Journal of diabetes and its complications最新文献

{"title":"Association of sodium glucose co-transporter-2 inhibitors with risk of diabetic ketoacidosis among hospitalized patients: A multicentre cohort study","authors":"Shohinee Sarma ,&nbsp;Benazir Hodzic-Santor ,&nbsp;Afsaneh Raissi ,&nbsp;Michael Colacci ,&nbsp;Amol A. Verma ,&nbsp;Fahad Razak ,&nbsp;Mats C. Højbjerg Lassen ,&nbsp;Michael Fralick","doi":"10.1016/j.jdiacomp.2024.108827","DOIUrl":"10.1016/j.jdiacomp.2024.108827","url":null,"abstract":"<div><h3>Introduction</h3><p>Sodium glucose co-transporter-2 inhibitors (SGLT-2i) are increasingly being used among hospitalized patients. Our objective was to assess the risk of diabetic ketoacidosis (DKA) among hospitalized patients receiving an SGLT-2i.</p></div><div><h3>Research design and methods</h3><p>We conducted a multicentre cohort study of patients hospitalized at 19 hospitals. We included patients over 18 years of age who received an SGLT-2i or a dipeptidyl peptidase-4 inhibitor (DPP-4i) in hospital. The primary outcome was the risk of DKA during their hospitalization.</p></div><div><h3>Results</h3><p>61,517 patients received a DPP-4i and 11,061 received an SGLT-2i. The risk of inpatient DKA was 0.07 % (<em>N</em> = 41 events) among adults who received a DPP-4i and 0.18 % (<em>N</em> = 20 events) among adults who received an SGLT-2i; adjusted odds ratio of 3.30 (95 % CI: 1.85–5.72).</p></div><div><h3>Conclusions</h3><p>In hospitalized patients, the absolute risk of DKA was 0.2 %, which corresponded to a three-fold higher relative risk.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 9","pages":"Article 108827"},"PeriodicalIF":2.9,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141889405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An online tool using clinical factors to estimate the probability of partial clinical remission of adult-onset Type 1 diabetes","authors":"Andrzej S. Januszewski ,&nbsp;Agata Grzelka-Wozniak ,&nbsp;Justyna Flotynska ,&nbsp;Alicia J. Jenkins ,&nbsp;Dorota A. Zozulinska-Ziolkiewicz ,&nbsp;Aleksandra A. Uruska","doi":"10.1016/j.jdiacomp.2024.108828","DOIUrl":"10.1016/j.jdiacomp.2024.108828","url":null,"abstract":"<div><p>A type 1 diabetes (T1D) diagnosis is often followed by a period of reduced exogenous insulin requirement, with acceptable glucose control, called partial clinical remission (pCR). Various criteria exist to define pCR, which is associated with better clinical outcomes.</p><p>We aimed to develop formulae and a related online calculator to predict the probability of pCR at 3- and 12-months post-T1D diagnosis.</p><p>We analysed data from 133 adults at their T1D diagnosis (mean ± SD age: 27 ± 6 yrs., HbA1c 11.1 ± 2.0 %, 98 ± 22 mmol/mol), 3- and 12-months later. All patients were enrolled in the prospective observational InLipoDiab1 study (<span><span>NCT02306005</span><svg><path></path></svg></span>). We compared four definitions of pCR: 1) stimulated C-peptide &gt;300 pmol/l; 2) insulin dose-adjusted HbA1c ≤9 %; 3) insulin dose &lt;0.3 IU/kg/24 h; and HbA1c ≤6.4 % (46 mmol/mol); and 4) insulin dose &lt;0.5 IU/kg/24 h and HbA1c &lt;7 % (53 mmol/mol). Using readily available demographics and clinical chemistry data exhaustive search methodology was used to model pCR probability.</p><p>There was low concordance between pCR definitions (kappa 0.10). The combination of age, HbA1c, diastolic blood pressure, triglycerides and smoking at T1D onset predicted pCR at 12-months with an area under the curve (AUC) = 0.87. HbA1c, triglycerides and insulin dose 3-mths post-diagnosis had an AUC = 0.89. A related calculator for pCR in adult-onset T1D is available at <span><span>http://www.bit.ly/T1D-partial-remission</span><svg><path></path></svg></span>.