1.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
2.Ruptured triple hormone-secreting adrenal cortical carcinoma with hyperaldosteronism, hypercortisolism, and elevated normetanephrine: a case report
Sin Yung WOO ; Seongji PARK ; Kun Young KWON ; Dong-Mee LIM ; Keun-Young PARK ; Jong-Dai KIM
Journal of Yeungnam Medical Science 2024;41(4):306-311
We report a case of a ruptured triple hormone-secreting adrenal mass with hyperaldosteronism, hypercortisolism, and elevated normetanephrine levels, diagnosed as adrenal cortical carcinoma (ACC) by histology. A 53-year-old male patient who initially presented with abdominal pain was referred to our hospital for angiocoagulation of an adrenal mass rupture. Abdominal computed tomography revealed a heterogeneous 19×11×15 cm right adrenal mass with invasion into the right lobe of the liver, inferior vena cava, retrocaval lymph nodes, and aortocaval lymph nodes. Angiocoagulation was performed. Laboratory evaluation revealed excess cortisol via a positive 1-mg overnight dexamethasone suppression test, primary hyperaldosteronism via a positive saline infusion test, and plasma normetanephrine levels three times higher than normal. An adrenal mass biopsy was performed for pathological confirmation to commence palliative chemotherapy because surgical management was not deemed appropriate considering the extent of the tumor. Pathological examination revealed stage T4N1M1 ACC. The patient started the first cycle of adjuvant mitotane therapy along with adjuvant treatment with doxorubicin, cisplatin, and etoposide, and was discharged. Clinical cases of dual cortisol- and aldosterone-secreting ACCs or ACCs presenting as pheochromocytomas have occasionally been reported; however, both are rare. Moreover, to the best of our knowledge, a triple hormone-secreting ACC has not yet been reported. Here, we report a rare case and its management. This case report underscores the necessity of performing comprehensive clinical and biochemical hormone evaluations in patients with adrenal masses because ACC can present with multiple hormone elevations.
3.Developmental Delay and Rehabilitation in an Infant with Partial Trisomy 1q32.1 to 1q44: A Case Report
Woo Kyung KIM ; Na Mi LEE ; In Seok LIM ; Soo Ahn CHAE ; Sin Weon YUN ; Dae Yong YI ; Su Yeong KIM
Neonatal Medicine 2022;29(2):91-95
Partial trisomy 1q is a rare chromosomal disorder characterized by ventriculomegaly with craniofacial, renal, cardiac, and finger and toe anomalies. Most reported cases of partial trisomy1q have involved stillborn or premature deaths due to cardiac or liver failure. This case report describes an 18-month-old patient with partial duplication of the 1q32-44 segments and consequent developmental delays who exhibited improvement in developmental status with rehabilitation. Prenatal ultrasonography and magnetic resonance imaging of the mother revealed ventriculomegaly and atrophic changes in the left cerebral hemisphere of the fetus. The infant was born with micrognathia, microphthalmia, macrocephaly, low-set ears, polydactyly, and long feet at 37+5 weeks of gestation. A chromosomal study revealed an abnormal male karyotype of 46,XY,rec(1)dup(1)(q32.1q44)inv(1)(p36.3q32.1)pat. In this rare case of a patient with partial trisomy, we observed improvement in developmental delays following treatment using appropriate rehabilitation techniques. Further research is required to help validate the findings of this case study and establish a standardized rehabilitation technique that can be subsequently applied to such cases.
