Hiroyuki Ito

Background/Objectives: Although dietary therapy forms the cornerstone of type 2 diabetes management, strict regimens frequently impose significant cognitive and psychosocial burdens, reducing adherence. This cross-sectional study investigated patient acceptability of individual dietary advice commonly used in nutritional counseling and its clinical associations, aiming to identify a practical screening method for potentially poor adherence. Methods: Among 128 outpatients with type 2 diabetes receiving regular nutritional counseling, patients evaluated their acceptability of 13 standard dietary advice items using a 4-point scale (0 points = Cannot do, 3 points = Can do). We comprehensively analyzed correlations between item-specific acceptability scores and clinical characteristics, including hemoglobin A1c (HbA1c), dietary adherence, and complications. Results: While acceptability for eating vegetables before carbohydrates was extremely high (98%), weighing staple foods and seasonings yielded the highest proportion of 0-point responses (17%, 22 patients). The acceptability score for weighing correlated positively with the nutritional counseling adherence rate (ρ = 0.25) and negatively with HbA1c (ρ = −0.19), estimated salt intake (ρ = −0.28), and diabetic retinopathy (ρ = −0.28) (all p < 0.05). In multivariate logistic regression, the 0-point response to weighing remained significantly associated with lower nutritional adherence (odds ratio [OR] = 0.36, p = 0.02), higher salt intake (OR = 1.96, p < 0.01), and elevated HbA1c (OR = 1.53, p = 0.04), even after adjusting for covariates. Conclusions: Low acceptability of weighing staple foods and seasonings was associated with poorer dietary adherence and worse glycemic control in patients with type 2 diabetes. Assessing this item may help identify patients who could benefit from individualized nutritional counseling. Further prospective studies are needed to validate its utility as a screening indicator.

Background/Objectives: Diabetes-related stigma decreases treatment motivation. While subjective financial burden is a known barrier, the impact of actual medical costs on stigma remains unclear. We investigated the relationship between annual outpatient medical costs (total and out-of-pocket) and stigma in type 2 diabetes to explore whether this association might be more closely related to direct financial hardship or underlying treatment complexity. Methods: In a cross-sectional study, we evaluated stigma in 232 outpatients using the Kanden Institute Stigma Scale (KISS). Patients scoring ≥20 formed the high stigma group (n = 59). Annual medical costs were extracted from electronic hospital claims. We examined associations between medical costs and high stigma using multivariable logistic regression and restricted cubic spline (RCS) models. Results: Adjusted for sex and age, higher total medical cost (per 10,000 JPY/year) was significantly associated with high stigma (odds ratio [OR] = 1.03, 95% confidence interval [CI]: 1.01–1.05, p < 0.01). However, this significance was attenuated after additionally adjusting for HbA1c and antidiabetic agent count (OR = 1.02, 95% CI: 1.00–1.04, p = 0.05). RCS analysis confirmed this dose–response association disappeared upon adjusting for treatment intensity. Notably, out-of-pocket costs showed no significant association with high stigma in any fully adjusted models (OR = 1.03, 95% CI: 0.95–1.11, p = 0.45). Conclusions: While total medical costs are associated with high stigma, the attenuation of this relationship after adjusting for clinical factors suggests that this association may be closely intertwined with the psychosocial burden of treatment complexity, such as polypharmacy and insulin injections, rather than acting solely through direct economic pain from out-of-pocket expenses. Clinicians should prioritize shared decision-making to mitigate psychological distress when intensifying treatment.

Aims: Conventional biomarkers such as estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (uACR) primarily reflect glomerular damage and often fail to detect early tubular injury. Consequently, patients with “non-albuminuric diabetic kidney disease (DKD)” may be overlooked. This study evaluated the independent association between urinary post-translationally modified fetuin-A fragments (uPTM-FetA) and DKD risk stratification in Japanese patients with type 2 diabetes. Methods: We conducted a cross-sectional study of 219 outpatients with type 2 diabetes between November 2023 and February 2024 at Edogawa Hospital. First-morning urine samples were analyzed for uPTM-FetA and urinary liver-type fatty acid-binding protein (uL-FABP) using enzyme-linked immunosorbent assays. DKD risk was classified into four categories based on the KDIGO guidelines. The association between uPTM-FetA and higher DKD-risk (categories 2 + 3 + 4) was assessed using multiple logistic regression and restricted cubic spline (RCS) analyses, validated by bootstrapping. Results: The optimal cutoff value for uPTM-FetA was determined to be 11.76 ng/mgCr. Multivariable analysis adjusted for potential confounders revealed that high uPTM-FetA levels were significantly and independently associated with DKD-risk categories 2 + 3 + 4 (adjusted odds ratio: 3.88; 95% CI: 2.02–7.45; P < 0.01). RCS analysis indicated a significant non-linear association (P = 0.04). Notably, high uPTM-FetA was detected in 38.8% of patients with normoalbuminuria and 42.0% of those with preserved eGFR. A striking discrepancy was observed compared to uL-FABP: while high uL-FABP was completely absent (0.0%) in patients within the low-to-moderate risk categories (categories 1 and 2), high uPTM-FetA was observed in 34.0% and 60.8% of these patients, respectively. Conclusions: uPTM-FetA is independently associated with DKD severity and is elevated in a substantial proportion of patients with early-stage disease where conventional markers remain normal. Unlike uL-FABP, which increases predominantly in advanced stages, uPTM-FetA appears to identify tubular stress earlier. Thus, uPTM-FetA serves as a valuable complementary biomarker to uACR for refining DKD risk stratification.

