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.Evaluating the Influence of Scan Timing on Dosimetric Accuracy in EBT3 and EBT4 Radiochromic Films
Jin Dong CHO ; Su Chul HAN ; Jason Joon Bock LEE ; Hyebin LEE ; Heerim NAM
Progress in Medical Physics 2024;35(4):135-144
Purpose:
This study compares the dosimetric properties of EBT3 and EBT4 GAFchromic films in transmission and reflection scanning modes, focusing on dose response, sensitivity, and postirradiation stability.
Methods:
The EBT3 and EBT4 films were irradiated at doses of 0–10 Gy using a Varian TrueBeam linear accelerator at 6 MV. The films were scanned at intervals between 1 and 336 hours after irradiation in both transmission and reflection modes. Net optical density (NetOD) values from each scan were used to evaluate dose response and sensitivity, with calibration curves created for each film and scan mode. Dose differences between calculated and delivered doses were assessed over time.
Results:
The EBT3 and EBT4 films exhibited similar dose–response curves and stable NetOD values across both scanning modes. However, EBT4 exhibited reduced sensitivity variability in response to dose changes. After irradiation, NetOD values increased up to 24 hours before stabilizing, suggesting that a 24-hour scan time is sufficient for consistent measurements. Dose differences between films and modes remained within ±4%.
Conclusions
EBT4 offers comparable dosimetric performance to EBT3, with additional benefits, such as improved dose–response linearity and reduced sensitivity fluctuations. The findings indicate that EBT4 can serve as a reliable successor to EBT3.
6.Evaluating the Influence of Scan Timing on Dosimetric Accuracy in EBT3 and EBT4 Radiochromic Films
Jin Dong CHO ; Su Chul HAN ; Jason Joon Bock LEE ; Hyebin LEE ; Heerim NAM
Progress in Medical Physics 2024;35(4):135-144
Purpose:
This study compares the dosimetric properties of EBT3 and EBT4 GAFchromic films in transmission and reflection scanning modes, focusing on dose response, sensitivity, and postirradiation stability.
Methods:
The EBT3 and EBT4 films were irradiated at doses of 0–10 Gy using a Varian TrueBeam linear accelerator at 6 MV. The films were scanned at intervals between 1 and 336 hours after irradiation in both transmission and reflection modes. Net optical density (NetOD) values from each scan were used to evaluate dose response and sensitivity, with calibration curves created for each film and scan mode. Dose differences between calculated and delivered doses were assessed over time.
Results:
The EBT3 and EBT4 films exhibited similar dose–response curves and stable NetOD values across both scanning modes. However, EBT4 exhibited reduced sensitivity variability in response to dose changes. After irradiation, NetOD values increased up to 24 hours before stabilizing, suggesting that a 24-hour scan time is sufficient for consistent measurements. Dose differences between films and modes remained within ±4%.
Conclusions
EBT4 offers comparable dosimetric performance to EBT3, with additional benefits, such as improved dose–response linearity and reduced sensitivity fluctuations. The findings indicate that EBT4 can serve as a reliable successor to EBT3.
7.Evaluating the Influence of Scan Timing on Dosimetric Accuracy in EBT3 and EBT4 Radiochromic Films
Jin Dong CHO ; Su Chul HAN ; Jason Joon Bock LEE ; Hyebin LEE ; Heerim NAM
Progress in Medical Physics 2024;35(4):135-144
Purpose:
This study compares the dosimetric properties of EBT3 and EBT4 GAFchromic films in transmission and reflection scanning modes, focusing on dose response, sensitivity, and postirradiation stability.
Methods:
The EBT3 and EBT4 films were irradiated at doses of 0–10 Gy using a Varian TrueBeam linear accelerator at 6 MV. The films were scanned at intervals between 1 and 336 hours after irradiation in both transmission and reflection modes. Net optical density (NetOD) values from each scan were used to evaluate dose response and sensitivity, with calibration curves created for each film and scan mode. Dose differences between calculated and delivered doses were assessed over time.
Results:
The EBT3 and EBT4 films exhibited similar dose–response curves and stable NetOD values across both scanning modes. However, EBT4 exhibited reduced sensitivity variability in response to dose changes. After irradiation, NetOD values increased up to 24 hours before stabilizing, suggesting that a 24-hour scan time is sufficient for consistent measurements. Dose differences between films and modes remained within ±4%.
Conclusions
EBT4 offers comparable dosimetric performance to EBT3, with additional benefits, such as improved dose–response linearity and reduced sensitivity fluctuations. The findings indicate that EBT4 can serve as a reliable successor to EBT3.
8.Evaluating the Influence of Scan Timing on Dosimetric Accuracy in EBT3 and EBT4 Radiochromic Films
Jin Dong CHO ; Su Chul HAN ; Jason Joon Bock LEE ; Hyebin LEE ; Heerim NAM
Progress in Medical Physics 2024;35(4):135-144
Purpose:
This study compares the dosimetric properties of EBT3 and EBT4 GAFchromic films in transmission and reflection scanning modes, focusing on dose response, sensitivity, and postirradiation stability.
