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.Anatomical study to determine a new approach to treat benign masses located in the anterior condyle region: a case report
Sin Guen KIM ; Sung Chul BOK ; Suk In CHOI ; Jun Woo PARK ; Dong Ju CHOI
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2024;50(2):110-115
A 22-year-old male patient presented to the clinic with severe pain in the preauricular area with an inability to completely occlude the jaw. Facial computed tomography and magnetic resonance imaging revealed a well-defined lesion that was tentatively diagnosed as a benign tumor or cystic mass. Surgical approach of a lesion in the condyle is delicate and problematic as many vulnerable anatomical structures are present. There are several methods for surgery in this area. Typically, an extraoral approach is dangerous because of potential injuries to nerves and arteries. The intraoral approach also presents difficulties due to the lack of visibility and accessibility. On occasion, coronoidectomy may be performed. The goal here was to determine an easier and safer new surgical approach to the condyle. We reached the anterior part of the pterygoid plate in the same method as in Le Fort I surgery.From this point, through the external pterygoid muscle, approaching the anterior aspect of the condyle is relatively easy and safe, with minimal damage to the surrounding tissues. Pus was drained at the site, and the lesion was diagnosed as an abscess. Pain and inability to close the mouth resolved without recurrence.
6.Avulsion Fracture of the Lesser Tuberosity of the Humerus in Adolescent:A Case Report and Literature Review
Jae Chul YOO ; Sung Hwan KIM ; Sin Hyung PARK ; Jae Hyun KIM ; Yong Bok PARK
The Korean Journal of Sports Medicine 2024;42(3):229-232
During adolescence, traumas in the subscapularis muscle lead more often to osseous avulsion of the lesser tuberosity or subscapularis tendon, as opposed to often to intrasubstance tendinous injury in adults. This injury is commonly diagnosed as persistent shoulder pain, and it is difficult to diagnose immediately. This article is a case report of teenage patient who underwent open reduction and internal fixation for a displaced lesser tuberosity avulsion fracture. After experiencing a sports trauma 8 months ago, a 14-year-old male came to our clinic complaining of right shoulder pain and weakness. We used a cannulated screw to humeral lesser tuberosity and repaired infraspinatus additionally. We applied a progressive physical therapy regimen postoperatively. On postoperative 6 months, full range of motion of shoulder joint and strength was restored. We report our successful surgical treatment outcome of a fracture of the lesser tuberosity in an adolescent.
7.2022 Seoul Consensus on Clinical Practice Guidelines for Functional Constipation
Young Sin CHO ; Yoo Jin LEE ; Jeong Eun SHIN ; Hye-Kyung JUNG ; Seon-Young PARK ; Seung Joo KANG ; Kyung Ho SONG ; Jung-Wook KIM ; Hyun Chul LIM ; Hee Sun PARK ; Seong-Jung KIM ; Ra Ri CHA ; Ki Bae BANG ; Chang Seok BANG ; Sung Kyun YIM ; Seung-Bum RYOO ; Bong Hyeon KYE ; Woong Bae JI ; Miyoung CHOI ; In-Kyung SUNG ; Suck Chei CHOI ;
Journal of Neurogastroenterology and Motility 2023;29(3):271-305
Chronic constipation is one of the most common digestive diseases encountered in clinical practice. Constipation manifests as a variety of symptoms, such as infrequent bowel movements, hard stools, feeling of incomplete evacuation, straining at defecation, a sense of anorectal blockage during defecation, and use of digital maneuvers to assist defecation. During the diagnosis of chronic constipation, the Bristol Stool Form Scale, colonoscopy, and a digital rectal examination are useful for objective symptom evaluation and differential diagnosis of secondary constipation. Physiological tests for functional constipation have complementary roles and are recommended for patients who have failed to respond to treatment with available laxatives and those who are strongly suspected of having a defecatory disorder. As new evidence on the diagnosis and management of functional constipation emerged, the need to revise the previous guideline was suggested. Therefore, these evidence-based guidelines have proposed recommendations developed using a systematic review and meta-analysis of the treatment options available for functional constipation. The benefits and cautions of new pharmacological agents (such as lubiprostone and linaclotide) and conventional laxatives have been described through a meta-analysis. The guidelines consist of 34 recommendations, including 3 concerning the definition and epidemiology of functional constipation, 9 regarding diagnoses, and 22 regarding managements. Clinicians (including primary physicians, general health professionals, medical students, residents, and other healthcare professionals) and patients can refer to these guidelines to make informed decisions regarding the management of functional constipation.
