Significant Greater Reduction Research Articles

770-P: Efficacy and Safety of Once-Weekly PB-119 Monotherapy vs. Placebo in Chinese Patients with Type 2 Diabetes in a Randomized Controlled Trial

Background: PB-119 is a novel once-weekly polyethylene glycolated exenatide developed in China for T2DM treatment. Favorable efficacy and safety profile had been demonstrated in two phase 2 studies respectively completed in US and China. Methods: In this multicenter, double-blind, placebo-controlled, 52-week phase 3 study, 273 drug-naïve Chinese patients with type 2 diabetes were randomized (1:1) to receive subcutaneous PB-119 150ug once weekly or volume-matched placebo once weekly for 24 weeks, followed by 28-week extension during which all the patients were treated with PB-119 150ug once weekly. The primary endpoint was the HbA1c change from baseline to week 24. ClinicalTrials.gov, NCT04504370 Results: At week 24, HbA1c showed a significantly decrease with PB-119 (-1.35%) than placebo (-0.51%, p<0.001). Significant more patients reached the target of HbA1c less than 7.0% in the PB-119 group versus the placebo group (50.4% vs 14.2%; p<0.001). Significant greater reduction in FPG (-1.26mmol/L vs. -0.52mmol/L) and PPG (-2.52 vs. -0.85mmol/L) were achieved (P<0.001). The remarkable glycemic lowering effect sustained till the end of week 52. Meanwhile, Insulin, C-peptide and HOMA-ß were significantly increased with PB-119 versus placebo. HOMA-IR was significantly reduced with PB-119 compared with placebo. Significant improvement of blood pressure and blood lipid profile were demonstrated with PB-119 treatment early from week 8 (TC -0.2mmol/L, LDL-C -0.19mmol/L, DBP -1.8mmHg at week 52, p<0.05 compared to the baseline). Most adverse events were mild and transient. Incidence of nausea (8%) and vomit (5.1%) were low. No Grade 2 or above hypoglycemia (< 3.0mmol/L) occurred. Conclusion: PB-119 significantly and sustainably improves glycemic control, lipid profile, blood pressure, beta-cell function and insulin resistance, and well tolerated. Dose titration is not needed. Disclosure Pegbio study group: n/a. M.Xu: None. R.Liang: None.

Discovery of new therapeutic targets in ovarian cancer through identifying significantly non-mutated genes

BackgroundMutated and non-mutated genes interact to drive cancer growth and metastasis. While research has focused on understanding the impact of mutated genes on cancer biology, understanding non-mutated genes that are essential to tumor development could lead to new therapeutic strategies. The recent advent of high-throughput whole genome sequencing being applied to many different samples has made it possible to calculate if genes are significantly non-mutated in a specific cancer patient cohort.MethodsWe carried out random mutagenesis simulations of the human genome approximating the regions sequenced in the publicly available Cancer Growth Atlas Project for ovarian cancer (TCGA-OV). Simulated mutations were compared to the observed mutations in the TCGA-OV cohort and genes with the largest deviations from simulation were identified. Pathway analysis was performed on the non-mutated genes to better understand their biological function. We then compared gene expression, methylation and copy number distributions of non-mutated and mutated genes in cell lines and patient data from the TCGA-OV project. To directly test if non-mutated genes can affect cell proliferation, we carried out proof-of-concept RNAi silencing experiments of a panel of nine selected non-mutated genes in three ovarian cancer cell lines and one primary ovarian epithelial cell line.ResultsWe identified a set of genes that were mutated less than expected (non-mutated genes) and mutated more than expected (mutated genes). Pathway analysis revealed that non-mutated genes interact in cancer associated pathways. We found that non-mutated genes are expressed significantly more than mutated genes while also having lower methylation and higher copy number states indicating that they could be functionally important. RNAi silencing of the panel of non-mutated genes resulted in a greater significant reduction of cell viability in the cancer cell lines than in the non-cancer cell line. Finally, as a test case, silencing ANKLE2, a significantly non-mutated gene, affected the morphology, reduced migration, and increased the chemotherapeutic response of SKOV3 cells.ConclusionWe show that we can identify significantly non-mutated genes in a large ovarian cancer cohort that are well-expressed in patient and cell line data and whose RNAi-induced silencing reduces viability in three ovarian cancer cell lines. Targeting non-mutated genes that are important for tumor growth and metastasis is a promising approach to expand cancer therapeutic options.

