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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, on Behalf of Investigators of ENVELOP Study
Received May 9, 2024  Accepted August 14, 2024  Published online January 6, 2025  
DOI: https://doi.org/10.4093/dmj.2024.0238    [Epub ahead of print]
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  • 54 Download
AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
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.
Review
Complications
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Dyslipidemia in Patients with Chronic Kidney Disease: An Updated Overview
Sang Heon Suh, Soo Wan Kim
Diabetes Metab J. 2023;47(5):612-629.   Published online July 24, 2023
DOI: https://doi.org/10.4093/dmj.2023.0067
  • 9,812 View
  • 864 Download
  • 16 Web of Science
  • 16 Crossref
AbstractAbstract PDFPubReader   ePub   
Dyslipidemia is a potentially modifiable cardiovascular risk factor. Whereas the recommendations for the treatment target of dyslipidemia in the general population are being more and more rigorous, the 2013 Kidney Disease: Improving Global Outcomes clinical practice guideline for lipid management in chronic kidney disease (CKD) presented a relatively conservative approach with respect to the indication of lipid lowering therapy and therapeutic monitoring among the patients with CKD. This may be largely attributed to the lack of high-quality evidence derived from CKD population, among whom the overall feature of dyslipidemia is considerably distinctive to that of general population. In this review article, we cover the characteristic features of dyslipidemia and impact of dyslipidemia on cardiovascular outcomes in patients with CKD. We also review the current evidence on lipid lowering therapy to modify the risk of cardiovascular events in this population. We finally discuss the association between dyslipidemia and CKD progression and the potential strategy to delay the progression of CKD in relation to lipid lowering therapy.

