Pasta Consumption and Connected Dietary Habits: Associations with Glucose Control, Adiposity Measures, and Cardiovascular Risk Factors in People with Type 2 Diabetes-TOSCA.IT Study.

BACKGROUND: Pasta is a refined carbohydrate with a low glycemic index. Whether pasta shares the metabolic advantages of other low glycemic index foods has not really been investigated. The aim of this study is to document, in people with type-2 diabetes, the consumption of pasta, the connected dietary habits, and the association with glucose control, measures of adiposity, and major cardiovascular risk factors. METHODS: We studied 2562 participants. The dietary habits were assessed with the European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaire. Sex-specific quartiles of pasta consumption were created in order to explore the study aims. RESULTS: A higher pasta consumption was associated with a lower intake of proteins, total and saturated fat, cholesterol, added sugar, and fiber. Glucose control, body mass index, prevalence of obesity, and visceral obesity were not significantly different across the quartiles of pasta intake. No relation was found with LDL cholesterol and triglycerides, but there was an inverse relation with HDL-cholesterol. Systolic blood pressure increased with pasta consumption; but this relation was not confirmed after correction for confounders. CONCLUSIONS: In people with type-2 diabetes, the consumption of pasta, within the limits recommended for total carbohydrates intake, is not associated with worsening of glucose control, measures of adiposity, and major cardiovascular risk factors.

Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial.

BACKGROUND: The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. METHODS: TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50-75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2-3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15-45 mg) or a sulfonylurea (5-15 mg glibenclamide, 2-6 mg glimepiride, or 30-120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. FINDINGS: Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 per 100 person-years) who were given sulfonylureas (hazard ratio 0·96, 95% CI 0·74-1·26, p=0·79). Fewer patients had hypoglycaemias in the pioglitazone group than in the sulfonylureas group (148 [10%] vs 508 [34%], p<0·0001). Moderate weight gain (less than 2 kg, on average) occurred in both groups. Rates of heart failure, bladder cancer, and fractures were not significantly different between treatment groups. INTERPRETATION: In this long-term, pragmatic trial, incidence of cardiovascular events was similar with sulfonylureas (mostly glimepiride and gliclazide) and pioglitazone as add-on treatments to metformin. Both of these widely available and affordable treatments are suitable options with respect to efficacy and adverse events, although pioglitazone was associated with fewer hypoglycaemia events. FUNDING: Italian Medicines Agency, Diabete Ricerca, and Italian Diabetes Society.

Polyphenol intake and cardiovascular risk factors in a population with type 2 diabetes: The TOSCA.IT study.

BACKGROUND: The role of polyphenol intake on cardiovascular risk factors is little explored, particularly in people with diabetes. AIM: To evaluate the association between the intake of total polyphenols and polyphenol classes with the major cardiovascular risk factors in a population with type 2 diabetes. METHODS: Dietary habits were investigated in 2573 males and females participants of the TOSCA.IT study. The European Prospective Investigation on Cancer and Nutrition (EPIC) questionnaire was used to assess dietary habits. In all participants, among others, we assessed anthropometry, plasma lipids, blood pressure, C-reactive protein and HbA1c following a standard protocol. The USDA and Phenol-Explorer databases were used to estimate the polyphenol content of the habitual diet. RESULTS: Average intake of polyphenols was 683.3 ± 5.8 mg/day. Flavonoids and phenolic acids were the predominant classes (47.5% and 47.4%, respectively). After adjusting for potential confounders, people with the highest intake of energy-adjusted polyphenols (upper tertile) had a more favorable cardiovascular risk factors profile as compared to people with the lowest intake (lower tertile) (BMI was 30.7 vs 29.9 kg/m2, HDL-cholesterol was 45.1 vs 46.9 mg/dl, LDL-cholesterol was 103.2 vs 102.1 mg/dl, triglycerides were 153.4 vs 148.0 mg/dl, systolic and diastolic blood pressure were respectively 135.3 vs 134.3 and 80.5 vs 79.6 mm/Hg, HbA1c was 7.70 vs 7.67%, and C-reactive Protein was 1.29 vs 1.25 mg/dl, p < .001 for all). The findings were very similar when the analysis was conducted separately for flavonoids or phenolic acids, the two main classes of polyphenols consumed in this population. CONCLUSIONS: Polyphenol intake is associated with a more favorable cardiovascular risk factors profile, independent of major confounders. These findings support the consumption of foods and beverages rich in different classes of polyphenols particularly in people with diabetes. CLINICAL TRIAL: http://www.clinicaltrials.gov; Study ID number: NCT00700856.

Post-traumatic stress disorder, coping strategies and type 2 diabetes: psychometric assessment after L'Aquila earthquake.

AIM: After natural and collective catastrophes, many behavioral phenomena can occur through psychobiological responses that involve also the diabetic condition.The aim of this study was to investigate post-traumatic stress disorder (PTSD) and coping strategies in type 2 diabetic patients after L'Aquila earthquake, with a particular attention to the newly diagnosed patients and to the gender differences. METHODS: Among the local diabetic population, we recruited 100 diabetic patients (46 women and 54 men). Sixty of these had diabetes before the earthquake (pre-quake patients), and other 40 received diabetes diagnosis after the earthquake (post-quake patients). A psychometric protocol composed by Davidson Trauma Scale for PTSD and Brief-COPE for coping strategies was administered. RESULTS: We found significant differences in the levels of PTSD when comparing both post-quake with pre-quake patients (post-quake = 51.72 ± 26.05 vs. pre-quake = 31.65 ± 22.59; p < 0.05) and the female patients with males (women = 53.50 ± 27.01 vs. men = 31.65 ± 23.06; p < 0.05) and also in the prevalence [post-quake = 27/40 (67.5 %) vs. pre-quake = 20/60 (33.3 %); p < 0.05], [women = 27/46 (58.69 %) vs. men = 16/54 (29.62 %); p < 0.05]. Moreover, maladaptive coping was a predictive factor for PTSD in the post-quake group only (OR 1.682; 95 % CI 1.155-2.450; p = 0.006). CONCLUSIONS: Our results revealed that PTSD may be considered an important comorbidity factor in newly diagnosed patients and in diabetic women. Hence, a psychological support seems particularly important in these patients after a collective traumatic event to help them react to both PTSD and diabetes and to help them improve their coping skills.

Possible correlation between type 1 diabetes mellitus and female sexual dysfunction: case report and literature review.

INTRODUCTION: Sexual dysfunction in diabetic women has received less attention in clinical research than the sexual symptoms of diabetic men. Although conflicting results have been reported, several studies suggest an increased prevalence of deficient vaginal lubrication in women with diabetes mellitus. As support to the hypothesis of a potential diabetes-related arousal dysfunction caused by a decrease in vaginal lubrication of women with Type 1 diabetes mellitus, we describe the following case report. METHODS: A 29-year-old white woman was found with a sexual arousal disorder of sudden onset, complicated by loss of orgasm and sexual desire, in absence of any marital, relational, psychological, or gynecological cause. RESULTS: One month later she was diagnosed with severe Type 1 diabetes. With the correction of diabetes and without other treatment of the sexual dysfunction, she experienced a full recovery of her sexual complaints. CONCLUSIONS: The case illustrates the importance of being aware of female sexual dysfunction as an early symptom of diabetes mellitus and suggests that a good glycemic control would be fundamental to restore a normal sexual activity in diabetic women. It also demonstrates the need to take into account, not only in males, a sexual history in the management of diabetes mellitus.