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Purpose: Information on the general health of transgender and gender diverse (TGD) individuals continues to be lacking. To bridge this gap, the National Institute of Health in Italy together with the National Office against Racial Discriminations, clinical centres, and TGD organizations carried out a cross-sectional study to define the sociodemographic profile, health-related behaviours, and experiences of healthcare access in Italian TGD adult population. Methods: A national survey was conducted by Computer-Assisted Web Interviewing (CAWI) technique. Collected data were compared within the TGD subgroups and between TGD people and the Italian general population (IGP). Results: TGD respondents were 959: 65% assigned female at birth (AFAB) and 35% assigned male at birth (AMAB). 91.8% and 8.2% were binary and non-binary TGD respondents, respectively. More than 20% of the TGD population reported to be unemployed with the highest rate detectable in AMAB and non-binary people. Cigarette smoking and binge drinking were higher in the TGD population compared with IGP (p< 0.05), affecting TGD subgroups differently. A significant lower percentage of AFAB TGD people reported having had screening for cervical and breast cancer in comparison with AFAB IGP (p< 0.0001, in both cases). Over 40% was the percentage of AFAB and non-binary TGD people accessing healthcare who felt discriminated against because of their gender identity. Conclusions: Our results are a first step towards a better understanding of the health needs of TGD people in Italy in order to plan the best policy choices for a more inclusive public health.

Purpose: That thyroid hormones exert pleiotropic effects and have a contributory role in triggering seizures in patients with traumatic brain injury (TBI) can be hypothesized. We aimed at investigating thyroid function tests as prognostic factors of the development of seizures and of functional outcome in TBI. Methods: This retrospective study enrolled 243 adult patients with a diagnosis of mild-to-severe TBI, consecutively admitted to our rehabilitation unit for a 6-month neurorehabilitation program. Data on occurrence of seizures, brain imaging, injury characteristics, associated neurosurgical procedures, neurologic and functional assessments, and death during hospitalization were collected at baseline, during the workup and on discharge. Thyroid function tests (serum TSH, fT4, and fT3 levels) were performed upon admission to neurorehabilitation. Results: Serum fT3 levels were positively associated with an increased risk of late post-traumatic seizures (LPTS) in post-TBI patients independent of age, sex and TBI severity (OR = 1.85, CI 95% 1.22–2.61, p< 0.01). Measured at admission, fT3 values higher than 2.76 pg/mL discriminated patients with late post-traumatic seizures from those without, with a sensitivity of 74.2% and a specificity of 60.9%. Independently from the presence of post-traumatic epilepsy and TBI severity, increasing TSH levels and decreasing fT3 levels were associated with worse neurological and functional outcome, as well as with higher risk of mortality within 6 months from the TBI event. Conclusions: Serum fT3 levels assessed in the subacute phase post-TBI are associated with neurological and functional outcome as well as with the risk of seizure occurrence. Further studies are needed to investigate the mechanisms underlying these associations.

To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope®, a somatropin biosimilar to Genotropin®, in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study. The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope®, which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels. Here we report the data from the Italian patients enrolled in the study. Sixty-seven patients (mean age 50.4 years, 61.2% male) have been enrolled and have received a mean 45.4 ± 24.3 months of Omnitrope®. A total of 55.2% of patients were reported to have experienced adverse events (AEs), including arthralgia, myalgia, abdominal distension and hypoaesthesia, and 4.5% had adverse drug reactions. Fourteen serious AEs have been recorded; none of these are considered related to the study drug. The effectiveness of Omnitrope®was similar to other available somatropin preparations. This study confirms the effectiveness and safety of Omnitrope®in adult patients with GHD in Italy. However, due to the limited size of the study population, these results need to be further confirmed by the global PATRO Adults study.

Background: Granulosa-cells are able to produce and store leptin, suggesting that this hormone is locally involved in the regulation of follicular growth. In this study, the role of follicular fluid (FF) leptin concentration in predicting oocyte fertilization and embryo quality was evaluated in 35 normogonadotrophic women undergoing controlled ovarian stimulation (COS) for assisted reproductive techniques. Materials and Methods: Leptin concentration was measured in 47 consecutively collected FF in which a mature oocyte had been found during the ovum pick-up. Embryos deriving from fertilized oocytes were submitted to quality scoring systems. Results: Mean leptin concentration was significantly higher in FF whose oocytes showed 2 pronuclei (no. 25) when compared with those with no evidence of fertilization (no. 22) at the 16–18 h check (26.0±6.1 vs 15.3±10.6 ng/ml, respectively, p<0.01). Follicular mean diameters were similar in the two groups (21.4±3.4 and 21.0±5.1 mm, respectively). Logistic regression analysis identified FF leptin levels as the best predictive parameter for oocyte fertilization (p<0.001). When receiving operating characteristics curve was employed, a FF leptin concentration of 20.25 ng/ml was the most reliable cut-off in predicting fertilization of oocytes. FF with leptin concentrations higher than this value (no. 27) had an oocyte fertilization rate of 85.7%. In contrast, FF levels ≤20.25 ng/ml (no. 20) were associated with a rate of 16.7% (p<0.05). No correlation emerged between FF leptin and the score attributed to 15 valuable embryos at the zygote stage (r=−0.01) and at 48 h after insemination (r=0.1). Conclusions: FF leptin levels are a better predictor of oocyte fertilization success rates than follicular diameter. These results underline the relevance of FF variables in developing methods for oocyte selection.

