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.Primary Esophageal Mucosa-associated Lymphoid Tissue Lymphoma: A Rare Case Report and Review of Other Published Data
Ji Hea BANG ; Jin Hyong KANG ; Seung Han KIM ; Jong Jae PARK ; Beom Jae LEE ; Moon Kyung JOO ; Tae Sung JEON
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2023;23(3):207-213
The gastrointestinal tract is the most common extranodal site for lymphomas, and mucosa-associated lymphoid tissue lymphoma is the second most common histological lymphoma subtype. However, primary esophageal mucosa-associated lymphoid tissue lymphomas are extremely rare. Few such cases are documented, and the reports demonstrate inconsistent diagnostic and therapeutic strategies. Herein, a 54-year-old man was referred to our hospital for treatment of dysphagia. Esophagogastroduodenoscopy revealed a large, horseshoe-shaped subepithelial mass in the upper esophagus. Endoscopic ultrasonography and computed tomography revealed that the mass was well-demarcated and confined to the muscularis mucosa, with no abnormalities in other organs or lymph nodes. The mass was presumptively diagnosed as benign, and the patient underwent endoscopic mucosal dissection for pathological confirmation and symptom relief. Pathological examination of the dissection specimen revealed that it was a primary esophageal mucosa-associated lymphoid tissue lymphoma. As the patient had an elevated immunoglobulin G level and Helicobacter pylori infection, we administered adjuvant eradication therapy. The patient remains under surveillance and is free of lymphoma recurrence 36 months postoperatively. This case report demonstrates that endoscopic resection and H. pylori eradication are effective treatment strategies for early-stage esophageal mucosa-associated lymphoid tissue lymphoma.
3.The incidence and risk factors of extrapulmonary manifestations in Mycoplasma pneumoniae pneumonia
Yoo Kyung PARK ; You Na PARK ; Ji Eun MOON ; Hyo-Bin KIM ; Meeyong SHIN ; Eun LEE ; Chul-Hong KIM ; Ju Suk LEE ; Yong Ju LEE ; Bong-Seong KIM ; Hyung Young KIM ; Sungsu JUNG ; Yunsun KIM ; Sangyoung KIM ; Chorong PARK ; Ju-Hee SEO ; Jung Yeon SHIM ; In Suk SOL ; Myongsoon SUNG ; Dae Jin SONG ; Young Min AHN ; Hea Lin OH ; Jinho YU ; Kyung Suk LEE ; Gwang Cheon JANG ; Yoon-Young JANG ; Hai Lee CHUNG ; Eun Hee CHUNG ; Sung-Min CHOI ; Yun Jung CHOI ; Man Yong HAN ; Jin Tack KIM ; Chang-Keun KIM ; Hyeon-Jong YANG
Allergy, Asthma & Respiratory Disease 2022;10(4):207-214
Purpose:
Mycoplasma pneumoniae pneumonia (MP) is a major cause of community-acquired pneumonia (CAP) in children and is associated with extrapulmonary manifestations (EPM). The incidence and risk factors for EPM in children are unknown.
Methods:
This was a retrospective study involving 65,243 pediatric patients with CAP between 2010 and 2015 at 23 nationwide hospitals in South Korea. Medical records were reviewed to collect information regarding the clinical characteristics, radiological results, and laboratory findings. Logistic regression with multivariate analysis was performed to evaluate the risk factors associated with EPM in MP.
Results:
The incidence of EPM was 23.9%, including elevation of liver enzymes (18.1%), mucocutaneous manifestations (4.4%), proteinuria (4.1%), cardiovascular and neurological manifestations (0.4%), hematologic manifestations (0.2%), and arthritis (0.2%). Statistical analysis showed that mucocutaneous manifestations significantly increased with elevated alanine aminotransferase (adjusted odds ratio [aOR], 3.623; 95% confidence interval [CI], 1.933-6.790) and atopic sensitization (aOR, 2.973; 95% CI, 1.615–5.475) and decreased with respiratory virus coinfection (aOR, 0.273; 95% CI, 0.084–0.887). Elevated liver enzymes were significantly associated with elevated lactate dehydrogenase (aOR, 3.055; 95% CI, 2.257–4.137), presence of pleural effusion (aOR, 2.635; 95% CI, 1.767–3.930), and proteinuria with respiratory virus coinfection (aOR, 2.245; 95% CI, 1.113–4.527).
Conclusion
Approximately 24% of pediatric patients with MP had various EPM. As the risk factors associated with each EPM were different, it is necessary to evaluate the various clinical aspects and findings of MP to predict and prepare for the occurrence of EPM.
