Long-term efficacy and safety of enavogliflozin in Korean people with type 2 diabetes: A 52-week extension of a Phase 3 randomized controlled trial.

AIMS: To evaluate the long-term safety and efficacy of enavogliflozin monotherapy (0.3 mg/day) in individuals with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: Following a 24-week randomized, double-blind treatment period with enavogliflozin 0.3 mg/day (n = 77) or placebo (n = 69), consenting participants received enavogliflozin 0.3 mg/day for an additional 28 weeks during an open-label extension (OLE) period. The safety and efficacy of enavogliflozin were assessed at Week 52. RESULTS: A total of 37 participants continued enavogliflozin (maintenance group), and 26 participants switched from placebo to enavogliflozin (switch group). No additional adverse drug reactions related to enavogliflozin were observed during the OLE period. At Week 52, glycated haemoglobin (HbA1c) and fasting plasma glucose were significantly lower than at the baseline, by 0.9% and 24.9 mg/dL, respectively, in the maintenance group (p < 0.0001 for both), and by 0.7% and 18.0 mg/dL, respectively, in the switch group (p < 0.0001 and p = 0.002). The proportions of participants reaching HbA1c 7.0% (53 mmol/mol) at Week 52 were 69.4% in the maintenance group and 65.4% in the switch group. A significant increase in urine glucose-to-creatinine ratio was observed at Week 52, by 84.9 g/g and 67.1 g/g in the maintenance and switch groups, respectively (p < 0.0001 for both). Body weight in both groups decreased significantly (p < 0.0001) from baseline to Week 52, by 3.5 kg and 3.8 kg in the maintenance and switch groups, respectively. CONCLUSIONS: Enavogliflozin 0.3 mg monotherapy provides long-term glycaemic control in T2DM and is safe and well tolerated during a 52-week treatment period.

Cytotoxic Peptaibols from Trichoderma strigosum.

Five new lipopeptaibols (1-5) and eight new 19-residue peptaibols (8-15) along with two known lipopeptaibols, lipovelutibols C (6) and D (7) were isolated from Trichoderma strigosum. The planar structures of the newly discovered peptaibols (1-5, 8-15) were elucidated using 1D and 2D NMR, and UPLC-MS/MS data. The absolute configurations for new peptaibols (1-5, 8-15) were elucidated using the advanced Marfey's method and GITC (2,3,4,6-tetra-O-acetyl-ß-d-glucopyranosyl isothiocyanate) derivatization. Through analysis of CD spectra, these peptabols were found to have right-handed helical conformations. While most of the new compounds were significantly more active than the positive control, 9, 10, 12, and 15 containing Ser and Leu at positions 10 and 11, respectively, were the most cytotoxic against MDA-MB-231, SNU449, SKOV3, DU145, and HCT116 cancer cell lines, and the 19-residue peptaibols were generally more potent than lipopeptaibols.

Selection of climate variables in ant species distribution models: case study in South Korea.

The selection of explanatory variables is important in modeling prediction of changes in species distribution in response to climate change. In this study, we evaluated the importance of variable selection in species distribution models. We compared two different types of models for predicting the distribution of ant species: temperature-only and both temperature and precipitation. Ants were collected at 343 forest sites across South Korea from 2006 through 2009. We used a generalized additive model (GAM) to predict the future distribution of 16 species that showed significant responses to changes in climatic factors (temperature and/or precipitation). Four types of GAMs were constructed: temperature, temperature with interaction of precipitation, temperature and precipitation without interaction, and temperature and precipitation with interaction. Most species displayed similar results between the temperatureonly and the temperature and precipitation models. The results for predicted changes in species richness were different from the temperature-only model. This indicates higher uncertainty in the prediction of species richness, which is obtained by combining the prediction results of distribution change for each species, than in the prediction of distribution change. The turnover rate of the ant assemblages was predicted to increase with decreases in temperature and increases in elevation, which was consistent with other studies. Finally, our results showed that the prediction of the distribution or diversity of organisms responding to climate change is uncertain because of the high variability of the model outputs induced by the variables used in the models.

