Background: The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated. Methods: This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243). Conclusion This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.

Background: The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated. Methods: This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243). Conclusion This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.

Background: The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated. Methods: This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243). Conclusion This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.

Background: The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated. Methods: This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243). Conclusion This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.

No abstract available.
Anniversaries and Special Events* ; Cooperative Behavior* ; Empathy*

To identify the Helicobacter pylori antigens operating during early infection in sera from infected infants using proteomics and immunoblot analysis. Two-dimensional (2D) large and small gel electrophoresis was performed using H. pylori strain 51. We performed 2D immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) antibody immunoblotting using small gels on sera collected at the Gyeongsang National University Hospital from 4–11-month-old infants confirmed with H. pylori infection by pre-embedding immunoelectron microscopy. Immunoblot spots appearing to represent early infection markers in infant sera were compared to those of the large 2D gel for H. pylori strain 51. Corresponding spots were analyzed by matrix-assisted laser desorption/ionization time of flight-mass spectrometry (MALDI-TOF-MS). The peptide fingerprints obtained were searched in the National Center for Biotechnology Information (NCBI) database. Eight infant patients were confirmed with H. pylori infection based on urease tests, histopathologic examinations, and pre-embedding immunoelectron microscopy. One infant showed a 2D IgM immunoblot pattern that seemed to represent early infection. Immunoblot spots were compared with those from whole-cell extracts of H. pylori strain 51 and 18 spots were excised, digested in gel, and analyzed by MALDI-TOF-MS. Of the 10 peptide fingerprints obtained, the H. pylori proteins flagellin A (FlaA), urease β subunit (UreB), pyruvate ferredoxin oxidoreductase (POR), and translation elongation factor Ts (EF-Ts) were identified and appeared to be active during the early infection periods. These results might aid identification of serological markers for the serodiagnosis of early H. pylori infection in infants.
Biotechnology ; Electrophoresis ; Flagellin ; Gels ; Helicobacter pylori* ; Helicobacter* ; Humans ; Immunoblotting ; Immunoglobulin A ; Immunoglobulin G ; Immunoglobulin M ; Infant* ; Microscopy, Immunoelectron ; Peptide Elongation Factors ; Peptide Mapping ; Proteomics ; Pyruvate Synthase ; Serologic Tests ; Spectrum Analysis ; Urease

BACKGROUND: OneTouch Diabetes Management Software (OTDMS) is an efficient way to track and monitor the blood glucose level. It is possible to download data from the OneTouch Ultra via the meter's data port, and to transform the numbers of the blood glucose level into a graph, a chart, or statistics. The objectives of this study were to evaluate whether the use of OTDMS in consultation hours would improve patients' knowledge of diabetes mellitus (DM), compliance, satisfaction with doctor and medical treatment, doctor-patient reliability, and glucose control. METHODS: All patients were randomized into either the OTDMS group using OneTouch Ultra or the control groups not using it. Both groups had conventional DM education and only the OTDMS group used data from OTDMS as explanation materials during consultation hours. At enrollment and after 6 months, we performed a questionnaire survey consisting of the diabetes knowledge test, items for compliance of treatment, patient's satisfaction, doctor-patient reliability, and glycosylated hemoglobin (HbA1c). RESULTS: We analyzed 6-month follow-up data from 92 patients (OTDMS 42 vs. control 50). Both groups showed significant improvements in HbA1c, diabetes knowledge, compliance, reliability, and satisfaction after 6 months. However, there were no significant differences between OTDMS and control groups overall. Only "weekly frequency of checking blood glucose level" of compliance and "trying to follow doctor's order" of reliability showed better results in the OTDMS group. CONCLUSION: Using the OTDMS system for explanation during consultation hours seems to be more helpful to improve patient's compliance and reliability, especially for checking blood glucose level and trying to follow the doctor's order.
Blood Glucose ; Compliance ; Diabetes Mellitus ; Diabetes Mellitus, Type 2* ; Disease Management ; Education ; Follow-Up Studies ; Glucose ; Hemoglobin A, Glycosylated ; Humans ; Self Care

