Journal of Diabetes Investigation最新文献

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Two decades of diabetes prevention: Sustained benefits, heterogeneous effects, and implications for precision prevention 二十年的糖尿病预防:持续的益处,异质性的影响,以及对精确预防的影响。
IF 3 3区 医学
Journal of Diabetes Investigation Pub Date : 2025-09-02 DOI: 10.1111/jdi.70150
Seung-Hwan Lee
{"title":"Two decades of diabetes prevention: Sustained benefits, heterogeneous effects, and implications for precision prevention","authors":"Seung-Hwan Lee","doi":"10.1111/jdi.70150","DOIUrl":"10.1111/jdi.70150","url":null,"abstract":"<p>The global burden of type 2 diabetes continues to rise, driven by population aging, urbanization, and the increasing prevalence of obesity and sedentary lifestyles. In Asia, including Japan, Korea, and China, the rapid pace of change in dietary and physical activity patterns has created a parallel surge in diabetes prevalence, making prevention an urgent priority<span><sup>1</sup></span>. Despite significant progress in glucose-lowering therapies, the most cost-effective and sustainable approach remains preventing diabetes before it develops. Few studies have shaped this field more profoundly than the Diabetes Prevention Program (DPP) and its long-term follow-up, the Diabetes Prevention Program Outcomes Study (DPPOS). The DPP, published in 2002, demonstrated that intensive lifestyle intervention reduced the incidence of type 2 diabetes by 58% and metformin by 31% over 3 years compared with placebo<span><sup>2</sup></span>. These results established lifestyle modification as the gold standard for diabetes prevention and validated metformin as an adjunct option in selected individuals. These findings became the cornerstone of diabetes prevention strategies worldwide. Yet a critical question has remained: Are the benefits of these interventions durable over the long term?</p><p>In their recent publication in <i>The Lancet Diabetes & Endocrinology</i>, Knowler <i>et al</i>.<span><sup>3</sup></span> provide a long-term perspective of the DPP cohort, with follow-up extending approximately 21 years. Compared with placebo, diabetes incidence rate was reduced by 24% in the intensive lifestyle intervention group and by 17% in the metformin group, with a corresponding delay in diabetes onset by a median of 3.5 and 2.5 years (Table 1). Both interventions reduced cumulative diabetes incidence, although the absolute risk differences narrowed over time. The critical insight is that most of the benefit accrued during the first 3 years of the trial, when intervention intensity and adherence were highest. The curves diverged early and remained separated, demonstrating a “legacy effect” that persisted for two decades. This long-term durability reinforces a central principle of prevention that early and intensive interventions leave a lasting imprint on disease trajectories. Similar patterns were observed in the Da Qing study in China, where modest lifestyle changes implemented over 6 years translated into lower rates of diabetes and cardiovascular events over 30 years<span><sup>4</sup></span>. In that trial, 577 adults with impaired glucose tolerance were randomized to diet, exercise, diet plus exercise, or control. After 6 years of intervention, diabetes incidence was significantly reduced in the lifestyle groups compared with control. Importantly, long-term follow-up over 30 years revealed not only a persistent reduction in diabetes risk but also meaningful clinical outcomes: a 26% lower incidence of cardiovascular disease, a 35% reduction in microvascular","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1779-1781"},"PeriodicalIF":3.0,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70150","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144937475","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}
引用次数: 0
Distinct patterns of hypogonadism in a cross-sectional study of Malaysian men with type 2 diabetes mellitus: The role of insulin resistance, visceral adiposity, and aging 在马来西亚2型糖尿病男性的横断面研究中,性腺功能减退的不同模式:胰岛素抵抗、内脏脂肪和衰老的作用。
IF 3 3区 医学
