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Effectiveness of the presence of diabetologists for perioperative complications in patients with diabetes undergoing colorectal cancer surgery: A nationwide inpatient database in Japan 糖尿病专家参与治疗结直肠癌手术患者围手术期并发症的有效性:日本全国住院患者数据库
IF 3 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-08-18 DOI: 10.1111/jdi.70139
Masataka Shikata, Atsushi Goto, Sayuri Shimizu, Nozomu Kamei, Daisuke Chujo, Itaru Endo, Akira Shimada, Kiyohide Fushimi, Kohjiro Ueki, Kazuyuki Tobe

Aims/Introduction

Little is known about the effect of diabetologists on perioperative complication risk. Given that colorectal cancer surgery is known to carry a high complication risk among patients with diabetes, this study aimed to examine the association between the presence of diabetologists at the facility level and the risk of perioperative complications during colorectal cancer surgery.

Materials and Methods

In this retrospective cohort study, we sourced the number of board-certified diabetologists from the Japan Diabetes Society and combined it with Diagnosis Procedure Combination (DPC) data, encompassing receipt data from acute care facilities across Japan. We used a modified Poisson model to estimate the risk of perioperative complications associated with the presence of diabetologists by adjusting for potential confounding patient and facility factors.

Results

Analysis included 887 facilities, of which 299 (34%) had no diabetologists. A total of 24,714 patients with diabetes underwent colorectal cancer surgery between April 2018 and March 2019, with a median age of 73 years (interquartile range: 67–79 years) and 16,274 (66%) men. There were 3,165 (13%) perioperative complications. After adjustment, the risk of perioperative complications was 0.86 times (95% confidence interval: 0.77–0.96) lower in centers with at least one diabetologist than in those without a diabetologist.

Conclusions

Our study suggests that the presence of a diabetologist may be important in reducing the risk of perioperative complications during colorectal cancer surgery in patients with diabetes. Future studies factoring in other facility factors and surgical types may be required to further validate our findings.

