1.Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
Nam Hoon KIM ; Soo LIM ; In-Kyung JEONG ; Eun-Jung RHEE ; Jun Sung MOON ; Ohk-Hyun RYU ; Hyuk-Sang KWON ; Jong Chul WON ; Sang Soo KIM ; Sang Yong KIM ; Bon Jeong KU ; Heung Yong JIN ; Sin Gon KIM ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2025;49(2):225-234
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.
2.Impact of Meal Frequency on Insulin Resistance in Middle-Aged and Older Adults: A Prospective Cohort Study
Ha-Eun RYU ; Jong Hee LEE ; Byoungjin PARK ; Seok-Jae HEO ; Yu-Jin KWON
Diabetes & Metabolism Journal 2025;49(2):311-320
Background:
Insulin resistance (IR) is central to metabolic disorders and significantly influenced by diet. Studies on meal frequency (MF) and metabolic indicators have shown mixed results. This study explores the link between MF and IR in middle-aged and older adults.
Methods:
This prospective cohort study included 4,570 adults aged 40 to 69 years from the Korean Genome and Epidemiologic Study. MF were divided into two groups based on whether they consumed three or more, or fewer than three, meals daily. IR was evaluated using the homeostasis model assessment of insulin resistance (HOMA-IR); participants were classified as IR if their HOMA-IR value was ≥2.5. Multiple Cox proportional hazard regression analyses were conducted to examine the association between MF and the incidence of IR.
Results:
After adjusting for all variables, individuals in the MF ≥3 group showed a reduced incidence of IR compared to those in the MF <3 group (hazard ratio, 0.880; 95% confidence interval, 0.782 to 0.990). Additionally, subgroup analyses by sex, diabetes mellitus (DM), and body mass index (BMI) showed that this association persisted only in men, individuals without DM, and those with a BMI <25.
Conclusion
Our findings indicate that a higher MF among middle-aged and older adults is associated with a reduced incidence of IR. However, this association was maintained only in men, individuals without DM, and those without obesity.
3.Sphingomonas Paucimobilis-derived Extracellular Vesicles Reverse Aβ-induced Dysregulation of Neurotrophic Factors, Mitochondrial Function, and Inflammatory Factors through MeCP2-mediated Mechanism
Eun-Hwa LEE ; Hyejin KWON ; So-Young PARK ; Jin-Young PARK ; Jin-Hwan HONG ; Jae-Won PAENG ; Yoon-Keun KIM ; Pyung-Lim HAN
Experimental Neurobiology 2025;34(1):20-33
Recent studies have shown an increased abundance of Sphingomonas paucimobilis, an aerobic, Gram-negative bacterium with a distinctive cell envelope rich in glycosphingolipids, within the gut microbiome of individuals with Alzheimer Disease (AD). However, the fact that S. paucimobilis is a well-known pathogen associated with nosocomial infections presents a significant challenge in investigating whether its presence in the gut microbiome is detrimental or beneficial, particularly in the context of AD. This study examines the impact of S. paucimobilis-derived extracellular vesicles (Spa-EV) on Aβ-induced pathology in cellular and animal models of AD. Microarray analysis reveals that Spa-EV treatment modulates Aβ42-induced alterations in gene expression in both HT22 neuronal cells and BV2 microglia cells. Among the genes significantly affected by SpaEV, notable examples include Bdnf, Nt3/4, and Trkb, which are key players of neurotrophic signaling; Pgc1α, an upstream regulator of mitochondrial biogenesis; Mecp2 and Sirt1, epigenetic factors that regulate numerous gene expressions; and Il1β, Tnfα, and Nfκb-p65, which are associated with neuroinflammation. Remarkably, Spa-EV effectively reverses Aβ42-induced alteration in the expression of these genes through the upregulation of Mecp2. Furthermore, administration of Spa-EV in Tg-APP/PS1 mice restores the reduced expression of neurotrophic factors, Pgc1α, MeCP2, and Sirt1, while suppressing the increased expression of proinflammatory genes in the brain. Our results indicate that Spa-EV has the potential to reverse Aβ-induced dysregulation of gene expression in neuronal and microglial cells. These alterations encompass those essential for neurotrophic signaling and neuronal plasticity, mitochondrial function, and the regulation of inflammatory processes.