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 9","pages":"Article 108828"},"PeriodicalIF":2.9,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1056872724001545/pdfft?md5=034167d2b4b13fe8c2d9af3cc8265271&pid=1-s2.0-S1056872724001545-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141845802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of continuous subcutaneous insulin therapy and diabetic retinopathy in type 1 diabetes: A national cohort study","authors":"Anne S. Thykjær ,&nbsp;Louise Rosengaard ,&nbsp;Nis Andersen ,&nbsp;Jens Andresen ,&nbsp;Javad Hajari ,&nbsp;Steffen Heegaard ,&nbsp;Kurt Højlund ,&nbsp;Ryo Kawasaki ,&nbsp;Caroline S. Laugesen ,&nbsp;Sören Möller ,&nbsp;Frederik N. Pedersen ,&nbsp;Katja Schielke ,&nbsp;Lonny M. Stokholm ,&nbsp;Jakob Grauslund","doi":"10.1016/j.jdiacomp.2024.108830","DOIUrl":"10.1016/j.jdiacomp.2024.108830","url":null,"abstract":"<div><h3>Aim</h3><p>This study aimed to investigate the short-and long-term effect on diabetic retinopathy (DR) in individuals with type 1 diabetes treated with continuous subcutaneous insulin injections (CSII) compared to those using multiple daily injections (MDI).</p></div><div><h3>Methods</h3><p>We conducted a register-based matched cohort study utilizing data from the Danish Registry of Diabetic Retinopathy as well as several other national Danish health registers. Our cohort consisted of all individuals with type 1 diabetes who attended the Danish screening program for DR from 2013 to 2022. We included individuals registered with CSII treatment, and compared them to individuals using MDI, matched by age, sex, and DR level. Cox regression analysis was performed to evaluate the outcomes.</p></div><div><h3>Results</h3><p>The study included 674 individuals treated with CSII and 2006 matched MDI users. In our cohort 53.4 % were female and median age was 36 (IQR 27–47). Average follow-up risk-time was 4.8 years. There was no difference in the risk of DR worsening between the CSII group and MDI group (HR 1.05 [95%CI 0.91; 1.22], <em>p</em> = 0.49). However, an increased risk of focal photocoagulation was observed in the CSII group (HR 2.40 [95%CI 1.11; 5.19], <em>p</em> = 0.03).</p></div><div><h3>Conclusions</h3><p>Our findings indicate that CSII treatment does not confer a significant difference in the overall short- and long-term risk of DR worsening or ocular intervention compared to MDI treatment. These results provide insights into the DR outcomes of CSII treatment in individuals with type 1 diabetes.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 9","pages":"Article 108830"},"PeriodicalIF":2.9,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1056872724001569/pdfft?md5=49695d16b6004e8f2fee7adc54d8bcf6&pid=1-s2.0-S1056872724001569-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141847298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correlation of cerebral small vessel disease burden with outcome after lower extremity amputation","authors":"Marcin Kolasa ,&nbsp;Otso Arponen ,&nbsp;Ilkka Kaartinen ,&nbsp;Eva Saarinen ,&nbsp;Eino Solje ,&nbsp;Jussi Hirvonen ,&nbsp;Miska Vuorlaakso","doi":"10.1016/j.jdiacomp.2024.108829","DOIUrl":"10.1016/j.jdiacomp.2024.108829","url":null,"abstract":"<div><h3>Aims</h3><p>This study assessed whether changes associated with cerebral small vessel disease (CSVD) evaluated from head computed tomography (CT) images captured for non-related clinical purposes predict overall survival (OS), leg salvage (LS), and amputation-free survival (AFS) after lower extremity amputation (LEA).