4.Clinical and Laboratory Factors Associated with Symptom Development in Asymptomatic COVID-19 Patients at the Time of Diagnosis
Hong Sang OH ; Joon Ho KIM ; Myoung Lyeol WOO ; Ji-Yeon KIM ; Chul Hee PARK ; Hyejin WON ; Seungkwan LIM ; Hyeonju JEONG ; Sin Young HAM ; Eun Jin KIM ; Seungsoo SHEEN ; Yu Min KANG ; Doran YOON ; Seung Youp LEE ; Kyoung-Ho SONG
Infection and Chemotherapy 2021;53(4):786-791
In preparation for the surge of coronavirus disease 2019 (COVID-19), it is crucial to allocate medical resources efficiently for distinguishing people who remain asymptomatic until the end of the disease. Between January 27, 2020, and April 21, 2020, 517 COVID-19 cases from 13 healthcare facilities in Gyeonggi province, Korea, were identified out of which the epidemiologic and clinical information of 66 asymptomatic patients at the time of diagnosis were analyzed retrospectively. An exposure-diagnosis interval within 7 days and abnormal aspartate aminotransferase levels were identified as characteristic symptom development in asymptomatic COVID-19 patients. If asymptomatic patients without these characteristics at the time of diagnosis could be differentiated early, more medical resources could be secured for mild or moderate cases in this COVID-19 surge.
5.Frequency and Severity of Hypoglycemia in Type 2 Diabetes Mellitus Patients Treated with a Sulfonylurea-Based Regimen at University-Affiliated Hospitals in Korea: The Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects Study
Yon Su KIM ; Be Long CHO ; Woo Sik KIM ; Sang Hyun KIM ; In Hyeon JUNG ; Won Yong SIN ; Dong Hoon CHOI ; Sang Jae LEE ; Chun Soo LIM ; Kyung Pyo KANG ; Byung Yeon YU ; Wonju JEUNG ; Chang Gyu PARK
Korean Journal of Family Medicine 2019;40(4):212-219
BACKGROUND: We assessed the frequency and severity of hypoglycemia in type 2 diabetes mellitus patients treated with sulfonylurea monotherapy or sulfonylurea+metformin. METHODS: We conducted a retrospective, observational, cross-sectional study in 2011 and 2012 including patients with type 2 diabetes mellitus aged ≥30 years who were treated with ≥6 months of sulfonylurea monotherapy or sulfonylurea+metformin at 20 university-affiliated hospitals in Korea. At enrollment, glycated hemoglobin (HbA1c) was assessed; participants completed self-reported questionnaires describing hypoglycemia incidents over the past 6 months. A review of medical records up to 12 months before enrollment provided data on demographics, disease history, comorbidities, laboratory results, and drug usage. RESULTS: Of 726 enrolled patients, 719 were included (55.6% male); 31.7% and 68.3% were on sulfonylurea monotherapy and sulfonylurea+metformin, respectively. Mean±standard deviation age was 65.9±10.0 years; mean HbA1c level was 7.0%±1.0%; 77.8% of patients had hypertension (89.4% used antihypertensive medication); 60.5% had lipid disorders (72.5% used lipid-lowering medication); and 52.0% had one or more micro- or macrovascular diseases. Among patients with A1c measurement (n=717), 56.4% achieved therapeutic goals (HbA1c <7.0%); 42.4% (305/719) experienced hypoglycemia within 6 months of enrollment; and 38.8%, 12.9%, 12.7%, and 3.9% of patients experienced mild, moderate, severe, and very severe hypoglycemia symptoms, respectively. Several reported hypoglycemia frequency as 1–2 times over the last 6 months. The mean number of very severe hypoglycemia episodes was 3.5±5.5. CONCLUSION: Among type 2 diabetes mellitus patients treated with sulfonylurea-based regimens, glycemic levels were relatively well controlled but hypoglycemia remained a prevalent side effect.
Comorbidity
;
Cross-Sectional Studies
;
Demography
;
Diabetes Mellitus, Type 2
;
Hemoglobin A, Glycosylated
;
Humans
;
Hypertension
;
Hypoglycemia
;
Korea
;
Medical Records
;
Metformin
;
Retrospective Studies
6.Effects of Lobeglitazone, a Novel Thiazolidinedione, on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus over 52 Weeks.
