Pub Date : 2024-07-22DOI: 10.1016/j.jdiacomp.2024.108826
Natasha Z. Anita , Nathan Herrmann , Si Won Ryoo , Chelsi Major-Orfao , William Z. Lin , Felicia Kwan , Shiropa Noor , Jennifer S. Rabin , Susan Marzolini , Sean Nestor , Myuri T. Ruthirakuhan , Bradley J. MacIntosh , Maged Goubran , Pearl Yang , Hugo Cogo-Moreira , Mark Rapoport , Damien Gallagher , Sandra E. Black , Benjamin I. Goldstein , Krista L. Lanctôt , Walter Swardfager
Aims
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).
Methods
Clinically cognitively normal T2DM individuals were recruited (NCT04455867). 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.
Results
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 (F1,101 = 6.094, p = 0.015 and F1,101 = 5.598, p = 0.020, respectively). Concentrations of multiple sEH substrates interacted with depressive symptoms to predict 1) poorer executive function, including 9(10)-EpOME (F1,100 = 12.137, p < 0.001), 5(6)-epoxyeicosatrienoic acid (5(6)-EpETrE; F1,100 = 6.481, p = 0.012) and 11(12)-EpETrE (F1,100 = 4.409, p = 0.038), and 2) verbal memory, including 9(10)-EpOME (F1,100 = 4.286, p = 0.041), 5(6)-EpETrE (F1,100 = 6.845, p = 0.010), 11(12)-EpETrE (F1,100 = 3.981, p = 0.049) and 14(15)-EpETrE (F1,100 = 5.019, p = 0.027).
Conclusions
Associations of CYP450-sEH metabolites and depressive symptoms with cognition highlight the biomarker and therapeutic potential of the CYP450-sEH pathway in T2DM.
{"title":"Cytochrome P450-soluble epoxide hydrolase oxylipins, depression and cognition in type 2 diabetes","authors":"Natasha Z. Anita , Nathan Herrmann , Si Won Ryoo , Chelsi Major-Orfao , William Z. Lin , Felicia Kwan , Shiropa Noor , Jennifer S. Rabin , Susan Marzolini , Sean Nestor , Myuri T. Ruthirakuhan , Bradley J. MacIntosh , Maged Goubran , Pearl Yang , Hugo Cogo-Moreira , Mark Rapoport , Damien Gallagher , Sandra E. Black , Benjamin I. Goldstein , Krista L. Lanctôt , 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<sub>1,101</sub> = 6.094, <em>p</em> = 0.015 and F<sub>1,101</sub> = 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<sub>1,100</sub> = 12.137, <em>p</em> < 0.001), 5(6)-epoxyeicosatrienoic acid (5(6)-EpETrE; F<sub>1,100</sub> = 6.481, <em>p</em> = 0.012) and 11(12)-EpETrE (F<sub>1,100</sub> = 4.409, <em>p</em> = 0.038), and 2) verbal memory, including 9(10)-EpOME (F<sub>1,100</sub> = 4.286, <em>p</em> = 0.041), 5(6)-EpETrE (F<sub>1,100</sub> = 6.845, <em>p</em> = 0.010), 11(12)-EpETrE (F<sub>1,100</sub> = 3.981, <em>p</em> = 0.049) and 14(15)-EpETrE (F<sub>1,100</sub> = 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}
Pub Date : 2024-07-16DOI: 10.1016/j.jdiacomp.2024.108810
Jerry K. Benites-Meza , Jussara Malo-Castillo , Percy Herrera-Añazco , Vicente A. Benites-Zapata
Aim
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.
Methods
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.
Results
A TyG index of >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 >4.69 [RR: 1.38 (0.94–2.03)] and a TG/HDL-C ratio > 3.57 [RR: 1.35 (0.89–2.06)] did not show associations with risk of amputation after 1-year.
Conclusions
Only a TyG index of >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.
{"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 , Jussara Malo-Castillo , Percy Herrera-Añazco , 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 >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 >4.69 [RR: 1.38 (0.94–2.03)] and a TG/HDL-C ratio > 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 >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}
Pub Date : 2024-07-15DOI: 10.1016/j.jdiacomp.2024.108814
Jordan Tasman , Devin J. Clegg , Colten Carver , Saahit Adabala , Michael R. Buckley , Mitchell H. Goldman , Patricia N.E. Roberson
Objective
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.