Journal of Diabetes Investigation Pub Date : 2025-08-08 DOI: 10.1111/jdi.70127
Waye-Hann Kang, Norlela Sukor, Nor Azmi Kamaruddin
{"title":"Distinct patterns of hypogonadism in a cross-sectional study of Malaysian men with type 2 diabetes mellitus: The role of insulin resistance, visceral adiposity, and aging","authors":"Waye-Hann Kang,&nbsp;Norlela Sukor,&nbsp;Nor Azmi Kamaruddin","doi":"10.1111/jdi.70127","DOIUrl":"10.1111/jdi.70127","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Hypogonadism is common among male patients living with type 2 diabetes mellitus and can be divided into hypergonadotropic hypogonadism (hyper-H) and hypogonadotropic hypogonadism (hypo-H). Hypo-H is strongly linked to insulin resistance and visceral adiposity, while hyper-H in type 2 diabetes mellitus males has not been extensively studied. We aimed to study factors associated with the two subtypes of hypogonadal type 2 diabetes mellitus males in Malaysia, where obesity and poorly controlled diabetes are highly prevalent.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Patients and Methods</h3>\u0000 \u0000 <p>We screened 360 type 2 diabetes mellitus males for hypogonadism (H), defined by total testosterone &lt;12 nmol/L, repeated calculated free testosterone &lt;0.255 nmol/L, and Aging Male Symptoms (AMS) scale &gt;26. Subjects were classified into hypogonadotropic hypogonadism (hypo-H) and hypergonadotropic hypogonadism (hyper-H) based on luteinizing hormone (LH) levels. We further analyzed their sociodemographic and clinical parameters in comparison to the control group of eugonadal males.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>55.6% of the 63 hypogonadal subjects have hypo-H. Significant differences in weight (<i>P =</i> 0.001), BMI (<i>P &lt;</i> 0.001), waist circumference (<i>P &lt;</i> 0.001), serum HDL-C (<i>P &lt;</i> 0.001), serum triglycerides (<i>P =</i> 0.001) and TyG index (<i>P &lt;</i> 0.001) were observed between hypo-H and eugonadal males. For hyper-H males, only age differed significantly from eugonadal males (<i>P</i> = 0.034).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Age is significantly associated with hyper-H, while insulin resistance and visceral adiposity are strongly linked to hypo-H. Older and obese Malaysian type 2 diabetes mellitus males, particularly those with coronary artery disease and lower HDL-C levels, are at a higher risk of developing hypogonadism. Diabetic treatments aimed at improving insulin resistance and reducing visceral adiposity could be highly effective for hypogonadal type 2 diabetes mellitus males in Malaysia.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1881-1889"},"PeriodicalIF":3.0,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70127","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144797748","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}
引用次数: 0
Letter to editor in response to “Clinical features of overt versus diagnosed pre-existing diabetes in pregnancy” 致编辑回应“妊娠期显性糖尿病与确诊糖尿病的临床特征”的信。
IF 3 3区 医学
Journal of Diabetes Investigation Pub Date : 2025-08-07 DOI: 10.1111/jdi.70136
Adnan Memon, Zareen Gull
{"title":"Letter to editor in response to “Clinical features of overt versus diagnosed pre-existing diabetes in pregnancy”","authors":"Adnan Memon,&nbsp;Zareen Gull","doi":"10.1111/jdi.70136","DOIUrl":"10.1111/jdi.70136","url":null,"abstract":"<p>Dear Editor,</p><p>I recently read with great interest the article by Fujikawa Shingu <i>et al</i>.<span><sup>1</sup></span> titled, “Clinical features of overt versus diagnosed pre-existing diabetes in pregnancy”. The study offers an interesting viewpoint on the comparison of clinical differences between overt and diagnosed pre-existing diabetes in pregnancy. The authors done an impressive job, but certain methodological elements of the study need further refinement to further strengthen the study's findings.