Methods:
The EBT3 and EBT4 films were irradiated at doses of 0–10 Gy using a Varian TrueBeam linear accelerator at 6 MV. The films were scanned at intervals between 1 and 336 hours after irradiation in both transmission and reflection modes. Net optical density (NetOD) values from each scan were used to evaluate dose response and sensitivity, with calibration curves created for each film and scan mode. Dose differences between calculated and delivered doses were assessed over time.
Results:
The EBT3 and EBT4 films exhibited similar dose–response curves and stable NetOD values across both scanning modes. However, EBT4 exhibited reduced sensitivity variability in response to dose changes. After irradiation, NetOD values increased up to 24 hours before stabilizing, suggesting that a 24-hour scan time is sufficient for consistent measurements. Dose differences between films and modes remained within ±4%.
Conclusions
EBT4 offers comparable dosimetric performance to EBT3, with additional benefits, such as improved dose–response linearity and reduced sensitivity fluctuations. The findings indicate that EBT4 can serve as a reliable successor to EBT3.
9.Evaluating the Influence of Scan Timing on Dosimetric Accuracy in EBT3 and EBT4 Radiochromic Films
Jin Dong CHO ; Su Chul HAN ; Jason Joon Bock LEE ; Hyebin LEE ; Heerim NAM
Progress in Medical Physics 2024;35(4):135-144
Purpose:
This study compares the dosimetric properties of EBT3 and EBT4 GAFchromic films in transmission and reflection scanning modes, focusing on dose response, sensitivity, and postirradiation stability.
Methods:
The EBT3 and EBT4 films were irradiated at doses of 0–10 Gy using a Varian TrueBeam linear accelerator at 6 MV. The films were scanned at intervals between 1 and 336 hours after irradiation in both transmission and reflection modes. Net optical density (NetOD) values from each scan were used to evaluate dose response and sensitivity, with calibration curves created for each film and scan mode. Dose differences between calculated and delivered doses were assessed over time.
Results:
The EBT3 and EBT4 films exhibited similar dose–response curves and stable NetOD values across both scanning modes. However, EBT4 exhibited reduced sensitivity variability in response to dose changes. After irradiation, NetOD values increased up to 24 hours before stabilizing, suggesting that a 24-hour scan time is sufficient for consistent measurements. Dose differences between films and modes remained within ±4%.
Conclusions
EBT4 offers comparable dosimetric performance to EBT3, with additional benefits, such as improved dose–response linearity and reduced sensitivity fluctuations. The findings indicate that EBT4 can serve as a reliable successor to EBT3.
10.CTLA4 expression profiles and their association with clinical outcomes of breast cancer: a systemic review
TongYi JIN ; Kyoung Sik PARK ; Sang Eun NAM ; Seung Hwan LIM ; Jong Hyun KIM ; Woo Chul NOH ; Young Bum YOO ; Won Seo PARK ; Ik Jin YUN
Annals of Surgical Treatment and Research 2024;106(5):263-273
Purpose:
The cytotoxic T-lymphocyte-associated protein 4 (CTLA4) is involved in the progression of various cancers, but its biological roles in breast cancer (BRCA) remain unclear. Therefore, we performed a systematic multiomic analysis to expound on the prognostic value and underlying mechanism of CTLA4 in BRCA.
Methods:
We assessed the effect of CTLA4 expression on BRCA using a variety of bioinformatics platforms, including Oncomine, GEPIA, UALCAN, PrognoScan database, Kaplan-Meier plotter, and R2: Kaplan-Meier scanner.
Results:
CTLA4 was highly expressed in BRCA tumor tissue compared to normal tissue (P < 0.01). The CTLA4 messenger RNA levels in BRCA based on BRCA subtypes of Luminal, human epidermal growth factor receptor 2, and triple-negative BRCA were considerably higher than in normal tissues (P < 0.001). However, the overexpression of CTLA4 was associated with a better prognosis in BRCA (P < 0.001) and was correlated with clinicopathological characteristics including age, T stage, estrogen receptors, progesterone receptors, and prediction analysis of microarray 50 (P < 0.01). The infiltration of multiple immune cells was associated with increased CTLA4 expression in BRCA (P < 0.001). CTLA4 was highly enriched in antigen binding, immunoglobulin complexes, lymphocyte-mediated immunity, and cytokine-cytokine receptor interaction.
Conclusion
This study provides suggestive evidence of the prognostic role of CTLA4 in BRCA, which may be a therapeutic target for BRCA. Furthermore, CTLA4 may influence BRCA prognosis through antigen binding, immunoglobulin complexes, lymphocyte-mediated immunity, and cytokine-cytokine receptor interaction. These findings help us understand how CTLA4 plays a role in BRCA and set the stage for more research.

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