目的/简介:关于糖尿病专科医生对围手术期并发症风险的影响知之甚少。鉴于已知结直肠癌手术对糖尿病患者具有较高的并发症风险,本研究旨在研究设施水平的糖尿病医生的存在与结直肠癌手术围手术期并发症风险之间的关系。材料和方法:在这项回顾性队列研究中,我们从日本糖尿病学会获得了委员会认证的糖尿病学家的数量,并将其与诊断程序组合(DPC)数据相结合,包括来自日本各地急性护理机构的接收数据。我们使用一个改进的泊松模型,通过调整潜在的混淆患者和设施因素,来估计与糖尿病医生存在相关的围手术期并发症的风险。结果:分析纳入887家医院,其中299家(34%)没有糖尿病专家。2018年4月至2019年3月期间,共有24714名糖尿病患者接受了结直肠癌手术,中位年龄为73岁(四分位数范围:67-79岁),男性为16274名(66%)。围手术期并发症3165例(13%)。调整后,至少有一名糖尿病医生的中心围手术期并发症的风险比没有糖尿病医生的中心低0.86倍(95%可信区间:0.77-0.96)。结论:我们的研究表明,糖尿病医生的在场可能对降低糖尿病患者结直肠癌手术围手术期并发症的风险很重要。未来的研究可能需要考虑其他设施因素和手术类型来进一步验证我们的发现。
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引用次数: 0
Letter to the Editor in response to the article ‘Retrospective analysis of influences of sacubitril/valsartan in patients with diabetes with poorly controlled blood pressure in Japan’ 致编辑的信,回应文章“回顾性分析日本糖尿病患者血压控制不佳时服用苏比里尔/缬沙坦的影响”。
IF 3 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-08-15 DOI: 10.1111/jdi.70142
Daniyal Khalid, Muhammad Saim Siddiqui
<p>To the Editor,</p><p>We read with great interest the study by Kobayashi <i>et al</i>.<span><sup>1</sup></span>, which retrospectively compared the efficacy and safety of sacubitril/valsartan (SacVal) vs thiazide diuretics (THZ) in patients with type 2 diabetes and poorly controlled blood pressure. It is commendable that the authors tackled the difficult problem of maximizing antihypertensive treatment in patients with high-risk diabetes. Their application of multiple imputation and propensity score weighting offers a solid methodological foundation for comparing actual results. Notably, while both regimens achieved similar blood pressure control, SacVal showed better tolerability and more favorable effects on uric acid, HbA1c, and eGFR decline. The authors conclude that SacVal's superior side effect profile supports its clinical advantage, despite comparable BP outcomes.</p><p>However, several limitations may have skewed these findings. Most importantly, the timing of treatment initiation introduces potential time gap bias. The authors' note: ‘Most patients in the SacVal group started treatment during the coronavirus disease-19 (COVID-19) pandemic, whereas 60% of those in the THZ group started treatment beforehand.’ This temporal imbalance is critical, as the pandemic brought confounding factors such as altered lifestyle habits, reduced clinic access, and increased psychological stress—all of which could independently affect blood pressure, metabolic parameters, and treatment adherence. A large-scale analysis of global clinical trial activity reported a 76.8% decline in new patient screening rates from March to May 2020 compared to the same period in 2019, highlighting the disruptive impact of COVID-19 on trial conduct and patient engagement<span><sup>2</sup></span>. These external influences may have affected outcomes like HbA1c, uric acid, and eGFR, making it difficult to attribute observed differences solely to SacVal's pharmacological effects. Moreover, pandemic-era prescribing patterns and limited follow-up may have artificially improved SacVal's tolerability profile, complicating direct comparisons. The study also reports increased discontinuations in the THZ group post-pandemic but does not clarify whether these were due to drug intolerance or pandemic-related disruptions. This lack of transparency, combined with the exclusion of early SacVal dropouts—patients who discontinued treatment within the first 4 months—may have biased the tolerability findings in favor of SacVal.</p><p>To address these limitations, future analyses should consider time-stratified sensitivity models that adjust for calendar year of treatment initiation. This would help separate pharmacologic effects from pandemic-related confounders. Recent methodological advances have introduced multi-period sensitivity models that relax assumptions of sequential non-confounding, enabling more robust causal inference in longitudinal studies with time-varying treatments and cova
致编辑:我们怀着极大的兴趣阅读了Kobayashi等人1的研究,该研究回顾性比较了SacVal /缬沙坦(SacVal)与噻嗪类利尿剂(THZ)在2型糖尿病和血压控制不良患者中的疗效和安全性。值得赞扬的是,作者解决了高危糖尿病患者降压治疗最大化的难题。他们对多重归算和倾向得分加权的应用为比较实际结果提供了坚实的方法基础。值得注意的是,虽然两种方案的血压控制效果相似,但SacVal在尿酸、HbA1c和eGFR下降方面表现出更好的耐受性和更有利的效果。作者得出结论,SacVal的优越的副作用特征支持其临床优势,尽管有类似的BP预后。然而,一些限制可能会影响这些发现。最重要的是,治疗开始的时间引入了潜在的时间间隙偏差。作者指出:“SacVal组的大多数患者在冠状病毒病-19 (COVID-19)大流行期间开始治疗,而THZ组中60%的患者事先开始治疗。这种时间上的不平衡是至关重要的,因为大流行带来了一些混杂因素,如生活习惯的改变、就诊次数的减少和心理压力的增加——所有这些因素都可能独立影响血压、代谢参数和治疗依从性。一项对全球临床试验活动的大规模分析显示,2020年3月至5月,新患者筛查率与2019年同期相比下降了76.8%,凸显了COVID-19对试验进行和患者参与的破坏性影响2。这些外部影响可能会影响HbA1c、尿酸和eGFR等结果,因此很难将观察到的差异仅仅归因于SacVal的药理作用。此外,大流行时期的处方模式和有限的随访可能人为地改善了SacVal的耐受性,使直接比较复杂化。该研究还报告了大流行后THZ组停药的增加,但没有澄清这是由于药物不耐受还是与大流行相关的中断。缺乏透明度,再加上排除了SacVal早期退出治疗的患者(在前4个月内停止治疗的患者),可能会使耐受性研究结果偏向SacVal。为了解决这些局限性,未来的分析应考虑调整治疗开始日历年的时间分层敏感性模型。这将有助于将药物效应与大流行相关的混杂因素区分开来。最近的方法学进展引入了多周期敏感性模型,该模型放宽了顺序无混杂的假设,从而在具有时变处理和协变量的纵向研究中实现了更可靠的因果推断。此外,包括早期停药,特别是在SacVal组,将允许更准确的耐受性和不良事件评估,减少生存偏差,提高推广。作者声明无利益冲突。研究方案批准:无。知情同意:无。注册表及注册编号研究/试验:无。动物实验:没有。
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引用次数: 0
Non-linear relationship between liver fibrosis and femoral neck bone mineral density in metabolic dysfunction-associated fatty liver disease patients with type 2 diabetes mellitus 代谢功能障碍相关脂肪肝合并2型糖尿病患者肝纤维化与股骨颈骨密度的非线性关系
IF 3 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-08-13 DOI: 10.1111/jdi.70129
Jie Tao, Lin Wang, Honggang Wang, Juan Tan