</p><p>First, the authors relied on a very small sample size of the pre-existing diabetic group, comprising 61 women compared to 1,084 in the overt diabetes group. This small sample size may restrict statistical power and produce false-positive results. As Hackshaw mentioned in his article that small studies can provide results quickly, they typically do not deliver reliable or precise estimates<span><sup>2</sup></span>.</p><p>Second, in the overt group in pregnancy, there was an absence of pre-pregnancy glycemic control data, which could influence the interpretation of perinatal complication risks as mentioned by Wendland <i>et al</i>. in their study regarding the significance of glycemic control before and throughout pregnancy in mitigating risks such as perinatal complications and congenital anomalies. They noted that the WHO and the IADPSG criteria for gestational diabetes mellitus (GDM) have identified women at a slightly elevated risk for adverse pregnancy outcomes<span><sup>3</sup></span>.</p><p>Furthermore, no clinical or behavioral confounder data including diet, exercise, and patient's education are mentioned. These factors can significantly influence maternal glycemic control and perinatal outcomes, as mentioned by Xu <i>et al</i>.<span><sup>4</sup></span> in their article<span><sup>4</sup></span>. Without accounting these confounders, it is difficult to understand contributors to adverse pregnancy outcomes and to interpret the differences observed between the overt and pre-existing diabetes groups.</p><p>In conclusion, although the study offers important insights in the medical field, addressing the limitations such as small sample size, absence of pre-pregnancy glycemic data and lack of confounders could enhance the robustness of the findings. We appreciate the author's contribution to this significant topic.</p><p>None.</p><p>The authors declare no conflict of interest.</p><p>Approval of the research protocol: None.</p><p>Informed consent: None.</p><p>Registry and the registration no. of the study/trial: None.</p><p>Animal studies: None.</p>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70136","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793099","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}
引用次数: 0
The relationship between depressive symptoms and glycemic control is stronger in women with type 2 diabetes in South Asians: Results from a cross-sectional multicenter study 南亚女性2型糖尿病患者抑郁症状与血糖控制之间的关系更强:来自一项横断面多中心研究的结果
IF 3 3区 医学
Journal of Diabetes Investigation Pub Date : 2025-08-06 DOI: 10.1111/jdi.70134
Md Kamruzzaman, Jessica A. Marathe, Karen L. Jones, Matthew A. Borg, Michael Horowitz, Scott R. Clark, Chinmay S. Marathe
{"title":"The relationship between depressive symptoms and glycemic control is stronger in women with type 2 diabetes in South Asians: Results from a cross-sectional multicenter study","authors":"Md Kamruzzaman,&nbsp;Jessica A. Marathe,&nbsp;Karen L. Jones,&nbsp;Matthew A. Borg,&nbsp;Michael Horowitz,&nbsp;Scott R. Clark,&nbsp;Chinmay S. Marathe","doi":"10.1111/jdi.70134","DOIUrl":"10.1111/jdi.70134","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>While the bidirectional relationship between depression and diabetes is well recognized, the outcome of studies evaluating the potential for sex disparity, especially in low-to-middle-income (LMIC) South Asian countries, is unexplored. We evaluated sex differences in the relationship between depressive symptoms and glycemic control in individuals with type 2 diabetes in Bangladesh.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>1,485 unselected individuals with, and 228 without, type 2 diabetes completed the PHQ-9 (depression screening questionnaire), and sociodemographic and clinical data were obtained. The PHQ-9 scores were categorized as mild (5–10), moderate (10–15), moderately severe (15–20), and severe (≥20) depressive symptoms, with scores ≥10 indicating clinically relevant symptoms. Descriptive statistics and ordinal and binary logistic regression analyses were performed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In individuals with type 2 diabetes, mean HbA1c was 9.8 ± 0.1%, with no difference between sexes (9.9 ± 0.1% vs 9.7 ± 0.2%, <i>P</i> = 0.39). The overall mean PHQ-9 score was 8.5 ± 0.2, with females