Methods
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 >18 years old, with type II diabetes mellitus, and diabetic foot ulcer were included.
Results
ANCOVA analyses showed rural patients had significantly higher WIfI composite scores (F(1,451) = 9.61, p = .002), grades of wound (F(1,439) = 11.03, p = .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, p = .037) than patients who lived in transitional economic counties, and higher foot infection grading (F(2,440) = 3.02, p = .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, p = .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, p = .02) and grade 0 ischemia (χ2(3) = 16.18, p = .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, p = .008).
Conclusions
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.
{"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 , Devin J. Clegg , Colten Carver , Saahit Adabala , Michael R. Buckley , Mitchell H. Goldman , 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 >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 , Paschalis Karakasis , Mohamed El-Tanani , 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}
Pub Date : 2024-07-15DOI: 10.1016/j.jdiacomp.2024.108811
Emily Gianatti , Wendy A. Davis , Timothy M.E. Davis
Background
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.
Methods
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.
Results
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 HbA1c levels, and were more dyslipidemic (P ≤ 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 (P ≥ 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 (P ≤ 0.023); GDM status did not add to the most parsimonious model (P = 0.62).
Conclusions
Prior GDM does not increase CVD risk or all-cause mortality in women with type 2 diabetes.
{"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 , Wendy A. Davis , 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<sub>1c</sub> 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}
Pub Date : 2024-07-14DOI: 10.1016/j.jdiacomp.2024.108809
Kyong Hye Joung , Tae Nyun Kim , Eu Jeong Ku , Seong Su Lee , Won Sang Yoo , Kang Seo Park , Su Kyoung Kwon , Bon Jeong Ku
Aims
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.
Methods
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.
Results
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.
Conclusions
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.
Trial registration
ClinicalTrials.gov, NCT05624853.
目的本研究旨在证明缓释(SR)普瑞巴林在减轻糖尿病周围神经病理性(DPN)疼痛以及患者满意度和依从性方面不劣于速释(IR)普瑞巴林。符合条件的受试者已服用红外普瑞巴林 4 周,按照 1:1 的比例随机分配,要么继续服用每日两次的红外普瑞巴林(75 毫克),要么改用每日一次的 SR 普瑞巴林(150 毫克)。主要疗效终点是SR组和IR普瑞巴林组治疗8周后视觉模拟量表(VAS)评分与基线相比的变化。VAS疼痛评分变化的最小二乘法(LS)均值分别为-17.95(SR普瑞巴林)和-18.74(IR普瑞巴林),两组间的LS均值差为0.79,95%置信区间的上限[-5.99, 7.58]低于9.2毫米的预设非劣效边距。结论本研究表明,每日一次的SR普瑞巴林新制剂在缓解DPN疼痛方面与每日两次的IR普瑞巴林没有差异,这表明它有可能成为一种治疗DPN疼痛的有前途的药物,且安全性相当。试验注册ClinicalTrials.gov,NCT05624853。
{"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 , Tae Nyun Kim , Eu Jeong Ku , Seong Su Lee , Won Sang Yoo , Kang Seo Park , Su Kyoung Kwon , 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}
Pub Date : 2024-07-14DOI: 10.1016/j.jdiacomp.2024.108815
Namitha Mary Varghese , Jithin Sam Varghese
Aims
To characterize the risk of falls among males and females by joint glycemic, blood pressure (BP) and cholesterol control among older adults (≥65 years) with diagnosed diabetes in USA.
Methods
Using longitudinal data from the Health and Retirement Study (2006–2019), we studied the association of joint glycemic (HbA1c < 7.5 %), BP (systolic <140 and diastolic <90 mmHg) and cholesterol (total < 200 mg/dL) control with two-year risk of falls. We estimated risk ratios (RR) to describe the associations for joint ABC control and independent biomarker control by sex, using modified Poisson regressions after adjusting for known individual and household risk factors.
Results
The analytic sample consisted of 4509 observations from 2829 older adults (54.7 % female) with a mean age of 72.2 (SD: 6.6) years and duration of diabetes of 9.9 years. Joint ABC control was not associated with risk of falls among females but was associated with lower risk among males (0.91 [95%CI: 0.81–1.02]). Furthermore, achievement of glycemic control (0.85 [95%CI: 0.73–0.98]) and BP control (0.89 [95%CI: 0.79–1.01]) were associated with lower risk but cholesterol control (1.15 [95%CI: 0.99, 1.34]) was associated with higher risk of falls among males.
