Policaptil Gel Retard in adult subjects with the metabolic syndrome: Efficacy, safety, and tolerability compared to metformin.

Abstract Background Policaptil Gel Retard® (PGR), is a new macromolecule complex based on polysaccharides slowing the rate of carbohydrate and fat absorption. It proved to significantly reduce body weight, acanthosis nigricans expression, HbA1c levels, and glucose metabolism abnormalities in obese, hyper-insulinemic adolescents. No such data are available for adults. Aim to compare the effects of PGR vs. metformin in adult subjects with the Metabolic Syndrome (MS) and T2DM on a Low Glycemic Index diet. Subjects and methods This spontaneous clinical, longitudinal, single-blind, randomized study based on a per-protocol analysis enrolled 100 outpatients with MS and T2DM consecutively referring to our clinic for three months, and randomly assigned to either the active treatment (Group A:, 6 tablets/day) or the comparator (Group B: Metformin tablets, 1500–2000 mg/day in two divided doses during the two main meals, to minimize side effects) to be taken 30 min before each main meal in equally divided doses. Serum lipid profile, anthropometry, HOMA-IR index, and tolerability parameters were evaluated before and after a 6-month follow-up period. Results all parameters improved at a similar rate in both groups but for the lipid profile, which got even better in Group A. Group A also experienced less prominent gastrointestinal side effects than its counterpart. Conclusion For the first time, we showed the non-inferiority of PGR compared to metformin in obese adult subjects with the MS and T2DM as for glycemic control and a clear-cut superiority of PGR in terms of both serum lipid-lowering capacity and tolerability

INFOGRAPHIC MODELING BASED ON 3D LASER SURVEYING FOR INFORMED UNIVERSAL DESIGN IN ARCHAEOLOGICAL AREAS: THE CASE OF OPPIDUM OF THE ANCIENT CITY OF TUSCULUM

The valorisation of archaeological sites represents a fundamental action for the social and economic development of a country. An archaeological park is often a territory characterized by significant testimonies of antiquity of great landscape value. For this reason, it should be configured as an authentic outdoor museum, enriched by natural, environmental, architectural and urban components. In order to fulfill these requirements, it is fundamental the elaboration of a coherent scientific project of preservation, fruition and valorisation of the area, which merge the different components necessary for the establishment of an archaeological museum-park. One of the most critical aspects related to the fruition of archaeological sites is the accessibility to areas and routes, not always – if ever – designed for people with reduced mobility, also temporary (for example elderly, obese, visually impaired, etc.). In general, an established principle used in the new design is to pay attention to the so-called wide users, in accordance with the international guidelines summarized in the concept of Universal Design. In particular, this paper presents the use of three-dimensional models obtained from laser scanning surveys for the design of walking trails for people with reduced mobility in the Tusculum Archaeological-Cultural Park. The work was based on the fundamental implementation of the three-dimensional survey with terrestrial laser scanning for the construction and the control of the complex morphology of the site, and on the subsequent integration of models of the intervention in the three-dimensional reality "as-built" of the site. The obtained infographic model allowed to study and simulate the impact of the routes for people with reduced mobility, and to verify its efficiency in the historical and landscape context. Moreover, it was possible to verify the construction of other facilities in the real conditions of the site

