Endocrinology and Metabolism

Original Article

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; Received April 1, 2024 Accepted June 12, 2024 Published online August 22, 2024; DOI: https://doi.org/10.3803/EnM.2024.1995 [Epub ahead of print]

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Abstract PDF PubReader ePub: 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.

Editorial

Diabetes, obesity and metabolism
Lipid Swings Provoke Vascular Inflammation: Jae-Han Jeon; Endocrinol Metab. 2024;39(3):448-449. Published online June 24, 2024; DOI: https://doi.org/10.3803/EnM.2024.302

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Brief Report

Diabetes, Obesity and Metabolism
Year-Long Trend in Glycated Hemoglobin Levels in Patients with Type 2 Diabetes during the COVID-19 Pandemic: Jonghwa Jin, Seong Wook Lee, Won-Ki Lee, Jae-Han Jeon, Jung-Guk Kim, In-Kyu Lee, Yeon-Kyung Choi, Keun-Gyu Park; Endocrinol Metab. 2021;36(5):1142-1146. Published online October 21, 2021; DOI: https://doi.org/10.3803/EnM.2021.1154

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It has been suggested that the coronavirus disease 2019 (COVID-19) pandemic has had a negative impact on glycemic control in patients with type 2 diabetes mellitus (T2DM). However, no study has examined yearly trends in glycated hemoglobin (HbA1c) levels after the start of the COVID-19 outbreak. Here, we performed a retrospective analysis of HbA1c concentrations during the early period of the COVID-19 outbreak (COVID-19 cohort) and then compared the yearly trend in the mean HbA1c level, along with fluctuations in HbA1c levels, with those during previous years (non-COVID-19 cohorts). We observed that the mean HbA1c level in patients with T2DM increased during the first 6 months of the COVID-19 outbreak. After 6 months, HbA1c levels in the COVID-19 cohort returned to levels seen in the non-COVID-19 cohorts. The data suggest that vulnerable patients with T2DM should be monitored closely during the early period of a pandemic to ensure they receive appropriate care.

Citations

Citations to this article as recorded by

Physical and Mental Health Characteristics of Hospitalized COVID-19 Patients with and without Type 2 Diabetes Mellitus in Turkey
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A Hybrid Model of In-Person and Telemedicine Diabetes Education and Care for Management of Patients with Uncontrolled Type 2 Diabetes Mellitus: Findings and Implications from a Multicenter Prospective Study
Ayla M. Tourkmani, Turki J. Alharbi, Abdulaziz M. Bin Rsheed, Azzam F. Alotaibi, Mohammed S. Aleissa, Sultan Alotaibi, Amal S. Almutairi, Jancy Thomson, Ahlam S. Alshahrani, Hadil S. Alroyli, Hend M. Almutairi, Mashael A. Aladwani, Eman R. Alsheheri, Hyfa
Telemedicine Reports.2024; 5(1): 46. CrossRef
Navigating Cardiometabolic Health Behavior during the Pandemic: Strategies for Metabolic Syndrome Management
Junghyun Noh
Journal of Obesity & Metabolic Syndrome.2024; 33(2): 89. CrossRef
The indirect impact of the COVID-19 pandemic on people with type 2 diabetes mellitus and without COVID-19 infection: Systematic review and meta-analysis
Zhuoran Hu, Hin Moi Youn, Jianchao Quan, Lily Luk Siu Lee, Ivy Lynn Mak, Esther Yee Tak Yu, David Vai-Kiong Chao, Welchie Wai Kit Ko, Ian Chi Kei Wong, Gary Kui Kai Lau, Chak Sing Lau, Cindy Lo Kuen Lam, Eric Yuk Fai Wan
Primary Care Diabetes.2023; 17(3): 229. CrossRef
Evaluating Effects of Virtual Diabetes Group Visits in Community Health Centers During the COVID-19 Pandemic
Tracy Dinh, Erin M Staab, Daisy Nuñez, Mengqi Zhu, Wen Wan, Cynthia T Schaefer, Amanda Campbell, Michael Quinn, Arshiya A Baig
Journal of Patient Experience.2023;[Epub] CrossRef
Cardiovascular-related health behavior changes: lessons from the COVID-19 pandemic and post-pandemic challenges
Inha Jung, Won-Young Lee
Cardiovascular Prevention and Pharmacotherapy.2023; 5(4): 99. CrossRef

Original Articles

Diabetes, Obesity and Metabolism
High Fibrosis-4 Index Is Related with Worse Clinical Outcome in Patients with Coronavirus Disease 2019 and Diabetes Mellitus: A Multicenter Observational Study: Sung-Woo Kim, Jae-Han Jeon, Jun Sung Moon, Mi Kyung Kim; Endocrinol Metab. 2021;36(4):800-809. Published online August 20, 2021; DOI: https://doi.org/10.3803/EnM.2021.1040