BACKGROUND/AIMS: Early detection of gallbladder (GB) cancer is essential for better survival rates. Most cases of GB cancer are diagnosed incidentally via pathology of the cholecystectomy specimen. Data on the clinical characteristics of early GB cancer are lacking. The aim of the current study was to investigate the clinical characteristics of early GB cancer to aid earlier diagnosis. METHODS: Sixty-four patients who were diagnosed with early GB cancer after surgical resection at the Samsung Medical Center were enrolled in this study. Clinical characteristics, preoperative diagnoses, preoperative tumor size, laboratory findings including carbohydrate antigen 19-9 (CA19-9) levels, imaging features, and survival rate were investigated. RESULTS: Clinical symptoms and serum tumor markers such as carcinoembryonic antigen and CA19-9 levels were not helpful indicators of early GB cancer. Radiologic modalities showed abnormal findings in every case of early GB cancer; a polypoid mass was the most common feature. Less common features included GB wall thickening, cholecystitis, and GB stones. The clinical outcome of early GB cancer was excellent. CONCLUSIONS: Screening with imaging modalities such as computed tomography (CT) or ultrasonography (US) is helpful in detecting early GB cancer. Even in the presence of GB wall thickening, cholecystitis, or GB stones on the CT or US, any abnormal findings should prompt careful examination and intensive follow up, considering the possibility of occult gallbladder cancer.
Carcinoembryonic Antigen ; Cholecystectomy ; Cholecystitis ; Diagnosis ; Gallbladder ; Gallbladder Neoplasms* ; Humans ; Mass Screening ; Pathology ; Survival Rate ; Biomarkers, Tumor ; Ultrasonography

BACKGROUND/AIMS: Second-look endoscopy is performed to check for the possibility of post-endoscopic submucosal dissection (ESD) bleeding and to perform prophylactic hemostasis in most hospitals; however, there is little evidence about the efficacy of second-look endoscopy. We investigated whether second-look endoscopy after ESD is useful in the prevention of post-ESD bleeding. METHODS: A total of 550 lesions with gastric epithelial neoplasms in 502 patients (372 men and 130 women) were treated with ESD between August 18, 2009 and August 18, 2010. After the exclusion of three lesions of post-ESD bleeding within 24 hours, 547 lesions (335 early gastric cancers and 212 gastric adenomas) were included for the final analysis. RESULTS: The occurrence rate of delayed post-ESD bleeding was not significantly different between the second-look group and the no second-look group (1% vs 2.5%, p>0.05). The only predictor of delayed bleeding was tumor size, regardless of second-look endoscopy after ESD (22.8+/-9.87 vs 15.1+/-10.47, p<0.05). There was no difference between the prophylactic hemostasis and nonprophylactic hemostasis groups, including the occurrence rate of delayed bleeding. In the second-look group with prophylactic hemostasis, the hospital stay was more prolonged than in the second-look group without prophylactic hemostasis, but there was no significant difference (p=0.08). CONCLUSIONS: Second-look endoscopy to prevent delayed bleeding after ESD provides no significant medical benefits.
Adult ; Aged ; Aged, 80 and over ; Female ; Gastrectomy/adverse effects ; Gastric Mucosa/surgery ; *Gastroscopy ; Humans ; Length of Stay ; Male ; Middle Aged ; Postoperative Hemorrhage/*diagnosis/etiology ; Retrospective Studies ; Risk Factors ; Second-Look Surgery ; Stomach/pathology/surgery ; Stomach Neoplasms/pathology/*surgery ; Time Factors

Insulin-induced allergy is a rare adverse drug reaction since the introduction of recombinant human insulin. However, recombinant insulin-induced allergy is still being reported in 0.1% to 2% of all patients treated with insulin. This allergic reaction varies from mild localized skin reactions to life-threatening anaphylaxis. It has been shown that one-third of insulin allergy cases is related to insulin itself and the remaining occur due to preservatives contained in the insulin preparations, such as protamine, zinc, or metacresol. This case report describes a 75-year-old woman with poorly controlled diabetes who experienced insulin allergy. She complained of urticaria with itching after the injection of insulin. Allergic skin tests showed positive responses to all available human insulin preparations, and specific IgE to human insulin was also detected, which suggested that her urticaria was developed by insulin itself. This is the first case of insulin allergy that was sensitive to all available human insulin preparations and confirmed by the presence of specific IgE to human insulin. It is important to remember that allergic reactions to insulin may be directly associated with adherence and can be the reason of poor glucose control.
Aged ; Anaphylaxis ; Drug-Related Side Effects and Adverse Reactions ; Female ; Glucose ; Humans* ; Hypersensitivity* ; Immunoglobulin E ; Insulin Antibodies ; Insulin* ; Pruritus ; Skin ; Skin Tests ; Urticaria ; Zinc