Early use of high-efficacy disease‑modifying therapies makes the difference in people with multiple sclerosis: an expert opinion

Multiple sclerosis (MS) is a chronic and progressive neurological disease that is characterized by neuroinflammation, demyelination and neurodegeneration occurring from the earliest phases of the disease and that may be underestimated. MS patients accumulate disability through relapse-associated worsening or progression independent of relapse activity. Early intervention with high-efficacy disease-modifying therapies (HE-DMTs) may represent the best window of opportunity to delay irreversible central nervous system damage and MS-related disability progression by hindering underlying heterogeneous pathophysiological processes contributing to disability progression. In line with this, growing evidence suggests that early use of HE-DMTs is associated with a significant greater reduction not only of inflammatory activity (clinical relapses and new lesion formation at magnetic resonance imaging) but also of disease progression, in terms of accumulation of irreversible clinical disability and neurodegeneration compared to delayed HE-DMT use or escalation strategy. These beneficial effects seem to be associated with acceptable long-term safety risks, thus configuring this treatment approach as that with the most positive benefit/risk profile. Accordingly, it should be mandatory to treat people with MS early with HE-DMTs in case of prognostic factors suggestive of aggressive disease, and it may be advisable to offer an HE-DMT to MS patients early after diagnosis, taking into account drug safety profile, disease severity, clinical and/or radiological activity, and patient-related factors, including possible comorbidities, family planning, and patients’ preference in agreement with the EAN/ECTRIMS and AAN guidelines. Barriers for an early use of HE-DMTs include concerns for long-term safety, challenges in the management of treatment initiation and monitoring, negative MS patients’ preferences, restricted access to HE-DMTs according to guidelines and regulatory rules, and sustainability. However, these barriers do not apply to each HE-DMT and none of these appear insuperable.

Positive Effects of Advanced Daylight Supply of Buildings on Schoolchildren—A Controlled, Single-Blinded, Longitudinal, Clinical Trial with Real Constructive Implementation

Sunlight controls endogen hormone balances and numerous health effects. Therefore, it is important to provide building users, such as schoolchildren, with sufficient daylight. Too much of it, however, leads to overheating, which is why shading systems are used. Consequently, these systems improve energy balance, but might not have positive effects on present people’s health. Within this study, shading systems were installed in classrooms of a middle school: common shading in two rooms, while two others were equipped with shading blades “Schlotterer RETROLux 80D” in an innovative design, reflecting more daylight indoors. The participating classes were divided between rooms with ordinary daylighting (n = 43) and advanced daylighting (n = 42). They spent, on average, 5 days weekly and 5–8 h daily in these classrooms. Saliva samples were collected during three semesters to detect hormonal changes. Questionnaires were collected to obtain more information about the mental alterations and, furthermore, to support the physiological results. A significant reduction in cortisol levels between 6:30 AM and 11:30 AM (p < 0.001) was observed within the group that had advanced daylighting. Questionnaires show that both groups sleep less as study duration increases (p < 0.001 time effect), but only the control group has a concurrent increase in daytime sleepiness according to relative treatment effects. The results show that increased daylight supply indoors leads to a significant greater reduction in cortisol levels of children and that those positive outcomes can be achieved by using innovative technologies for buildings.

Benefit of human moderate running boosting mood and executive function coinciding with bilateral prefrontal activation

Running, compared to pedaling is a whole-body locomotive movement that may confer more mental health via strongly stimulating brains, although running impacts on mental health but their underlying brain mechanisms have yet to be determined; since almost the mechanistic studies have been done with pedaling. We thus aimed at determining the acute effect of a single bout of running at moderate-intensity, the most popular condition, on mood and executive function as well as their neural substrates in the prefrontal cortex (PFC). Twenty-six healthy participants completed both a 10-min running session on a treadmill at 50%{dot{text{V}}text{O}}_{{{text{2peak}}}} and a resting control session in randomized order. Executive function was assessed using the Stroop interference time from the color-word matching Stroop task (CWST) and mood was assessed using the Two-Dimensional Mood Scale, before and after both sessions. Prefrontal hemodynamic changes while performing the CWST were investigated using functional near-infrared spectroscopy. Running resulted in significant enhanced arousal and pleasure level compared to control. Running also caused significant greater reduction of Stroop interference time and increase in Oxy-Hb signals in bilateral PFCs. Besides, we found a significant association among pleasure level, Stroop interference reaction time, and the left dorsolateral PFCs: important brain loci for inhibitory control and mood regulation. To our knowledge, an acute moderate-intensity running has the beneficial of inducing a positive mood and enhancing executive function coinciding with cortical activation in the prefrontal subregions involved in inhibitory control and mood regulation. These results together with previous findings with pedaling imply the specificity of moderate running benefits promoting both cognition and pleasant mood.

