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.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.
3.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.
4.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.
5.Fifty Years of Compassionate Care and Harmonious Collaboration of the Korean Diabetes Association: The 50th Anniversary of Korean Diabetes Association.
Jong Chul WON ; Eun Jung RHEE ; Hyung Joon YOO
Diabetes & Metabolism Journal 2018;42(6):475-479
No abstract available.
Anniversaries and Special Events*
;
Cooperative Behavior*
;
Empathy*
6.Helicobacter pylori Antigens Inducing Early Immune Response in Infants.
Ji Hyun SEO ; Jong Hyuk YOUN ; Eun A KIM ; Jin Su JUN ; Ji Sook PARK ; Jung Sook YEOM ; Jae Young LIM ; Hyang Ok WOO ; Hee Shang YOUN ; Gyung Hyuck KO ; Jin Sik PARK ; Seung Chul BAIK ; Woo Kon LEE ; Myung Je CHO ; Kwang Ho RHEE
Journal of Korean Medical Science 2017;32(7):1139-1146
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
7.Clinical Evaluation of OneTouch Diabetes Management Software System in Patients with Type 2 Diabetes Mellitus.
Jung Min KIM ; Hey Jean LEE ; Keum Ok KIM ; Jong Chul WON ; Kyung Soo KO ; Byung Doo RHEE
Diabetes & Metabolism Journal 2016;40(2):129-139
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
8.The Role of the CpG Island Methylator Phenotype on Survival Outcome in Colon Cancer.
Ki Joo KANG ; Byung Hoon MIN ; Kyung Ju RYU ; Kyoung Mee KIM ; Dong Kyung CHANG ; Jae J KIM ; Jong Chul RHEE ; Young Ho KIM
Gut and Liver 2015;9(2):202-207
BACKGROUND/AIMS: CpG island methylator phenotype (CIMP)- high colorectal cancers (CRCs) have distinct clinicopathological features from their CIMP-low/negative CRC counterparts. However, controversy exists regarding the prognosis of CRC according to the CIMP status. Therefore, this study examined the prognosis of Korean patients with colon cancer according to the CIMP status. METHODS: Among a previous cohort population with CRC, a total of 154 patients with colon cancer who had available tissue for DNA extraction were included in the study. CIMP-high was defined as 3/5 methylated markers using the five-marker panel (CACNA1G, IGF2, NEUROG1, RUNX3, and SOCS1). RESULTS: CIMP-high and CIMP-low/negative cancers were observed in 27 patients (17.5%) and 127 patients (82.5%), respectively. Multivariate analysis adjusting for age, gender, tumor location, tumor stage and CIMP and microsatellite instability (MSI) statuses indicated that CIMP-high colon cancers were associated with a significant increase in colon cancer-specific mortality (hazard ratio [HR], 3.23; 95% confidence interval [CI], 1.20 to 8.69; p=0.02). In microsatellite stable cancers, CIMP-high cancer had a poor survival outcome compared to CIMP-low/negative cancer (HR, 2.91; 95% CI, 1.02 to 8.27; p=0.04). CONCLUSIONS: Regardless of the MSI status, CIMP-high cancers had poor survival outcomes in Korean patients.
Adult
;
Age Factors
;
Aged
;
Colorectal Neoplasms/*genetics/*mortality
;
CpG Islands/*physiology
;
*DNA Methylation
;
Female
;
Humans
;
Male
;
Microsatellite Instability
;
Middle Aged
;
Multivariate Analysis
;
Neoplasm Staging
;
*Phenotype
;
Prognosis
;
Republic of Korea
;
Sex Factors
;
Survival Analysis
9.The Role of the CpG Island Methylator Phenotype on Survival Outcome in Colon Cancer.
Ki Joo KANG ; Byung Hoon MIN ; Kyung Ju RYU ; Kyoung Mee KIM ; Dong Kyung CHANG ; Jae J KIM ; Jong Chul RHEE ; Young Ho KIM
Gut and Liver 2015;9(2):202-207
BACKGROUND/AIMS: CpG island methylator phenotype (CIMP)- high colorectal cancers (CRCs) have distinct clinicopathological features from their CIMP-low/negative CRC counterparts. However, controversy exists regarding the prognosis of CRC according to the CIMP status. Therefore, this study examined the prognosis of Korean patients with colon cancer according to the CIMP status. METHODS: Among a previous cohort population with CRC, a total of 154 patients with colon cancer who had available tissue for DNA extraction were included in the study. CIMP-high was defined as 3/5 methylated markers using the five-marker panel (CACNA1G, IGF2, NEUROG1, RUNX3, and SOCS1). RESULTS: CIMP-high and CIMP-low/negative cancers were observed in 27 patients (17.5%) and 127 patients (82.5%), respectively. Multivariate analysis adjusting for age, gender, tumor location, tumor stage and CIMP and microsatellite instability (MSI) statuses indicated that CIMP-high colon cancers were associated with a significant increase in colon cancer-specific mortality (hazard ratio [HR], 3.23; 95% confidence interval [CI], 1.20 to 8.69; p=0.02). In microsatellite stable cancers, CIMP-high cancer had a poor survival outcome compared to CIMP-low/negative cancer (HR, 2.91; 95% CI, 1.02 to 8.27; p=0.04). CONCLUSIONS: Regardless of the MSI status, CIMP-high cancers had poor survival outcomes in Korean patients.
Adult
;
Age Factors
;
Aged
;
Colorectal Neoplasms/*genetics/*mortality
;
CpG Islands/*physiology
;
*DNA Methylation
;
Female
;
Humans
;
Male
;
Microsatellite Instability
;
Middle Aged
;
Multivariate Analysis
;
Neoplasm Staging
;
*Phenotype
;
Prognosis
;
Republic of Korea
;
Sex Factors
;
Survival Analysis
10.Is a Second-Look Endoscopy Necessary after Endoscopic Submucosal Dissection for Gastric Neoplasm?.
Eun Ran KIM ; Jung Ha KIM ; Ki Joo KANG ; Byung Hoon MIN ; Jun Haeng LEE ; Poong Lyul RHEE ; Jong Chul RHEE ; Jae J KIM
Gut and Liver 2015;9(1):52-58
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

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