</p></div><div><h3>Methods</h3><p>We retrospectively included a cohort of 240 patients who had undergone a lower extremity amputation in Tampere University Hospital between the years 2007 and 2020 and had a head CT scan (within one year before amputation). A neuroradiologist graded the white matter lesions (WMLs) and reported infarcts, and the latter's effects on OS, LS, and AFS were evaluated.</p></div><div><h3>Results</h3><p>Altogether, 162 (67.5 %) and 91 (38.1 %) patients had WMLs and infarcts, respectively. Mild/moderate (HR 1.985, CI 95 % 1.317–2.992) and severe (HR 2.259, CI 95 % 1.501–3.399) WMLs and infarcts (HR 1.413, CI 95 % 1.029–1.940) were associated with inferior OS. After a minor amputation, mild/moderate (HR 2.012, CI 95 % 1.054–3.843) and severe (HR 3.879, CI 95 % 2.096–7.180) WMLs were similarly associated with inferior AFS.</p></div><div><h3>Conclusions</h3><p>Overall, WML and infarcts detected on head CT scans were associated with impaired OS after LEA and AFS after minor LEA. Evaluation of CSVD could provide useful prognostic information for clinicians.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 9","pages":"Article 108829"},"PeriodicalIF":2.9,"publicationDate":"2024-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1056872724001557/pdfft?md5=1679cbc2e7718c13f96f1575739ff008&pid=1-s2.0-S1056872724001557-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141766231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cytochrome P450-soluble epoxide hydrolase oxylipins, depression and cognition in type 2 diabetes","authors":"Natasha Z. Anita ,&nbsp;Nathan Herrmann ,&nbsp;Si Won Ryoo ,&nbsp;Chelsi Major-Orfao ,&nbsp;William Z. Lin ,&nbsp;Felicia Kwan ,&nbsp;Shiropa Noor ,&nbsp;Jennifer S. Rabin ,&nbsp;Susan Marzolini ,&nbsp;Sean Nestor ,&nbsp;Myuri T. Ruthirakuhan ,&nbsp;Bradley J. MacIntosh ,&nbsp;Maged Goubran ,&nbsp;Pearl Yang ,&nbsp;Hugo Cogo-Moreira ,&nbsp;Mark Rapoport ,&nbsp;Damien Gallagher ,&nbsp;Sandra E. Black ,&nbsp;Benjamin I. Goldstein ,&nbsp;Krista L. Lanctôt ,&nbsp;Walter Swardfager","doi":"10.1016/j.jdiacomp.2024.108826","DOIUrl":"10.1016/j.jdiacomp.2024.108826","url":null,"abstract":"<div><h3>Aims</h3><p>This study examined serum cytochrome P450-soluble epoxide hydrolase (CYP450-sEH) oxylipins and depressive symptoms together in relation to cognitive performance in individuals with type 2 diabetes mellitus (T2DM).</p></div><div><h3>Methods</h3><p>Clinically cognitively normal T2DM individuals were recruited (<span><span>NCT04455867</span><svg><path></path></svg></span>). Depressive symptom severity was assessed using the Beck Depression Inventory-II (BDI-II; total scores ≤13 indicated minimal depressive symptoms and ≥ 14 indicated significant depressive symptoms). Executive function and verbal memory were assessed. Fasting serum oxylipins were quantified by ultra-high-performance liquid chromatography tandem mass-spectrometry.</p></div><div><h3>Results</h3><p>The study included 85 participants with minimal depressive symptoms and 27 with significant symptoms (mean age: 63.3 ± 9.8 years, 49 % women). In all participants, higher concentrations of linoleic acid derived sEH (12,13-dihydroxyoctadecamonoenoic acid; DiHOME) and CYP450 (12(13)-epoxyoctadecamonoenoic acid; EpOME) metabolites were associated with poorer executive function (F_1,101 = 6.094, <em>p</em> = 0.015 and F_1,101 = 5.598, <em>p</em> = 0.020, respectively). Concentrations of multiple sEH substrates interacted with depressive symptoms to predict 1) poorer executive function, including 9(10)-EpOME (F_1,100 = 12.137, <em>p</em> &lt; 0.001), 5(6)-epoxyeicosatrienoic acid (5(6)-EpETrE; F_1,100 = 6.481, <em>p</em> = 0.012) and 11(12)-EpETrE (F_1,100 = 4.409, <em>p</em> = 0.038), and 2) verbal memory, including 9(10)-EpOME (F_1,100 = 4.286, <em>p</em> = 0.041), 5(6)-EpETrE (F_1,100 = 6.845, <em>p</em> = 0.010), 11(12)-EpETrE (F_1,100 = 3.981, <em>p</em> = 0.049) and 14(15)-EpETrE (F_1,100 = 5.019, <em>p</em> = 0.027).