exhibiting higher scores (9.5 ± 0.2 vs 7.1 ± 0.2, <i>P</i> &lt; 0.001). Depressive symptoms correlated with older age, lower education level, longer diabetes duration (&gt;5 years: OR: 1.5, 95% CI: 1.1–2.3), suboptimal (HbA1c 7–9%: OR: 1.8, 95% CI: 1.1–3.2), and poorer glycemic control (HbA1c ≥9%: OR, 1.7; 95% CI, 1.1–2.9). Suboptimal (OR: 2.2, 95% CI: 1.1–4.3) or poor (OR: 2.5, 95% CI: 1.3–4.9) glycemic control and diabetes duration of 1–5 years (OR: 1.9, 95% CI: 1.2–3.0) and &gt;5 years (OR: 2.4, 95% CI: 1.5–3.9) were associated with an increased likelihood of mild-to-severe depressive symptoms in females, but not in males.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The association of depressive symptoms and poor glycemic control in type 2 diabetes in South Asians is stronger in females.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1950-1959"},"PeriodicalIF":3.0,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70134","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144787917","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}
引用次数: 0
TyG-BMI index as a valuable risk of acute kidney injury in patients with heart failure: Insights from the MIMIC-IV and eICU cohorts TyG-BMI指数作为心力衰竭患者急性肾损伤的有价值的风险:来自MIMIC-IV和eICU队列的见解
IF 3 3区 医学
Journal of Diabetes Investigation Pub Date : 2025-08-06 DOI: 10.1111/jdi.70133
Yiming Hua, Ze Chen, Lele Cheng, Ning Ding, Yifei Xie, Hao Wu, Huaizhi Jing, Yu Xu, Yue Wu, Beidi Lan
{"title":"TyG-BMI index as a valuable risk of acute kidney injury in patients with heart failure: Insights from the MIMIC-IV and eICU cohorts","authors":"Yiming Hua,&nbsp;Ze Chen,&nbsp;Lele Cheng,&nbsp;Ning Ding,&nbsp;Yifei Xie,&nbsp;Hao Wu,&nbsp;Huaizhi Jing,&nbsp;Yu Xu,&nbsp;Yue Wu,&nbsp;Beidi Lan","doi":"10.1111/jdi.70133","DOIUrl":"10.1111/jdi.70133","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The triglyceride glucose-body mass index (TyG-BMI) has emerged as a predictor of complications in patients with heart failure (HF). While elevated TyG-BMI levels have been linked to adverse outcomes in HF patients, their predictive value for acute kidney injury (AKI) risk remains unclear. This study aimed to examine the association between TyG-BMI and the incidence of AKI in patients with HF.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> METHODS</h3>\u0000 \u0000 <p>Data were obtained from the Medical Information Mart for Intensive Care-IV version 3.1 (MIMIC-IV v3.1) and the eICU Collaborative Research Database version 2.0 (eICU-CRD v2.0). The primary outcome was the occurrence of AKI, with secondary outcomes including the need for renal replacement therapy (RRT) and in-hospital mortality. Kaplan–Meier survival analysis, restricted cubic spline modeling, and Cox proportional hazards regression models were used to assess the associations between TyG-BMI and clinical outcomes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The study included 1,250 patients from MIMIC-IV and 2,300 patients from eICU-CRD. Patients with higher TyG-BMI levels had a significantly higher cumulative incidence of AKI and increased rates of RRT use and in-hospital mortality. After adjusting for potential confounders, higher TyG-BMI remained independently associated with an increased risk of AKI among HF patients in multivariable models.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This multicenter analysis demonstrates that higher TyG-BMI levels are associated with an increased risk of AKI, greater need for RRT, and higher in-hospital mortality in patients with HF. TyG-BMI may serve as a useful marker for early risk stratification and prognostic assessment in this population. Further prospective studies are needed to validate these findings.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1844-1858"},"PeriodicalIF":3.0,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70133","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144787918","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}
引用次数: 0
Alcohol consumption, alcohol-metabolizing enzyme genotypes, and glycemic control in type 2 diabetes: Sex-specific findings from the Fukuoka Diabetes Registry 2型糖尿病的酒精消耗、酒精代谢酶基因型和血糖控制:来自福冈糖尿病登记处的性别特异性发现