8.2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease
Hye-Kyung JUNG ; Chung Hyun TAE ; Kyung Ho SONG ; Seung Joo KANG ; Jong Kyu PARK ; Eun Jeong GONG ; Jeong Eun SHIN ; Hyun Chul LIM ; Sang Kil LEE ; Da Hyun JUNG ; Yoon Jin CHOI ; Seung In SEO ; Joon Sung KIM ; Jung Min LEE ; Beom Jin KIM ; Sun Hyung KANG ; Chan Hyuk PARK ; Suck Chei CHOI ; Joong Goo KWON ; Kyung Sik PARK ; Moo In PARK ; Tae Hee LEE ; Seung Young KIM ; Young Sin CHO ; Han Hong LEE ; Kee Wook JUNG ; Do Hoon KIM ; Hee Seok MOON ; Mi-Young CHOI ; Kwang Jae LEE ;
Korean Journal of Medicine 2022;97(2):70-92
Gastroesophageal reflux disease (GERD) is a condition in which gastric contents regurgitate into the esophagus or beyond, resulting in either troublesome symptoms or complications. GERD is heterogeneous in terms of varied manifestations, test findings, and treatment responsiveness. GERD diagnosis can be established with symptomatology, pathology, or physiology. Recently the Lyon consensus defined the “proven GERD” with concrete evidence for reflux, including advanced grade erosive esophagitis (Los Angeles classification grades C and or D esophagitis), long-segment Barrett’s mucosa or peptic strictures on endoscopy or distal esophageal acid exposure time > 6% on 24-hour ambulatory pH-impedance monitoring. However, some Asian researchers have different opinions on whether the same standards should be applied to the Asian population. The prevalence of GERD is increasing in Asia. The present evidence-based guidelines were developed using a systematic review and meta-analysis approach. In GERD with typical symptoms, a proton pump inhibitor test can be recommended as a sensitive, cost-effective, and practical test for GERD diagnosis. Based on a meta-analysis of 19 estimated acid-exposure time values in Asians, the reference range upper limit for esophageal acid exposure time was 3.2% (95% confidence interval 2.7-3.9%) in the Asian countries. Esophageal manometry and novel impedance measurements, including mucosal impedance and a post-reflux swallow-induced peristaltic wave, are promising in discrimination of GERD among different reflux phenotypes, thus increasing its diagnostic yield. We also propose a long-term strategy of evidence-based GERD treatment with proton pump inhibitors and other drugs.
9.2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease
Hye-Kyung JUNG ; Chung Hyun TAE ; Kyung Ho SONG ; Seung Joo KANG ; Jong Kyu PARK ; Eun Jeong GONG ; Jeong Eun SHIN ; Hyun Chul LIM ; Sang Kil LEE ; Da Hyun JUNG ; Yoon Jin CHOI ; Seung In SEO ; Joon Sung KIM ; Jung Min LEE ; Beom Jin KIM ; Sun Hyung KANG ; Chan Hyuk PARK ; Suck Chei CHOI ; Joong Goo KWON ; Kyung Sik PARK ; Moo In PARK ; Tae Hee LEE ; Seung Young KIM ; Young Sin CHO ; Han Hong LEE ; Kee Wook JUNG ; Do Hoon KIM ; Hee Seok MOON ; Hirota MIWA ; Chien-Lin CHEN ; Sutep GONLACHANVIT ; Uday C GHOSHAL ; Justin C Y WU ; Kewin T H SIAH ; Xiaohua HOU ; Tadayuki OSHIMA ; Mi-Young CHOI ; Kwang Jae LEE ; The Korean Society of Neurogastroenterology and Motility
Journal of Neurogastroenterology and Motility 2021;27(4):453-481
Gastroesophageal reflux disease (GERD) is a condition in which gastric contents regurgitate into the esophagus or beyond, resulting in either troublesome symptoms or complications. GERD is heterogeneous in terms of varied manifestations, test findings, and treatment responsiveness. GERD diagnosis can be established with symptomatology, pathology, or physiology. Recently the Lyon consensus defined the “proven GERD” with concrete evidence for reflux, including advanced grade erosive esophagitis (Los Angeles classification grades C and or D esophagitis), long-segment Barrett’s mucosa or peptic