Development of a Protocol for the Direct Breastfeeding of Premature Infants in Neonatal Intensive Care Units.

PURPOSE: This study aimed to develop a direct breastfeeding protocol for premature infants admitted to neonatal intensive care units (NICUs) and investigate its efficacy. BACKGROUND: Direct breastfeeding increases the amount and duration of breastfeeding. However, NICUs have low direct feeding rates owing to medical staff anxiety, lack of knowledge and experience, and fear of overwork. Accordingly, this study developed a protocol for direct breastfeeding in the NICU and evaluated its effect. METHODS: The protocol was developed through a literature review, expert validation, and preliminary investigation. Its application effects were identified using a nonexperimental, evidence-based research design targeting premature infants, their mothers, and NICU nurses. RESULTS: The protocol comprised 5 areas and 23 items. Application of the protocol resulted in continuous weight gain of the infants and increased self-efficacy in the mothers' direct breastfeeding ( t = 3.219, P = .004). Significant increases were noted in NICU nurses' direct breastfeeding activities ( t = 3.93, P < .001), breastfeeding rates in the NICU ( P = .037), and direct breastfeeding rates ( P = .007). CONCLUSIONS: Results underscore the value of an evidence-based protocol for improving breastfeeding rates in premature infants. This study highlights the need for continuous nursing education on protocol applications and human resource support.

Alcohol-induced increase in BMP levels promotes fatty liver disease in male prediabetic stage Otsuka Long-Evans Tokushima Fatty rats.

Alcohol consumption exacerbates liver abnormalities in animal models, but whether it increases the severity of liver disease in early diabetic or prediabetic rats is unclear. To investigate the molecular mechanisms underlying alcohol-induced liver steatosis or hepatitis, we used a prediabetic animal model. Otsuka Long-Evans Tokushima Fatty (OLETF) and Long-Evans Tokushima Fatty (LETO) rats were pair-fed with an ethanol-containing liquid diet for 6 weeks. Compared with controls, OLETF and LETO rats displayed more pronounced liver steatosis and higher plasma levels of serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SPGT), indicating liver injury. Ethanol-fed LETO (Pd-L-E) rats showed mild liver steatosis and no inflammation compared with ethanol-fed OLETF (Pd-O-E) rats. Although precursor and active SREBP-1 levels in the liver of ethanol-fed OLETF rats significantly increased compared with control diet-fed OLETF rats (Pd-O-C), those of Pd-L-E rats did not. Bone morphogenetic protein (BMP) and TGF-ß1 balance in Pd-O-E rats was significantly altered because BMP signaling was upregulated by inducing BMP2, BMP4, BMP7, BMP9, Smad1, and Smad4, whereas TGF-ß1, Smad3, and Erk were downregulated. Activation of TGF-ß/Smad signaling inhibited BMP2 and BMP9 expression and increased epithelial-mesenchymal transition (EMT) marker levels (Hepcidin, Snail, and Twist) in the liver of LETO rats. Livers of ethanol-fed OLETF rats showed increased levels of vimentin, FSP-1, α-SMA, MMP1, MMP13, and collagen III compared with rats of other groups, whereas EMT marker levels did not change. Thus, BMP exerted anti- and/or pro-fibrotic effects in ethanol-fed rats. Therefore, BMP and TGF-ß, two key members of the TGF-ß superfamily, play important but diverse roles in liver steatosis in young LETO and OLETF rats.

Lipid raft protein flotillin-1 is important for the interaction between SOS1 and H-Ras/K-Ras, leading to Ras activation.