</p></div><div><h3>Conclusions</h3><p>Associations of CYP450-sEH metabolites and depressive symptoms with cognition highlight the biomarker and therapeutic potential of the CYP450-sEH pathway in T2DM.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 9","pages":"Article 108826"},"PeriodicalIF":2.9,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1056872724001521/pdfft?md5=b48c09117a48aa4b6ee187f5254cb133&pid=1-s2.0-S1056872724001521-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141766232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Atherogenic markers and 1-year amputation risk in adults with diabetic foot in a tertiary level hospital: A retrospective cohort study","authors":"Jerry K. Benites-Meza ,&nbsp;Jussara Malo-Castillo ,&nbsp;Percy Herrera-Añazco ,&nbsp;Vicente A. Benites-Zapata","doi":"10.1016/j.jdiacomp.2024.108810","DOIUrl":"10.1016/j.jdiacomp.2024.108810","url":null,"abstract":"<div><h3>Aim</h3><p>To determine the association between atherogenic markers, such as total cholesterol/high density lipoprotein cholesterol ratio (TC/HDL-C), triglycerides/HDL-C ratio (TG/HDL-C), and triglycerides-glucose index (TyG), and the risk of 1-year amputation in adults with diabetic foot in a tertiary level hospital.</p></div><div><h3>Methods</h3><p>Retrospective cohort study conducted in 162 adult patients with diabetic foot. The outcome was amputation, defined as “primary amputation in patients' clinical history after their first hospitalization due to foot ulcer.”. The cutoff point was determined using Youden's J statistic. The relative risk (RR) was presented as an association measure.</p></div><div><h3>Results</h3><p>A TyG index of &gt;9.4 [RR: 1.64 (1.10–2.45)] was associated with a high risk of amputation after 1-year in adults with diabetic foot. However, while a TC/HDL ratio of &gt;4.69 [RR: 1.38 (0.94–2.03)] and a TG/HDL-C ratio &gt; 3.57 [RR: 1.35 (0.89–2.06)] did not show associations with risk of amputation after 1-year.</p></div><div><h3>Conclusions</h3><p>Only a TyG index of &gt;9.4 was associated with an increased risk of 1-year amputation in adults with diabetic foot. Future studies with larger samples and a longitudinal design may provide more robust evidence and a better understanding of clinical implications.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 9","pages":"Article 108810"},"PeriodicalIF":2.9,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the influence of rural residence and economic distress on lower extremity risk stratification among diabetic foot ulcer patients utilizing the Wound, Ischemia, and Foot Infection (WIfI) classification system","authors":"Jordan Tasman ,&nbsp;Devin J. Clegg ,&nbsp;Colten Carver ,&nbsp;Saahit Adabala ,&nbsp;Michael R. Buckley ,&nbsp;Mitchell H. Goldman ,&nbsp;Patricia N.E. Roberson","doi":"10.1016/j.jdiacomp.2024.108814","DOIUrl":"10.1016/j.jdiacomp.2024.108814","url":null,"abstract":"<div><h3>Objective</h3><p>Diabetic foot ulcers (DFU) are a major sequela of uncontrolled diabetes with a high risk of adverse outcomes. Poor DFU outcomes disproportionately impact patients living in rural and economically distressed communities with lack of access to consistent, quality care. This study aimed to analyze the risk of geographic and economic disparities, including rural status and county economic distress, on the disease burden of DFU at presentation utilizing the SVS WIfI classification system.