Reduction of cardiovascular events in patients with cardiovascular disease with the CV-polypill: a retrospective and propensity score matching study

Abstract Background Previous clinical trials suggested that a strategy based on a cardiovascular (CV) polypill improves risk factor control and reduces the incidence of CV events. The CNIC-Polyill (aspirin (ASA) 100mg, atorvastatin 20/40mg (or simvastatin 40mg) and ramipril 2,5–10mg) has shown to improve adherence and risk factors control. Methods The NEPTUNO study is a retrospective, non-interventional analysis of an anonymized medical history dataset in the BIG-PAC administrative database in the years 2015–2018. Patients at age ≥18 years with previous CV disease were allocated in four different cohorts according to their therapy: CNIC-polypill containing ASA 100mg, R 2.5/5/10mg and A 20/40mg (1:case cohort), identical mono-components (ASA,R,A) (C2), equipotent medication (ASA 100mg, simvastatin 40/80mg or rosuvastatin 5/10mg, enalapril 5–20mg or valsartan 40–160mg) (C3) and usual care (C4) (control cohorts) and were followed for 2 years. To ensure comparability of the study cohorts, a propensity score matching (PSM) was performed. The primary endpoint was the incidence first major cardiovascular event (MACE) including: myocardial infarction, angina, ischemic stroke, transitory ischemic attack, peripheral artery disease and CV mortality. Results 8,946 patients were recruited. After the PSM, 4 well-balanced cohorts of 1,614 patients were obtained. The mean age was 63.3 years and 60.4% were men. Cohort 1 (Case cohort, CNIC-polypill) compared with cohorts 2, 3 and 4 showed a significant reduction in MACEs (19.8% vs. 23.3%, 25.5% and 26.8%; p<0.001), respectively although the CV death rate (8.1% vs. 8.1%, 8.9% and 9.2%; p=0.357) did not show differences. The hazard ratio (HR) for a MACE in the CV polypill cohort vs cohort 2 was 0.761 (IC95%; 0.657–0.881), p=0.001; vs Cohort 3 was 0.821 (IC95%; 0.714–0.944), p=0.006 and vs. Cohort 4 was 0.834 (IC95%; 0.716–0,950), p=0.008. Time to the event was also longer in the CV-polypill cohort compared the other 3 cohorts (274.8 days vs 249.2 days; 226.4 days and 217 days; p<0.001). There was a significant greater reduction in the case cohort vs the 3 control cohorts in the absolute levels of all the analyzed lipidic variables (LDL (−19.6 vs. −12.9, −12.3 and −9.1 mg/dL; p<0.001), triglycerides (−67.5 vs. −59.9, −56.1 and −54.4 mg/dL; p<0.001)) and in reduction of blood pressure (PAS (−14.1 vs. −11.7, −10.4 and −10.4 mmHg; p<0.001) and PAD (−4.5 vs −2.5, −2.1, −1.2 mmHg; p<0.001)). Higher persistence to treatment in the CNIC- polypill cohort (72.1% vs. 62. 2%, 60.0% and 54.2%; p<0.001) was also found. Conclusion This study shows the reduction of clinical events by the CNIC-polypill in a large population of real-life patients. In spite of the retrospective design of this study, the results of our analysis support the use of a CV-polypill in secondary prevention of cardiovascular events. These results need to be confirmed by prospective randomized clinical trials with major clinical outcomes. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Ferrer International Figure 1

Reducing depressive symptoms and increasing positive feelings with expressive writing

This experimental study examined the effect of expressive writing on depressive symptoms. 86 undergraduate students were recruited from a private university to perform online positive experience writing (PEW) (n=31), negative experience (NEW) (n=32) and control topic (CW) (n=23) for three sessions in three consecutive weeks. The depressive symptoms of participants were measured at pre-treatment and post-treatment. It was hypothesized that PEW has significant greater reduction in depressive symptoms compared to NEW and CW based on broaden and build model. Nevertheless, results showed that PEW had significantly greater symptoms reduction than CW, yet there was no significant difference between PEW and NEW. The findings suggested that PEW might be potentially useful in reducing depressive symptoms among undergraduates.

