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.Angiomatoid Spitz Nevus.
Oh Eon KWON ; Bon Seok KU ; Yeong Kyu LEE ; Young Hun KIM ; Ki Ho KIM
Annals of Dermatology 2008;20(1):14-17
Spitz nevus is a variant of melanocytic nevus which is histopathologically defined as large spindle and/or epithelioid cells. Angiomatoid Spitz nevus is a rare histologic variant of desmoplastic Spitz nevus characterized by prominent vasculature. We present a case of angiomatoid Spitz nevus, celluar type, that has not been reported before. We provide another example to show the remarkable diversity of Spitz nevus.
Epithelioid Cells
;
Nevus, Epithelioid and Spindle Cell
;
Nevus, Pigmented
6.Histopathologic Gradings Correlate with Clinical Prognostic Factors and Therapeutic Effects in Patient with Alopecia Areata.
Oh Eon KWON ; Bon Seok KU ; Yeong Kyu LEE ; Chae Wook LEE ; Ki Ho KIM
Korean Journal of Dermatology 2007;45(2):111-118
BACKGRUND & OBJECTIVE: Prognosis of alopecia areata have been attributed to various factors; age of onset, duration before treatment, extent of hair loss, clinical type of alopecia areata, sex, nail changes or accompaniment of atopy. The study on prognostic factors has only been conducted from statistical data of patients and individualized medical conditions. The histopathologic findings of alopecia areata have been investigated by the minute pathologic changes associated with the hair growth cycle in the transverse section. Moreover, these findings were used mainly for diagnostic purpose, but clinical significance of histopathologic severity in prognosis has not been established to date. METHODS: A clinical study, including histopathological and clinical evaluation was conducted on 108 alopecia areata patients between July 1997 and August 2005 at the Department of Dermatology, Dong-A University Hospital. The evaluation criteria INCLUDED: sex, age, age at onset, duration before treatment, clinical types, extent of hair loss, nail changes, accompaniment of atopy, and scalp biopsy finding. The clinical types of alopecia areata were classified as follows; patchy, subtotalis, totalis, and universalis. The extent of hair loss before treatment was classified into 5 grades (S1~S5), according to the method designed by Olsen and Canfield. Clinical improvements after treatment were classified into 5 grades according to degree of regrowth and reduction of the alopecia areata area. Biopsy findings were classified into 4 grades (type I, II, III, and IV) according to classification by Uno and Orecchia. RESULTS: The mean age was 28.6 years, without any sex predominance. The severe histopathologic gradings were significantly associated with early age of onset (p=0.008), a long disease duration before treatment (p=0.003), a greater extent of hair loss (p=0.009), and poor response to treatment (p=0.036). The histopathologic gradings were not significantly associated with sex (p=0.657), clinical types of alopecia areata (p=0.529), nail changes (p=0.746), or accompaniment of atopy (p=0.924). CONCLUSION: Histopathologic gradings in alopecia areata, using vertical sections are significantly associated with prognostic factors such as age of onset, extent of hair loss, disease duration before treatment, as well as the response to treatment. Therefore we consider that the histopathologic grading system is recommendable as an independent prognostic factor in alopecia areata, in addition to the well-known clinical prognostic factors. They may also be used to predict the response to treatment.
Age of Onset
;
Alopecia Areata*
;
Alopecia*
;
Biopsy
;
Classification
;
Dermatology
;
Hair
;
Humans
;
Prognosis
;
Scalp
7.SIADH closely related to a non-functioning pituitary adenoma: case report.
Jun Chul LEE ; Ki Hyun KWON ; Ihn Suk LEE ; Yun Jeung KIM ; Sarah JEONG ; Seul Young KIM ; Bon Jeong KU
Korean Journal of Medicine 2007;72(3):315-321
We present a case of severe hyponatremia in a 64-year-old man who had a pituitary tumor. He had nausea and recurrent vomiting with a severe headache, and was admitted to Chungnam National University Hospital for further evaluation. On physical examination, he was alert, and had bitemporal hemianopsia. There was no indication of dehydration or edema. Laboratory data showed a serum sodium level of 126 mEq/L, plasma osmolality of 259 mOsm/kg, and urinary osmolality of 544 mOsm/kg. The plasma argipressin level was 2.88 pg/mL, despite marked hyposmolality. Otherwise, pituitary function was normal. Brain magnetic resonance imaging showed a pituitary macroadenoma measuring 25x16x13 mm and no visible normal pituitary stalk or gland in the sella turcica. After the adenomectomy, the serum sodium level maintained normal without treatment. Histology showed the presence of a pituitary adenoma. These findings indicate that a non-functioning pituitary tumor may cause the exaggerated secretion of argipressin, resulting in inappropriate antidiuretic hormone syndrome.