Aim

While both metabolic dysfunction-associated fatty liver disease (MAFLD) and osteoporosis are closely linked to metabolic disorders, their relationship remains controversial. This study aimed to investigate the association between liver fibrosis and femoral neck bone mineral density (BMD) in MAFLD patients with type 2 diabetes mellitus (T2DM-MAFLD) and to evaluate metabolic influences.

Materials and Methods

We retrospectively enrolled 569 hospitalized T2DM-MAFLD patients between September 2018 and May 2021. Liver fibrosis was assessed using the Fibrosis-4 score (FIB-4), and femoral neck BMD was measured by dual-energy X-ray absorptiometry. Generalized additive models evaluated non-linear relationships, piecewise linear regression identified threshold effects, and stratified analyses explored metabolic modifiers.

Results

A non-linear, inverted U-shaped relationship was observed between FIB-4 and femoral neck BMD in postmenopausal women and men ≥50 years, with a turning point at FIB-4 = 2.091. Below this threshold, FIB-4 showed a significant positive correlation with femoral neck BMD (β = 0.039, 95%CI: 0.006–0.072, P = 0.020). Above the threshold, the association became negative but non-significant (β = −0.032, 95%CI: −0.075 to 0.011, P = 0.141). Stratified analysis revealed that in patients with triglycerides ≥1.7 mmol/L, FIB-4 was significantly negatively correlated with femoral neck BMD (β = −0.025, 95%CI: −0.048, −0.003), with a significant interaction effect (P = 0.011).

Conclusions

A non-linear association between liver fibrosis and femoral neck BMD was observed in T2DM-MAFLD patients, particularly postmenopausal women and men aged ≥50 years, modulated by serum triglyceride. Hypertriglyceridemia may represent a crucial metabolic risk factor for osteoporosis development in MAFLD patients, suggesting the importance of bone loss screening in this patient population, particularly those with elevated triglycerides.