The effects of topical erythropoietin on non-surgical treatment of periodontitis: a preliminary study

BackgroundThe purpose of periodontal treatments is to reduce inflammation, restore gingival health and clinical attachment level gain by controlling microbial plaque formation and other etiological factors. One of the drugs that has been tested in many areas and shown good anti-inflammatory properties is erythropoietin (EPO). We evaluated the effect of this drug on the improvement of periodontitis after the phase I treatment.MethodsThis study was conducted on 30 patients with stage III periodontitis who had at least two bilateral teeth with CAL of ≥ 5 mm and PPD ≥ 6 mm at ≥ 2 non‐adjacent teeth and bleeding on probing. After oral hygiene instruction and scaling and root planning (SRP), EPO gel containing a solution of 4000 units was applied deeply in the test group and placebo gel was deeply administered in the control pockets (5 times, every other day). The clinical parameters of the plaque index (PI), gingival index (GI), clinical attachment level (CAL), probing depth (PD) and bleeding index (BI) were measured at baseline and after three months of follow up. The P-value was set at 0.05.ResultsAll clinical variables improved after treatment in both groups. The BI and GI scores (which reflects the degree of gingival inflammation) showed statistically more reduction in test group. The CAL decreased from 5.1 ± 4.1 to 3.40 ± 2.71 mm; and 5.67 ± 4.32 to 4.33 ± 3.19 mm in test and control group, respectively (P < 0.00). After the treatment, there was a significant greater reduction in CAL and also PD values in test group (P < 0.01).ConclusionLocal application of EPO gel in adjunct to SRP can improve clinical inflammation and CAL gain in periodontitis.Trial registration: This study was registered at 2017-11-06 in IRCT. All procedures performed in this study were approved with ID number of IR.TUMS.DENTISTRY.REC.1396.3139 in Tehran University of medical science.

Packaging fortified with Natamycin nanoparticles for hindering the growth of toxigenic Aspergillus flavus and aflatoxin production in Romy cheese.

Objective:This study assessed the effect of cellulose sheets fortified with Natamycin-loaded alginate nanoparticles on the growth of toxigenic Aspergillus flavus and aflatoxin production on the superficial layer of Egyptian Romy cheese after 12 weeks of maturation.Materials and Methods:Toxigenic A. flavus (GenBank accession No. MT645073) was inoculated into the outer surface of Egyptian Romy cheese (at 5 log CFU/gm) and wrapped with a cellulose sheet fortified with Natamycin-loaded alginate nanoparticles. Unwrapped control contaminated Romy wheels were made as well as non-contaminated wrapped cheese wheels for sensory evaluation. Romy cheese wheels were stored at a temperature similar to commercial methods for 12 weeks. Fungal counts were enumerated during this time, and enzyme-linked immune sorbent assay detected aflatoxin after the 4th week of maturation storage.Results:In cheese samples covered with cellulose sheets containing Natamycin-loaded alginate nanoparticles, the fungal count was reduced by 2 log approximately in contrast to control samples after the 2nd week of storage. However, within the 8th week of storage, the greatest significant reduction (p < 0.05) was seen where fungal growth was hindered entirely to the end of the ripening period. The mean values for taste, color, flavor, and overall acceptability were 4, 4.7, 4.09, and 4.3, respectively. Furthermore, in the treated samples, the total aflatoxin concentration was decreased by 78.6% relative to the untreated control one.Conclusion:Using cellulose sheets fortified with Natamycin-loaded alginate nanoparticles in Egyptian Romy cheese wrapping could be an effective way of controlling A. flavus and subsequent aflatoxin production without influencing the typical taste, color, flavor, and overall appearance of traditional Romy cheese.

The combined effects of probiotics and restricted calorie diet on the anthropometric indices, eating behavior, and hormone levels of obese women with food addiction: a randomized clinical trial

ABSTRACT Background and aim Food addiction (FA) is an important contributor to obesity. Alterations in gut microbiota (GM) diversity and composition have also been proposed to play a pivotal role in obesity pathogenesis. This trial aimed to assess the effects of probiotic supplementation on the anthropometric indices, eating behavior, and hormone levels of obese women with FA Methods This randomized, double-blind, placebo-controlled clinical trial was conducted among obese women with FA. Participants (n = 62) received a restricted calorie diet (RCD) plus either probiotic, or placebo for 12 weeks. Anthropometric measurements, biochemical markers, eating behavior and appetite were assessed during the study period. Results Probiotics administration significantly reduced weight, body mass index (BMI), waist circumference (WC), waist to hip ratio (WHR), body fat percentage (BFP), and trunk fat percentage (TFP) compared to the placebo group (p < 0.001). Also, a significant improvement was observed in eating behavior in the probiotic group compared to the placebo group (p < 0.001).Serum levels of oxytocin increased and NPY decreased significantly in the probiotic group compared to the placebo group (p = 0.02, p = 0.002, respectively). Moreover, leptin level significantly decreased in the probiotic group compared to the baseline values (p < 0.001), while probiotics did not cause a greater significant reduction in leptin level, compared to the placebo group. Conclusion Multi-probiotic supplementation may have beneficial effects on anthropometric indices, eating behavior, and some appetite-regulating hormones in obese women with FA. Trial registration: Iranian Registry of Clinical Trials identifier: IRCT20131228015968N5.