</p></div><div><h3>Methods</h3><p>We conducted a retrospective review of 454 patients diagnosed with a DFU from 2011 to 2020 at a single institution's inpatient and outpatient wound care service. Patients &gt;18 years old, with type II diabetes mellitus, and diabetic foot ulcer were included.</p></div><div><h3>Results</h3><p>ANCOVA analyses showed rural patients had significantly higher WIfI composite scores (F(1,451) = 9.61, <em>p</em> = .002), grades of wound (F(1,439) = 11.03, <em>p</em> = .001), and ischemia (F(1,380) = 12.574, p = .001) compared to the urban patients. Patients that resided in at-risk economic counties had significantly higher overall WIfI composite scores (F(2,448) = 3.31, <em>p</em> = .037) than patients who lived in transitional economic counties, and higher foot infection grading (F(2,440) = 3.02, <em>p</em> = .05) compared to patients who lived in distressed economic counties. DFU patients who resided in distressed economic counties presented with higher individual grades of ischemia (F(2, 377) = 3.14, <em>p</em> = .04) than patients in transitional economic counties. Chi-Square analyses demonstrated patients who resided in urban counties were significantly more likely to present with grade 1 wounds (χ2(3) = 9.86, <em>p</em> = .02) and grade 0 ischemia (χ2(3) = 16.18, <em>p</em> = .001) compared to patients in rural areas. Economically distressed patients presented with significantly less grade 0 ischemia compared to patients in transitional economic counties (χ2(6) = 17.48, <em>p</em> = .008).</p></div><div><h3>Conclusions</h3><p>Our findings are the first to demonstrate the impact of geographic and economic disparities on the disease burden of DFU at presentation utilizing the SVS WIfI classification system. This may indicate need for improved multidisciplinary primary care prevention strategies with vascular specialists in these communities to mitigate worsening DFU and promote early intervention.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 8","pages":"Article 108814"},"PeriodicalIF":2.9,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141630158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Can tirzepatide untie the Gordian knot of eating disorders among individuals with type 2 diabetes and obesity?","authors":"Dimitrios Patoulias ,&nbsp;Paschalis Karakasis ,&nbsp;Mohamed El-Tanani ,&nbsp;Manfredi Rizzo","doi":"10.1016/j.jdiacomp.2024.108812","DOIUrl":"10.1016/j.jdiacomp.2024.108812","url":null,"abstract":"","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 8","pages":"Article 108812"},"PeriodicalIF":2.9,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141630159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of prior gestational diabetes on the risk of cardiovascular disease and death in women with type 2 diabetes: The Fremantle Diabetes Study Phase II","authors":"Emily Gianatti ,&nbsp;Wendy A. Davis ,&nbsp;Timothy M.E. Davis","doi":"10.1016/j.jdiacomp.2024.108811","DOIUrl":"10.1016/j.jdiacomp.2024.108811","url":null,"abstract":"<div><h3>Background</h3><p>To examine whether prior gestational diabetes mellitus (GDM) is associated with prevalent coronary heart disease (CHD), cerebrovascular disease (CeVD) and peripheral arterial disease (PAD), and all-cause mortality, in community-based women with type 2 diabetes.</p></div><div><h3>Methods</h3><p>Baseline prevalences of CHD/CeVD/PAD/prior GDM were determined in 718 females (mean ± SD age 65.5 ± 11.9 years) from the Fremantle Diabetes Study Phase II. Deaths between baseline (2008–2011) and end-2016 were ascertained. Cox regression identified predictors of mortality with GDM as a candidate variable.