Citations

Citations to this article as recorded by  
  • Impact of remnant cholesterol on short-term and long-term prognosis in patients with prediabetes or diabetes undergoing coronary artery bypass grafting: a large-scale cohort study
    Zhongchen Li, Chunyu Yu, Heng Zhang, Runze Chen, Yan Zhao, Zhe Zheng
    Cardiovascular Diabetology.2025;[Epub]     CrossRef
  • Effects of Tocotrienol on Cardiovascular Risk Markers in Patients With Chronic Kidney Disease: A Randomized Controlled Trial
    Liana Trugilho, Lívia Alvarenga, Ludmila Cardozo, Bruna Paiva, Jessyca Brito, Isis Barboza, Jonatas Almeida, Juliana dos Anjos, Pramod Khosla, Marcelo Ribeiro-Alves, Denise Mafra, Eric Gumpricht
    Journal of Nutrition and Metabolism.2025;[Epub]     CrossRef
  • The Impact of Glomerular Disease on Dyslipidemia in Pediatric Patients Treated with Dialysis
    Edward Zitnik, Elani Streja, Marciana Laster
    Nutrients.2025; 17(3): 459.     CrossRef
  • Statin Therapy and Lipid Indices in Chronic Kidney Disease: A Systematic Review and Meta-analysis of Randomized Control Trials
    Jafar Karami, Bahman Razi, Danyal Imani, Saeed Aslani, Mahdi Pakjoo, Mahdieh Fasihi, Keyhan Mohammadi, Amirhossein Sahebkar
    Current Pharmaceutical Design.2024; 30(5): 362.     CrossRef
  • Lipoprotein glomerulopathy with markedly increased arterial stiffness successfully treated with a combination of fenofibrate and losartan: a case report
    Junichiro Kato, Hideo Okonogi, Go Kanzaki, Haruki Katsumata, Yasuyuki Nakada, Makoto Sagasaki, Kazumasa Komine, Kenji Ito, Takao Saito, Akira Matsunaga, Koh Tokutou, Kazuho Honda, Nobuo Tsuboi, Takashi Yokoo
    BMC Nephrology.2024;[Epub]     CrossRef
  • Atherogenic index of plasma: a new indicator for assessing the short-term mortality of patients with acute decompensated heart failure
    Meng Yu, Hongyi Yang, Maobin Kuang, Jiajun Qiu, Changhui Yu, Guobo Xie, Guotai Sheng, Yang Zou
    Frontiers in Endocrinology.2024;[Epub]     CrossRef
  • Association between lipid accumulation product index and chronic kidney disease: A systematic review and meta-analysis
    Feixiang Wu, Chenmin Cui, Junping Wu, Yunqing Wang
    Experimental and Therapeutic Medicine.2024;[Epub]     CrossRef
  • Potential impact of sodium glucose co-transporter (SGLT2) inhibitors on cholesterol fractions in stage 3 chronic kidney disease
    Rabab Mahmoud Ahmed, Nehal Kamal Rakha, Ahmed Yousry, Amin Roshdy Soliman
    The Egyptian Journal of Internal Medicine.2024;[Epub]     CrossRef
  • Pulmonary Hypertension in Hemodialysis Patients and Its Determinants: A Hospital Based Cross-Sectional Study
    Qingfei Yu, Qin Zhang
    International Journal of General Medicine.2024; Volume 17: 3919.     CrossRef
  • Relationship Between Serum Uromodulin as a Marker of Kidney Damage and Metabolic Status in Patients with Chronic Kidney Disease of Non-Diabetic Etiology
    Radmila Žeravica, Branislava Ilinčić, Dragan Burić, Ana Jakovljević, Veljko Crnobrnja, Dalibor Ilić, Marija Vukmirović Papuga
    International Journal of Molecular Sciences.2024; 25(20): 11159.     CrossRef
  • Dyslipidemia in Peritoneal Dialysis: Implications for Peritoneal Membrane Function and Patient Outcomes
    Natalia Stepanova
    Biomedicines.2024; 12(10): 2377.     CrossRef
  • Causal associations between kidney function and aortic valve stenosis: a bidirectional Mendelian randomization analysis
    Wanqian Pan, Le Zhou, Rui Han, Xiaojiao Du, Weixiang Chen, Tingbo Jiang
    Renal Failure.2024;[Epub]     CrossRef
  • U-shaped association between dietary niacin intake and chronic kidney disease among US elderly: a nationwide cross-sectional study
    Zhouzhou Xie, Shansen Peng, Gejun Ou, Xiaoqi Zhou, Guihao Zhang, Huiming Jiang, Tianhui Zhang, Nanhui Chen
    Frontiers in Endocrinology.2024;[Epub]     CrossRef
  • Association between dried fruit intake and kidney function: research from univariate and multivariate Mendelian randomized studies
    Yuhang Gao, Xinghai Yue, Wanchao Zhao, Fang Yuan
    Frontiers in Nutrition.2024;[Epub]     CrossRef
  • The Dual Burden: Exploring Cardiovascular Complications in Chronic Kidney Disease
    Alfredo Caturano, Raffaele Galiero, Maria Rocco, Giuseppina Tagliaferri, Alessia Piacevole, Davide Nilo, Giovanni Di Lorenzo, Celestino Sardu, Vincenzo Russo, Erica Vetrano, Marcellino Monda, Raffaele Marfella, Luca Rinaldi, Ferdinando Carlo Sasso
    Biomolecules.2024; 14(11): 1393.     CrossRef
  • Association between the EHBP1 SNPs and dyslipidemia in the end-stage renal disease patients with dialysis in Chinese Han population
    Yan-Fei Lai, Zhong-E Liang, Chun-Xiang Wu, Min Zhang, Zong-Hu Shi, Xiao-Yan Meng, Chun-Xiao Liu
    Lipids in Health and Disease.2024;[Epub]     CrossRef
Original Article
Obesity and Metabolic Syndrome
Associations between Body Mass Index and Chronic Kidney Disease in Type 2 Diabetes Mellitus Patients: Findings from the Northeast of Thailand
Sojib Bin Zaman, Naznin Hossain, Muntasirur Rahman
Diabetes Metab J. 2018;42(4):330-337.   Published online August 21, 2018
DOI: https://doi.org/10.4093/dmj.2017.0052
  • 5,054 View
  • 67 Download
  • 11 Web of Science
  • 14 Crossref
AbstractAbstract PDFPubReader   
Background

Chronic kidney disease (CKD) has emerged as a public health burden globally. Obesity and long-term hyperglycaemia can initiate the renal vascular complications in patients with type 2 diabetes mellitus (T2DM). This study aimed to investigate the association of body mass index (BMI) with the CKD in patients with T2DM.

Methods

This study has used retrospective medical records, biochemical reports, and anthropometric measurements of 3,580 T2DM patients which were collected between January to December 2015 from a district hospital in Thailand. CKD was defined according to the measurement of estimated glomerular filtration rate (<60 mL/min/1.73 m2). Multiple logistic regression analysis was used to explore the association between BMI and CKD in patients with T2DM.

Results

The mean age of the participants was 60.86±9.67 years, 53.68% had poor glycaemic control, and 45.21% were overweight. About one-in-four (23.26%) T2DM patients had CKD. The mean BMI of non-CKD group was slightly higher (25.30 kg/m2 vs. 24.30 kg/m2) when compared with CKD patients. Multivariable analysis showed that older age, female sex, hypertension, and microalbuminuria were associated with the presence of CKD. No association was observed between CKD and poorly controlled glycosylated hemoglobin or hypercholesterolemia. Adjusted analysis further showed overweight and obesity were negatively associated with CKD (adjusted odds ratio [AOR], 0.73; 95% confidence interval [CI], 0.58 to 0.93) and (AOR, 0.53; 95% CI, 0.35 to 0.81), respectively.

Conclusion

The negative association of BMI with CKD could reflect the reverse causality. Lower BMI might not lead a diabetic patient to develop CKD, but there are possibilities that CKD leads the patient to experience reduced BMI.