Skeletal growth in class II malocclusion from childhood to adolescence: does the profile straighten?

BackgroundThere is relatively little appreciation of the changes in maxillary-mandibular relationships occurring during adolescence among subjects with normal and increased overjet. The aim of this study was to assess differences in changes in maxillo-mandibular relationships during the adolescent growth period based on the presence of a normal (< 4 mm) or increased (> 4 mm) overjet in childhood. Our hypothesis was that there is no difference in the change of the A point, nasion, B point (ANB) angle during growth between these two overjet groups. Lateral cephalograms were obtained from 65 subjects taken from the American Association of Orthodontists Foundation (AAOF) Craniofacial Growth Legacy Collections Project. Cephalograms were obtained at ages 7–10 (T0) and 14–17 (T1) with allocation into two groups based on baseline overjet (> 4 mm: group 1, 2-4 mm: group 2). Random effects linear regression was used to account for multiple within -patient measurements with dependent variables including antero-posterior skeletal pattern (based on sella, nasion, A point (SNA); sella, nasion, B point (SNB); and ANB angles).ResultsWe included a similar number of males (n = 34; 52.3%) and females (n = 31; 47.7%). The mean ANB was higher at baseline in group 1 (5.42, SD 2.16°) than in group 2 (3.08, SD 1.91°). The hypothesis was rejected as the ANB angle reduced by 1.92° more in the larger overjet group with the association being statistically significant after accounting for age and gender (P < 0.001; 95% CI 1.06 to 2.77). No significant gender-related effect (P = 0.624; 95% CI − 0.637 to 1.07) was observed overall. However, there was no significant increase in SNA angle in the > 4 mm overjet group compared to the 2–4 mm group (0.857°, P = 0.271; 95% CI − 0.669 to 2.383). The SNB angle increased by 1.15° more in the higher overjet group but there was only weak evidence of an association (P = 0.086; 95% CI − 2.464 to 0.164).ConclusionsA slight straightening of the facial profile was observed in both groups with a statistically significant greater reduction in ANB arising in the group with larger baseline overjet. This translated into a marginal reduction in the overjet in this group.

Impact of Exercise-Nutritional State Interactions in Patients with Type 2 Diabetes.

This study examines the role of nutritional status during exercise training in patients with type 2 diabetes mellitus by investigating the effect of endurance-type exercise training in the fasted versus the fed state on clinical outcome measures, glycemic control, and skeletal muscle characteristics in male type 2 diabetes patients. Twenty-five male patients (glycated hemoglobin (HbA1c), 57 ± 3 mmol·mol (7.4% ± 0.3%)) participated in a randomized 12-wk supervised endurance-type exercise intervention, with exercise being performed in an overnight-fasted state (n = 13) or after consuming breakfast (n = 12). Patients were evaluated for glycemic control, blood lipid profiles, body composition and physical fitness, and skeletal muscle gene expression. Exercise training was well tolerated without any incident of hypoglycemia. Exercise training significantly decreased whole-body fat mass (-1.6 kg) and increased high-density lipoprotein concentrations (+2 mg·dL), physical fitness (+1.7 mL·min·kg), and fat oxidation during exercise in both groups (PTIME < 0.05), with no between-group differences (PTIME × GROUP > 0.05). HbA1c concentrations significantly decreased after exercise training (PTIME < 0.001), with a significant greater reduction after consuming breakfast (-0.30% ± 0.06%) compared with fasted state (-0.08% ± 0.06%; mean difference, 0.21%; PTIME × GROUP = 0.016). No interaction effects were observed for skeletal muscle genes related to lipid metabolism or oxidative capacity. Endurance-type exercise training in the fasted or fed state do not differ in their efficacy to reduce fat mass, increase fat oxidation capacity, and increase cardiorespiratory fitness and high-density lipoprotein concentrations or their risk of hypoglycemia in male patients with type 2 diabetes. HbA1c seems to be improved more with exercise performed in the postprandial compared with the postabsorptive state.