Conclusions
Joint achievement of glycemic, BP and cholesterol targets may prevent falls among older males. Future studies among people with diabetes should consider biomarker control as a preventive factor for falls.
{"title":"Sex differences in association of joint glycemic, blood pressure and lipid control and two-year risk of falls among older adults with diabetes","authors":"Namitha Mary Varghese , Jithin Sam Varghese","doi":"10.1016/j.jdiacomp.2024.108815","DOIUrl":"10.1016/j.jdiacomp.2024.108815","url":null,"abstract":"<div><h3>Aims</h3><p>To characterize the risk of falls among males and females by joint glycemic, blood pressure (BP) and cholesterol control among older adults (≥65 years) with diagnosed diabetes in USA.</p></div><div><h3>Methods</h3><p>Using longitudinal data from the Health and Retirement Study (2006–2019), we studied the association of joint glycemic (HbA1c < 7.5 %), BP (systolic <140 and diastolic <90 mmHg) and cholesterol (total < 200 mg/dL) control with two-year risk of falls. We estimated risk ratios (RR) to describe the associations for joint ABC control and independent biomarker control by sex, using modified Poisson regressions after adjusting for known individual and household risk factors.</p></div><div><h3>Results</h3><p>The analytic sample consisted of 4509 observations from 2829 older adults (54.7 % female) with a mean age of 72.2 (SD: 6.6) years and duration of diabetes of 9.9 years. Joint ABC control was not associated with risk of falls among females but was associated with lower risk among males (0.91 [95%CI: 0.81–1.02]). Furthermore, achievement of glycemic control (0.85 [95%CI: 0.73–0.98]) and BP control (0.89 [95%CI: 0.79–1.01]) were associated with lower risk but cholesterol control (1.15 [95%CI: 0.99, 1.34]) was associated with higher risk of falls among males.</p></div><div><h3>Conclusions</h3><p>Joint achievement of glycemic, BP and cholesterol targets may prevent falls among older males. Future studies among people with diabetes should consider biomarker control as a preventive factor for falls.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 8","pages":"Article 108815"},"PeriodicalIF":2.9,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141639238","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}
Pub Date : 2024-07-14DOI: 10.1016/j.jdiacomp.2024.108808
Alexander Phu , Mark Banghart , Mozhdeh Bahrainian , T.Y. Alvin Liu , Risa M. Wolf , Roomasa Channa
Aims
There are limited studies on dipeptidyl-peptidase 4 inhibitor (DPP-4i), sodium glucose cotransporter 2 inhibitor (SGLT2-i), and glucagon-like peptide 1 (GLP-1) receptor agonist use and occurrence of diabetic macular edema (DME). The objective of this study was to determine the association between DPP-4i, SGLT2-i, and GLP-1 receptor agonist use and occurrence of DME.
Methods
Proportional hazard models were used to evaluate the change in hazard of developing DME associated with DPP-4i, SGLT2-i, or GLP-1 receptor agonist use. Models accounted for age at DR diagnosis, DR severity (proliferative vs non-proliferative stage), time-weighted average of HbA1c level, sex, and self-reported race/ethnicity. A p-value ≤ 0.05 was considered statistically significant.
Results
The hazard ratio of developing DME after diagnosis of DR was 1.2 (CI = 0.75 to 1.99; p = 0.43) for DPP-4i use, 0.93 (CI = 0.54 to 1.61; p = 0.81) for GLP-1 receptor agonist use, 0.82 (CI = 0.20 to 3.34; p = 0.78) for SGLT2-i use, 1.1 (CI = 0.75 to 1.59; p = 0.66) for any one medication use, 1.1 (CI = 0.62 to 2.09; p = 0.68) and for any two or more medications use.
Conclusions
We did not find an association between DPP-4i, SGLT2-i, or GLP-1 receptor agonist use and increased hazard of development of DME among patients with DR.