目的:虽然代谢功能障碍相关的脂肪性肝病(MAFLD)和骨质疏松症都与代谢紊乱密切相关,但它们之间的关系仍存在争议。本研究旨在探讨MAFLD合并2型糖尿病(T2DM-MAFLD)患者肝纤维化与股骨颈骨密度(BMD)的关系,并评估其代谢影响。材料和方法:我们回顾性地纳入了2018年9月至2021年5月期间住院的569例T2DM-MAFLD患者。采用纤维化-4评分(FIB-4)评估肝纤维化,采用双能x线骨密度仪测量股骨颈骨密度。广义加性模型评估非线性关系,分段线性回归识别阈值效应,分层分析探索代谢修饰因子。结果:≥50岁的绝经后女性和男性FIB-4与股骨颈骨密度呈非线性倒u型关系,FIB-4 = 2.091为转折点。低于此阈值,FIB-4与股骨颈骨密度呈显著正相关(β = 0.039, 95%CI: 0.006-0.072, P = 0.020)。超过阈值,相关性变为负但不显著(β = -0.032, 95%CI: -0.075 ~ 0.011, P = 0.141)。分层分析显示,在甘油三酯≥1.7 mmol/L的患者中,FIB-4与股骨颈BMD呈显著负相关(β = -0.025, 95%CI: -0.048, -0.003),交互作用显著(P = 0.011)。结论:在T2DM-MAFLD患者中,肝纤维化与股骨颈骨密度呈非线性关系,尤其是绝经后的女性和年龄≥50岁的男性,受血清甘油三酯调节。高甘油三酯血症可能是MAFLD患者骨质疏松发展的一个关键代谢危险因素,提示对这类患者进行骨质流失筛查的重要性,特别是那些甘油三酯升高的患者。
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引用次数: 0
Anthropometric and lipid indices in relation to prediabetes and diabetes: A cross-sectional study in resource-limited areas of northwestern China 与前驱糖尿病和糖尿病相关的人体测量和脂质指数:中国西北资源有限地区的横断面研究。
IF 3 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-08-12 DOI: 10.1111/jdi.70137
Ling Ma, Yin Cheng, Lanqiqi Wu, Hongjuan Shi, Yining Liu, Jinyu Ma, Huitian Tong, Chao Shi

Aims

This cross-sectional study was conducted to assess the association of triglyceridemic-waist phenotype, waist-to-height ratio (WHtR), lipid accumulation product (LAP), visceral adiposity index (VAI), and triglyceride-glucose (TyG) index with prediabetes and diabetes (PAD) using data from the Ningxia Cardiovascular Disorders and Related Risk Factors Survey.

Materials and Methods

This study included 10,803 patients. Logistic regression analysis and restricted cubic splines were applied to identify the association between the PAD and each index. The receiver operating characteristic curve was analyzed to identify and compare the discriminative power of different indexes in identifying PAD.

Results

A total of 43.87% patients were diagnosed with prediabetes and 11.75% patients were diagnosed with diabetes. After adjusting for confounders, participants with elevated high triglyceride levels with increased waist circumference (HTGW) were associated with a 2.65-fold (odds ratio [OR] 2.65, 95% confidence interval [95% CI] 2.31–3.03) risk of PAD. Comparing with the lowest quartile, those in the highest quartile of WHtR, LAP, VAI, and TyG index had a significantly increased risk of developing PAD. TyG index (area under the curve [AUC] 0.71, 95% CI 0.70–0.72) was better than WHtR (AUC 0.66, 95% CI 0.65–0.67), LAP (AUC 0.68, 95% CI 0.67–0.69), and VAI (AUC 0.65, 95% CI 0.64–0.66) at predicting the risk of PAD.

Conclusions

The HTGW and elevated WHtR, LAP, VAI, and TyG index are associated with a greater risk of PAD. The TyG index is a more favorable anthropometric measure for predicting PAD, but its clinical utility needs to be validated in prospective cohorts, especially in resource-limited areas.