4.Analgesic effect of structured anal skin care for perianal dermatitis after low anterior resection in the rectal cancer patients: prospective, single-center, open-label, therapeutic confirmatory, randomized clinical trial
Gyung Mo SON ; In Young LEE ; Mi Sook YUN ; Jung-Hea YOUN ; Hong Min AN ; Kyung Hee KIM ; Seung Mi YEO ; Bokyung KU ; Myeong Suk KWON ; Kun Hyung KIM
Annals of Surgical Treatment and Research 2022;103(6):360-371
Purpose:
This prospective, single-center, open-label, therapeutic confirmatory, randomized clinical trial aimed to assess the alleviation of anal pain by applying structured anal skin care including skin protectants in rectal cancer patients with low anterior resection syndrome (LARS) combined with anal pain.
Methods:
From December 2017 to May 2020, 42 patients with LARS (scores of ≥21) and anal pain (visual analogue scale [VAS] score of ≥3) were randomly assigned and observed for 4 weeks. The conventional treatment consisted of dietary management, sitz baths, prohibition of anal scrubbing, loperamide, and dioctahedral smectite. In the anal care group, cleanser, barrier cream, and barrier spray were applied to the anal skin after defecation following the conventional treatment. The primary outcome was analgesic effect on anal pain after 2 weeks of structured treatment (anal care group) or conventional (control group). The cutoff for analgesic effect was a decrease in the anal pain score (VAS score of ≥2 or ≥30% reduction).
Results:
As a primary outcome, the analgesic effect was significantly higher in the anal care group (P = 0.034). The incontinence-associated dermatitis skin condition score was significantly improved in the anal care group than control group after 4 weeks (P = 0.023). There were no significant differences in LARS scores and quality of life scores between 2 groups.
Conclusion
Structured anal skin care has a significant analgesic effect in reducing anal pain and improving anal skin conditions in patients with LARS after rectal cancer surgery.
5.IgA Levels Are Associated with Coronary Artery Lesions in Kawasaki Disease
Jae-Jung KIM ; Hea-Ji KIM ; Jeong Jin KIM ; Sin Weon YUN ; Kyung-Yil LEE ; Kyung Lim YOON ; Hong-Ryang KIL ; Gi Beom KIM ; Myung-Ki HAN ; Min Seob SONG ; Hyoung Doo LEE ; Hyun Ok JUN ; Kee Soo HA ; Young Mi HONG ; Gi Young JANG ; Jong-Keuk LEE ;
Korean Circulation Journal 2021;51(3):267-278
Background and Objectives:
Kawasaki disease (KD) is an acute systemic vasculitis that affects the coronary arteries. Abnormal immune reactions are thought to contribute to disease pathogenesis. The effect of immunoglobulin (Ig) isotype (IgG, IgA, IgM, and IgE) on inflammatory data and clinical outcomes of patients with KD was examined.
Methods:
Ig levels in 241 patients with KD were measured during the acute, subacute, convalescent, and normal phases of the disease.
Results:
Compared with reference Ig values, IgG, IgA, and IgM levels were significantly higher in the subacute phase, while IgE levels were elevated in 73.9% (178/241) of patients with KD in all clinical phases. However, high IgE levels were not associated with clinical outcomes, including intravenous immunoglobulin unresponsiveness and coronary artery lesions (CALs).Significantly more CALs were observed in the high IgA group than in the normal IgA group (44.7% vs. 20.8%, respectively; p<0.01). In addition, IgA levels in the acute phase (p=0.038) were 2.2-fold higher, and those in the subacute phase were 1.7-fold higher (p <0.001), in the CAL group than in the non-CAL group. IgA concentrations increased along with the size of the coronary artery aneurysm (p <0.001). Furthermore, there was a strong correlation between IgA levels and CAL size (r=0.435, p<0.001), with a high odds ratio of 2.58 (p=0.022).
Conclusions
High IgA levels in patients with KD are prognostic for the risk of CALs.
6.IgA Levels Are Associated with Coronary Artery Lesions in Kawasaki Disease
Jae-Jung KIM ; Hea-Ji KIM ; Jeong Jin KIM ; Sin Weon YUN ; Kyung-Yil LEE ; Kyung Lim YOON ; Hong-Ryang KIL ; Gi Beom KIM ; Myung-Ki HAN ; Min Seob SONG ; Hyoung Doo LEE ; Hyun Ok JUN ; Kee Soo HA ; Young Mi HONG ; Gi Young JANG ; Jong-Keuk LEE ;
Korean Circulation Journal 2021;51(3):267-278
Background and Objectives:
Kawasaki disease (KD) is an acute systemic vasculitis that affects the coronary arteries. Abnormal immune reactions are thought to contribute to disease pathogenesis. The effect of immunoglobulin (Ig) isotype (IgG, IgA, IgM, and IgE) on inflammatory data and clinical outcomes of patients with KD was examined.