4.Assessing the Efficacy of Bortezomib and Dexamethasone for Induction and Maintenance Therapy in Relapsed/Refractory Cutaneous T-Cell Lymphoma: A Phase II CISL1701/BIC Study
Yoon Seok CHOI ; Joonho SHIM ; Ka-Won KANG ; Sang Eun YOON ; Jun Sik HONG ; Sung Nam LIM ; Ho-Young YHIM ; Jung Hye KWON ; Gyeong-Won LEE ; Deok-Hwan YANG ; Sung Yong OH ; Ho-Jin SHIN ; Hyeon-Seok EOM ; Dok Hyun YOON ; Hong Ghi LEE ; Seong Hyun JEONG ; Won Seog KIM ; Seok Jin KIM
Cancer Research and Treatment 2025;57(1):267-279
Purpose:
This multicenter, open-label, phase II trial evaluated the efficacy and safety of bortezomib combined with dexamethasone for the treatment of relapsed/refractory cutaneous T-cell lymphoma (CTCL) in previously treated patients across 14 institutions in South Korea.
Materials and Methods:
Between September 2017 and July 2020, 29 patients with histologically confirmed CTCL received treatment, consisting of eight 4-week cycles of induction therapy followed by maintenance therapy, contingent upon response, for up to one year. The primary endpoint was the proportion of patients achieving an objective global response.
Results:
Thirteen of the 29 patients (44.8%) achieved an objective global response, including two complete responses. The median progression-free survival (PFS) was 5.8 months, with responders showing a median PFS of 14.0 months. Treatment-emergent adverse events were generally mild, with a low incidence of peripheral neuropathy and hematologic toxicities. Despite the trend toward shorter PFS in patients with higher mutation burdens, genomic profiling before and after treatment showed no significant emergence of new mutations indicative of disease progression.
Conclusion
This study supports the use of bortezomib and dexamethasone as a viable and safe treatment option for previously treated CTCL, demonstrating substantial efficacy and manageability in adverse effects. Further research with a larger cohort is suggested to validate these findings and explore the prognostic value of mutation profiles.
5.18F‑FDG PET/CT in Inflammation and Infection: Procedural Guidelineby the Korean Society of Nuclear Medicine
Joon Ho CHOI ; Yong‑Jin PARK ; Hyunjong LEE ; Hye Ryeong KWON ; Jinkyoung OH ; Chae Hong LIM ; Eun Ji HAN ; Joon Young CHOI ;
Nuclear Medicine and Molecular Imaging 2025;59(1):27-40
This guideline outlines the use of 18F-fluoro-2-deoxyglucose positron emission tomography / computed tomography for the diagnosis and management of infectious and inflammatory diseases. It provides detailed recommendations for healthcare providers on patient preparation, imaging procedures, and the interpretation of results. Adapted from international standards and tailored to local clinical practices, the guideline emphasizes safety, quality control, and effective use of the technology in various conditions, including spinal infections, diabetic foot, osteomyelitis, vasculitis, and cardiac inflammation. The aim is to assist nuclear medicine professionals in delivering accurate diagnoses and improving patient outcomes while allowing flexibility to adapt to individual patient needs, technological advancements, and evolving medical knowledge. This document is a comprehensive resource for enhancing the quality and safety of 18F-fluoro-2-deoxyglucose positron emission tomography / computed tomography for the evaluation of infectious and inflammatory diseases.Preamble The Korean Society of Nuclear Medicine (KSNM) was established in 1961 to promote the clinical and technological advancement of nuclear medicine in South Korea, with members that include nuclear medicine physicians and associated scientists. The KSNM regularly formulates and revises procedural guidelines for nuclear medicine examinations to enhance the field and improve the quality of patient care. These guidelines are designed to support healthcare professionals in providing appropriate medical care to patients. However, they are not immutable rules or mandatory requirements for conducting examinations.Therefore, KSNM states that these guidelines should not be used in legal actions challenging a healthcare professional’s medical decisions. The ultimate judgment regarding specific procedures or appropriate measures should be made by nuclear medicine physicians, considering the unique circumstances of each case. Deviation from these guidelines does not imply substandard medical practice. Rather, reasonable judgments differing from the guidelines can be made based on the patient’s condition, available resources, and advancements in knowledge or technology. Due to the diversity and complexity of patients, it is often challenging to predict the most appropriate diagnostic and accurate therapeutic responses. Thus, adherence to these guidelines does not always guarantee an exact diagnosis or successful outcomes.The purpose of this guideline is to assist healthcare providers in making reasonable decisions and conducting effective and safe examinations based on current medical knowledge, available resources, and patient needs when performing 18F-fluoro-2-deoxyglucose (18F-FDG) positron emission tomography (PET)/computed tomography (CT) examinations for infectious/ inflammatory diseases.
