BackgroundThis prospective, open-label, non-comparative, multicentre, long-term phase IV study is examining the efficacy and safety of somatropin [recombinant human growth hormone (rhGH)] in short children born small for gestational age (SGA) and its impact on the incidence of diabetes. This report is the first interim analysis of patients who have completed 1 year of treatment.MethodsA total of 278 pre-pubertal patients were enrolled. Key eligibility criteria included height standard deviation score (HSDS) <−2.5; parental adjusted SDS <−1; birth weight and/or length <−2 SD and failure to show catch-up growth by ≥4 years of age. Patients were treated with rhGH 0.035 mg/kg/day. The primary objective was to evaluate the long-term effect of rhGH on carbohydrate metabolism [including fasting glucose, stimulated glucose (2-h oral glucose tolerance test, OGTT) and glycated haemoglobin (HbA1c)]. Secondary objectives included evaluation of height parameters [body height, HSDS, height velocity (HV), HVSDS]; insulin-like growth factor 1 (IGF-I) and insulin-like growth factor-binding protein 3 (IGFBP-3) serum levels during treatment; and incidence and severity of adverse events (AEs).ResultsNone of the children developed diabetes mellitus within the first year of treatment. Mean levels of fasting glucose, HbA1c and 2-h OGTT values remained stable during the study period. Treatment with rhGH was effective, as documented by all height parameters. Mean HSDS improved from −3.39 at baseline to −2.57 at Year 1. Mean HV increased markedly from 4.25 cm/year at baseline to 8.99 cm/year during the first year. Similarly, mean peak-centred HVSDS increased from −2.13 at baseline to +4.16 at Year 1. Mean IGF-I SDS and IGFBP-3 SDS also increased within the first year (by +1.80 and +0.41, respectively). 13 patients (4.7%) did not respond adequately to treatment (HVSDS <1); they were withdrawn from the study. In total, 192 children (69.3%) experienced treatment-emergent AEs; most (98.7%) were mild-to-moderate, and the majority (96.5%) were unrelated to study treatment.ConclusionThis interim analysis shows that short children born SGA can be effectively and safely treated with rhGH and that rhGH treatment has no major impact on carbohydrate metabolism after the first year of treatment.Electronic supplementary materialThe online version of this article (doi:10.1007/s13554-014-0014-4) contains supplementary material, which is available to authorized users.

Background and aim. The goals of bariatric surgery are to improve the quality of life by lowering body mass index (BMI) but also to treat obesity comorbidities. The aim of our study was to evaluate the impact of laparoscopic sleeve gastrectomy (LSG) on metabolic parameters. Methods. 85 obese patients treated by bariatric surgery LSG procedure were included in the study. Basal, 6 and 12 months after surgery serum glucose levels and lipid fractions were measured. Metabolic syndrome criteria according to IDF 2006 were evaluated at baseline and after bariatric surgery. Results. Our group included 61.2 % female patients, the mean age was 40.2 ±10.2 years and the metabolic syndrome criteria at baseline were confirmed in 69.4% of the study group. At twelve months after the intervention, the mean excess weight loss (%EWL) was 72%, with age and BMI subgroups variations. We found significant improvements of serum concentrations for triglycerides (P-value = 0.001, decreased by 30%), HDL-cholesterol (P-value = 0.017, increased by 26%), total cholesterol (P-value = 0.043, decreased by 12%) and glucose (P-value = 0.007, decreased by 12%). Conclusions. The positive effect of bariatric surgery was confirmed for lipid fractions and fasting glucose levels, also the metabolic syndrome prevalence was significantly reduced, all these changes contribute to lower cardiovascular risk together with significant weight loss.

No abstract

No abstract

No abstract