Methods:
Ig levels in 241 patients with KD were measured during the acute, subacute, convalescent, and normal phases of the disease.
Results:
Compared with reference Ig values, IgG, IgA, and IgM levels were significantly higher in the subacute phase, while IgE levels were elevated in 73.9% (178/241) of patients with KD in all clinical phases. However, high IgE levels were not associated with clinical outcomes, including intravenous immunoglobulin unresponsiveness and coronary artery lesions (CALs).Significantly more CALs were observed in the high IgA group than in the normal IgA group (44.7% vs. 20.8%, respectively; p<0.01). In addition, IgA levels in the acute phase (p=0.038) were 2.2-fold higher, and those in the subacute phase were 1.7-fold higher (p <0.001), in the CAL group than in the non-CAL group. IgA concentrations increased along with the size of the coronary artery aneurysm (p <0.001). Furthermore, there was a strong correlation between IgA levels and CAL size (r=0.435, p<0.001), with a high odds ratio of 2.58 (p=0.022).
Conclusions
High IgA levels in patients with KD are prognostic for the risk of CALs.
7.Three cases of oral immunotherapy for IgE-mediated egg allergy
Insung KIM ; Bo Ra LEE ; Yechan KYUNG ; Minyoung JUNG ; Hea-Kyoung YANG ; Minji KIM ; Ji Young LEE ; Jihyun KIM ; Kangmo AHN ; Hye-In JEONG
Allergy, Asthma & Respiratory Disease 2020;8(3):161-164
Food allergy is an immune-mediated adverse reaction that occurs mainly by food ingestion. Some children with food allergies manifest fatal symptoms like anaphylaxis. Oral immunotherapy (OIT) may offer an effective therapeutic modality for persistent and severe forms of food allergies. We report our experience with OIT in 3 patients with IgE-mediated hen’s egg allergy. Our treatment strategy consists of 1–3 days of initial escalation, 47 to 65 weeks of build-up phase, and 1 year of maintenance phase. Lactobacillus plantarum CJLP133, 1×1010 colony-forming unit/day was taken during OIT. As a result, 1 patient achieved successful desensitization, and 1 patient reached maintenance therapy, but did not obtain desensitization. In addition, 1 patient withdrew from treatment due to anxiety symptoms. Despite the limited number of patients, we experienced and herein presented 3 cases of OIT in egg allergy. More trials of OIT need to be performed as a treatment option in Korean children with food allergies.
8.Relationship between the Intake of Children's Favorite Foods and Policy based on Special Act on Safety Control of Children's Dietary Life
Taejung WOO ; Jihye YOO ; Kyung Hea LEE
Korean Journal of Community Nutrition 2019;24(2):106-116
OBJECTIVES: This study examined the status of children's favorite foods intake and the relationship with the policy environment based on the Special Act on Safety Control of Children's Dietary Life for suggesting a supportive policy strategy. METHODS: The subjects were 4th grade students (n=1,638) in elementary school from 45 schools collected from seven areas (Seoul, Daegu, Daejeon, Gyeonggi, Chungnam, Jeonbuk, and Gyeongnam). The children participated in a self-administered questionnaire survey in class under the supervision of the teacher. The questionnaire consisted of items, such as social demographic characteristics, frequency of intake of the children's favorite foods, and policy cognition. A t-test and ANOVA were applied to explore the relationship between the frequency of children's favorite foods intake and policy cognition. The survey was implemented from August 2016 to September 2016. RESULTS: For the boys, the frequency of ‘high-calorie low nutrient foods intake’ (HCLN) was significantly higher than that of the girls (p<0.01). For the children who received information on their favorite foods from the internet, the frequency of HCLN was higher than the other sources (p<0.01). The time of TV viewing and computer usage, and smartphone usage was associated with a higher frequency of HCLN, and a lower healthy favorite food intake (all p<0.001). The intake frequency of healthy favorite foods indicated a positive correlation with the policy cognition, including policy perception, usefulness, necessity and buying intention, and educational experience. CONCLUSIONS: This study showed a correlation with the frequency of children's favorite foods intake and policy. In particular, the frequency of children's healthy favorite foods intake indicated a meaningful relationship with the policy than the frequency of HCLN. This study also found that the consumption of children's healthy favorite foods was positively correlated with the educational experience. To develop a supportive policy for a good dietary environment for children, there is a need to focus on how to collaborate with multiple levels of influences, such as the national level, school level, and family.
