Søren Gullaksen , Liv Vernstrøm , Steffen S. Sørensen , Steffen Ringgaard , Christoffer Laustsen , Henrik Birn , Kristian L. Funck , Per L. Poulsen , Esben Laugesen
{"title":"塞马鲁肽、empagliflozin及其组合对磁共振成像肾钠信号的影响：一项随机临床试验的预设二次分析","authors":"Søren Gullaksen , Liv Vernstrøm , Steffen S. Sørensen , Steffen Ringgaard , Christoffer Laustsen , Henrik Birn , Kristian L. Funck , Per L. Poulsen , Esben Laugesen","doi":"10.1016/j.jdiacomp.2023.108673","DOIUrl":null,"url":null,"abstract":"<div><h3>Aims</h3><p>To evaluate the effect of treatment with semaglutide and empagliflozin on the cortico-medullary sodium gradient (MCR; medulla/cortex ratio), urine sodium/creatinine ratio (UNACR), and estimated plasma volume (ePV) and to compare the MCR between persons with and without type 2 diabetes.</p></div><div><h3>Methods</h3><p>Using the <sup>23</sup>Na magnetic resonance imaging (<sup>23</sup>Na-MRI) technique, we investigated the effects of 32 weeks of treatment with semaglutide, empagliflozin or their combination on MCR in 65 participants with type 2 diabetes and high risk of cardiovascular disease. The participants were recruited from a randomized, controlled interventional trial and further characterized by UNACR and ePV. In addition, in a cross-sectional design, we compared MCR by <sup>23</sup>Na-MRI in 12 persons with type 2 diabetes and 17 matched controls. Data from the interventional trial were analyzed using a single, multivariate linear mixed model strategy for repeated measurements. Data from the cross-sectional study were analyzed by fitting a linear regression model adjusted for age and sex.</p></div><div><h3>Results</h3><p>Compared to placebo, semaglutide, but not empagliflozin, significantly decreased the MCR (−9 %, 95%CI (−18, −0.06)%, <em>p</em> = 0.035 and −0.05 %, 95%CI(−0.15, 0.05)%, <em>p</em> = 0.319, respectively). The UNACR decreased in the semaglutide group(−35 %, 95 % CI(−52, −14) %, <em>p</em> = 0.003) but not in the empagliflozin group (7 %, 95 % CI(−21, 44)%, <em>p</em> = 0.657), whereas the ePV decreased in the combination group. The MCR was not different between persons with and without type 2 diabetes.</p></div><div><h3>Conclusion</h3><p><sup>23</sup>Na magnetic resonance imaging can identify drug induced changes in the MCR in persons with type 2 diabetes, and 32 weeks of semaglutide decreases the MCR in such persons. There is no difference in the MCR between persons with and without type 2 diabetes.</p></div><div><h3>Trial number and registry</h3><p>EUDRACT 2019-000781-38, clinicaltrialsregister.eu.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":null,"pages":null},"PeriodicalIF":2.9000,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1056872723002714/pdfft?md5=fe0591cfa5db3f32af88b9801ab4473a&pid=1-s2.0-S1056872723002714-main.pdf","citationCount":"0","resultStr":"{\"title\":\"The effects of semaglutide, empagliflozin and their combination on the kidney sodium signal from magnetic resonance imaging: A prespecified, secondary analysis from a randomized, clinical trial\",\"authors\":\"Søren Gullaksen , Liv Vernstrøm , Steffen S. Sørensen , Steffen Ringgaard , Christoffer Laustsen , Henrik Birn , Kristian L. Funck , Per L. Poulsen , Esben Laugesen\",\"doi\":\"10.1016/j.jdiacomp.2023.108673\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Aims</h3><p>To evaluate the effect of treatment with semaglutide and empagliflozin on the cortico-medullary sodium gradient (MCR; medulla/cortex ratio), urine sodium/creatinine ratio (UNACR), and estimated plasma volume (ePV) and to compare the MCR between persons with and without type 2 diabetes.</p></div><div><h3>Methods</h3><p>Using the <sup>23</sup>Na magnetic resonance imaging (<sup>23</sup>Na-MRI) technique, we investigated the effects of 32 weeks of treatment with semaglutide, empagliflozin or their combination on MCR in 65 participants with type 2 diabetes and high risk of cardiovascular disease. The participants were recruited from a randomized, controlled interventional trial and further characterized by UNACR and ePV. In addition, in a cross-sectional design, we compared MCR by <sup>23</sup>Na-MRI in 12 persons with type 2 diabetes and 17 matched controls. Data from the interventional trial were analyzed using a single, multivariate linear mixed model strategy for repeated measurements. Data from the cross-sectional study were analyzed by fitting a linear regression model adjusted for age and sex.</p></div><div><h3>Results</h3><p>Compared to placebo, semaglutide, but not empagliflozin, significantly decreased the MCR (−9 %, 95%CI (−18, −0.06)%, <em>p</em> = 0.035 and −0.05 %, 95%CI(−0.15, 0.05)%, <em>p</em> = 0.319, respectively). The UNACR decreased in the semaglutide group(−35 %, 95 % CI(−52, −14) %, <em>p</em> = 0.003) but not in the empagliflozin group (7 %, 95 % CI(−21, 44)%, <em>p</em> = 0.657), whereas the ePV decreased in the combination group. The MCR was not different between persons with and without type 2 diabetes.