Soo LIM ; Kyoung Min KIM ; Sin Gon KIM ; Doo Man KIM ; Jeong Taek WOO ; Choon Hee CHUNG ; Kyung Soo KO ; Jeong Hyun PARK ; Yongsoo PARK ; Sang Jin KIM ; Hak Chul JANG ; Dong Seop CHOI
Diabetes & Metabolism Journal 2017;41(5):377-385
BACKGROUND: The aim of this multicenter, randomized, double-blind study was to examine the effect of lobeglitazone, a novel thiazolidinedione, on the changes in bone mineral density (BMD) in patients with type 2 diabetes mellitus. METHODS: A 24-week, double-blinded phase was followed by a 28-week, open-label phase, in which the placebo group also started to receive lobeglitazone. A total of 170 patients aged 34 to 76 years were randomly assigned in a 2:1 ratio to receive lobeglitazone 0.5 mg or a matching placebo orally, once daily. BMD was assessed using dual-energy X-ray absorptiometry at week 24 and at the end of the study (week 52). RESULTS: During the double-blinded phase, the femur neck BMD showed decreasing patterns in both groups, without statistical significance (−0.85%±0.36% and −0.78%±0.46% in the lobeglitazone and placebo groups, respectively). The treatment difference between the groups was 0.07%, which was also not statistically significant. Further, minimal, nonsignificant decreases were observed in both groups in the total hip BMD compared to values at baseline, and these differences also did not significantly differ between the groups. During the open-label phase, the BMD was further decreased, but not significantly, by −0.32% at the femur neck and by −0.60% at the total hip in the lobeglitazone group, and these changes did not significantly differ compared with the original placebo group switched to lobeglitazone. CONCLUSION: Our results indicate that treatment with lobeglitazone 0.5 mg over 52 weeks showed no detrimental effect on the BMD compared to the placebo.
Absorptiometry, Photon
;
Bone Density*
;
Diabetes Mellitus, Type 2*
;
Double-Blind Method
;
Femur Neck
;
Hip
;
Humans
;
Thiazolidinediones
7.Granular cell tumor of the esophagus in an adolescent.
Ji Sun LEE ; Kyung Ok KO ; Jae Woo LIM ; Eun Jeong CHEON ; Young Jin KIM ; Jang Sin SON ; Jung Min YOON
Korean Journal of Pediatrics 2016;59(Suppl 1):S88-S91
Esophageal granular cell tumor (GCT) is a rare neoplasm originating from the Schwann cells of the submucosal neuronal plexus. Histology is the gold standard for its diagnosis. Endoscopic resection or surgical excision should be considered, depending on the potential for malignancy. Here, we report a case of an esophageal GCT in an adolescent. A 12-year-old boy presented with a 1-year history of dysphagia and vomiting. Upper gastrointestinal endoscopic examination and esophagography showed narrowing of the midesophagus, and computed tomography angiography of the thoracic aorta revealed an esophageal or periesophageal mass posterior to the paratracheal segment of the esophagus. The tumor was surgically excised, and based on the pathological findings, esophageal GCT was diagnosed.
Adolescent*
;
Angiography
;
Aorta, Thoracic
;
Child
;
Deglutition Disorders
;
Diagnosis
;
Esophageal Neoplasms
;
Esophagus*
;
Granular Cell Tumor*
;
Humans
;
Male
;
Neurons
;
Pediatrics
;
Schwann Cells
;
Vomiting
8.Percutaneous cervical nucleoplasty using the L'DISQ(R) in patients with posterolateral disc extrusion: Three cases report.
Yong Seok LIM ; Cheon Hee PARK ; Ki Tea JUNG ; Sang Woo WEE ; Sung Sik SIN ; Joon KIM ; Dae Il PARK
Anesthesia and Pain Medicine 2015;10(3):165-170
Recently, various studies evaluating percutaneous cervical nucleoplasty have reported good results. Percutaneous cervical nucleoplasty has been commonly used for treating contained herniated disc or protrusion, but a posterolateral extruded disc has not been considered to be an indication. The tip of the L'DISQ(R) wand can be curved to the desired angles by the rotation of the control wheel. Therefore, L'DISQ(R) can directly access the extruded disc. We report the application of percutaneous cervical nucleoplasty by using the L'DISQ(R) in three patients with an extruded disc. Decompression was successfully performed, and the symptoms improved immediately. In one patient, a 6-month follow-up magnetic resonance imaging study showed disappearance of the extruded cervical disc. Percutaneous cervical nucleoplasty using the L'DISQ(R) can be an effective, low complication, minimally invasive procedure for treating cervical disc herniation.