目的:本横断面研究利用宁夏心血管疾病及相关危险因素调查的数据,评估甘油三酯-腰围表型、腰高比(WHtR)、脂质积累产物(LAP)、内脏脂肪指数(VAI)和甘油三酯-葡萄糖(TyG)指数与糖尿病前期和糖尿病(PAD)的关系。材料和方法:本研究纳入10803例患者。应用Logistic回归分析和限制三次样条分析确定PAD与各指标之间的关系。分析受试者工作特征曲线,鉴别并比较不同指标对PAD的鉴别能力。结果:43.87%的患者诊断为糖尿病前期,11.75%的患者诊断为糖尿病。在调整混杂因素后,高甘油三酯水平升高且腰围增加(HTGW)的参与者患PAD的风险为2.65倍(优势比[OR] 2.65, 95%可信区间[95% CI] 2.31-3.03)。与最低四分位数相比,WHtR、LAP、VAI和TyG指数最高四分位数的患者发生PAD的风险显著增加。TyG指数(曲线下面积[AUC] 0.71, 95% CI 0.70-0.72)在预测PAD风险方面优于WHtR (AUC 0.66, 95% CI 0.65-0.67)、LAP (AUC 0.68, 95% CI 0.67-0.69)和VAI (AUC 0.65, 95% CI 0.64-0.66)。结论:HTGW、WHtR、LAP、VAI和TyG指数升高与PAD风险增加相关。TyG指数是预测PAD的更有利的人体测量指标,但其临床效用需要在前瞻性队列中验证,特别是在资源有限的地区。
{"title":"Anthropometric and lipid indices in relation to prediabetes and diabetes: A cross-sectional study in resource-limited areas of northwestern China","authors":"Ling Ma,&nbsp;Yin Cheng,&nbsp;Lanqiqi Wu,&nbsp;Hongjuan Shi,&nbsp;Yining Liu,&nbsp;Jinyu Ma,&nbsp;Huitian Tong,&nbsp;Chao Shi","doi":"10.1111/jdi.70137","DOIUrl":"10.1111/jdi.70137","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>This cross-sectional study was conducted to assess the association of triglyceridemic-waist phenotype, waist-to-height ratio (WHtR), lipid accumulation product (LAP), visceral adiposity index (VAI), and triglyceride-glucose (TyG) index with prediabetes and diabetes (PAD) using data from the Ningxia Cardiovascular Disorders and Related Risk Factors Survey.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>This study included 10,803 patients. Logistic regression analysis and restricted cubic splines were applied to identify the association between the PAD and each index. The receiver operating characteristic curve was analyzed to identify and compare the discriminative power of different indexes in identifying PAD.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 43.87% patients were diagnosed with prediabetes and 11.75% patients were diagnosed with diabetes. After adjusting for confounders, participants with elevated high triglyceride levels with increased waist circumference (HTGW) were associated with a 2.65-fold (odds ratio [OR] 2.65, 95% confidence interval [95% CI] 2.31–3.03) risk of PAD. Comparing with the lowest quartile, those in the highest quartile of WHtR, LAP, VAI, and TyG index had a significantly increased risk of developing PAD. TyG index (area under the curve [AUC] 0.71, 95% CI 0.70–0.72) was better than WHtR (AUC 0.66, 95% CI 0.65–0.67), LAP (AUC 0.68, 95% CI 0.67–0.69), and VAI (AUC 0.65, 95% CI 0.64–0.66) at predicting the risk of PAD.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The HTGW and elevated WHtR, LAP, VAI, and TyG index are associated with a greater risk of PAD. The TyG index is a more favorable anthropometric measure for predicting PAD, but its clinical utility needs to be validated in prospective cohorts, especially in resource-limited areas.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 11","pages":"2070-2081"},"PeriodicalIF":3.0,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70137","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144820255","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 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-08-08 DOI: 10.1111/jdi.70127
Waye-Hann Kang, Norlela Sukor, Nor Azmi Kamaruddin

Introduction

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.

Patients and Methods

We screened 360 type 2 diabetes mellitus males for hypogonadism (H), defined by total testosterone <12 nmol/L, repeated calculated free testosterone <0.255 nmol/L, and Aging Male Symptoms (AMS) scale >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.

Results

55.6% of the 63 hypogonadal subjects have hypo-H. Significant differences in weight (P = 0.001), BMI (P < 0.001), waist circumference (P < 0.001), serum HDL-C (P < 0.001), serum triglycerides (P = 0.001) and TyG index (P < 0.001) were observed between hypo-H and eugonadal males. For hyper-H males, only age differed significantly from eugonadal males (P = 0.034).

Conclusions

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.