Child
;
Chungcheongnam-do
;
Cognition
;
Daegu
;
Eating
;
Female
;
Gyeonggi-do
;
Humans
;
Intention
;
Internet
;
Jeollabuk-do
;
Organization and Administration
;
Smartphone
9.Relationship between the Intake of Children's Favorite Foods and Policy based on Special Act on Safety Control of Children's Dietary Life
Taejung WOO ; Jihye YOO ; Kyung Hea LEE
Korean Journal of Community Nutrition 2019;24(2):106-116
OBJECTIVES: This study examined the status of children's favorite foods intake and the relationship with the policy environment based on the Special Act on Safety Control of Children's Dietary Life for suggesting a supportive policy strategy. METHODS: The subjects were 4th grade students (n=1,638) in elementary school from 45 schools collected from seven areas (Seoul, Daegu, Daejeon, Gyeonggi, Chungnam, Jeonbuk, and Gyeongnam). The children participated in a self-administered questionnaire survey in class under the supervision of the teacher. The questionnaire consisted of items, such as social demographic characteristics, frequency of intake of the children's favorite foods, and policy cognition. A t-test and ANOVA were applied to explore the relationship between the frequency of children's favorite foods intake and policy cognition. The survey was implemented from August 2016 to September 2016. RESULTS: For the boys, the frequency of ‘high-calorie low nutrient foods intake’ (HCLN) was significantly higher than that of the girls (p<0.01). For the children who received information on their favorite foods from the internet, the frequency of HCLN was higher than the other sources (p<0.01). The time of TV viewing and computer usage, and smartphone usage was associated with a higher frequency of HCLN, and a lower healthy favorite food intake (all p<0.001). The intake frequency of healthy favorite foods indicated a positive correlation with the policy cognition, including policy perception, usefulness, necessity and buying intention, and educational experience. CONCLUSIONS: This study showed a correlation with the frequency of children's favorite foods intake and policy. In particular, the frequency of children's healthy favorite foods intake indicated a meaningful relationship with the policy than the frequency of HCLN. This study also found that the consumption of children's healthy favorite foods was positively correlated with the educational experience. To develop a supportive policy for a good dietary environment for children, there is a need to focus on how to collaborate with multiple levels of influences, such as the national level, school level, and family.
Child
;
Chungcheongnam-do
;
Cognition
;
Daegu
;
Eating
;
Female
;
Gyeonggi-do
;
Humans
;
Intention
;
Internet
;
Jeollabuk-do
;
Organization and Administration
;
Smartphone
10.Exploring parenting variables associated with sweetness preferences and sweets intake of children
Nutrition Research and Practice 2019;13(2):169-177
BACKGROUND/OBJECTIVES: Excessive sugar intake is one of the causes associated with obesity and several chronic diseases prevalent in the modern society. This study was undertaken to investigate the effect of parenting variables based on the theory of planned behavior, on the sweetness preferences and sweets intake of children. SUBJECTS/METHODS: Parents and their children (n = 103, aged 5–7 years) were enrolled to participate in a survey for this study, after providing the required informed consent. Parents were asked to fill out a self-administered questionnaire at their residence. The sweetness preference test for children was conducted at a kindergarten (or daycare center) by applying the one-on-one interview method. RESULTS: The children were divided into two clusters categorized by the K-mean cluster analysis: Cluster 1 had higher sweetness preference (0.42 M sugar, 35%; 0.61 M sugar, 65%); Cluster 2 exhibited lower sweetness preference (0.14 M sugar, 9.5%; 0.20 M sugar, 9.5%; 0.29 M sugar, 81%). Cluster 1 had a higher frequency of sweets intake (P < 0.01), and lower sweets restriction (P < 0.05) and nutrition quotient score (P < 0.05). Sweets intake was negatively correlated with the nutritional quotient (r = −0.204, P < 0.05). The behavioral intention of parents was higher in cluster 2 (P < 0.05), while affective attitude, feeding practice, and reward were higher in cluster 1 (P < 0.001, P < 0.05, and P < 0.01, respectively). Furthermore, behavioral intention of parents showed a negative correlation with affective attitude (r = −0.282, P < 0.01) and feeding practice (r = −0.380, P < 0.01), and a positive correlation with subjective norm (r = 0.203, P < 0.05) and parenting attitude (r = 0.433, P < 0.01). CONCLUSIONS: This study indicates that the sweetness preferences and sweets intake of children is related to the parent's affective attitude, feeding practice and reward. We suggest that to reduce the sugar consumption of children, guidelines for access to sweets and pertinent parenting practices are required.
Child
;
Chronic Disease
;
Food Preferences
;
Humans
;
Informed Consent
;
Intention
;
Methods
;
Obesity
;
Parenting
;
Parents
;
Reward

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