Citations

Citations to this article as recorded by  
  • Increased Body Mass Index is Independently Associated with Chronic Kidney Disease among People with Type 2 Diabetes
    Vijay Viswanathan, Sivashankari SelvaElavarasan, Satyavani Kumpatla
    Indian Journal of Nephrology.2024; 0: 1.     CrossRef
  • Prevalence and predictors of chronic kidney disease among type 2 diabetic patients worldwide, systematic review and meta-analysis
    Eneyew Talie Fenta, Habitu Birhan Eshetu, Natnael Kebede, Eyob Ketema Bogale, Amare Zewdie, Tadele Derbew Kassie, Tadele Fentabil Anagaw, Elyas Melaku Mazengia, Sintayehu Shiferaw Gelaw
    Diabetology & Metabolic Syndrome.2023;[Epub]     CrossRef
  • Risk Factors of Chronic Kidney Disease (CKD) in Type 2 Diabetes Mellitus (DM) Patients at Dr. Soetomo General Academic Hospital, Surabaya
    Joshua Teofilus Sutadji, Agung Pranoto, Risky Vitria Prasetyo
    JUXTA: Jurnal Ilmiah Mahasiswa Kedokteran Universitas Airlangga.2023; 14(1): 12.     CrossRef
  • Profile of Obesity and Comorbidities and their Correlation among Hemodialysis Patients, Elbasan
    Brunilda Elezi, Skender Topi, Erjona Abazaj
    Open Access Macedonian Journal of Medical Sciences.2022; 10(E): 225.     CrossRef
  • Association of eNOS and MCP-1 Genetic Variants with Type 2 Diabetes and Diabetic Nephropathy Susceptibility: A Case–Control and Meta-Analysis Study
    Priyanka Raina, Ruhi Sikka, Himanshu Gupta, Kawaljit Matharoo, Surinder Kumar Bali, Virinder Singh, AJS Bhanwer
    Biochemical Genetics.2021; 59(4): 966.     CrossRef
  • New Pandemic: Obesity and Associated Nephropathy
    Isha Sharma, Yingjun Liao, Xiaoping Zheng, Yashpal S. Kanwar
    Frontiers in Medicine.2021;[Epub]     CrossRef
  • Associations between obesity, weight change and decreased renal function in Korean type 2 diabetic patients: a longitudinal follow-up study
    Bo-Yeon Kim, Dug-Hyun Choi, Chan-Hee Jung, Ji-Oh Mok, Chul-Hee Kim
    BMC Endocrine Disorders.2021;[Epub]     CrossRef
  • The burden of chronic kidney disease among people with diabetes by insurance schemes: Findings from a primary referral hospital in Thailand
    Sojib Bin Zaman, Rajat Das Gupta, Putthikrai Pramual, Raihan Kabir Khan, Chinakorn Sujimongkol, Naznin Hossain, Mohammad Rifat Haider, Md. Nazmul Karim, Gulam Muhammed Kibria, Sheikh Mohammdad Shariful Islam
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  • Association between body mass index and estimated glomerular filtration rate in patients with chronic kidney disease of unknown aetiology in Sri Lanka
    M. R. D. L. Kulathunga, M. A. A. Wijayawardena, Ravi Naidu, S. J. Wimalawansa, A. W. Wijeratne
    Environmental Geochemistry and Health.2020; 42(9): 2645.     CrossRef
  • The prevalence of diabetic chronic kidney disease in adult Greek subjects with type 2 diabetes mellitus: A series from hospital-based diabetes clinics
    Ilias N. Migdalis, Nikolaos Papanas, Athanasios E. Raptis, Ioannis M. Ioannidis, Alexios E. Sotiropoulos, George D. Dimitriadis
    Diabetes Research and Clinical Practice.2020; 166: 108243.     CrossRef
  • Underweight Increases the Risk of End-Stage Renal Diseases for Type 2 Diabetes in Korean Population: Data From the National Health Insurance Service Health Checkups 2009–2017
    Yang-Hyun Kim, Jun Goo Kang, Seong Jin Lee, Kyung-do Han, Sung-Hee Ihm, Kyung-Hwan Cho, Yong-Gyu Park
    Diabetes Care.2020; 43(5): 1118.     CrossRef
  • Prevalence and risk factors of chronic kidney disease among Palestinian type 2 diabetic patients: a cross-sectional study
    Zaher Nazzal, Zakaria Hamdan, Dunia Masri, Oday Abu-Kaf, Mohammad Hamad
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    Mee Kyoung Kim, Kyungdo Han, Hun-Sung Kim, Yong-Moon Park, Hyuk-Sang Kwon, Kun-Ho Yoon, Seung-Hwan Lee
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    Abozaid Mohammed Elemam
    Sudan Journal of Medical Sciences.2019;[Epub]     CrossRef

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