IF 3 3区 医学
Journal of Diabetes Investigation Pub Date : 2025-08-06 DOI: 10.1111/jdi.70122
Toshiaki Ohkuma, Masanori Iwase, Ayaka Oshiro, Taiki Higashi, Takanari Kitazono
{"title":"Alcohol consumption, alcohol-metabolizing enzyme genotypes, and glycemic control in type 2 diabetes: Sex-specific findings from the Fukuoka Diabetes Registry","authors":"Toshiaki Ohkuma,&nbsp;Masanori Iwase,&nbsp;Ayaka Oshiro,&nbsp;Taiki Higashi,&nbsp;Takanari Kitazono","doi":"10.1111/jdi.70122","DOIUrl":"10.1111/jdi.70122","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims/Introduction</h3>\u0000 \u0000 <p>The sex-specific association between alcohol consumption and glycemic level and whether the association differs by genetic susceptibility to alcohol is unclear. The present study aimed to examine the association of alcohol consumption and genetic variants in alcohol-metabolizing enzymes with glycemic level, as well as their sex differences, in East Asian individuals with type 2 diabetes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>In total, 4,923 Japanese individuals with type 2 diabetes were included. Participants were classified based on alcohol drinking status, alcohol consumption amount (&lt;20, 20–39, or ≥40 g/day), and ADH1B (rs1229984) and ALDH2 (rs671) genotype, and the associations with HbA<sub>1c</sub> levels were examined cross-sectionally.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In men, compared with never drinkers, an increase in the alcohol consumption amount was associated with a decrease in HbA<sub>1c</sub> levels (<i>P</i> for trend &lt;0.001). By contrast, in women, a mild-to-moderate consumption amount (&lt;20 g/day) was associated with decreased HbA<sub>1c</sub> levels, whereas ≥20 g/day consumption was associated with increased HbA<sub>1c</sub> levels, indicating a J-shaped relationship. Regarding the association with genetic variants in alcohol-metabolizing enzymes, HbA<sub>1c</sub> increased linearly with an increasing number of A alleles in ALDH2 (<i>P</i> for trend &lt;0.001). However, the HbA<sub>1c</sub> level did not show a significant trend across the ADH1B genotype. The association between alcohol consumption and HbA<sub>1c</sub> levels was not modified by genetic variants in ADH1B or ALDH2.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>These findings highlight the importance of a sex-specific approach to alcohol drinking habits in managing glycemic control for individuals with type 2 diabetes, irrespective of genetic predisposition to alcohol metabolism.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1941-1949"},"PeriodicalIF":3.0,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70122","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144787916","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}
引用次数: 0
Long-term safety and efficacy of imeglimin in Japanese individuals with type 2 diabetes and chronic kidney disease: A 52-week postmarketing clinical study (TWINKLE) 伊米明在日本2型糖尿病和慢性肾脏疾病患者中的长期安全性和有效性:一项52周的上市后临床研究(TWINKLE)
IF 3 3区 医学
Journal of Diabetes Investigation Pub Date : 2025-08-04 DOI: 10.1111/jdi.70135
Tetsuya Babazono, Takeshi Osonoi, Hideki Okamoto, Yukiko Onishi, Shinya Nakamoto, Masayuki Kashima, Daiji Kawanami, Eitaro Nakashima, Kei Watabe, Noriko Nunami, Katsuhiko Hagi
{"title":"Long-term safety and efficacy of imeglimin in Japanese individuals with type 2 diabetes and chronic kidney disease: A 52-week postmarketing clinical study (TWINKLE)","authors":"Tetsuya Babazono,&nbsp;Takeshi Osonoi,&nbsp;Hideki Okamoto,&nbsp;Yukiko Onishi,&nbsp;Shinya Nakamoto,&nbsp;Masayuki Kashima,&nbsp;Daiji Kawanami,&nbsp;Eitaro Nakashima,&nbsp;Kei Watabe,&nbsp;Noriko Nunami,&nbsp;Katsuhiko Hagi","doi":"10.1111/jdi.70135","DOIUrl":"10.1111/jdi.70135","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>To evaluate the long-term safety and efficacy of imeglimin in Japanese individuals with type 2 diabetes (T2D) and advanced chronic kidney disease (CKD).