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.Sulfuretin Prevents Obesity and Metabolic Diseases in Diet Induced Obese Mice.
Suji KIM ; No Joon SONG ; Seo Hyuk CHANG ; Gahee BAHN ; Yuri CHOI ; Dong Kwon RHEE ; Ui Jeong YUN ; Jinhee CHOI ; Jeon LEE ; Jae Hyuk YOO ; Donghan SHIN ; Ki Moon PARK ; Hee KANG ; Sukchan LEE ; Jin Mo KU ; Yoon Shin CHO ; Kye Won PARK
Biomolecules & Therapeutics 2019;27(1):107-116
The global obesity epidemic and associated metabolic diseases require alternative biological targets for new therapeutic strategies. In this study, we show that a phytochemical sulfuretin suppressed adipocyte differentiation of preadipocytes and administration of sulfuretin to high fat diet-fed obese mice prevented obesity and increased insulin sensitivity. These effects were associated with a suppressed expression of inflammatory markers, induced expression of adiponectin, and increased levels of phosphorylated ERK and AKT. To elucidate the molecular mechanism of sulfuretin in adipocytes, we performed microarray analysis and identified activating transcription factor 3 (Atf3) as a sulfuretin-responsive gene. Sulfuretin elevated Atf3 mRNA and protein levels in white adipose tissue and adipocytes. Consistently, deficiency of Atf3 promoted lipid accumulation and the expression of adipocyte markers. Sulfuretin’s but not resveratrol’s anti-adipogenic effects were diminished in Atf3 deficient cells, indicating that Atf3 is an essential factor in the effects of sulfuretin. These results highlight the usefulness of sulfuretin as a new anti-obesity intervention for the prevention of obesity and its associated metabolic diseases.
Activating Transcription Factor 3
;
Adipocytes
;
Adiponectin
;
Adipose Tissue, White
;
Animals
;
Diet*
;
Insulin Resistance
;
Metabolic Diseases*
;
Mice
;
Mice, Obese*
;
Microarray Analysis
;
Obesity*
;
RNA, Messenger
6.Clinical Features and Treatment Pattern of Migrainous Vertigo in Korea: A Nationwide Prospective Multicenter Study
Seong Ki AHN ; Kyusik KANG ; Ja Won KOO ; Kyu Sung KIM ; Beom Gyu KIM ; Byung Kun KIM ; Ji Soo KIM ; Kyoung Ho PARK ; Shi Nae PARK ; Eun Ho PARK ; Hong Ju PARK ; Jae Yong BYUN ; Myung Whan SUH ; Ki Bum SUNG ; Sun Young OH ; Chung Ku RHEE ; Tae Kyeong LEE ; Seong Hae JEONG ; Won Ho CHUNG ; Chang Il CHA ; Sung Won CHAE ; Eui Kyung GOH
Journal of the Korean Balance Society 2009;8(2):122-131
BACKGROUND AND OBJECTIVES It is being increasing recognized that the morbidities of migraine and balance disorders are interrelated. In fact, migrainous vertigo (MV) is one of frequent causes of recurrent vertigo in patients presenting to specialized dizziness clinics. Nevertheless, not many studies have reported clinical manifestations and treatment. Therefore, the aim of study was designed to assess clinical features and treatment patterns by a nationwide multicenter study. MATERIALS AND METHODS Patients between 9 and 74 years of age who visited 17 Korean tertiary referral centers and 1 clinic from February to March 2009 were investigated using two forms of questionnaires. RESULTS Overall, 318 patients with MV were enrolled. MV was responsible for ~8.45% of visits to the specialized dizziness clinics. One hundred seventy-five of these patients had definite MV and were included in assessing the clinical features. Vertigo characteristics of patients with definite MV were various. Vertigo was regularly as sociated with headache in 87% of the patients. The duration of vertigo ranged from seconds to days. For the treatment patterns, an acute and prophylactic therapies were carried in most clinics. There were no differences in either acute or prophylactic therapies between department of neurology and otorhinolaryngology. CONCLUSIONS The results of this study suggest that MV the clinical features of MV also varies in Korea. In addition, most clinics provide similar patterns of practice in treatment for MV. The syndrome of MV deserves further research activity as it is relatively common and clinically relevant.
Dizziness
;
Headache
;
Humans
;
Korea
;
Migraine Disorders
;
Neurology
;
Prospective Studies
;
Tertiary Care Centers
;
Vertigo
7.Clinical Characteristics of Dizziness after Motor Vehicle Accident.
Min Young LEE ; Sung Won CHUNG ; Myung Whan SUH ; Chung Ku RHEE ; Jae Yun JUNG
Korean Journal of Otolaryngology - Head and Neck Surgery 2009;52(9):718-723
BACKGROUND AND OBJECTIVES: Diagnosis and treatment of dizziness after motor vehicle accident (MVA) is not challenging. Psychological factors may be important and patient's quality of life can be underestimated due to nonspecific vague symptoms. The aim of this study is to reveal the clinical characteristics of dizziness after motor vehicle accident. SUBJECTS AND METHOD: Of the patients who have visited Dankook University hospital for traumatic dizziness from Jan. 1994 through Jan. 2008, we enrolled 51 patients who had history of motor vehicle accident and performed vestibular function test (VFT). Patients were divided into groups according to VFT findings. Patients who had unilateral hypo-function in VFT were classified as Group A. Patients who showed typical nystagmus for benign paroxismal positional vertigo (BPPV) were classified as Group B. And the others were classified as Group C who showed fair VFT results. RESULTS: Group C was found with unidentified dizziness, a tendency of late onset and long term recovery. Also they complained different distributions of their symptoms, that is, the rate of patients with headache and visual symptoms were higher in Group C. CONCLUSION: There were no remarkable characteristics in unidentified dizziness after MVA. Although the objective test results were non-specific, their clinical progress was not favorable. They complained of headache and visual symptoms more than other groups.