Arginine Vasopressin
;
Brain
;
Chungcheongnam-do
;
Dehydration
;
Edema
;
Headache
;
Hemianopsia
;
Humans
;
Hyponatremia
;
Inappropriate ADH Syndrome*
;
Magnetic Resonance Imaging
;
Middle Aged
;
Nausea
;
Osmolar Concentration
;
Physical Examination
;
Pituitary Gland
;
Pituitary Neoplasms*
;
Plasma
;
Sella Turcica
;
Sodium
;
Vomiting
8.Multiple Cutaneous Edema and Infiltration of Signet-ring Cells in the Lymphatics as an Initial Manifestation of Metastatic Gastric Adenocarcinoma.
Oh Eon KWON ; Bon Seok KU ; Dae Cheol KIM ; Chae Wook LEE ; Ki Ho KIM
Korean Journal of Dermatology 2006;44(5):601-604
Signet-ring cells are cells in which the nucleus is crescentically compressed with a cellular border, so that the cell looks like a signet-ring. Many cutaneous signet-ring cell neoplasms originate from the stomach, lung and breast, and these appear to be the most common sites of origin. In skin, the appearance of signet-ring cells within a neoplasm can indicate metastatic adenocarcinoma of the stomach, lung and breast. Thus, the primary origin and other metastatic sites should be evaluated. A 44-year-old man presented with a six month history of cutaneous swelling on the left axillary and left supraclavicular area. Histopathologic findings of the axillary lesion showed signet-ring cells in the lymphatics. These clustered cells were PAS-positive, diastase-resistant, and stained with colloidal iron and CEA. During the work-up study to find the primary origin, we discovered advanced gastric cancer and multiple lymph node metastases.
Adenocarcinoma*
;
Adult
;
Breast
;
Colloids
;
Edema*
;
Humans
;
Iron
;
Lung
;
Lymph Nodes
;
Neoplasm Metastasis
;
Skin
;
Stomach
;
Stomach Neoplasms
9.A Case of Calcifying Aponeurotic Fibroma with Gait Disturbance.
Oh Eon KWON ; Bon Seok KU ; Dae Cheol KIM ; Chae Wook LEE ; Ki Ho KIM
Korean Journal of Dermatology 2006;44(1):71-74
Calvus, callus, plantar warts and piezogenic papules are well known to cause discomfort and disturbance of gait in ordinary physical and sports activities. Furthermore, calcifying aponeurotic fibroma, whose mass slowly grows on the palms and soles of children and young adults, leads to pain, disturbance of gait, and even to skeletal deformities. A 22-year-old woman noticed an elevated subcutaneous mass on the left plantar surface of her big toe, which was accompanied with pain, tenderness and gait disturbance. The histologic findings showed an ill-circumscribed fibroblastic proliferation with foci of calcification and chondroid differentiation. After total excision of the mass, the patient became free of the above symptoms and the lesion did not recur for 9 months.
Bony Callus
;
Child
;
Congenital Abnormalities
;
Female
;
Fibroblasts
;
Fibroma*
;
Gait*
;
Humans
;
Sports
;
Toes
;
Warts
;
Young Adult
10.A Case of Lentigo Maligna Melanoma Treated with Mohs Micrographic Surgery.
Bon Seok KU ; Oh Eon KWON ; Dae Cheol KIM ; Keun Cheol LEE ; Chae Wook LEE ; Ki Ho KIM
Korean Journal of Dermatology 2006;44(4):457-461
Lentigo maligna melanoma and lentigo maligna are typically located on photo-exposed sites such as the head and neck, with the cheek being the most common site. Since lentigo maligna melanoma and lentigo maligna are found predominantly on such cosmetically-sensitive areas, it is critical to determine the exact histologic margin for maximal sparing of tissue and complete extirpation of the tumor. Since Mohs micrographic surgery has been recommended for tumors on cosmetically-sensitive locations where the tumor margin is indistinct, it appears to be a reasonable treatment modality for this type of tumor. We describe a case of lentigo maligna melanoma on the cheek, which was resected with Mohs micrographic surgery.
Cheek
;
Head
;
Hutchinson's Melanotic Freckle*
;
Lentigo*
;
Melanoma*
;
Mohs Surgery*
;
Neck

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