italy, by adults and pediatric patients. However, further work is needed to unify treatment strategies throughout the country and to encourage optimal pump use and applications

La terapia insulinica sottocutanea continua (CSII) in Italia. Terza indagine nazionale

Continuous subcutaneous insulin infusion (CSII) is increasingly being used worldwide, mostly thanks to technical improvements. This study examined the current status of CSII in Italy. Physicians in charge of 272 diabetes centers caring for patients using CSII were sent a questionnaire investigating clinical features, pump technology and management of these patients; a large proportion (217 centers, 79.8%) joined the study. By end-April 2013, data had been collected on 10152 patients treated with CSII; 98.2% had type 1 diabetes, 82.4% were adults, 57% female. Only just over half the centers (59%) managed more than 20 CSII patients each. The distribution of patients varied widely both among and within different regions. The main indication for CSII was the de- sire to improve glycemic control. Dropouts (8.65%) were mainly due to difficulties with pump wearability or non-optimal glycemic control. Among CSII patients 61% used a traditional pump, 39% a sensor augmented pump. Only 68% used the CSII advanced functions and glucose sensors were used twelve days per month on average. Round-the-clock assistance was guaranteed in 81% of centers; a full diabetes team followed patients in only 40% of adult-care centers and 50% of pediatric units. CSII is increasingly used in Italy, by adults and pediatric patients. However, further work is needed to unify treatment strategies throughout the country and to encourage optimal pump use and applications

Continuous subcutaneous insulin infusion in Italy: third national survey.

BACKGROUND: Continuous subcutaneous insulin infusion (CSII) is increasing worldwide, mostly because of improved technology. The aim of this study was to evaluate the current status of CSII in Italy. MATERIALS AND METHODS: Physicians from 272 diabetes centers received a questionnaire investigating clinical features, pump technology, and management of patients on CSII. RESULTS: Two hundred seventeen centers (79.8%) joined the study and, by the end of April 2013, gave information about 10,152 patients treated with CSII: 98.2% with type 1 diabetes mellitus, 81.4% adults, 57% female, and 61% with a conventional pump versus 39% with a sensor-augmented pump. CSII advanced functions were used by 68% of patients, and glucose sensors were used 12 days per month on average. Fifty-eight percent of diabetes centers had more than 20 patients on CSII, but there were differences among centers and among regions. The main indication for CSII was poor glucose control. Dropout was mainly due to pump wearability or nonoptimal glycemic control. Twenty-four hour assistance was guaranteed in 81% of centers. A full diabetes team (physician+nurse+dietician+psychologist) was available in 23% of adult-care diabetes centers and in 53% of pediatric diabetes units. CONCLUSIONS: CSII keeps increasing in Italy. More work is needed to ensure uniform treatment strategies throughout the country and to improve pump use

Kidney dysfunction and related cardiovascular risk factors among patients with type 2 diabetes

Background. Kidney dysfunction is a strong predictor of end-stage renal disease and cardiovascular (CV) events. The main goal was to study the clinical correlates of diabetic kidney disease in a large cohort of patients with type 2 diabetes mellitus (T2DM) attending 236 Diabetes Clinics in Italy.Methods. Clinical data of 120 903 patients were extracted from electronic medical records by means of an ad hoc-developed software. Estimated glomerular filtration rate (GFR) and increased urinary albumin excretion were considered. Factors associated with the presence of albuminuria only, GFR &lt; 60 mL/min/1.73 m(2) only or both conditions were evaluated through multivariate analysis.Results. Mean age of the patients was 66.6 +/- 11.0 years, 58.1% were male and mean duration of diabetes was 11.1 +/- 9.4 years. The frequency of albuminuria, low GFR and both albuminuria and low GFR was 36.0, 23.5 and 12.2%, respectively. Glycaemic control was related to albuminuria more than to low GFR, while systolic and pulse pressure showed a trend towards higher values in patients with normal kidney function compared with those with both albuminuria and low GFR. Multivariate logistic analysis showed that age and duration of disease influenced both features of kidney dysfunction. Male gender was associated with an increased risk of albuminuria. Higher systolic blood pressure levels were associated with albuminuria, with a 4% increased risk of simultaneously having albuminuria and low GFR for each 5 mmHg increase.Conclusions. In this large cohort of patients with T2DM, reduced GFR and increased albuminuria showed, at least in part, different clinical correlates. A worse CV risk profile is associated with albuminuria more than with isolated low GFR