6.Erratum: Induction of apoptotic cell death in human bladder cancer cells by ethanol extract of Zanthoxylum schinifolium leaf, through ROSdependent inactivation of the PI3K/ Akt signaling pathway
Cheol PARK ; Eun Ok CHOI ; Hyun HWANGBO ; Hyesook LEE ; Jin-Woo JEONG ; Min Ho HAN ; Sung-Kwon MOON ; Seok Joong YUN ; Wun-Jae KIM ; Gi-Young KIM ; Hye-Jin HWANG ; Yung Hyun CHOI
Nutrition Research and Practice 2025;19(2):328-330
7.18F‑FDG PET/CT in Inflammation and Infection: Procedural Guidelineby the Korean Society of Nuclear Medicine
Joon Ho CHOI ; Yong‑Jin PARK ; Hyunjong LEE ; Hye Ryeong KWON ; Jinkyoung OH ; Chae Hong LIM ; Eun Ji HAN ; Joon Young CHOI ;
Nuclear Medicine and Molecular Imaging 2025;59(1):27-40
This guideline outlines the use of 18F-fluoro-2-deoxyglucose positron emission tomography / computed tomography for the diagnosis and management of infectious and inflammatory diseases. It provides detailed recommendations for healthcare providers on patient preparation, imaging procedures, and the interpretation of results. Adapted from international standards and tailored to local clinical practices, the guideline emphasizes safety, quality control, and effective use of the technology in various conditions, including spinal infections, diabetic foot, osteomyelitis, vasculitis, and cardiac inflammation. The aim is to assist nuclear medicine professionals in delivering accurate diagnoses and improving patient outcomes while allowing flexibility to adapt to individual patient needs, technological advancements, and evolving medical knowledge. This document is a comprehensive resource for enhancing the quality and safety of 18F-fluoro-2-deoxyglucose positron emission tomography / computed tomography for the evaluation of infectious and inflammatory diseases.Preamble The Korean Society of Nuclear Medicine (KSNM) was established in 1961 to promote the clinical and technological advancement of nuclear medicine in South Korea, with members that include nuclear medicine physicians and associated scientists. The KSNM regularly formulates and revises procedural guidelines for nuclear medicine examinations to enhance the field and improve the quality of patient care. These guidelines are designed to support healthcare professionals in providing appropriate medical care to patients. However, they are not immutable rules or mandatory requirements for conducting examinations.Therefore, KSNM states that these guidelines should not be used in legal actions challenging a healthcare professional’s medical decisions. The ultimate judgment regarding specific procedures or appropriate measures should be made by nuclear medicine physicians, considering the unique circumstances of each case. Deviation from these guidelines does not imply substandard medical practice. Rather, reasonable judgments differing from the guidelines can be made based on the patient’s condition, available resources, and advancements in knowledge or technology. Due to the diversity and complexity of patients, it is often challenging to predict the most appropriate diagnostic and accurate therapeutic responses. Thus, adherence to these guidelines does not always guarantee an exact diagnosis or successful outcomes.The purpose of this guideline is to assist healthcare providers in making reasonable decisions and conducting effective and safe examinations based on current medical knowledge, available resources, and patient needs when performing 18F-fluoro-2-deoxyglucose (18F-FDG) positron emission tomography (PET)/computed tomography (CT) examinations for infectious/ inflammatory diseases.
8.Erratum: Induction of apoptotic cell death in human bladder cancer cells by ethanol extract of Zanthoxylum schinifolium leaf, through ROSdependent inactivation of the PI3K/ Akt signaling pathway
Cheol PARK ; Eun Ok CHOI ; Hyun HWANGBO ; Hyesook LEE ; Jin-Woo JEONG ; Min Ho HAN ; Sung-Kwon MOON ; Seok Joong YUN ; Wun-Jae KIM ; Gi-Young KIM ; Hye-Jin HWANG ; Yung Hyun CHOI
Nutrition Research and Practice 2025;19(2):328-330
9.Evaluating Rituximab Failure Rates in Neuromyelitis Optica Spectrum Disorder: A Nationwide Real-World Study From South Korea
Su-Hyun KIM ; Ju-Hong MIN ; Sung-Min KIM ; Eun-Jae LEE ; Young-Min LIM ; Ha Young SHIN ; Young Nam KWON ; Eunhee SOHN ; Sooyoung KIM ; Min Su PARK ; Tai-Seung NAM ; Byeol-A YOON ; Jong Kuk KIM ; Kyong Jin SHIN ; Yoo Hwan KIM ; Jin Myoung SEOK ; Jeong Bin BONG ; Sohyeon KIM ; Hung Youl SEOK ; Sun-Young OH ; Ohyun KWON ; Sunyoung KIM ; Sukyoon LEE ; Nam-Hee KIM ; Eun Bin CHO ; Sa-Yoon KANG ; Seong-il OH ; Jong Seok BAE ; Suk-Won AHN ; Ki Hoon KIM ; You-Ri KANG ; Woohee JU ; Seung Ho CHOO ; Yeon Hak CHUNG ; Jae-Won HYUN ; Ho Jin KIM
Journal of Clinical Neurology 2025;21(2):131-136
Background:
and Purpose Treatments for neuromyelitis optica spectrum disorder (NMOSD) such as eculizumab, ravulizumab, satralizumab, and inebilizumab have significantly advanced relapse prevention, but they remain expensive. Rituximab is an off-label yet popular alternative that offers a cost-effective solution, but its real-world efficacy needs better quantification for guiding the application of newer approved NMOSD treatments (ANTs). This study aimed to determine real-world rituximab failure rates to anticipate the demand for ANTs and aid in resource allocation.