In vitro effects of simulated microgravity on Sertoli cell function

With the advent of space flights questions concerning the effects of microgravity (0G) on human reproductive physiology have received great attention. The aim of this study was to evaluate the influence of 0G on Sertoli cells. A Sertoli cell line from mouse testis (42GPA9) was analyzed for cytoskeletal and Sex Hormone Binding Globilin (SHBG) changes by immunohistochemistry, for antioxidant content by RT-PCR and for culture medium lactate concentrations by protein chemistry. Cells were cultured for 6, 24 and 48 h on a three-dimensional Random Positioning Machine (3D-RPM); static controls (1G) were positioned on the supporting frame. At the end of each experiment, cultured cells were either fixed in paraformaldehyde or lysed and RNA-extracted or used for culture medium lactate measurements as needed. At 0G, Sertoli cytoskeleton became disorganized, microtubules fragmented and SHBG undetectable already after 24 h, with alterations worsening by 48 h. It was evident that various antioxidant systems appreciably increased during the first 24 h but significantly decreased at 48 h. No changes occurred in the 1G samples. Initially, 0G seemed to disturb antioxidant pro- tection strategies allowing the testes to support sperm production, thus generating an aging-like state of oxidative stress. Lactate pro- duction at 0G slightly decreased after 24 h. Further experiments are needed in space to investigate upon steroidogenesis and germ cell differentiation within the testis, to rule out male infertility as a possible consequence, which could be a problem, as life expectancy increases.With the advent of space flights questions concerning the effects of microgravity (0G) on human reproductive physiology have 13 received great attention. The aim of this study was to evaluate the influence of 0G on Sertoli cells. A Sertoli cell line from mouse testis 14 (42GPA9) was analyzed for cytoskeletal and Sex Hormone Binding Globilin (SHBG) changes by immunohistochemistry, for antioxidant 15 content by RT-PCR and for culture medium lactate concentrations by protein chemistry. Cells were cultured for 6, 24 and 48 h on a 16 three-dimensional Random Positioning Machine (3D-RPM); static controls (1G) were positioned on the supporting frame. At the 17 end of each experiment, cultured cells were either fixed in paraformaldehyde or lysed and RNA-extracted or used for culture medium 18 lactate measurements as needed. At 0G, Sertoli cytoskeleton became disorganized, microtubules fragmented and SHBG undetectable 19 already after 24 h, with alterations worsening by 48 h. It was evident that various antioxidant systems appreciably increased during the 20 first 24 h but significantly decreased at 48 h. No changes occurred in the 1G samples. Initially, 0G seemed to disturb antioxidant pro- 21 tection strategies allowing the testes to support sperm production, thus generating an aging-like state of oxidative stress. Lactate pro- 22 duction at 0G slightly decreased after 24 h. Further experiments are needed in space to investigate upon steroidogenesis and germ 23 cell differentiation within the testis, to rule out male infertility as a possible consequence, which could be a problem, as life expectancy 24 increase

Ions and water transmembrane transport in nervous and testicular cultured cells in low gravity conditions

Aim of the present study was to investigate on the possible alter- ations induced by on ground modeled microgravity on ion-water transport proteins at cellular level. For the purpose we used astrocytes, C6 line, neurons (NT2 line from human teratocarci- noma) and testicular cells (germ cells, Sertoli cells, and Leydig cells; primary cultures from trypsinised prepuberal pig testes). Modeled microgravity was achieved by a desktop 3D Random Positioning Machine, cultures were kept rotating for 30’, 1h and 24h. After 30’, immunopositivity for the antibodies to Na+/K+ATPase and Na+/K+/Cl- co-transporters was greatly diminished, the plasma membrane appeared to be altered, and the mitochondria inner cristae were disrupted. Immunostaining to the antibody to the water channel aquaporin 4 was very bright. After 1h at random rotation immunostaining for the heat shock protein Hsp27 was visible, After 24h, immunostaining for the ion transport proteins was again like that of the controls,plasma membrane and the mitochondria were again normal. Immunostaining for aquaporin 4 become again similar to that of the controls. We conclude that low gravity induces only tran- sient alterations in the cell’s transmembrane ion-water trans- port: the cells are able to adapt to the gravity vector changes in few hours

Adipokines and Sexual Hormones Associated with the Components of the Metabolic Syndrome in Pharmacologically Untreated Subjects: Data from the Brisighella Heart Study

We evaluated the association of the sex hormone pattern and the serum level of the main adipokines to metabolic syndrome (MS) and its components in 199 pharmacologically untreated subjects. Men and women included in the age-class subgroups were matched for body mass index, waist circumference, blood pressure, heart rate, fasting plasma glucose, and plasma lipids. Men without MS had significantly lower leptin/adiponectin ratio than men with MS. Women without MS had lower leptin and leptin/adiponectin ratio than women with MS but had significantly higher adiponectin, estrone, and dehydroepiandrosterone levels. In men, the leptin/adiponectin ratio is the main factor associated to MS diagnosis (OR: 3.36, 95% CI 1.40–8.08), while in women adiponectin alone appears to be a protective factor (OR: 0.87, 95% CI 0.79–0.95). In conclusion, in a sample of pharmacologically untreated subjects, leptin/adiponectin ratio seems to be the factor more strongly associated to MS and its components

Body composition and metabolic changes during a 520\u2011day mission simulation to Mars

