The article [The basal to total insulin ratio in outpatients with diabetes on basal-bolus regimen], written by [Elena Castellano, R. Attanasio, V. A. Giagulli, A. Boriano, M. Terzolo, E. Papini, E. Guastamacchia, S. Monti, A. Aglialoro, D. Agrimi, E. Ansaldi, A. C. Babini, A. Blatto, D. Brancato].

Background and aims: Diabetic women have a more adverse plasma lipid profile than men. Sex differences in dietary habits may play a role, but are little investigated. The study evaluates the quality of diet, adherence to the nutritional recommendations of the Diabetes and Nutrition Study Group and their relation with plasma lipid in men and women with diabetes.Methods and results: We studied 2573 people, aged 50-75, enrolled in the TOSCA.IT study (clinicaltrials.gov; NCT00700856). Plasma lipids were measured centrally. Diet was assessed with a semi-quantitative food frequency questionnaire. Women had a more adverse plasma lipid profile than men. Women consumed significantly more legumes, vegetables, fruits, eggs, milk, vegetable oils, and added sugar, whereas men consumed more starchy foods, soft drinks and alcoholic beverages. This stands for a higher proportion (%) of energy intake from saturated fat and added sugar (12.0 +/- 2.4 vs 11.5 +/- 2.5 and 3.4 +/- 3.2 vs 2.3 +/- 3.2, P < 0.04), and a higher intake of fiber (11.2 +/- 2.8 vs 10.4 +/- 2.6 g/1000 Kcal/day) in women. Adherence to the recommendations for saturated fat and fiber consumption was associated with significantly lower LDL-cholesterol regardless of sex. Adherence to the recommendations for added sugars was associated with significantly lower triglycerides and higher HDL-cholesterol in men and women.Conclusions: Men and women with diabetes show significant differences in adherence to nutritional recommendations, but sex differences in plasma lipid profile are unlikely to be explained by nutritional factors. Adherence to the nutritional recommendations is associated with a better plasma lipid profile regardless of sex, thus reinforcing the importance of substituting saturated for unsaturated fat sources, increasing fiber and reducing added sugar intake. (C) 2016 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

The optimal macronutrient composition of the diet for the management of type 2 diabetes is debated, particularly with regard to the ideal proportion of fat and carbohydrates. The aim of the study was to explore the association of different proportions of fat and carbohydrates of the diet—within the ranges recommended by different guidelines—with metabolic risk factors.

Background and aims: Metformin is the first-line therapy in type 2 diabetes. In patients inadequately controlled with metformin, the addition of a sulfonylurea or pioglitazone are equally plausible options to improve glycemic control. However, these drugs have profound differences in their mechanism of action, side effects, and impact on cardiovascular risk factors. A formal comparison of these two therapies in terms of cardiovascular morbidity and mortality is lacking. The TOSCA. IT study was designed to explore the effects of adding pioglitazone or a sulfonylurea on cardiovascular events in type 2 diabetic patients inadequately controlled with metformin.Methods: Multicentre, randomized, open label, parallel group trial of 48 month duration. Type 2 diabetic subjects, 50-75 years, BMI 20-45 Kg/m(2), on secondary failure to metformin monotherapy will be randomized to add-on a sulfonylurea or pioglitazone. The primary efficacy outcome is a composite endpoint of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned coronary revascularization. Principal secondary outcome is a composite ischemic endpoint of sudden death, fatal and non-fatal myocardial infarction and stroke, endovascular or surgical intervention on the coronary, leg or carotid arteries, major amputations. Side effects, quality of life and economic costs will also be evaluated. Efficacy, safety, tolerability, and study conduct will be monitored by an independent Data Safety Monitoring Board. End points will be adjudicated by an independent external committee.Conclusions: TOSCA. IT is the first on-going study investigating the head-to-head comparison of adding a sulfonylurea or pioglitazone to existing metformin treatment in terms of hard cardiovascular outcomes. Registration: Clinicaltrials. gov ID NCT00700856. (C) 2012 Elsevier B. V. All rights reserved.

Fibrinogen, factor VII and plasminogen activator inhibitor (PAI) are now considered hematologic risk factors for cardiovascular disease and it is well known that their levels are increased in obesity. 52 obese healthy subjects (31 women), with BMI>30, were investigated to assess: (a) fibrinogen, factor VII and PAI levels in relation to the different types of body fat distribution, and (b) the effect of a prolonged period (3 months) of very low calorie diet (VLCD, 514 and 470 Kcal/day in women and men respectively) on the above mentioned variables. Only significantly higher factor VII and insulin levels were found in the subjects with the highest waist/hip ratio (WHR) values and no significant correlations were found between test results and WHR levels. After 3 months VLCD, body weight and BMI decreased markedly, and factor VII and PAI levels dropped significantly in 32/34 individuals who were compliant with the diet; changes in factor VII and PAI were correlated with decreases in BMI and apolipoprotein Al, but not with changes in insulin values or their sum after glucose load. Fibrinogen did not change significantly after diet. In conclusion, the present study in a group of highly obese subjects shows that a severe dietary restriction associated with marked weight loss consistently lowers factor VII and PAI, but not fibrinogen.

Epidemiological studies have shown that obesity, as well as haemorheological changes are risk factors for cardiovascular disease. The aim of this study performed in grossly obese subjects was to investigate: (a) the effects on haemorheological parameters of a 3 month period of very low calorie diet (VLCD, 514 and 470 Kcal/day in women and men respectively), and (b) the relationship between haemorheological test results at baseline and the different types of body fat distribution. Fifty-two obese healthy subjects (31 women), with BMI > 30, were examined at baseline; 34 of these (19 women), compliant with the diet, were also examined after 3 months VLCD. At baseline, the results of haemorheological variables were not significantly different for patients in the highest waist-to-hip ratio (WHR) tertile vs those in the other two tertiles. After VLCD, body weight and BMI decreased markedly. The values of Ht, plasma viscosity (PV), erythrocyte aggregation index (EAI) values (P < 0.001) and white blood cell (WBC) counts (P < 0.01) significantly dropped. Globulin levels decreased, while albumin levels increased leading to significantly (P < 0.001) higher A/G ratios. No significant changes in fibrinogen (Fgn) levels were recorded after diet. In conclusion, the present study demonstrates that prolonged VLCD associated with slimming in grossly obese subjects is effective in improving related haemorheological disorders, mainly of plasmatic type, except Fgn. Second, we found that, at least in these grossly obese subjects, there is no clear evidence of a relationship between the degree of haemorheological changes and WHR values.

The influence of a very-low-calorie diet (VLCD) on lipid pattern is controversial. To evaluate the long-term effect of semistarvation on lipid patterns, a group of severely obese patients [aged 37 ± 12 y, body mass index (BMI) 40.0 ± 0.9] underwent a VLCD for 8 wk. Total cholesterol (TC), LDL cholesterol (LDL-C), and HDL cholesterol (HDL-C), triglycerides (TGs), apolipoproteins A1 (apo A1) and B (apo B) were analyzed every week. TC (6.07 ± 0.23 vs 5.53 ± 0.25 mmol/L, P < 0.0008), HDL-C (mmol//L 1.26 ± 0.06 vs 1.04 ± 0.05 mmol/L, P < 0.0001), TGs (1.46 ± 0.19 vs 1.06 ± 0.10 mmol/L, P < 0.0008), and apo A1 (1.57 ± 0.06 vs 1.32 ± 0.06 g/L, P < 0.0002) decreased, whereas LDL-C and apo B showed a biphasic behavior: they significantly fell during the first 3 wk, but during the last weeks returned to their initial values.