Ras mutations have been frequently observed in human cancer. Although there is a high degree of similarity between Ras isomers, they display preferential coupling in specific cancer types. The binding of Ras to the plasma membrane is essential for its activation and biological functions. The present study elucidated Ras isoform-specific interactions with the membrane and their role in Ras-mediated biological activities. We investigated the role of a lipid raft protein flotillin-1 (Flot-1) in the activations of Ras. We found that Flot-1 was co-localized with H-Ras, but not with N-Ras, in lipid rafts of MDA-MB-231 human breast cells. The amino-terminal hydrophobic domain (1-38) of Flot-1 interacted with the hypervariable region of H-Ras. The epidermal growth factor-stimulated activation of H-Ras required Flot-1 which was not necessary for that of N-Ras in breast cancer cells. Flot-1 interacted with son of sevenless (SOS)-1, which promotes the conversion of Ras-bound GDP to GTP. Notably, Flot-1 was crucial for the interaction between SOS1 and H-Ras/K-Ras in breast and pancreatic cancer cells. Stable knockdown of Flot-1 reduced the in vivo metastasis in a mouse xenograft model with human breast carcinoma cells. A tissue microarray composed of 61 human pancreatic cancer samples showed higher levels of Flot-1 expression in pancreatic tumor tissues compared to normal tissues, and a correlation between K-Ras and Flot-1. Taken together, our findings suggest that Flot-1 may serve as a membrane platform for the interaction of SOS1 with H-Ras/K-Ras in human cancer cells, presenting Flot-1 as a potential target for Ras-driven cancers.

Psychometric properties of the Korean version of the Palliative Care Nursing Self-Competence scale for infant use.

BACKGROUND: Despite the significant advances in neonatal treatment and care over the past 30 years, palliative care in the neonatal intensive care unit has not been fully provided in South Korea. Neonatal nurses are essential professionals in palliative care as they are directly involved in the care, but there is little information on their palliative care competency because no assessment instrument is available in Korea. OBJECTIVES: The aim of this study was to develop and test the validity and reliability of the Korean version of the Palliative Care Nursing Self-Competence scale for neonatal palliative care. METHODS: This scale for infant care was developed through parallel translation techniques and revised based on cognitive interviews. Survey data were then collected from 220 neonatal nurses who worked in 13 neonatal intensive care units in Korea. Internal consistency reliability, construct validity based on exploratory factor analysis, and criterion-related validity were tested. RESULTS: The final version of the scale included 40 items in five domains that explained 53.4% of the variance. Criterion-related validity was confirmed based on a positive correlation with the Korean version of the attitudes towards neonatal palliative care measurement tool. The Cronbach's alpha for the scale was 0.95. CONCLUSIONS: The Korean version of the Palliative Care Nursing Self-Competence scale for infant care has satisfactory construct validity and reliability to measure palliative care self-competence of neonatal nurses in Korea and evaluate an education program in future studies.

cDNA-Derived RNA Phage Assembly Reveals Critical Residues in the Maturation Protein of the Pseudomonas aeruginosa Leviphage PP7.

PP7 is a leviphage, with a single-stranded RNA genome, that infects Pseudomonas aeruginosa PAO1. A reverse genetic system for PP7 was previously created by using reverse-transcribed cDNA (PP7O) from a virion-derived RNA genome. Here, we have found that the PP7O cDNA contained 20 nucleotide differences from the PP7 genome sequence deposited in the database. We created another reverse genetic system exploiting chemically synthesized cDNA (PP7S) based on the database sequence. Unlike PP7O, which yielded infectious PP7 virions, PP7S-derived particles were incapable of plaque formation on PAO1 cells, which was restored in the PAO1 cells expressing the maturation protein (MP) from PP7O Using this reverse genetic system, we revealed two amino acid residues involved in the known roles of MP (i.e., adsorption and genome replication), fortuitously providing a lesson that the viral RNA genome sequencing needs functional verification, possibly by a reverse genetic system.IMPORTANCE The biological significance of RNA phages has been largely ignored, ironically, because few studies have focused on RNA phages. As an initial attempt to properly represent RNA phages in the phageome, we previously created, by using reverse-transcribed cDNA, a reverse genetic system for the small RNA phage PP7, which infects the opportunistic human pathogen Pseudomonas aeruginosa We report another system by using chemically synthesized cDNA based on the database genome that has 20 nucleotide differences from the previous cDNA. Investigation of those cDNA-derived phage virions revealed that two amino acids of the maturation protein are crucial for the normal phage lifecycle at different steps. Our study provides insight into the molecular basis for the RNA phage lifecycle and a lesson that the RNA genome sequencing needs to be carefully validated by cDNA-based phage assembly systems.