性腺功能减退症在男性2型糖尿病患者中较为常见,可分为促性腺功能亢进症(hyper-H)和促性腺功能减退症(hypogonadotropic Hypogonadism, hypoh)。低h与胰岛素抵抗和内脏脂肪密切相关,而高h在2型糖尿病男性中尚未得到广泛研究。我们的目的是研究与马来西亚男性性腺功能低下2型糖尿病的两种亚型相关的因素,在马来西亚,肥胖和控制不良的糖尿病非常普遍。患者和方法:我们筛选了360例2型糖尿病男性性腺功能减退(H),由总睾酮26定义。根据黄体生成素(LH)水平将受试者分为促性腺功能减退症(hypoh)和促性腺功能亢进症(hyper-H)。我们进一步分析了他们的社会人口学和临床参数,并与性腺正常的男性对照组进行了比较。结果:63例性腺功能低下者中有55.6%存在低h。结论:年龄与高h显著相关,而胰岛素抵抗和内脏肥胖与低h密切相关。老年和肥胖的马来西亚2型糖尿病男性,特别是那些患有冠状动脉疾病和低HDL-C水平的男性,患性腺功能减退的风险更高。在马来西亚,旨在改善胰岛素抵抗和减少内脏脂肪的糖尿病治疗可能对性腺功能低下的2型糖尿病男性非常有效。
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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 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-08-07 DOI: 10.1111/jdi.70136
Adnan Memon, Zareen Gull

Dear Editor,

I recently read with great interest the article by Fujikawa Shingu et al.1 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.

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 estimates2.

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 et al. 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 outcomes3.

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 et al.4 in their article4. 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.

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.

None.

The authors declare no conflict of interest.

Approval of the research protocol: None.

Informed consent: None.

Registry and the registration no. of the study/trial: None.

Animal studies: None.

亲爱的编辑,我最近怀着极大的兴趣读了Fujikawa Shingu等人的一篇文章,题为“妊娠期显性糖尿病与诊断性糖尿病的临床特征”。该研究提供了一个有趣的观点来比较妊娠期显性糖尿病和诊断前存在糖尿病的临床差异。作者做了令人印象深刻的工作,但研究的某些方法元素需要进一步完善,以进一步加强研究结果。首先,作者依赖于一个非常小的样本量,包括61名妇女,而显性糖尿病组有1084名妇女。这样小的样本量可能会限制统计能力并产生假阳性结果。正如哈克肖在他的文章中提到的那样,小型研究可以迅速提供结果,但它们通常不能提供可靠或精确的估计。其次,在妊娠期显性组中,缺乏孕前血糖控制数据,这可能会影响Wendland等人在其研究中提到的孕前和孕期血糖控制对减轻围产期并发症和先天性异常等风险的意义对围产期并发症风险的解释。他们注意到WHO和IADPSG妊娠期糖尿病(GDM)标准已经确定女性出现不良妊娠结局的风险略有升高3。此外,没有临床或行为混杂数据,包括饮食、运动和患者教育。徐等人在他们的文章中提到,这些因素可以显著影响母亲的血糖控制和围产期结局。如果不考虑这些混杂因素,就很难理解导致不良妊娠结局的因素,也很难解释显性和既往糖尿病组之间观察到的差异。总之,尽管该研究在医学领域提供了重要的见解,但解决样本量小、缺乏孕前血糖数据和缺乏混杂因素等局限性可以增强研究结果的稳健性。我们感谢作者对这一重要课题所做的贡献。研究方案批准:无。知情同意:无。注册表及注册编号研究/试验:无。动物实验:没有。
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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 Q2 ENDOCRINOLOGY & METABOLISM 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

Introduction

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.

Methods

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.

Results

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%, P = 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, P < 0.001). Depressive symptoms correlated with older age, lower education level, longer diabetes duration (>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 >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.

Conclusion

The association of depressive symptoms and poor glycemic control in type 2 diabetes in South Asians is stronger in females.