{"title":"Dipeptidyl peptidase 4 inhibitors, sodium glucose cotransporter 2 inhibitors, and glucagon-like peptide 1 receptor agonists do not worsen diabetic macular edema","authors":"Alexander Phu , Mark Banghart , Mozhdeh Bahrainian , T.Y. Alvin Liu , Risa M. Wolf , Roomasa Channa","doi":"10.1016/j.jdiacomp.2024.108808","DOIUrl":"10.1016/j.jdiacomp.2024.108808","url":null,"abstract":"<div><h3>Aims</h3><p>There are limited studies on dipeptidyl-peptidase 4 inhibitor (DPP-4i), sodium glucose cotransporter 2 inhibitor (SGLT2-i), and glucagon-like peptide 1 (GLP-1) receptor agonist use and occurrence of diabetic macular edema (DME). The objective of this study was to determine the association between DPP-4i, SGLT2-i, and GLP-1 receptor agonist use and occurrence of DME.</p></div><div><h3>Methods</h3><p>Proportional hazard models were used to evaluate the change in hazard of developing DME associated with DPP-4i, SGLT2-i, or GLP-1 receptor agonist use. Models accounted for age at DR diagnosis, DR severity (proliferative vs non-proliferative stage), time-weighted average of HbA1c level, sex, and self-reported race/ethnicity. A <em>p</em>-value ≤ 0.05 was considered statistically significant.</p></div><div><h3>Results</h3><p>The hazard ratio of developing DME after diagnosis of DR was 1.2 (CI = 0.75 to 1.99; <em>p</em> = 0.43) for DPP-4i use, 0.93 (CI = 0.54 to 1.61; <em>p</em> = 0.81) for GLP-1 receptor agonist use, 0.82 (CI = 0.20 to 3.34; <em>p</em> = 0.78) for SGLT2-i use, 1.1 (CI = 0.75 to 1.59; <em>p</em> = 0.66) for any one medication use, 1.1 (CI = 0.62 to 2.09; <em>p</em> = 0.68) and for any two or more medications use.</p></div><div><h3>Conclusions</h3><p>We did not find an association between DPP-4i, SGLT2-i, or GLP-1 receptor agonist use and increased hazard of development of DME among patients with DR.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 8","pages":"Article 108808"},"PeriodicalIF":2.9,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141630157","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}
Pub Date : 2024-07-14DOI: 10.1016/j.jdiacomp.2024.108813
Zhaonan Wang , Francesca L. Crowe , Abd A. Tahrani , Pushpa Singh , Jingya Wang , Luyuan Tan , Krishnarajah Nirantharakumar , Jonathan Hazlehurst
Background
Bariatric surgery leads to considerable weight loss and improved glycaemic control and seems to have a favourable impact on diabetes related foot complications (DFC).
Objectives
To assess the effect of bariatric surgery on diabetes related foot complications in patients with type 2 diabetes and determine whether DFC symptoms are improved after bariatric surgery.
Methods
We searched MEDLINE, Embase and Cochrane Central Register of Controlled Trials. The primary outcome was the presence of DFC after bariatric surgery. The secondary outcome was the improvement of DFC after bariatric surgery among patients who already had DFC before surgery.
Results
There were nine studies showing the presence of DFC post bariatric surgery and six detailing the changes in DFC post bariatric surgery. Bariatric surgery was not associated with a lower risk of developing or worsening DFC compared to conventional medical treatment based on 4 randomised control trials (IR 0.87, 95 % CI, 0.26, 2.98), while from observational studies was associated with 51 % lower risk of DFC (IR 0.49, 95 % CI, 0.31, 0.77). Bariatric surgery was associated with improvement in diabetic neuropathy assessment parameters including toe tuning fork score, self-reported neuropathy symptoms, neuropathy symptom score, and neuropathy symptom profile.
Conclusion
Bariatric surgery led to a greater reduction in developing or worsening DFC among patients with type 2 diabetes compared to medical treatment in observational studies, but not among RCTs. Bariatric surgery was associated with improvements in diabetic neuropathy related assessment parameters and symptoms. Bariatric surgery could be a promising treatment for patients with type 2 diabetes who are at high risk of DFC.