A double-blind, Randomized controlled trial on glucose-lowering EFfects and safety of adding 0.25 or 0.5 mg lobeglitazone in type 2 diabetes patients with INadequate control on metformin and dipeptidyl peptidase-4 inhibitor therapy: REFIND study.

AIMS: To compare the efficacy and safety of adding low-dose lobeglitazone (0.25 mg/day) or standard-dose lobeglitazone (0.5 mg/day) to patients with type 2 diabetes mellitus (T2DM) with inadequate glucose control on metformin and dipeptidyl peptidase (DPP4) inhibitor therapy. MATERIALS AND METHODS: In this phase 4, multicentre, double-blind, randomized controlled, non-inferiority trial, patients with T2DM insufficiently controlled by metformin and DPP4 inhibitor combination therapy were randomized to receive either low-dose or standard-dose lobeglitazone. The primary endpoint was non-inferiority of low-dose lobeglitazone in terms of glycaemic control, expressed as the difference in mean glycated haemoglobin levels at week 24 relative to baseline values and compared with standard-dose lobeglitazone, using 0.5% non-inferiority margin. RESULTS: At week 24, the mean glycated haemoglobin levels were 6.87 ± 0.54% and 6.68 ± 0.46% in low-dose and standard-dose lobeglitazone groups, respectively (p = .031). The between-group difference was 0.18% (95% confidence interval 0.017-0.345), showing non-inferiority of the low-dose lobeglitazone. Mean body weight changes were significantly greater in the standard-dose group (1.36 ± 2.23 kg) than in the low-dose group (0.50 ± 1.85 kg) at week 24. The changes in HOMA-IR, lipid profile and liver enzyme levels showed no significant difference between the groups. Overall treatment-emergent adverse events (including weight gain, oedema and hypoglycaemia) occurred more frequently in the standard-dose group. CONCLUSIONS: Adding low-dose lobeglitazone to metformin and DPP4 inhibitor combination resulted in a non-inferior glucose-lowering outcome and fewer adverse events compared with standard-dose lobeglitazone. Therefore, low-dose lobeglitazone might be one option for individualized strategy in patients with T2DM.

USP37 Deubiquitinates CDC73 in HPT-JT Syndrome.

The CDC73/HRPT2 gene, a defect which causes hyperparathyroidism-jaw tumor (HPT-JT) syndrome, encodes CDC73/parafibromin. We aimed to investigate whether CDC73 would be a target for ubiquitin-proteasome degradation. We cloned full-length cDNAs encoding a family of 58 ubiquitin-specific deubiquitinating enzymes (DUBs), also known as ubiquitin-specific proteases (USPs). Use of the yeast two-hybrid system then enabled us to identify USP37 as interacting with CDC73. The biochemical interaction between the USP37 and CDC73 and their reciprocal binding domains were studied. Co-localization of CDC73 and USP37 was observed in cells. CDC73 was found to be polyubiquitinated, and polyubiquitination of CDC73 was prominent in mutants. CDC73 was deubiquitinated via K48-specific ubiquitin chains by USP37, but not by the catalytically inactive USP37C350S mutant. Observation of the binding between deletion mutants of CDC73 and USP37 revealed that the ß-catenin binding site of CDC73 and the ubiquitin-interacting motifs 2 and 3 (UIM2 and 3) of USP37 were responsible for the interaction between the two proteins. Moreover, these two enzymes co-existed within the nucleus of COS7 cells. We conclude that USP37 is a DUB for CDC73 and that the two proteins interact through specific domains, suggesting that USP37 is responsible for the stability of CDC73 in HPT-JT syndrome.