P1841Left cardiac sympathetic denervation in patients with long QT syndrome and catecholaminergic polymorphic ventricular tachychardia: a systematic review and meta-regression

Abstract Background The evidence of benefit and safety of open surgery or Video-Assisted Thoracoscopic Surgery (VATS) for Left Cardiac Sympathetic Denervation (LCSD), for the management of patients with refractory Long QT Syndrome (LQTS) and Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), is not consistent. Purpose To undertake a systematic review and meta-regression to assess the current evidence for LCSD and to estimate the effects of the open surgery versus the VATS approach on outcomes following LCSD. Methods Databases (MEDLINE, EMBASE and Cochrane library) were searched without language or date restriction, from inception to December 2018, for studies reporting the long-term outcomes of LCSD in LQTS and CPVT patients. The number of patients experiencing cardiac events (CEs) before and after surgery, the change in QTc interval in milliseconds (ms), and the incidence of CEs and surgical complications after surgery were pooled to estimate the efficacy of LCSD in both LQTS and CPVT. A meta-regression analysis of outcomes based on the type of surgical approach (open vs VATS) was performed. Results Of 557 potentially relevant studies, 27 retrospective case series studies met our inclusion criteria, enrolling 647 patients (VATS, n=408 and Open, n=239). Average follow-up was 32 months. At the end of the follow-up period, 398/585 patients (68.0%) were free of CEs and QTc had decreased from 522±61.6 ms to 494±52.3 ms. Meta-regression analysis (14 studies, n=507) showed no differences between the two approaches in patients' responsiveness to surgery and the incidence of CEs or surgical complications. Open surgery had a statistically significant greater reduction in QTc duration than VATS (β −20.04, 95% CI −36.82 to −3.27, *p=0.019). Conclusions LCSD was associated with a reduction in the incidence of cardiac events in LQTS and CPVT patients and in the duration of QTc. Meta-regression analysis showed open surgery to be associated with a greater reduction in QTc. Higher evidence research studies are warranted to fully establish the safety and efficacy of LCSD. Acknowledgement/Funding None

5. A biomechanical investigation of the sacroiliac joint in the setting of lumbosacral fusion: the impact of pelvic fixation vs sacroiliac joint fixation

BACKGROUND CONTEXT The sacroiliac (SI) joint is a known source of lower back pain. Randomized clinical trials support sacroiliac fusion over conservative management for sacroiliac joint dysfunction. Clinical experience suggests degeneration of the sacroiliac joint in the setting of lumbosacral fusions. However, there are limited biomechanical studies to understand the effect of lumbosacral fusion on the sacroiliac joint. This study is a biomechanical investigation to understand the effect of pelvic vs sacroiliac joint fixation on the sacroiliac joint in lumbosacral fusion. Furthermore, researchers studied the effect of lumbosacral fixation on the SI joint in the absence of pelvic and SI joint fixation. PURPOSE To determine the immediate stability of various lumbopelvic fixation constructs. STUDY DESIGN/SETTING In-vitro biomechanical range of motion testing. METHODS Seven fresh-frozen human cadaver specimens were used. There was one intact and 6 operative constructs: (1) posterior pedicle screws and rods from T10–S1 (PS); (2) PS+bilateral iliac screw fixation (BIS); (3) PS+unilateral iliac screw fixation (UIS); (4) PS+UIS+3 contralateral unilateral SIJ screws (UIS+3SIJ); (5) PS+3 unilateral SIJ screws (3SIJ); and (6) PS+6 bilateral SIJ screws (6SIJ). A custom-built 6 degrees-of-freedom (6DOF) testing apparatus was used to simulate 3 bending modes: flexion extension (FE), lateral bending (LB), axial rotation (AR). Range of motion was recorded at L5–S1 and sacroiliac joint. RESULTS All 6 operative constructs had significantly reduced ROM at L5–S1 compared to the intact specimen in all 3 bending modes (p CONCLUSIONS This biomechanical investigation demonstrated the effects of various fusion constructs using pelvic and sacroiliac fixation in lumbosacral fusion. It adds biomechanical evidence to the literature showing adjacent segment stress in the SIJ in fusion constructs to S1. Unilateral pelvic fixation or SIJ fusion led to appreciable but nonsignificant reduction to the unfused contralateral SIJ. Finally, bilateral pelvic fixation showed the greatest significant reduction of movement at L5–S1 and was equivalent to bilateral sacroiliac fusion in reducing SIJ motion. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Effect of soy milk consumption on glycemic status, blood pressure, fibrinogen and malondialdehyde in patients with non-alcoholic fatty liver disease: a randomized controlled trial

