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.A Comparison between Keratograph 5M® and IDRA® in Dry Eye Patients
Seo Woo PARK ; Ha-Rim SO ; Ji Won BAEK ; Ho Sik HWANG ; Kyung-Sun NA ; Ho RA ; Nam Yeo KANG ; Hyun Seung KIM ; Eun Chul KIM
Journal of the Korean Ophthalmological Society 2025;66(4):175-180
Purpose:
To evaluate the compatibility and usability of test results obtained from the IDRA and Keratograph 5M in clinical settings by comparing their performance in patients with dry eye disease.
Methods:
From December 27 to 30, 2022, a study was conducted on 30 patients diagnosed with dry eye utilizing both the Keratograph 5M and IDRA devices. The parameters compared and analyzed included lipid layer thickness, tear meniscus height, tear film break-up time, and meibography. A paired t-test was used for statistical comparison. The lipid layer thickness in the Keratograph 5M was graded on a scale from 0 to 4 based on thickness.
Results:
No significant differences were found between the two devices in tear film break-up time, tear meniscus height, and meibography (p = 0.148, 0.072, 0.124, respectively). However, the tear lipid layer thickness measured by IDRA showed a proportional relationship with the grade assigned by the Keratograph 5M (Kendall R = 0.217, p = 0.037; Spearman R = 0.260, p = 0.045).
Conclusions
The IDRA device offers the advantage of performing multiple dry eye tests; simultaneously, thereby saving time compared to the Keratograph 5M. Both devices can be used compatibly with IDRA particularly advantageous for providing a numerical value for tear lipid layer thickness which enhances the convenience of dry eye diagnosis and treatment.
3.Comparison of Helical Interwoven Nitinol Stent Placement Versus Balloon Angioplasty for Arteriovenous Dialysis Graft Malfunction Caused by Stenosis of the Venous Anastomosis Site
Jae Hwan HYUN ; Doo Ri KIM ; In Chul NAM ; Jeong Sub LEE ; Jeong Jae KIM ; Hyunwoo KIM ; Miyeon KIM
Journal of the Korean Society of Radiology 2025;86(2):249-258
Purpose:
The study aimed to compare the differences in patency between helical interwoven nitinol stents and balloon angioplasty in patients with arteriovenous graft (AVG) malfunction caused by venous anastomosis stenosis.
Materials and Methods:
This retrospective study included patients who underwent helical interwoven nitinol stent placement (n = 15) or balloon angioplasty (n = 25) between January 2016 and September 2021. The primary and secondary patency rates were compared between the two groups.
Results:
Dialysis was possible post-intervention in all patients who showed no specific complications, including stent fracture. The average primary patency of the stent placement group was longer than that of the balloon angioplasty group but did not differ significantly (8.5 vs. 6.3 months, p = 0.319). The mean secondary patency period was 17.6 months in the stent placement group, which was shorter than that in the balloon angioplasty group (18.8 months); however, this difference was also not statistically significant (p = 0.660).
Conclusion
Helical interwoven nitinol stents could maintain patency in patients with AVG malfunction caused by venous anastomosis stenosis, but they did not improve patency compared to balloon angioplasty.
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.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.
6.A Comparison between Keratograph 5M® and IDRA® in Dry Eye Patients
Seo Woo PARK ; Ha-Rim SO ; Ji Won BAEK ; Ho Sik HWANG ; Kyung-Sun NA ; Ho RA ; Nam Yeo KANG ; Hyun Seung KIM ; Eun Chul KIM
Journal of the Korean Ophthalmological Society 2025;66(4):175-180
Purpose:
To evaluate the compatibility and usability of test results obtained from the IDRA and Keratograph 5M in clinical settings by comparing their performance in patients with dry eye disease.
Methods:
From December 27 to 30, 2022, a study was conducted on 30 patients diagnosed with dry eye utilizing both the Keratograph 5M and IDRA devices. The parameters compared and analyzed included lipid layer thickness, tear meniscus height, tear film break-up time, and meibography. A paired t-test was used for statistical comparison. The lipid layer thickness in the Keratograph 5M was graded on a scale from 0 to 4 based on thickness.
Results:
No significant differences were found between the two devices in tear film break-up time, tear meniscus height, and meibography (p = 0.148, 0.072, 0.124, respectively). However, the tear lipid layer thickness measured by IDRA showed a proportional relationship with the grade assigned by the Keratograph 5M (Kendall R = 0.217, p = 0.037; Spearman R = 0.260, p = 0.045).
Conclusions
The IDRA device offers the advantage of performing multiple dry eye tests; simultaneously, thereby saving time compared to the Keratograph 5M. Both devices can be used compatibly with IDRA particularly advantageous for providing a numerical value for tear lipid layer thickness which enhances the convenience of dry eye diagnosis and treatment.