Growth Trajectories of Peer Norms, Self-efficacy and Condom Use Behavior Among Sexually Active Chinese Men Who Have Sex with Men: Latent Class Analysis and Growth Mixture Modeling.

Data from a randomized controlled trial in 2015 were used to estimate the growth trajectories of peer norms, self-efficacy, and condom use behavior, and to identify associated sociodemographic and behavioral factors among a sample of 804 Chinese men who have sex with men (MSM). Latent class analysis and growth mixture modeling were conducted using Mplus. Two growth trajectories were estimated for each outcome variable with good model fit. The growth trajectories of peer norms were related to age (ß = - 0.066, p < 0.05). The growth trajectories of self-efficacy were related to age (ß = 0.057, p < 0.01) and using a condom during first sexual encounter with another man (ß = 0.777, p < 0.001). The growth trajectories of condom use behavior were related to income (ß = 0.366, p < 0.01) and having casual male partners (ß = - 1.016, p < 0.001). Predictors for the growth factors within each latent class were also estimated. For subsets of MSM who are older, richer, used a condom during their first sexual encounter with another man, and do not have a casual male partner, condom videos may not have sufficient efficacy and other interventions may be necessary.

Mediation Analysis of Peer Norms, Self-Efficacy, and Condom Use Among Chinese Men Who Have Sex with Men: A Parallel Process Latent Growth Curve Model.

The objective of this study was to examine direct and indirect relationships among peer norms, self-efficacy, and condom use among Chinese men who have sex with men (MSM). A longitudinal study determined the effectiveness of a condom use video promotion among Chinese MSM in 2015. In this analysis, 804 Chinese MSM were recruited at baseline and then followed at 3 weeks and 3 months after the intervention. Parallel process latent growth curve modeling (LGM) with multiple indicators and bootstrapping was conducted using Mplus 7.4. The LGM model fit indexes were good with RMSEA = 0.046, 90% CI (0.044, 0.048), CFI = 0.956, TLI = 0.955. Our results showed that the initial measure of peer norms affected the initial measure of condom use indirectly through the initial measure of self-efficacy (αß = 0.414, 95% CI 0.260-0.759). The rate of change in peer norms over time also significantly affected the rate of change in condom use through the rate of change in self-efficacy (αß = 0.101, 95% CI 0.014-0.262). Self-efficacy mediated the association between peer norms and condom use, indicating a strong potential of causal relationship between peer norms and self-efficacy among Chinese MSM.

Should Total Thyroidectomy Be Recommended for Patients with Familial Non-medullary Thyroid Cancer?

BACKGROUND: It is unknown whether familial non-medullary thyroid cancer (FNMTC) has more aggressive clinical features and a worse prognosis than sporadic non-medullary thyroid cancer (SNMTC). METHODS: We retrospectively reviewed 2894 patients with differentiated thyroid cancer who underwent primary thyroidectomy, identified 391 FNMTC cases, and compared the prevalence, surgical extension, and clinicopathologic features of FNMTC and SNMTC. RESULTS: A family history of thyroid cancer was noted in 391 patients (13.5%), with 85% having two affected relatives and 15% with ≥3 affected relatives. A sibling was affected in 52.9% of cases, and in 47.1%, both parent and child were affected. There were no significant between-group differences in sex, age, tumor size, extrathyroidal extension, or central lymph node metastases. Significantly more patients with FNMTC exhibited multifocal disease (p = 0.020) or benign nodules (p = 0.015). Lateral neck lymph node metastases were noted in 6.6% (SNMTC) and 9.7% (FNMTC, p = 0.021) of patients. Multifocality and combined benign masses were more frequently observed in patients with FNMTC in multivariate analysis. In the FNMTC group, seven experienced disease recurrence, with no mortality noted during follow-up. CONCLUSIONS: FNMTC is not more aggressive than SNMTC; however, FNMTC should be treated with total thyroidectomy because of the increased disease multifocality and the presence of benign nodules. Lateral neck lymph node metastases were more likely in patients with FNMTC, although we could not estimate prognosis. All patients with thyroid cancer should be checked for family disease history and undergo preoperative ultrasonography to determine the extent of node dissection and the need for total thyroidectomy.