ObjectiveDiet plays a critical role in the management of non-alcoholic fatty liver disease (NAFLD). Studies on the NAFLD's experimental models have reported that soy had positive effects on the improvement of metabolic parameters. However, there is a lack of clinical trials regarding the efficacy of whole soy foods. Therefore, this study was conducted to determine the effect of soy milk on some of the metabolic characteristics in patients with NAFLD. MethodsSixty-sex patients diagnosed with NAFLD were included in this randomized, parallel, controlled trial and were randomly assigned to either the soy milk or control group. Both groups received a 500-deficit calorie diet plan. Also, patients in the soy milk group consumed 240 ml/day soy milk for 8 weeks. Fasting blood sugar (FBS), serum insulin, HOMA-IR, HOMA-β%, and QUICKI as well as serum malondialdehyde (MDA), plasma fibrinogen, and blood pressure (BP) were measured at the beginning and end of the study. ResultsAfter 8-weeks of intervention, soy milk group had a greater significant reduction in serum insulin(-3.44 ± 5.02 vs. -1.09 ± 3.77 μIU/ml, P = 0.04), HOMA-IR (-0.45±0.64 vs -0.14 ± 0.47, P = 0.03), systolic (-3.81±4.15 vs -1.48±2.93 mmHg, P = 0.01) and diastolic (-2.39±2.80 vs. -0.94±2.76 mmHg, P = 0.04) BP, and also, a significant increase in QUICKI (0.02± 0.032 vs. 0.008±0.018, P = 0.04) compared to the control group. While, changes in the FBS, HOMA-β%, fibrinogen, and MDA were not significantly different between the study groups. ConclusionA low-calorie diet containing soy milk had beneficial effects on serum insulin, HOMA-IR, QUICKI, and BP in patients with NAFLD.

Effect of Participation with Accompanying Household Member in the Complete Health Improvement Program in Appalachia.

Intensive therapeutic lifestyle modification programs, such as the Complete Health Improvement Program (CHIP), reduce cardiovascular disease (CVD) risk factors. However, there are little data on how participation in CHIP with a household member can affect CVD biomarkers. This study focuses on the benefit of joint participation of household members in CHIP in order to have a better outcome in improving CVD risk factors compared with lone or individual participation. Data from 20 CHIP classes offered from 2011 to 2015 in Athens, Ohio, where each class was conducted over 2-4 months, consisting of 16-18 sessions, were collected. Body mass index (BMI), blood pressure, fasting glucose, and lipid profiles were measured before and near the completion of each class. A statistically significant greater reduction in BMI (p = 0.003) in those who attended with a household member compared to those who attended as individuals was found. CHIP has some effect on various CVD risk factors for those who attend intensive therapeutic lifestyle modification programs with an accompanying household member. Hence, encouragement of participation with a family member or a “buddy” may be prudent, especially if weight reduction is a key program participation goal. Further evaluation of the “buddy effect” involving both of those residing in the same household and those who do not but nevertheless provide mutual support is warranted.

Dentin pretreatment with 45S5 and niobophosphate bioactive glass: Effects on pH, antibacterial, mechanical properties of the interface and microtensile bond strength

ObjectivesThe aim of the study was to evaluate the effect of bioactive glass (45S5 and NbG) suspensions on bond strength (µTBS), hardness, modulus of elasticity, pH and antibacterial activity of the resin-dentin interfaces after 3 months. MethodsGroups with different concentrations (5% and 20%) of two types of glass (45S5 and NbG), and a control group (distilled water) were studied. Twenty-five extracted human third molars were etched with phosphoric acid. The data from µTBS, hardness and modulus of elasticity data were submitted to two-way ANOVA (suspension vs. time) and Holm-Sidak tests (=0.05). The antimicrobial activity data were analyzed by the Kruskal-Wallis test (α = 5%). ResultsThe interactions were significant among groups for µTBS (p = 0.033). Significant reductions in µTBS were observed after 3 months storage in PBS for the Control and 5% NbG Groups. Suspensions with 5% and 20% 45S5 glass and 20% NbG resulted in stable µTBS values and increased hardness after 3 months. Both 20% suspensions (45S5 and NbG) increased the elastic modulus. A significant greater reduction in bacterial growth was observed with the use of 20% 45S5. ConclusionRewetting dentin with the suspension of 20% 45S5 glass prevented the reduction in bond strength; increased hardness; modulus of elasticity of the resin-dentin interface, and demonstrated antibacterial activity against Streptococcus mutans.