导言:虽然抑郁症和糖尿病之间的双向关系是公认的,但评估性别差异潜力的研究结果,特别是在低收入和中等收入(LMIC)南亚国家,尚未探索。我们评估了孟加拉国2型糖尿病患者抑郁症状和血糖控制之间关系的性别差异。方法:1485名未入选的2型糖尿病患者和228名非2型糖尿病患者完成了PHQ-9(抑郁症筛查问卷),并获得了社会人口学和临床数据。PHQ-9评分分为轻度(5-10)、中度(10-15)、中度(15-20)和重度(≥20)抑郁症状,得分≥10为临床相关症状。描述性统计和有序和二元逻辑回归分析。结果:2型糖尿病患者的平均HbA1c为9.8±0.1%,性别间无差异(9.9±0.1% vs 9.7±0.2%,P = 0.39)。总体平均PHQ-9评分为8.5±0.2,其中女性评分较高(9.5±0.2 vs 7.1±0.2,P 5年:OR: 1.5, 95% CI: 1.1-2.3),次优(HbA1c 7-9%: OR: 1.8, 95% CI: 1.1-3.2),血糖控制较差(HbA1c≥9%:OR, 1.7;95% ci, 1.1-2.9)。血糖控制次优(OR: 2.2, 95% CI: 1.1-4.3)或不良(OR: 2.5, 95% CI: 1.3-4.9)和糖尿病病程1-5年(OR: 1.9, 95% CI: 1.2-3.0)和5年(OR: 2.4, 95% CI: 1.5-3.9)与女性出现轻度至重度抑郁症状的可能性增加相关,但与男性无关。结论:南亚2型糖尿病患者抑郁症状与血糖控制不良的相关性在女性中更强。
{"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 Q2 ENDOCRINOLOGY & METABOLISM 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

Background

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.

METHODS

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.

Results

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.

Conclusion

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.

背景:甘油三酯葡萄糖体重指数(TyG-BMI)已成为心力衰竭(HF)患者并发症的预测指标。虽然TyG-BMI水平升高与心衰患者的不良结局有关,但其对急性肾损伤(AKI)风险的预测价值尚不清楚。本研究旨在探讨TyG-BMI与心衰患者AKI发生率之间的关系。方法:数据来源于重症监护医学信息集市3.1版(MIMIC-IV v3.1)和eICU合作研究数据库2.0版(eICU- crd v2.0)。主要结局是AKI的发生,次要结局包括是否需要肾脏替代治疗(RRT)和住院死亡率。Kaplan-Meier生存分析、受限三次样条模型和Cox比例风险回归模型用于评估TyG-BMI与临床结局之间的关系。结果:该研究包括1250例MIMIC-IV患者和2300例eICU-CRD患者。TyG-BMI水平较高的患者AKI的累积发病率明显较高,RRT使用率和住院死亡率也增加。在对潜在混杂因素进行调整后,在多变量模型中,较高的TyG-BMI仍然与HF患者AKI风险增加独立相关。结论:这项多中心分析表明,较高的TyG-BMI水平与心衰患者AKI风险增加、RRT需求增加和住院死亡率升高相关。TyG-BMI可作为该人群早期风险分层和预后评估的有用指标。需要进一步的前瞻性研究来验证这些发现。
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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 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-08-06 DOI: 10.1111/jdi.70122
Toshiaki Ohkuma, Masanori Iwase, Ayaka Oshiro, Taiki Higashi, Takanari Kitazono

Aims/Introduction

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.

Materials and Methods

In total, 4,923 Japanese individuals with type 2 diabetes were included. Participants were classified based on alcohol drinking status, alcohol consumption amount (<20, 20–39, or ≥40 g/day), and ADH1B (rs1229984) and ALDH2 (rs671) genotype, and the associations with HbA1c levels were examined cross-sectionally.

Results

In men, compared with never drinkers, an increase in the alcohol consumption amount was associated with a decrease in HbA1c levels (P for trend <0.001). By contrast, in women, a mild-to-moderate consumption amount (<20 g/day) was associated with decreased HbA1c levels, whereas ≥20 g/day consumption was associated with increased HbA1c levels, indicating a J-shaped relationship. Regarding the association with genetic variants in alcohol-metabolizing enzymes, HbA1c increased linearly with an increasing number of A alleles in ALDH2 (P for trend <0.001). However, the HbA1c level did not show a significant trend across the ADH1B genotype. The association between alcohol consumption and HbA1c levels was not modified by genetic variants in ADH1B or ALDH2.