Enhancing effects of anagliptin on myoblast differentiation and the expression of mitochondrial biogenetic factors in C2C12 mouse skeletal muscle cells.

To investigate the regulatory effects of anagliptin, a DPP-IV inhibitor used to treat type 2 diabetes mellitus (T2DM), on myoblast differentiation and mitochondrial biogenesis in C2C12 mouse skeletal muscle cells. C2C12 myoblasts were differentiated into myotubes and then treated with anagliptin (10, 25, and 50 µmol/L) for 24 hours. In C2C12 myotubes, anagliptin treatment was significantly increased the expression of MHC, PGC1α, Sirt-1, NRF-1, and TFAM and the phosphorylation of AMPK and ACC in a concentration-dependent manner. Anagliptin also significantly increased the total ATP levels in the myotubes. These results suggest that anagliptin can help prevent skeletal muscle dysfunction in T2DM by promotion of myoblast differentiation and enhancement of energy production via upregulation of mitochondrial biogenetic factors and activation of the AMPK/ACC signalling pathway.

An oncogenic activity of PDGF-C and its splice variant in human breast cancer.

Despite strong evidence for the involvement of PDGF signaling in breast cancer, little is known about the PDGF ligand responsible for PDGFR activation during breast cancer progression. Here, we found PDGF-C to be highly expressed in breast carcinoma cell lines. Immunohistochemical analysis of invasive breast cancer revealed an association between increased PDGF-C expression and lymph node metastases, Ki-67 proliferation index, and poor disease-free survival. We also identified a PDGF-C splice variant encoding truncated PDGF-C (t-PDGF-C) isoform lacking the signal peptide and the N-terminal CUB domain. While t-PDGF C homodimer is retained intracellularly, it can be secreted as a heterodimer with full-length PDGF-C (FL-PDGF-C). PDGF-C downregulation reduced anchorage-independent growth and matrigel invasion of MDA-MB-231 cells. Conversely, ectopic expression of t-PDGF-C enhanced phenotypic transformation and invasion in BT-549 cells expressing endogenous FL-PDGF-C. The present study provides new insights into the functional significance of PDGF-C and its splice variant in human breast cancer.

Weight change and mortality and cardiovascular outcomes in patients with new-onset diabetes mellitus: a nationwide cohort study.

BACKGROUND: Because weight control is a cornerstone of diabetes management, it is important to understand the relationship of weight change to risk of cardiovascular disease (CVD) among patients with type 2 diabetes mellitus (DM). We aimed to investigate whether changes in weight early after diagnosis influence the incidence of CVD and all-cause mortality in patients with type 2 DM. METHODS: Using nationally representative data from the Korean National Health Insurance System, 173,246 subjects with new-onset DM who underwent health examinations during 2007-2012 were included. Weight was measured at the time of diabetes diagnosis and 2 years later. Weight change over 2 years was divided into five categories of 5% weight change, from weight loss ≥ - 10% to weight gain ≥ 10%. RESULTS: There were 3113 deaths (1.8%), 2060 cases of stroke (1.2%), and 1767 myocardial infarctions (MIs) (1.0%) during a median follow-up of 5.5 years. Subjects with weight gain ≥ 10% had a significantly higher risk of stroke (hazard ratio [HR] 1.51, 95% confidence interval [CI] 1.23-1.84), compared with the group with stable weight. There was no significant association between weight change after diagnosis of DM and incident MI. All-cause mortality showed a U-shaped curve according to weight change. The group with weight loss ≥ - 10% had the highest HR for all-cause mortality (HR 1.86; 95% CI 1.61-2.14) and the HR for weight gain ≥ 10% was 1.61 (95% CI 1.37-1.89). CONCLUSIONS: Weight changes of more than 10% after diabetes diagnosis were associated with higher mortality and over 10% weight gain was associated with increased risk of stroke.