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>This open-label, single-arm, multicenter, phase 4 study (TWINKLE) enrolled individuals with T2D and estimated glomerular filtration rate (eGFR) &lt; 45 mL/min/1.73 m<sup>2</sup>, treated with ≤1 oral hypoglycemic agent. Participants received 500 mg of imeglimin twice daily if eGFR was 15 to &lt;45 mL/min/1.73 m<sup>2</sup> or 500 mg once daily if eGFR was &lt;15 mL/min/1.73 m<sup>2</sup>, as monotherapy or in combination with their existing hypoglycemic agent, for 52 weeks. Dose adjustments were permitted based on safety and eGFR.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among 60 participants (CKD stages: G3b: <i>n</i> = 42; G4: <i>n</i> = 16; G5: <i>n</i> = 2), adverse events (AEs) occurred in 41 participants (68.3%), with no increased incidence across CKD stages. The most common AE was diarrhea (<i>n</i> = 6, 10.0%). Baseline mean (SD) HbA1c, glycated albumin (GA), and fasting plasma glucose (FPG) levels were 7.59% (0.68%), 22.53% (3.27%), and 151.8 (28.86) mg/dL, respectively. At week 24, mean (SD) changes from baseline were −0.53% (0.51%) for HbA1c, −2.37% (2.08%) for GA, and −13.6 (20.87) mg/dL for FPG. At week 52 (last observation carried forward [LOCF]), mean changes were −0.26% (0.88%), −1.59% (3.04%), and −7.0 (31.17) mg/dL. The proportion achieving HbA1c &lt; 7.0% increased from 13.3% at baseline to 50.0% at week 52 (LOCF).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study confirmed the favorable safety profile and sustained glycemic efficacy of imeglimin in Japanese individuals with T2D and CKD stages G3b–5, supporting its use with dose adjustment in this population.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1808-1819"},"PeriodicalIF":3.0,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70135","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144774387","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}
引用次数: 0
Research on the characteristics of gut microbiota in overweight patients with early-onset type 2 diabetes mellitus 超重合并早发型2型糖尿病患者肠道菌群特征的研究
IF 3 3区 医学
Journal of Diabetes Investigation Pub Date : 2025-08-04 DOI: 10.1111/jdi.70074
Ke Huang, Leilei Ma, Shousen Shi, Xi Wang, Sheng Jiang, Yanfang Zhang
{"title":"Research on the characteristics of gut microbiota in overweight patients with early-onset type 2 diabetes mellitus","authors":"Ke Huang,&nbsp;Leilei Ma,&nbsp;Shousen Shi,&nbsp;Xi Wang,&nbsp;Sheng Jiang,&nbsp;Yanfang Zhang","doi":"10.1111/jdi.70074","DOIUrl":"10.1111/jdi.70074","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Background&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Early-onset type 2 diabetes mellitus (EOD), defined as a metabolic disorder diagnosed before the age of 40, with higher risks of complications, vascular events, and mortality, poses a significant threat to public health. Its prevalence has risen markedly in overweight populations in recent years, yet the underlying mechanisms remain elusive. Emerging evidence highlights a close association between gut microbiota (GM) and metabolic disorders, suggesting that modulating gut microbial dysbiosis may serve as a potential strategy for preventing and managing overweight EOD.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;In this study, we enrolled 30 overweight EOD patients and 30 healthy controls, analyzing their GM profiles and correlations using physicochemical clinical parameters and fecal metabolites.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;The results demonstrated significant differences in GM composition between overweight EOD patients and healthy controls. EOD patients exhibited increased the ratio of &lt;i&gt;Firmicutes&lt;/i&gt;/&lt;i&gt;Bacteroidetes&lt;/i&gt; at the phylum level. At the genus level, &lt;i&gt;Bilophila&lt;/i&gt;, &lt;i&gt;Serratia&lt;/i&gt;, &lt;i&gt;Lachnospira&lt;/i&gt;, and &lt;i&gt;Parabacteroides&lt;/i&gt; were enriched in EOD patients, while taxa, such as &lt;i&gt;Faecalibacterium&lt;/i&gt;, &lt;i&gt;Ruminococcaceae&lt;/i&gt;, and &lt;i&gt;Clostridia_UCG-014&lt;/i&gt;, showed significant depletion. Correlation