Methods:
We conducted a nationwide retrospective study involving 605 aquaporin-4-antibody-positive NMOSD patients from 22 centers in South Korea that assessed the efficacy and safety of rituximab over a median follow-up of 47 months.
Results:
The 605 patients treated with rituximab included 525 (87%) who received continuous therapy throughout the follow-up period (median=47 months, interquartile range=15–87 months). During this period, 117 patients (19%) experienced at least 1 relapse. Notably, 68 of these patients (11% of the total cohort) experienced multiple relapses or at least 1 severe relapse.Additionally, 2% of the patients discontinued rituximab due to adverse events, which included severe infusion reactions, neutropenia, and infections.
Conclusions
This study has confirmed the efficacy of rituximab in treating NMOSD, as evidenced by an 87% continuation rate among patients over a 4-year follow-up period. Nevertheless, the occurrence of at least one relapse in 19% of the cohort, including 11% who experienced multiple or severe relapses, and a 2% discontinuation rate due to adverse events highlight the urgent need for alternative therapeutic options.
10.Prospective Multicenter Observational Study on Postoperative Quality of Life According to Type of Gastrectomy for Gastric Cancer
Sung Eun OH ; Yun-Suhk SUH ; Ji Yeong AN ; Keun Won RYU ; In CHO ; Sung Geun KIM ; Ji-Ho PARK ; Hoon HUR ; Hyung-Ho KIM ; Sang-Hoon AHN ; Sun-Hwi HWANG ; Hong Man YOON ; Ki Bum PARK ; Hyoung-Il KIM ; In Gyu KWON ; Han-Kwang YANG ; Byoung-Jo SUH ; Sang-Ho JEONG ; Tae-Han KIM ; Oh Kyoung KWON ; Hye Seong AHN ; Ji Yeon PARK ; Ki Young YOON ; Myoung Won SON ; Seong-Ho KONG ; Young-Gil SON ; Geum Jong SONG ; Jong Hyuk YUN ; Jung-Min BAE ; Do Joong PARK ; Sol LEE ; Jun-Young YANG ; Kyung Won SEO ; You-Jin JANG ; So Hyun KANG ; Bang Wool EOM ; Joongyub LEE ; Hyuk-Joon LEE ;
Journal of Gastric Cancer 2025;25(2):382-399
Purpose:
This study evaluated the postoperative quality of life (QoL) after various types of gastrectomy for gastric cancer.
Materials and Methods:
A multicenter prospective observational study was conducted in Korea using the Korean Quality of Life in Stomach Cancer Patients Study (KOQUSS)-40, a new QoL assessment tool focusing on postgastrectomy syndrome. Overall, 496 patients with gastric cancer were enrolled, and QoL was assessed at 5 time points: preoperatively and at 1, 3, 6, and 12 months after surgery.
Results:
Distal gastrectomy (DG) and pylorus-preserving gastrectomy (PPG) showed significantly better outcomes than total gastrectomy (TG) and proximal gastrectomy (PG) with regard to total score, indigestion, and dysphagia. DG, PPG, and TG also showed significantly better outcomes than PG in terms of dumping syndrome and worry about cancer. Postoperative QoL did not differ significantly according to anastomosis type in DG, except for Billroth I anastomosis, which achieved better bowel habit change scores than the others. No domains differed significantly when comparing double tract reconstruction and esophagogastrostomy after PG. The total QoL score correlated significantly with postoperative body weight loss (more than 10%) and extent of resection (P<0.05 for both).Reflux as assessed by KOQUSS-40 did not correlate significantly with reflux observed on gastroscopy 1 year postoperatively (P=0.064).
Conclusions
Our prospective observation using KOQUSS-40 revealed that DG and PPG lead to better QoL than TG and PG. Further study is needed to compare postoperative QoL according to anastomosis type in DG and PG.

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