Teneligliptin versus sitagliptin in Korean patients with type 2 diabetes inadequately controlled with metformin and glimepiride: A randomized, double-blind, non-inferiority trial.

AIM: To assess the efficacy and safety of add-on therapy with the dipeptidyl peptidase-4 inhibitor teneligliptin compared with sitagliptin in patients with type 2 diabetes (T2DM) inadequately controlled with metformin and glimepiride. MATERIALS AND METHODS: This was a phase 3, randomized, double-blind, non-inferiority study of adult Korean subjects with T2DM (n = 201), with HbA1c ranging from 7.0% to 11.0%, on stable doses of metformin plus glimepiride. Subjects were randomized in a 1:1 fashion to receive either oral teneligliptin 20 mg or sitagliptin 100 mg for 24 weeks. The primary endpoint was change from baseline in HbA1c. RESULTS: At baseline, mean age was 60.56 ± 9.41 years, body mass index was 25.23 ± 2.85 kg/m2 and HbA1c was 8.11% ± 0.79%. At 24 weeks, both groups achieved significant reductions from baseline in HbA1c (teneligliptin, -1.03% ± 0.10% [P < 0.0001]; sitagliptin, -1.02% ± 0.10% [P < 0.0001]). The inter-group difference was -0.01% (95% confidence interval [CI]: -0.28, 0.26; P = 0.9497); the upper limit of the 95% CI was within the preset limit for non-inferiority (0.4%). There were no significant differences between groups in the proportion of patients achieving HbA1c targets, or changes from baseline in fasting plasma glucose, body weight or lipid levels at 24 weeks. Rates of adverse events (teneligliptin, n = 63 [61.76%]; sitagliptin, n = 61 [62.24%]; P = 0.9442) and hypoglycaemia (teneligliptin, n = 32 [31.37%]; sitagliptin, n = 28 [28.57%]; P = 0.6656) were similar. CONCLUSION: Teneligliptin was non-inferior to sitagliptin in the context of triple therapy for T2DM and is an important option in this setting.

Analytical evaluation and clinical application of insulin and C-peptide by a whole blood, lateral flow, point of care (POC) assay system.

The analytical performance and clinical application of measuring insulin and connecting peptide (C-peptide) by point of care (POC) assay were evaluated. A POC assay system (SelexOn, Osang Healthcare Inc., Anyang-si, Korea) was evaluated for precision, linearity, limit of blank (LOB), and limit of detection (LOD). Method comparison was performed with the Cobas Elecsys insulin and C-peptide assay (Roche Diagnostics GmbH, Mannheim, Germany) using 215 and 201 patient specimens for insulin and C-peptide, respectively. For clinical application, insulin resistance indices were studied. Homeostasis model assessment (HOMA) 1 and 2, Quantitative insulin sensitivity check index (QUIKI), fasting insulin resistance index (FIRI), and other indices were evaluated. The coefficient of variation (CV) of imprecision for low, medium, and high concentrations was 10.8%1, 15.99%, and 12.05%, respectively, for insulin and 9.21%, 13.51%, and 13.77%, respectively, for C-peptide. The linearity was validated to 839.78 pmol/L for insulin and to 17.30 nmol/L for C-peptide. LOB and LOD were 8.05 and 9.72 pmol/L for insulin and 0.05 and 0.08 nmol/L for C-peptide, respectively. For the method comparison, the regression equation was y = 1.259x - 8.818 (r = 0.957) for insulin and y = 1.163x - 0.088 (r = 0.985) for C-peptide. The ROC value and overall accuracy were as follows: HOMA2 (C-peptide), 0.809, 79.7%; TyG, 0.788, 73.6%; CPR, 0.775, 74.8%; HOMA1, 0.725, 70.3%; QUIKI, 0.720, 70.3%; FIRI, 0.715, 70.1%; McAuley, 0.658, 65.1%; HOMA2 (Insulin), 0.645, 64.7%; Raynaud, 0.611, 61.4%, respectively. The POC assay system for insulin and C-peptide provided reliable results through a rapid and simple test that could be applied to clinical settings.