analyses revealed that &lt;i&gt;Clostridia_UCG-014&lt;/i&gt; abundance was negatively associated with body mass index (BMI) (&lt;i&gt;P&lt;/i&gt; &lt; 0.05), waist-to-height ratio (WHtR) (&lt;i&gt;P&lt;/i&gt; &lt; 0.05), fasting plasma glucose (FPG) (&lt;i&gt;P&lt;/i&gt; &lt; 0.05), low-density lipoprotein cholesterol (LDL-C) (&lt;i&gt;P&lt;/i&gt; &lt; 0.05), and triglycerides (TG) (&lt;i&gt;P&lt;/i&gt; &lt; 0.05), but positively correlated with high-density lipoprotein cholesterol (HDL-C) (&lt;i&gt;P&lt;/i&gt; &lt; 0.05). Conversely, &lt;i&gt;Bilophila&lt;/i&gt; abundance displayed positive correlations with BMI (&lt;i&gt;P&lt;/i&gt; &lt; 0.05), WHtR (&lt;i&gt;P&lt;/i&gt; &lt; 0.05), FPG (&lt;i&gt;P&lt;/i&gt; &lt; 0.05), LDL-C (&lt;i&gt;P&lt;/i&gt; &lt; 0.05), and TG (&lt;i&gt;P&lt;/i&gt; &lt; 0.05). Meanwhile, biofilm formation (&lt;i&gt;Escherichia coli&lt;/i&gt;), nitrogen metabolism, arginine and proline metabolism, beta-lactam resistance, drug metabolism (other enzymes), glycerolipid metabolism and sucrose metabolism showed decreases in overweight EOD patients, respectively (&lt;i&gt;P&lt;/i&gt; &lt; 0.05).&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Conclusions&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;These results indicate that &lt;i&gt;Bilophila&lt;/i&gt; and &lt;i&gt;Clostridia_UCG-014&lt;/i&gt; may serve as microbial biomarkers for the identification of obesity-related EOD.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 ","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1890-1899"},"PeriodicalIF":3.0,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70074","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144783109","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}
引用次数: 0
Endothelial Activation Stress Index predicts all-cause and cardiovascular mortality in patients with diabetes: A nationwide study 内皮活化应激指数预测糖尿病患者的全因死亡率和心血管死亡率:一项全国性研究。
IF 3 3区 医学
Journal of Diabetes Investigation Pub Date : 2025-07-30 DOI: 10.1111/jdi.70130
Gaiying Dong, Tingting Wu, Xiaofan Gu, Yuyi Feng, Liangliang Wu, Zhiwen Hu
{"title":"Endothelial Activation Stress Index predicts all-cause and cardiovascular mortality in patients with diabetes: A nationwide study","authors":"Gaiying Dong,&nbsp;Tingting Wu,&nbsp;Xiaofan Gu,&nbsp;Yuyi Feng,&nbsp;Liangliang Wu,&nbsp;Zhiwen Hu","doi":"10.1111/jdi.70130","DOIUrl":"10.1111/jdi.70130","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Evidence suggests that the Endothelial Activation and Stress Index (EASIX) predicts mortality in endothelium-related conditions, but its link to mortality risk in diabetes remains unclear. This study investigates the association between EASIX and mortality risk in diabetes patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We included 3,252 diabetes patients from seven National Health and Nutrition Examination Survey cycles (2003–2016). Mortality data were sourced from National Death Index records. Restricted cubic spline (RCS) regression assessed the EASIX-mortality risk relationship, while the maximally selected rank statistics method (MSRSM) identified the optimal EASIX cutoff for survival outcomes. Weighted multivariable Cox regression models evaluated the association of EASIX with all-cause and cardiovascular mortality.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Over a median follow-up of 91 months, 895 (27.5%) of 3,252 diabetes patients died, including 260 (8.0%) from cardiovascular and 635 (19.5%) from noncardiovascular causes. RCS analysis showed a positive association between EASIX and both all-cause and cardiovascular mortality. Each one-unit EASIX increase raised all-cause and cardiovascular mortality risks by 27% and 24%, respectively. MSRSM classified patients into higher (&gt;0.70) and lower (≤0.70) EASIX groups. Those with higher EASIX had a significantly greater risk of all-cause (HR 1.56, 95% CI 1.21–2.01) and cardiovascular mortality (HR 2.05, 95% CI 1.33–3.16). Time-dependent receiver operating characteristic analysis showed AUCs for 1-, 3-, 5-, and 10-year survival were 0.78, 0.72, 0.70, and 0.69 (all-cause) and 0.90, 0.81, 0.76, and 0.73 (cardiovascular).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Elevated EASIX is independently associated with increased all-cause and cardiovascular mortality in diabetes patients, highlighting its potential as a valuable clinical biomarker.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1870-1880"},"PeriodicalIF":3.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70130","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144740751","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}