{"title":"The effect of bariatric surgery on diabetes related foot complications among patients with type 2 diabetes: A systematic review","authors":"Zhaonan Wang , Francesca L. Crowe , Abd A. Tahrani , Pushpa Singh , Jingya Wang , Luyuan Tan , Krishnarajah Nirantharakumar , Jonathan Hazlehurst","doi":"10.1016/j.jdiacomp.2024.108813","DOIUrl":"10.1016/j.jdiacomp.2024.108813","url":null,"abstract":"<div><h3>Background</h3><p>Bariatric surgery leads to considerable weight loss and improved glycaemic control and seems to have a favourable impact on diabetes related foot complications (DFC).</p></div><div><h3>Objectives</h3><p>To assess the effect of bariatric surgery on diabetes related foot complications in patients with type 2 diabetes and determine whether DFC symptoms are improved after bariatric surgery.</p></div><div><h3>Methods</h3><p>We searched MEDLINE, Embase and Cochrane Central Register of Controlled Trials. The primary outcome was the presence of DFC after bariatric surgery. The secondary outcome was the improvement of DFC after bariatric surgery among patients who already had DFC before surgery.</p></div><div><h3>Results</h3><p>There were nine studies showing the presence of DFC post bariatric surgery and six detailing the changes in DFC post bariatric surgery. Bariatric surgery was not associated with a lower risk of developing or worsening DFC compared to conventional medical treatment based on 4 randomised control trials (IR 0.87, 95 % CI, 0.26, 2.98), while from observational studies was associated with 51 % lower risk of DFC (IR 0.49, 95 % CI, 0.31, 0.77). Bariatric surgery was associated with improvement in diabetic neuropathy assessment parameters including toe tuning fork score, self-reported neuropathy symptoms, neuropathy symptom score, and neuropathy symptom profile.</p></div><div><h3>Conclusion</h3><p>Bariatric surgery led to a greater reduction in developing or worsening DFC among patients with type 2 diabetes compared to medical treatment in observational studies, but not among RCTs. Bariatric surgery was associated with improvements in diabetic neuropathy related assessment parameters and symptoms. Bariatric surgery could be a promising treatment for patients with type 2 diabetes who are at high risk of DFC.</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 9","pages":"Article 108813"},"PeriodicalIF":2.9,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141691949","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}
Pub Date : 2024-07-08DOI: 10.1016/j.jdiacomp.2024.108804
Mengya Liao , Xin Wang
Background
Type 2 diabetes mellitus (T2DM) is a common metabolic disease characterized by insulin resistance and insufficient relative insulin secretion, leading to elevated blood sugar and the development of diabetic complications. T2DM not only seriously affects people's health and quality of life, but also brings a heavy burden to society and economy. At present, the treatment of T2DM mainly relies on drug therapy, but these drugs often have problems such as side effects, resistance and high cost, and can not fully meet the needs and expectations of patients. Therefore, it is of great significance and value to find safe and effective natural medicines or functional foods to assist the treatment and prevention of T2DM.
Objective
Chinese jujube are a common fruit that contain abundant polyphenolic compounds, which exhibit multiple physiological activities, such as antioxidation, anti-inflammation, and blood glucose lowering. The objective of this study was to explore the impact of red date polyphenols on glycemic control and oxidative stress status in patients with type 2 diabetes mellitus (T2DM).
{"title":"Ameliorating effect of Chinese jujube polyphenol on blood glucose oxidative stress in type 2 diabetic rats","authors":"Mengya Liao , Xin Wang","doi":"10.1016/j.jdiacomp.2024.108804","DOIUrl":"10.1016/j.jdiacomp.2024.108804","url":null,"abstract":"<div><h3>Background</h3><p>Type 2 diabetes mellitus (T2DM) is a common metabolic disease characterized by insulin resistance and insufficient relative insulin secretion, leading to elevated blood sugar and the development of diabetic complications. T2DM not only seriously affects people's health and quality of life, but also brings a heavy burden to society and economy. At present, the treatment of T2DM mainly relies on drug therapy, but these drugs often have problems such as side effects, resistance and high cost, and can not fully meet the needs and expectations of patients. Therefore, it is of great significance and value to find safe and effective natural medicines or functional foods to assist the treatment and prevention of T2DM.</p></div><div><h3>Objective</h3><p>Chinese jujube are a common fruit that contain abundant polyphenolic compounds, which exhibit multiple physiological activities, such as antioxidation, anti-inflammation, and blood glucose lowering. The objective of this study was to explore the impact of red date polyphenols on glycemic control and oxidative stress status in patients with type 2 diabetes mellitus (T2DM).</p></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 9","pages":"Article 108804"},"PeriodicalIF":2.9,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141689118","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}