Purpose The \u201cMars-500 project\u201d allowed to evaluate the changes in psychological/physiological adaptation over a prolonged confinement, in order to gather information for future missions. Here, we evaluated the impact of confinement and isolation on body composition, glucose metabolism/insulin resistance and adipokine levels. Methods The \u201cMars-500 project\u201d consisted of 520 consecutive days of confinement from June 3, 2010 to Nov 4, 2011. The crew was composed of six male subjects (three Russians, two Europeans, and one Chinese) with a median age of 31 years (range 27\u201338 years). Results During the 520-day confinement, total body mass and BMI progressively decreased, reaching a significant difference at the end (417 days) of the observation period ( 12 9.2 and 12 5.5%, respectively). Fat mass remained unchanged. A progressive and significant increase of fasting plasma glucose was observed between 249 and 417 days (+ 10/+ 17% vs baseline), with a further increase at the end of confinement (up to + 30%). Median plasma insulin showed a non-significant early increment (60 days; + 86%). Total adiponectin halved ( 12 47%) 60 days after hatch closure, remaining at this nadir ( 12 51%) level for a further 60 days. High molecular weight adiponectin remained significantly lower from 60 to 168 days. Conclusions Based on these data, countermeasures may be envisioned to balance the potentially harmful effects of prolonged confinement, including a better exercise program, with accurate monitoring of (1) the individual activity and (2) the relationship between body composition and metabolic derangement

Simulated microgravity induces nuclear translocation of Bax and BCL-2 in glial cultured C6 cells

Alterations in the control of apoptotic processes were observed in cells during space flight or under simulated microgravity, the latter obtained with the 3D-Random Positioning Machine (3D-RPM). Usually the proteins Bax and Bcl-2, act as pro- or anti-apoptotic regulators. Here we investigated the effects of simulated microgravity obtained by the 3D-RPM on cell viability, localization and expression of Bax and Bcl-2 in cultures of glial cancerous cells. We observed for the first time a transient cytoplasmic/nuclear translocation of Bax and Bcl-2 triggered by changing gravity vector. Bax translocates into the nucleus after 1 h, is present simultaneously in the cytoplasm after 6 h and comes back to the cytoplasm after 24 h. Bcl-2 translocate into the nucleus only after 6 h and comes back to the cytoplasm after 24 h. Physiological meaning, on the regulation of apoptotic event and possible applicative outcomes of such finding are discussed

Positive energy balance is associated with accelerated muscle atrophy and increased erythrocyte glutathione turnover during 5 wk of bed rest

Background: Physical inactivity is often associated with positive energy balance and fat gain. Objective: We aimed to assess whether energy intake in excess of requirement activates systemic inflammation and antioxidant defenses and accelerates muscle atrophy induced by inactivity. Design: Nineteen healthy male volunteers were studied before and at the end of 5 wk of bed rest. Subjects were allowed to spontaneously adapt to decreased energy requirement (study A, n = 10) or were provided with an activity-matched diet (study B, n = 9). Groups with higher (HEB) or lower (LEB) energy balance were identified according to median values of inactivity-induced changes in fat mass (\u394FM, assessed by bioelectrical impedance analysis). Results: In pooled subjects (n = 19; median \u394FM: 1.4 kg), bed rest-mediated decreases in fat-free mass (bioelectrical impedance analysis) and vastus lateralis thickness (ultrasound imaging) were significantly greater (P < 0.03) in HEBAB (-3.8 \ub1 0.4kg and -0.32 \ub1 0.04 cm, respectively) than in LEBab (-2.3 \ub1 0.5 kg and -0.09 \ub1 0.04 cm, respectively) subjects. In study A (median \u394FM: 1.8 kg), bed rest-mediated increases in plasma leptin, C-reactive protein, and myeloperoxidase were greater (P < 0.04) in HEBA than in LEBA subjects. Bed rest-mediated changes of glutathione synthesis rate in eythrocytes (L-[3,3-2H2]cysteine incorporation) were greater (P = 0.03) in HEBA (from 70 \ub1 19 to 164 \ub1 29%/d) than in LEBA (from 103 \ub1 23 to 84 \ub1 27%/d) subjects. Conclusions: Positive energy balance during inactivity is associated with greater muscle atrophy and with activation of systemic inflammation and of antioxidant defenses. Optimizing caloric intake may be a useful strategy for mitigating muscle loss during period of chronic inactivity

Schwannoma of the vagus nerve, a rare middle mediastinal neurogenic tumor: case report

Schwannoma originating from the vagus nerve within the mediastinum is a rare, usually benign tumor. A 44-year old male was presented with chest pain. Chest radiography, CT scan and MRI showed a well circumscribed mass, 5 × 4 cm located in the aortopulmonary window. The mass was found at surgery to be in close proximity with the aortic arch and the left pulmonary hilum, alongside the left vagus nerve. The encapsulated tumor was completely resected through a left thoracotomy incision and it was found to be a benign schwannoma in pathology. The patient is free of recurrence 6 years after surgery