Conclusions

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.

目的/简介:目前尚不清楚饮酒与血糖水平之间的性别特异性关联,以及这种关联是否因酒精遗传易感性而不同。本研究旨在研究东亚2型糖尿病患者饮酒和酒精代谢酶基因变异与血糖水平的关系,以及它们的性别差异。材料和方法:共纳入4923名日本2型糖尿病患者。参与者根据饮酒状况进行分类,饮酒量(1c水平)进行横断面检查。结果:在男性中,与从不饮酒者相比,饮酒量的增加与HbA1c水平的降低相关(P为1c趋势水平),而≥20 g/天的饮酒量与HbA1c水平升高相关,呈j型关系。关于与酒精代谢酶遗传变异的关系,HbA1c随着ALDH2中A等位基因数量的增加而线性增加(趋势1c水平的P在ADH1B基因型中没有显示出显著的趋势。酒精摄入量和HbA1c水平之间的关系不受ADH1B或ALDH2基因变异的影响。结论:这些发现强调了针对2型糖尿病患者酒精代谢的遗传易感性,采用性别特异性方法控制饮酒习惯对血糖控制的重要性。
{"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 Q2 ENDOCRINOLOGY & METABOLISM 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

Aim

To evaluate the long-term safety and efficacy of imeglimin in Japanese individuals with type 2 diabetes (T2D) and advanced chronic kidney disease (CKD).

Materials and Methods

This open-label, single-arm, multicenter, phase 4 study (TWINKLE) enrolled individuals with T2D and estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2, treated with ≤1 oral hypoglycemic agent. Participants received 500 mg of imeglimin twice daily if eGFR was 15 to <45 mL/min/1.73 m2 or 500 mg once daily if eGFR was <15 mL/min/1.73 m2, as monotherapy or in combination with their existing hypoglycemic agent, for 52 weeks. Dose adjustments were permitted based on safety and eGFR.

Results

Among 60 participants (CKD stages: G3b: n = 42; G4: n = 16; G5: n = 2), adverse events (AEs) occurred in 41 participants (68.3%), with no increased incidence across CKD stages. The most common AE was diarrhea (n = 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 < 7.0% increased from 13.3% at baseline to 50.0% at week 52 (LOCF).

Conclusions

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.

目的:评价伊米明在日本2型糖尿病(T2D)和晚期慢性肾脏疾病(CKD)患者中的长期安全性和有效性。材料和方法:这项开放标签、单组、多中心、4期研究(TWINKLE)招募了T2D患者,估计肾小球滤过率(eGFR) 2,接受≤1种口服降糖药治疗。如果eGFR为15 - 2,受试者接受500mg伊米明,每日2次;如果eGFR为2,受试者接受500mg,每日1次,作为单药治疗或与现有降糖药联合治疗,疗程52周。允许根据安全性和eGFR调整剂量。结果:60名参与者(CKD分期:G3b: n = 42;G4: n = 16;G5: n = 2), 41名参与者(68.3%)发生了不良事件(ae),在CKD分期中发生率没有增加。最常见的AE是腹泻(n = 6, 10.0%)。基线平均(SD) HbA1c、糖化白蛋白(GA)和空腹血糖(FPG)水平分别为7.59%(0.68%)、22.53%(3.27%)和151.8 (28.86)mg/dL。在第24周,与基线相比,HbA1c的平均(SD)变化为-0.53% (0.51%),GA为-2.37% (2.08%),FPG为-13.6 (20.87)mg/dL。第52周(最后一次观察结转[LOCF]),平均变化分别为-0.26%(0.88%)、-1.59%(3.04%)和-7.0 (31.17)mg/dL。结论:本研究证实伊米明在日本T2D和CKD G3b-5期患者中具有良好的安全性和持续的降糖疗效,支持在该人群中调整剂量使用。
{"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}
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Journal of Diabetes Investigation
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