Dizziness
;
Headache
;
Humans
;
Motor Vehicles
;
Quality of Life
;
Vertigo
;
Vestibular Function Tests
8.Bilateral Vestibular Hypofunction Induced by Unilateral Herpes Zoster Oticus.
Sung Won CHUNG ; Jae Yun JUNG ; Chung Ku RHEE ; Myung Whan SUH
Journal of the Korean Balance Society 2008;7(2):207-212
Herpes zoster oticus usually accompanies vestibulopathy on the ipsilateral ear. However we have encountered two herpes zoster oticus patients with bilateral vestibulopathies. Bilateral vestibulopathy was detected on the 2nd month and 19th day of herpes zoster oticus, respectively. While the contralateral vestibulopathy was detected 2 month after the ipsilateral vestibulopathy in the first patient, the vestibular function deteriorated simultaneously on the 19th day in the second patient. It seems that the bilateral vestibulopathy was caused by an autoimmune process in both cases, but the initiating event is different. The ipsilateral vestibular damage may have sensitized the immune system in the first patient resulting in sympathetic vestibulopathy. But in the second patient, the ipsilateral cochlear damage may have sensitized the immune system resulting in simultaneous bilateral vestibulopathy.
Ear
;
Herpes Zoster
;
Herpes Zoster Oticus
;
Humans
;
Immune System
9.Results of Otolithic Function Testing and Related Clinical Features in Unilateral Definite Meniere's Disease.
Jae Yun JUNG ; Jeong Beom KIM ; Tae Hyun MOON ; Yong Won CHUNG ; Chung Ku RHEE
Journal of the Korean Balance Society 2007;6(2):207-213
BACKGROUND AND OBJECTIVES: The purpose of this study is to identify the typical pattern of otolithic function tests in unilateral definite Meniere's disease patients. And we compared with clinical features and other tests results of patients who showed abnormal otolithic function tests. MATERIALS AND METHOD: We reviewed 42 patients (29 patients are female and 13 patients are male) who were diagnosed as unilateral definite Meniere's disease and underwent otolithic function tests in Hospital from December 2005 to April 2007. RESULTS: The patients who showed abnormal findings in vestibular evoked myogenic potential (VEMP) have suffered for longer period than the others. Those results of VEMP had positive correlation with summating potential/action potential (SP/AP) ratio. The average deviation of subjective visual vertical/ horizontal (SVV/SVH) were relatively higher in that disease patients than normal controls. There was no significant relation between VEMP results and other clinical features and result of other tests (caloric test and pure tone audiometry). CONCLUSION: The longer prevalence period of Meniere's disease is, the more susceptability of abnormal VEMP we can expect. In those, SVV/H can go out of normal range. Like a electrocochleography, otolithic function test could play a supportive role in diagnosing of Meniere's disease.
Audiometry, Evoked Response
;
Female
;
Humans
;
Meniere Disease*
;
Otolithic Membrane*
;
Prevalence
;
Reference Values
10.A Promotive Effect of Low-Level Laser on Hair Cell Regeneration Following Gentamicin Induced Ototoxicity in Postnatal Organotypic Culture of Rat Utricles.
Yong Won CHUNG ; Jin Chul AHN ; Eun Seok LIM ; Young Saeng KIM ; Sang Hun LEE ; Min Young LEE ; Chung Ku RHEE
Korean Journal of Otolaryngology - Head and Neck Surgery 2007;50(1):25-30
BACKGROUND AND OBJECTIVES: In normal postnatal mammalian inner ear sensory epithelium, regeneration of hair cells is a very rare event, but there is hair cell regeneration with partial restoration of the vestibular sensory epithelium following ototoxic damage. In this study, the effects of low-level laser on hair cell regeneration following gentamicin exposure in postnatal organotypic culture of rat utricles were investigated. MATERIALS AND METHOD: A long term organotypic culture of 2 to 7 day old rat utricular maculae was established to study aminoglycoside-induced vestibular hair cell renewal. The utricles were exposed to 1 mM of gentamicin for 48 hr and allowed to recover in a culture medium only or in a medium with daily irradiation of low-level laser, whereas the control group was not exposed to gentamicin. Whole-mount utricles were stained with FM1-43, which are known to be an efficient marker, to identify live hair cells in cultured tissues. RESULTS: Loss of hair cells was nearly stopped from 2 days after exposure to gentamicin ; a peak of regeneration was reached after 18 days and sustained for two weeks in the medium with the irradiation of low-level laser. CONCLUSION: These results suggest that low-level laser promotes spontaneous hair cell regeneration following gentamicin damage in utricular explants.
Animals
;
Ear, Inner
;
Epithelium
;
Gentamicins*
;
Hair Cells, Vestibular
;
Hair*
;
Rats*
;
Regeneration*
;
Saccule and Utricle*

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