Little is known about the association between prior gestational hyperglycemia of different severity and the subsequent risk for the metabolic syndrome. Eighty-one women with prior gestational diabetes mellitus (GDM), 25 with one abnormal value at the oral glucose tolerance test (OGTT), and 65 with normal OGTT were studied after a mean of 8.5 yr from the index pregnancy. Patients with prior gestational hyperglycemia (both one abnormal value at the OGTT and GDM) showed a worse metabolic pattern than subjects with gestational normoglycemia [respectively higher values of body mass index (BMI), waist, blood pressure, serum glucose, insulin, C-peptide, homeostatic model assessment (HOMA), fibrinogen and lower levels of HDL-cholesterol]. Prevalence of the metabolic syndrome and its components was 2–4-fold higher in women with prior gestational hyperglycemia (and 10-fold higher if pre-pregnancy obesity coexisted) when compared to normoglycemic controls; in a Cox proportional hazard model, after adjustments for age and pre-pregnancy BMI, gestational hyperglycemia and pre-pregnancy BMI predicted subsequent metabolic syndrome [respectively: hazard ratio (HR)=4.26 and HR=1.21] and most of its components. In the same model, the highest quartile of fasting serum glucose at the OGTT of the index pregnancy was significantly associated to the metabolic syndrome and its components. Gestational hyperglycemia and fasting glucose values were also associated to subsequent fibrinogen values, but not to albumin excretion rates. In young adult women, prior gestational hyperglycemia (particularly abnormal fasting glucose values), above all in combination with pre-pregnancy obesity, anticipates a subsequent syndrome at high cardiovascular risk and, possibly, a mild chronic inflammatory response.

The effect of the somatostatin analog (GHRIH-A) D-Trp8, D-Cys14on plasma levels of growth hormone, pancreatic glucagon, insulin and glucose was studied in four acromegalic patients and in four maturity-onset mild diabetics. Acromegalics received a bolus iv injection of 25 μg of GHRIH-A, followed by a continuous infusion of 25 μg in saline over an hour. Mild diabetics were submitted in two different days to two tests: arginine (30 g in 30 min) ± GHRIH-A (bolus iv injection of 25 μg followed by an infusion of 25 μg/h over 120 min) and arginine + saline. GHRIH-A lead to a significant (2 p<0.01) fall in GH basal secretion in acromegalics, and significantly reduced the GH response to arginine in maturity-onset diabetics. The inhibitory effect of insulin secretion was less impressive, but significative in both groups. No significant changes in plasma pancreatic glucagon values were noted. In mild diabetics, GHRIH-A infusion induced a small but significant increase in the blood glucose increment due to arginine. Our data suggest that this somatostatin analog may be potentially useful only when GH suppression is the main therapeutic goal to be reached, as in acromegaly and in severe diabetic retinopathy, but not in metabolic control of mild diabetic patients with a good residual insulin secretion.

This study was performed in order to investigate the possibility of rapid changes in glycosylated hemoglobin levels. Hb A1(a+b+c)values were evaluated by a chromatographic Column Test (Bio-Rad) in 20 insulin-dependent diabetic patients before and after 48 h of glycemic control obtained by an artificial pancreas (Biostator Miles). A significant decrease of glycosylated hemoglobin levels was observed: from 11.21±2.8% to 9.89±2.15% of total hemoglobin content (p< 0.005). Our data bring to the conclusion that rapid changes of glycosylated hemoglobin partially reduce, but do not abolish the clinical significance of Hb A, determination as a reliable index of long-term glycemic control in diabetic patients.

Insulin resistance in hyperthyroidism seems to depend on increased glucose production rather than on decreased glucose utilization. A decreased insulin binding on different target cells has been reported in patients in whom an in vivoevaluation of peripheral insulin sensitivity was lacking. In 20 patients with Graves’ disease (6 males, 14 females), aged 40.0 ± 2.0 yr, BMI 23.7 ± 0.7, and in 20 well-matched controls we performed the following tests: 75 g o.G.T.T., euglycemic-hyperinsulinemic clamp at 50 μU/ml combined with D-[3-3H] glucose infusion in tracer amounts, in vitroinsulin binding on circulating monocytes. Fasting plasma glucose values were similar in the two groups, whereas plasma insulin values were significantly higher in hyperthyroids (21.4 ± 2.5 vs 10.6 ± 0.6 μU/ml, p< 0.01). The values of peripheral glucose utilization (5.61 ± 0.24 vs 6.01 ± 0.22 mg/kg-min) and of total specific insulin binding (4.07 ± 0.20 vs 4.39 ± 0.23 % bound to 107cells/ml) were not significantly different in the two groups. These results indicate that in vitroand in vivodata, when recorded in the same patients, are concordant to confirm a normal peripheral tissue sensitivity to insulin in Graves’ disease.