引用次数: 0
A clinical model for highly accurate prediction of blood glucose depression after continuous intravenous insulin therapy in hyperglycemic emergencies, a multicenter retrospective cohort study 一项多中心回顾性队列研究,高度准确预测高血糖急诊患者持续静脉注射胰岛素治疗后血糖下降的临床模型。
IF 3 3区 医学
Journal of Diabetes Investigation Pub Date : 2025-07-28 DOI: 10.1111/jdi.70109
Yuichiro Iwamoto, Tomohiko Kimura, Masashi Shimoda, Yuichi Morimoto, Kazunori Dan, Hideyuki Iwamoto, Junpei Sanada, Yoshiro Fushimi, Yukino Katakura, Hayato Isobe, Fuminori Tatsumi, Yukiko Kimura, Fumiko Kawasaki, Mizuho Yamabe, Michihiro Matsuki, Shuhei Nakanishi, Tomoatsu Mune, Kohei Kaku, Hideaki Kaneto
{"title":"A clinical model for highly accurate prediction of blood glucose depression after continuous intravenous insulin therapy in hyperglycemic emergencies, a multicenter retrospective cohort study","authors":"Yuichiro Iwamoto,&nbsp;Tomohiko Kimura,&nbsp;Masashi Shimoda,&nbsp;Yuichi Morimoto,&nbsp;Kazunori Dan,&nbsp;Hideyuki Iwamoto,&nbsp;Junpei Sanada,&nbsp;Yoshiro Fushimi,&nbsp;Yukino Katakura,&nbsp;Hayato Isobe,&nbsp;Fuminori Tatsumi,&nbsp;Yukiko Kimura,&nbsp;Fumiko Kawasaki,&nbsp;Mizuho Yamabe,&nbsp;Michihiro Matsuki,&nbsp;Shuhei Nakanishi,&nbsp;Tomoatsu Mune,&nbsp;Kohei Kaku,&nbsp;Hideaki Kaneto","doi":"10.1111/jdi.70109","DOIUrl":"10.1111/jdi.70109","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Hyperglycemic emergencies are broadly classified into diabetic ketoacidosis and hyperosmotic hyperglycemic state. The purpose of this study was to develop a clinical model for predicting treatment of hyperglycemic emergencies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This study is a multicenter, retrospective cohort study. We used information on patients admitted to four medical institutions for treatment for hyperglycemic emergencies by diabetologists between April 1, 2010, and March 31, 2024, as the machine learning's training data. Multiple regression analysis was performed to find parameters that correlated with the difference between blood glucose levels before and after treatment initiation (ΔGlu), and a gradient boosting decision tree (GBDT) was created to predict ΔGlu.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Patients with type 1 diabetes (<i>n</i> = 47) and type 2 diabetes (<i>n</i> = 116) were included in the analysis of this study. We created a GBDT model using the following parameters as features: blood glucose level at the start of continuous intravenous insulin therapy, bicarbonate concentration, insulin flow rate, time elapsed since the start of continuous insulin therapy, and drip flow, which are important parameters for continuous intravenous insulin therapy for hyperglycemic emergencies. As a result, the correlation coefficient between predicted ΔGlu and actual ΔGlu was 0.83, showing a strong positive correlation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>A GBDT model was developed to predict treatment after continuous intravenous insulin therapy using several variables during emergency care of patients with hyperglycemic emergencies. It is hoped that the application of this GBDT will allow appropriate provision of initial treatment, especially in nonspecialized medical facilities.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1820-1828"},"PeriodicalIF":3.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70109","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726248","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}
引用次数: 0
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