</p></div><div><h3>Results</h3><p>Compared to the 673 women without GDM, the 39 (5.4 %) with prior GDM were younger, more likely Aboriginal, smokers and obese, had longer diabetes duration and higher HbA_1c levels, and were more dyslipidemic (<em>P</em> ≤ 0.046). Prevalences of CHD (24.6 versus 23.1 %), CeVD (7.5 % versus 2.6 %) and PAD (27.5 % versus 23.7 %) were not significantly different in those without versus with prior GDM (<em>P</em> ≥ 0.35). There were 116 deaths (16.2 %) during 6.8 ± 1.6 years of follow-up. Age, Aboriginal ethnicity, marital status, current smoking, heart rate, estimated glomerular filtration rate, CHD and PAD were independently associated with all-cause mortality (<em>P</em> ≤ 0.023); GDM status did not add to the most parsimonious model (<em>P</em> = 0.62).</p></div><div><h3>Conclusions</h3><p>Prior GDM does not increase CVD risk or all-cause mortality in women with type 2 diabetes.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 8","pages":"Article 108811"},"PeriodicalIF":2.9,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1056872724001375/pdfft?md5=c9dd159b8a51cfeb88b6dc4fbab8449c&pid=1-s2.0-S1056872724001375-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141639239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A phase 4 randomized active-controlled clinical study to compare the efficacy and safety of sustained-release pregabalin with immediate-release pregabalin in type 2 diabetic patients with peripheral neuropathic pain","authors":"Kyong Hye Joung ,&nbsp;Tae Nyun Kim ,&nbsp;Eu Jeong Ku ,&nbsp;Seong Su Lee ,&nbsp;Won Sang Yoo ,&nbsp;Kang Seo Park ,&nbsp;Su Kyoung Kwon ,&nbsp;Bon Jeong Ku","doi":"10.1016/j.jdiacomp.2024.108809","DOIUrl":"10.1016/j.jdiacomp.2024.108809","url":null,"abstract":"<div><h3>Aims</h3><p>The objective of this study was to demonstrate that sustained-release (SR) pregabalin is non-inferior to immediate-release (IR) pregabalin in attenuating diabetic peripheral neuropathic (DPN) pain along with patient satisfaction and compliance.</p></div><div><h3>Methods</h3><p>This was an 8-week, randomized, active-controlled, open-label, phase 4 study. Eligible subjects who had been on IR pregabalin for 4 weeks were randomized to 1:1 ratio to either continue with twice-daily IR pregabalin (75 mg), or to switch to once-daily SR pregabalin (150 mg). Primary efficacy endpoint was the change in visual analogue scale (VAS) scores after 8 weeks of treatment compared to baseline in both SR and IR pregabalin groups.</p></div><div><h3>Results</h3><p>Among 130 randomized subjects, 125 patients were included in full analysis set. For the change in VAS pain score, the least squares (LS) mean were −17.95 (SR pregabalin) and −18.74 (IR pregabalin) and the LS mean difference between both groups was 0.79, with the upper limit of the 95 % confidence interval [−5.99, 7.58] below the pre-specified non-inferiority margin of 9.2 mm.</p></div><div><h3>Conclusions</h3><p>This study demonstrates that the new once-daily SR pregabalin formulation is not different to the twice-daily IR pregabalin in alleviating DPN pain, indicating its potential as a promising treatment for DPN pain with a comparable safety profile.</p></div><div><h3>Trial registration</h3><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT05624853</span><svg><path></path></svg></span>.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 8","pages":"Article 108809"},"PeriodicalIF":2.9,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141630156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}