7.Comparison of Helical Interwoven Nitinol Stent Placement Versus Balloon Angioplasty for Arteriovenous Dialysis Graft Malfunction Caused by Stenosis of the Venous Anastomosis Site
Jae Hwan HYUN ; Doo Ri KIM ; In Chul NAM ; Jeong Sub LEE ; Jeong Jae KIM ; Hyunwoo KIM ; Miyeon KIM
Journal of the Korean Society of Radiology 2025;86(2):249-258
Purpose:
The study aimed to compare the differences in patency between helical interwoven nitinol stents and balloon angioplasty in patients with arteriovenous graft (AVG) malfunction caused by venous anastomosis stenosis.
Materials and Methods:
This retrospective study included patients who underwent helical interwoven nitinol stent placement (n = 15) or balloon angioplasty (n = 25) between January 2016 and September 2021. The primary and secondary patency rates were compared between the two groups.
Results:
Dialysis was possible post-intervention in all patients who showed no specific complications, including stent fracture. The average primary patency of the stent placement group was longer than that of the balloon angioplasty group but did not differ significantly (8.5 vs. 6.3 months, p = 0.319). The mean secondary patency period was 17.6 months in the stent placement group, which was shorter than that in the balloon angioplasty group (18.8 months); however, this difference was also not statistically significant (p = 0.660).
Conclusion
Helical interwoven nitinol stents could maintain patency in patients with AVG malfunction caused by venous anastomosis stenosis, but they did not improve patency compared to balloon angioplasty.
8.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.
9.A Comparison between Keratograph 5M® and IDRA® in Dry Eye Patients
Seo Woo PARK ; Ha-Rim SO ; Ji Won BAEK ; Ho Sik HWANG ; Kyung-Sun NA ; Ho RA ; Nam Yeo KANG ; Hyun Seung KIM ; Eun Chul KIM
Journal of the Korean Ophthalmological Society 2025;66(4):175-180
Purpose:
To evaluate the compatibility and usability of test results obtained from the IDRA and Keratograph 5M in clinical settings by comparing their performance in patients with dry eye disease.
Methods:
From December 27 to 30, 2022, a study was conducted on 30 patients diagnosed with dry eye utilizing both the Keratograph 5M and IDRA devices. The parameters compared and analyzed included lipid layer thickness, tear meniscus height, tear film break-up time, and meibography. A paired t-test was used for statistical comparison. The lipid layer thickness in the Keratograph 5M was graded on a scale from 0 to 4 based on thickness.
Results:
No significant differences were found between the two devices in tear film break-up time, tear meniscus height, and meibography (p = 0.148, 0.072, 0.124, respectively). However, the tear lipid layer thickness measured by IDRA showed a proportional relationship with the grade assigned by the Keratograph 5M (Kendall R = 0.217, p = 0.037; Spearman R = 0.260, p = 0.045).
Conclusions
The IDRA device offers the advantage of performing multiple dry eye tests; simultaneously, thereby saving time compared to the Keratograph 5M. Both devices can be used compatibly with IDRA particularly advantageous for providing a numerical value for tear lipid layer thickness which enhances the convenience of dry eye diagnosis and treatment.
10.Comparison of Helical Interwoven Nitinol Stent Placement Versus Balloon Angioplasty for Arteriovenous Dialysis Graft Malfunction Caused by Stenosis of the Venous Anastomosis Site
Jae Hwan HYUN ; Doo Ri KIM ; In Chul NAM ; Jeong Sub LEE ; Jeong Jae KIM ; Hyunwoo KIM ; Miyeon KIM
Journal of the Korean Society of Radiology 2025;86(2):249-258
Purpose:
The study aimed to compare the differences in patency between helical interwoven nitinol stents and balloon angioplasty in patients with arteriovenous graft (AVG) malfunction caused by venous anastomosis stenosis.
Materials and Methods:
This retrospective study included patients who underwent helical interwoven nitinol stent placement (n = 15) or balloon angioplasty (n = 25) between January 2016 and September 2021. The primary and secondary patency rates were compared between the two groups.
Results:
Dialysis was possible post-intervention in all patients who showed no specific complications, including stent fracture. The average primary patency of the stent placement group was longer than that of the balloon angioplasty group but did not differ significantly (8.5 vs. 6.3 months, p = 0.319). The mean secondary patency period was 17.6 months in the stent placement group, which was shorter than that in the balloon angioplasty group (18.8 months); however, this difference was also not statistically significant (p = 0.660).
Conclusion
Helical interwoven nitinol stents could maintain patency in patients with AVG malfunction caused by venous anastomosis stenosis, but they did not improve patency compared to balloon angioplasty.

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