Rye cover crop increases earthworm populations and reduces losses of broadcast, fall-applied, fertilizers in surface runoff

Corn (Zea mays L.) silage and soybean [Glycine max (L.) Merr.] rotations in the US Upper Midwest leave minimal amounts of surface residues, which can contribute to soil degradation, increased surface runoff, and reduced water quality. Planting cover crops after harvest can reduce these concerns, but their effectiveness in reducing nutrient losses in surface runoff shortly after fall planting and fertilization has not been thoroughly investigated. Therefore, we applied 65 mm of simulated rainfall in 60 min to five replicate, 1.5 by 3.0 m, field plots in a no-till, corn silage-soybean rotation into which a rye (Secale cereale L.) cover crop was planted for 14 consecutive years and to five replicate plots with no cover crop history. Natural slope of the plots ranged from 0.1 to 2.7%. The study was conducted in October 2014, about one month after corn silage harvest and rye planting and ∼1 h after broadcast application of monoammonium phosphate and potassium chloride fertilizers. The living rye cover crop significantly (P ≤ 0.05) delayed surface runoff by 5.7 min and decreased total runoff by 65% compared to plots with no cover crop. This resulted in a significant 68% reduction in sediment loss and even greater significant reductions in fertilizer nutrient losses (i.e., NH4-N - 86%; total P - 83%; total dissolved P - 84%; K - 91%). Earthworm population and biomass, measured using electrical extraction shortly after the rainfall simulations, were 1.2 and 1.4 times greater in cover crop plots than in no cover plots and 3.2 and 2.5 times greater the following spring. Our results suggested that a living cover crop and their long-term usage can contribute to improvements in soil structure and increased earthworm populations that can substantially reduce sediment and nutrient losses in surface runoff due to a severe storm shortly after post-harvest broadcast application of fertilizer.

Solitary and combined negative influences of diabetes, obesity and hypertension on health-related quality of life of elderly individuals: A population-based cross-sectional study

AimsThe health-related quality of life (HRQoL) is a matter of concern in elderly people with chronic diseases. The objective of this study was to investigate the impact of obesity, hypertension and diabetes on HRQoL among elderly. MethodsA population based cross sectional study was conducted with 750 representative sample of elderly people aged 60–90 years in Babol, the northern Iran. The demographic data and the measurement of blood pressure and other anthropometric measures were collected. The validated short form (SF-36) questionnaire was used to assess the HRQoL. A multiple linear regression model was applied to assess the impact of obesity, abdominal obesity, hypertension and diabetes on QoL. ResultsThe mean age (SD) of participants was 68.0±7.6 and 67.7±7.9 years for men and women respectively. Diabetes exerted the most negative effect on QoL score (adjusted coefficient=−9.2, 95% CI: −11.7, −6.5 points) followed by abdominal obesity and hypertension. Whereas a combination of three conditions was associated with a greater significant reduction in QoL scores in both sexes(adjusted coefficient=−14.5, 95% CI: −19.0, −9.9 points). However, the negative influence of obesity and hypertension on QoL was significant only in women. ConclusionMost components of the QoL is affected by diabetes, obesity and hypertension particularly in women. Diabetes alone or in combination with other conditions has a negative influence in both sexes with greater effect in women. These findings justify further professional support to compensate the negative influences chronic conditions on health-related QoL especially for older obese diabetic women.

Short-term efficacy to conventional blind injection versus ultrasound-guided injection of local corticosteroids in tenosynovitis in patients with inflammatory chronic arthritis: A randomized comparative study

ObjectiveTo compare the short-term efficacy of conventional blind injection (CBI) versus ultrasound-guided injection (USGI) of corticosteroids (CS) injection in tenosynovitis in patients with chronic arthritis and to investigate if the USGI is a less painful procedure and if there are differences in the changes of US findings during the post injection follow-up. MethodsPatients presenting tenosynovitis requiring CS injection were involved. After clinical and US evaluation, patients were randomized to receive CBI or USGI. Efficacy of procedure was assessed by the improvement in both Health Assessment Questionnaire (HAQ) and pain visual analogue scale (VAS), including procedure-VAS global-VAS and local-VAS, after 1 and 4 weeks post-procedure. Power Doppler (PD) and greyscale (GS) US findings were also object of the follow-up. CBI or USGI under an aseptic technique were performed according the local guidelines using 20mg of methylprednisolone acetate. ResultsA total of 114 patients were randomized to receive CBI (54 patients) or USGI (60 patients) procedure. No significant difference was observed in terms of gender, age and pain duration among CBI and USGI groups at baseline. USGI proved to be significantly less painful than CBI (P=0.0001). AUC analysis showed that during the follow up visits, the USGI procedure had significantly better response in HAQ, local-VAS and global-VAS (P=0.0001, P=0.012 and P=0.0001 respectively) compared to CBI. During the follow up period, a significant greater reduction in the PD scores was found in the USGI group compared to the CBI group (P=0.0002), whereas no statistical differences were found in the GS findings between the groups (P=0.5627). ConclusionOur study demonstrates superiority of USGI over CBI for CS injections in painful tenosynovitis, having better short-term outcomes measured by functional, clinical and US scores. These data support the use of USGI for tenosynovits in typical inpatient and/or outpatient in rheumatological practices.