Impact of error structure misspecification when testing measurement invariance and latent-factor mean difference using MIMIC and multiple-group confirmatory factor analysis.

When multiple groups are compared, the error variance-covariance structure is not always invariant between groups. In this study we investigated the impacts of misspecified error structures on testing measurement invariance and the latent-factor mean difference between groups. A Monte Carlo study was conducted to examine how measurement invariance and latent mean difference tests were affected when heterogeneous error structures were misspecified as being invariant across groups. Multiple-group confirmatory factor analysis (MGCFA) and the multiple-indicator multiple-causes model (MIMIC) were employed in the present study. The rejection rates of both metric and strict invariance in measurement invariance testing, as well as the estimation accuracy and statistical inference of the factor mean difference, were investigated under error structure misspecification. In addition, sensitivity of the model fit indices to error structure misspecification was examined. Overall, misspecification of the error structure affected testing for metric but not scalar invariance. Metric invariance was often rejected, especially when error covariance in one group was ignored. In contrast, MGCFA and MIMIC performed comparatively well at detecting latent-factor mean differences between groups, with acceptable power and well-controlled Type I errors. The practical implications of these findings are discussed, as well as recommendations.

Development and effect of a rational-emotive-behaviour-therapy-based self-management programme for early renal dialysis patients.

AIMS AND OBJECTIVES: This study attempts to develop and determine the effect a rational-emotive-behaviour-therapy-based self-management programme can have on the self-efficacy, self-care, depression and dyssomnia of patients undergoing early renal dialysis. BACKGROUND: When renal dialysis is initiated, changes in everyday life are inevitable, and patients can suffer from both psychological and physical symptoms. Hence, to obtain the best results from renal dialysis, active self-management is required. DESIGN: Quasi-experimental and longitudinal. METHODS: Forty-eight early-stage renal dialysis patients registered for and undergoing renal dialysis at a hospital located in S city participated in this study. These individuals were divided into an experimental and control group. The former group engaged in a self-management programme consisting of eight weekly sessions of 50 min in duration, while the latter received traditional nursing care. Data were collected from June 2012-May 2014 through the use of a preliminary survey, a postsurvey that was distributed after the eight sessions of the self-management programme had been completed, and a follow-up survey allocated 4 weeks after the postsurvey. Data collection was conducted using the Self-efficacy Scale, Self-care Practice Scale, Beck Depression Inventory, and Korean Sleep Scale, and a repeated-measures ANOVA was used to perform analysis. RESULTS: The experimental group significantly differed from the control group in regard to self-efficacy (p = 0.006) and self-care (p = 0.031), but differences in terms of depression (p = 0.492) and dyssomnia (p = 0.141) were nonsignificant. In the experimental group, the depression decreased but then increased again, while the dyssomnia gradually decreased. CONCLUSIONS: The provision of a rational-emotive-behaviour-therapy-based self-management programme that involves lectures, discussions, teach-backs, demonstrations and posters explaining diet choices improves the self-efficacy and self-care of patients receiving renal dialysis. RELEVANCE TO CLINICAL PRACTICE: Rational-emotive-behaviour-therapy-based self-management programmes can be used in clinical nursing sites to improve the self-efficacy and self-care of early renal dialysis patients.