</p></div><div><h3>Conclusion</h3><p><sup>23</sup>Na magnetic resonance imaging can identify drug induced changes in the MCR in persons with type 2 diabetes, and 32 weeks of semaglutide decreases the MCR in such persons. There is no difference in the MCR between persons with and without type 2 diabetes.</p></div><div><h3>Trial number and registry</h3><p>EUDRACT 2019-000781-38, clinicaltrialsregister.eu.</p></div>\",\"PeriodicalId\":15659,\"journal\":{\"name\":\"Journal of diabetes and its complications\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2024-01-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1056872723002714/pdfft?md5=fe0591cfa5db3f32af88b9801ab4473a&pid=1-s2.0-S1056872723002714-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of diabetes and its complications\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1056872723002714\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of diabetes and its complications","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1056872723002714","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
The effects of semaglutide, empagliflozin and their combination on the kidney sodium signal from magnetic resonance imaging: A prespecified, secondary analysis from a randomized, clinical trial
Aims
To evaluate the effect of treatment with semaglutide and empagliflozin on the cortico-medullary sodium gradient (MCR; medulla/cortex ratio), urine sodium/creatinine ratio (UNACR), and estimated plasma volume (ePV) and to compare the MCR between persons with and without type 2 diabetes.
Methods
Using the 23Na magnetic resonance imaging (23Na-MRI) technique, we investigated the effects of 32 weeks of treatment with semaglutide, empagliflozin or their combination on MCR in 65 participants with type 2 diabetes and high risk of cardiovascular disease. The participants were recruited from a randomized, controlled interventional trial and further characterized by UNACR and ePV. In addition, in a cross-sectional design, we compared MCR by 23Na-MRI in 12 persons with type 2 diabetes and 17 matched controls. Data from the interventional trial were analyzed using a single, multivariate linear mixed model strategy for repeated measurements. Data from the cross-sectional study were analyzed by fitting a linear regression model adjusted for age and sex.
Results
Compared to placebo, semaglutide, but not empagliflozin, significantly decreased the MCR (−9 %, 95%CI (−18, −0.06)%, p = 0.035 and −0.05 %, 95%CI(−0.15, 0.05)%, p = 0.319, respectively). The UNACR decreased in the semaglutide group(−35 %, 95 % CI(−52, −14) %, p = 0.003) but not in the empagliflozin group (7 %, 95 % CI(−21, 44)%, p = 0.657), whereas the ePV decreased in the combination group. The MCR was not different between persons with and without type 2 diabetes.
Conclusion
23Na magnetic resonance imaging can identify drug induced changes in the MCR in persons with type 2 diabetes, and 32 weeks of semaglutide decreases the MCR in such persons. There is no difference in the MCR between persons with and without type 2 diabetes.
期刊介绍：
Journal of Diabetes and Its Complications (JDC) is a journal for health care practitioners and researchers, that publishes original research about the pathogenesis, diagnosis and management of diabetes mellitus and its complications. JDC also publishes articles on physiological and molecular aspects of glucose homeostasis.
The primary purpose of JDC is to act as a source of information usable by diabetes practitioners and researchers to increase their knowledge about mechanisms of diabetes and complications development, and promote better management of people with diabetes who are at risk for those complications.
Manuscripts submitted to JDC can report any aspect of basic, translational or clinical research as well as epidemiology. Topics can range broadly from early prediabetes to late-stage complicated diabetes. Topics relevant to basic/translational reports include pancreatic islet dysfunction and insulin resistance, altered adipose tissue function in diabetes, altered neuronal control of glucose homeostasis and mechanisms of drug action. Topics relevant to diabetic complications include diabetic retinopathy, neuropathy and nephropathy; peripheral vascular disease and coronary heart disease; gastrointestinal disorders, renal failure and impotence; and hypertension and hyperlipidemia.
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