strictures on endoscopy or distal esophageal acid exposure time > 6% on 24-hour ambulatory pH-impedance monitoring. However, some Asian researchers have different opinions on whether the same standards should be applied to the Asian population. The prevalence of GERD is increasing in Asia. The present evidence-based guidelines were developed using a systematic review and meta-analysis approach. In GERD with typical symptoms, a proton pump inhibitor test can be recommended as a sensitive, cost-effective, and practical test for GERD diagnosis.Based on a meta-analysis of 19 estimated acid-exposure time values in Asians, the reference range upper limit for esophageal acid exposure time was 3.2% (95% confidence interval, 2.7-3.9%) in the Asian countries. Esophageal manometry and novel impedance measurements, including mucosal impedance and a post-reflux swallow-induced peristaltic wave, are promising in discrimination of GERD among different reflux phenotypes, thus increasing its diagnostic yield. We also propose a long-term strategy of evidence-based GERD treatment with proton pump inhibitors and other drugs.
10.2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease
Hye-Kyung JUNG ; Chung Hyun TAE ; Kyung Ho SONG ; Seung Joo KANG ; Jong Kyu PARK ; Eun Jeong GONG ; Jeong Eun SHIN ; Hyun Chul LIM ; Sang Kil LEE ; Da Hyun JUNG ; Yoon Jin CHOI ; Seung In SEO ; Joon Sung KIM ; Jung Min LEE ; Beom Jin KIM ; Sun Hyung KANG ; Chan Hyuk PARK ; Suck Chei CHOI ; Joong Goo KWON ; Kyung Sik PARK ; Moo In PARK ; Tae Hee LEE ; Seung Young KIM ; Young Sin CHO ; Han Hong LEE ; Kee Wook JUNG ; Do Hoon KIM ; Hee Seok MOON ; Hirota MIWA ; Chien-Lin CHEN ; Sutep GONLACHANVIT ; Uday C GHOSHAL ; Justin C Y WU ; Kewin T H SIAH ; Xiaohua HOU ; Tadayuki OSHIMA ; Mi-Young CHOI ; Kwang Jae LEE ; The Korean Society of Neurogastroenterology and Motility
Journal of Neurogastroenterology and Motility 2021;27(4):453-481
Gastroesophageal reflux disease (GERD) is a condition in which gastric contents regurgitate into the esophagus or beyond, resulting in either troublesome symptoms or complications. GERD is heterogeneous in terms of varied manifestations, test findings, and treatment responsiveness. GERD diagnosis can be established with symptomatology, pathology, or physiology. Recently the Lyon consensus defined the “proven GERD” with concrete evidence for reflux, including advanced grade erosive esophagitis (Los Angeles classification grades C and or D esophagitis), long-segment Barrett’s mucosa or peptic strictures on endoscopy or distal esophageal acid exposure time > 6% on 24-hour ambulatory pH-impedance monitoring. However, some Asian researchers have different opinions on whether the same standards should be applied to the Asian population. The prevalence of GERD is increasing in Asia. The present evidence-based guidelines were developed using a systematic review and meta-analysis approach. In GERD with typical symptoms, a proton pump inhibitor test can be recommended as a sensitive, cost-effective, and practical test for GERD diagnosis.Based on a meta-analysis of 19 estimated acid-exposure time values in Asians, the reference range upper limit for esophageal acid exposure time was 3.2% (95% confidence interval, 2.7-3.9%) in the Asian countries. Esophageal manometry and novel impedance measurements, including mucosal impedance and a post-reflux swallow-induced peristaltic wave, are promising in discrimination of GERD among different reflux phenotypes, thus increasing its diagnostic yield. We also propose a long-term strategy of evidence-based GERD treatment with proton pump inhibitors and other drugs.

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