Decompression
;
Follow-Up Studies
;
Humans
;
Intervertebral Disc Displacement
;
Magnetic Resonance Imaging
9.Acute Motor Weakness of Opposite Lower Extremity after Percutaneous Epidural Neuroplasty.
Yong Seok LIM ; Ki Tea JUNG ; Cheon Hee PARK ; Sang Woo WEE ; Sung Sik SIN ; Joon KIM
The Korean Journal of Pain 2015;28(2):144-147
Recently, percutaneous epidural neuroplasty has become widely used to treat radicular pain caused by spinal stenosis or a herniated intervertebral disc. A 19-year-old female patient suffering from left radicular pain caused by an L4-L5 intervertebral disc herniation underwent percutaneous epidural neuroplasty of the left L5 nerve root using a Racz catheter. After the procedure, the patient complained of acute motor weakness in the right lower leg, on the opposite site to where the neuroplasty was conducted. Emergency surgery was performed, and swelling of the right L5 nerve root was discovered. The patient recovered her motor and sensory functions immediately after the surgery. Theoretically, the injection of a large volume of fluid in a patient with severe spinal stenosis during epidural neuroplasty can increase the pressure on the opposite side of the epidural space, which may cause injury of the opposite nerve by barotrauma from a closed compartment. Practitioners should be aware of this potential complication.
Barotrauma
;
Catheters
;
Constriction, Pathologic
;
Emergencies
;
Epidural Space
;
Female
;
Hemiplegia
;
Humans
;
Intervertebral Disc
;
Leg
;
Lower Extremity*
;
Sensation
;
Spinal Stenosis
;
Young Adult
10.Classic Papillary Thyroid Carcinoma with Tall Cell Features and Tall Cell Variant Have Similar Clinicopathologic Features.
Woo Jin OH ; Young Sub LEE ; Uiju CHO ; Ja Seong BAE ; Sohee LEE ; Min Hee KIM ; Dong Jun LIM ; Gyeong Sin PARK ; Youn Soo LEE ; Chan Kwon JUNG
Korean Journal of Pathology 2014;48(3):201-208
BACKGROUND: The tall cell variant of papillary thyroid carcinoma (TCVPTC) is more aggressive than classic papillary thyroid carcinoma (PTC), but the percentage of tall cells needed to diagnose TCVPTC remains controversial. In addition, little is known about the clinicopathologic features of classic PTC with tall cell features (TCF). METHODS: We retrospectively selected and reviewed the clinicopathologic features and presence of the BRAF mutation in 203 cases of classic PTC, 149 cases of classic PTC with TCF, and 95 cases of TCVPTCs, which were defined as PTCs having <10%, 10-50%, and > or =50% tall cells, respectively. RESULTS: TCVPTCs and classic PTCs with TCF did not vary significantly in clinicopathologic characteristics such as pathologic (p) T stage, extrathyroidal extension, pN stage, lateral lymph node metastasis, or BRAF mutations; however, these features differed significantly in TCVPTCs and classic PTCs with TCF in comparison to classic PTCs. Similar results were obtained in a subanalysis of patients with microcarcinomas (< or =1.0 cm in size). CONCLUSIONS: Classic PTCs with TCF showed a similar BRAF mutation rate and clinicopathologic features to TCVPTCs, but more aggressive characteristics than classic PTCs.
Classification
;
Humans
;
Lymph Nodes
;
Mutation Rate
;
Neoplasm Metastasis
;
Retrospective Studies
;
Thyroid Neoplasms*

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