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Background
Based on recent evidence on the importance of the presence of diabetes mellitus (DM) and fibrosis-4 (FIB-4) index in coronavirus disease 2019 (COVID-19) mortality, we analyzed whether these factors could additively predict such mortality.
Methods
This multicenter observational study included 1,019 adult inpatients admitted to university hospitals in Daegu. The demographic and laboratory findings, mortality, prevalence of severe disease, and duration of quarantine were compared between patients with and without DM and/or a high FIB-4 index. The mortality risk and corresponding hazard ratio (HR) were analyzed using the Kaplan-Meier method and Cox proportional hazard models.
Results
The patients with DM (n=217) exhibited significantly higher FIB-4 index and mortality compared to those without DM. Although DM (HR, 2.66; 95% confidence interval [CI], 1.63 to 4.33) and a high FIB-4 index (HR, 4.20; 95% CI, 2.21 to 7.99) were separately identified as risk factors for COVID-19 mortality, the patients with both DM and high FIB-4 index had a significantly higher mortality (HR, 9.54; 95% CI, 4.11 to 22.15). Higher FIB-4 indices were associated with higher mortality regardless of DM. A high FIB-4 index with DM was more significantly associated with a severe clinical course with mortality (odds ratio, 11.24; 95% CI, 5.90 to 21.41) than a low FIB-4 index without DM, followed by a high FIB-4 index alone and DM alone. The duration of quarantine and hospital stay also tended to be longer in those with both DM and high FIB-4 index.
Conclusion
Both DM and high FIB-4 index are independent and additive risk factors for COVID-19 mortality.

Citations

Citations to this article as recorded by

Impact of liver fibrosis on COVID-19 in-hospital mortality in Southern Italy
Raffaele Galiero, Giuseppe Loffredo, Vittorio Simeon, Alfredo Caturano, Erica Vetrano, Giulia Medicamento, Maria Alfano, Domenico Beccia, Chiara Brin, Sara Colantuoni, Jessica Di Salvo, Raffaella Epifani, Riccardo Nevola, Raffaele Marfella, Celestino Sard
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Fares E M Ali, Mostafa K Abd El-Aziz, Mahmoud M Ali, Osama M Ghogar, Adel G Bakr
World Journal of Gastroenterology.2023; 29(3): 425. CrossRef
Differential Effects of COVID-19 Hospitalization on the Trajectory of Liver Disease Progression
Dilara Hatipoğlu, Connor Mulligan, Jeffrey Wang, Juan Peticco, Reid Grinspoon, Sanjay Gadi, Camilla Mills, Jay Luther, Raymond T. Chung
Gastro Hep Advances.2023; 2(4): 480. CrossRef
Association of non-alcoholic fatty liver and metabolic-associated fatty liver with COVID-19 outcomes: A systematic review and meta-analysis
Gowthami Sai Kogilathota Jagirdhar, Rakhtan K Qasba, Harsha Pattnaik, Kaanthi Rama, Akshat Banga, Shiva Teja Reddy, Anna Carolina Flumignan Bucharles, Rahul Kashyap, Praveen Reddy Elmati, Vikas Bansal, Yatinder Bains, Theodore DaCosta, Salim Surani
World Journal of Gastroenterology.2023; 29(21): 3362. CrossRef
COVID-19 and Fatty Liver Disorders
Maria Guarino, Valentina Cossiga, Francesco Cutolo, Maria Attanasio, Raffaele Lieto, Filomena Morisco
Journal of Clinical Medicine.2023; 12(13): 4316. CrossRef
Prevalence and Prognostic Significance of Liver Fibrosis in Patients With Aneurysmal Subarachnoid Hemorrhage
Tiangui Li, Peng Wang, Xiao Gong, Weelic Chong, Yang Hai, Chao You, Juan Kang, Fang Fang, Yu Zhang
Frontiers in Neurology.2022;[Epub] CrossRef

Clinical Study
Fasting Plasma Glucose Level Independently Predicts the Mortality of Patients with Coronavirus Disease 2019 Infection: A Multicenter, Retrospective Cohort Study: Min Cheol Chang, Jong-Moon Hwang, Jae-Han Jeon, Sang Gyu Kwak, Donghwi Park, Jun Sung Moon; Endocrinol Metab. 2020;35(3):595-601. Published online August 26, 2020; DOI: https://doi.org/10.3803/EnM.2020.719

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Abstract PDF Supplementary Material PubReader ePub

Background
Coronavirus disease 2019 (COVID-19) has become a global pandemic, which prompts a consensus for the necessity to seek risk factors for this critical disease. Risk factors affecting mortality of the disease remain elusive. Diabetes and hyperglycemia are known to negatively affect a host’s antiviral immunity. We evaluated the relationship between a history of diabetes, fasting plasma glucose (FPG) levels and mortality among severely ill patients with COVID-19.
Methods
This was a retrospective cohort study that assessed 106 adult inpatients (aged ≥18 years) from two tertiary hospitals in Daegu, South Korea. The participants were transferred to tertiary hospitals because their medical condition required immediate intensive care. The demographic and laboratory data were compared between COVID-19 patients who survived and those who did not.
Results
Compared with the survivor group, age, and the proportions of diabetes, chronic lung disease and FPG were significantly higher in the deceased group. In the Cox proportional hazards regression model for survival analysis, FPG level and age were identified as significant predictors of mortality (P<0.05). The threshold values for predicting high mortality were age >68 years and FPG of 168 mg/dL, respectively. Among those without diabetes, high FPG remained a significant predictor of mortality (P<0.04).
Conclusion
High FPG levels significantly predicted mortality in COVID-19, regardless of a known history of diabetes. These results suggest intensive monitoring should be provided to COVID-19 patients who have a high FPG level.

Citations

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