Diabetic peripheral neuropathy (DPN) is highly prevalent in type 2 diabetes, but its specific impact on long-term renal outcomes remains unclear. We aimed to determine whether DPN, objectively assessed using the DPN-Check^® device, independently predicts accelerated renal function decline. This retrospective cohort study evaluated 323 Japanese patients with type 2 diabetes who underwent neuropathy assessment using DPN-Check^® between 2015 and 2017. Propensity score matching for baseline covariates (including age, HbA1c, estimated glomerular filtration rate [eGFR], and albuminuria) yielded 174 well-matched patients (87 with DPN, 87 without DPN). The primary outcome was a composite of renal events (≥ 30% eGFR decline, renal replacement therapy, or renal or cardiovascular death) over a five-year follow-up. Secondary outcomes included annual eGFR slopes and sensitivity analyses stratified by baseline albuminuria categories. Over five years, renal events occurred significantly more frequently in the DPN group (19 versus 6 events; log-rank P < 0.01). Multivariate Cox regression confirmed DPN as an independent predictor of renal events (adjusted hazard ratio 3.18, 95% CI 1.34 to 8.77, P < 0.01). The DPN group exhibited a steeper annual eGFR decline (-1.9 vs. -1.1 mL/min/1.73 m²/year, P < 0.01). Stratified analysis revealed that DPN significantly predicted renal events even in patients with normoalbuminuria. DPN measured by DPN-Check^® independently predicts subsequent renal deterioration in type 2 diabetes. Routine objective neuropathy screening can enhance renal risk stratification and guide clinical management.

Aim: Overactive bladder (OAB) is a common lower urinary tract symptom that significantly impairs quality of life (QOL) in patients with diabetes. However, its true prevalence and its relationship with antidiabetic medications remain unclear. This study aimed to assess the prevalence of OAB and identify associated factors in Japanese patients with type 2 diabetes. Methods: We conducted a cross‐sectional study involving 289 outpatients aged ≥ 55 years with type 2 diabetes. OAB was assessed using the validated Overactive Bladder Symptom Score (OABSS). The diagnosis of OAB was defined as an urgency score (Q3) ≥ 2 and a total OABSS ≥ 3, or the current use of medications for OAB or benign prostatic hyperplasia (BPH). Logistic regression analyses were performed to identify factors independently associated with OAB. Results: The overall prevalence of OAB was 24%. Multiple regression analysis revealed that longer duration of diabetes (OR 1.04; 95% CI 1.00–1.08; p = 0.04), history of cerebrovascular disease (OR 2.67; 95% CI 1.05–76.77; p = 0.04), and use of sodium‐glucose cotransporter 2 (SGLT2) inhibitors (OR 2.34; 95% CI 1.20–4.67; p = 0.01) were independently associated with OAB. In contrast, no significant associations were observed with HbA1c levels or peripheral neuropathy. Notably, only 32% of OAB patients were receiving relevant pharmacological treatment. Conclusions: OAB is prevalent among older adults with type 2 diabetes. The use of SGLT2 inhibitors may contribute to its development. Clinicians should actively monitor urinary symptoms and consider OAB when selecting antidiabetic therapies. Early detection and appropriate treatment of OAB may help maintain QOL in this population.

Objective To determine the clinical background factors of patients with type 2 diabetes who showed deterioration of defecation status after hospitalization. Methods The defecation status of 128 patients with type 2 diabetes who were admitted to our department for diabetes education was evaluated for 7 days after hospitalization. New-onset constipation was diagnosed when patients without constipation before hospitalization met the criteria for constipation after hospitalization. Worsening constipation was diagnosed when patients with constipation required a larger laxative dose than that before hospitalization. New-onset constipation and worsening constipation were defined as the deterioration of defecation status. The major outcome was the incidence of deterioration of defecation status after hospitalization. Results After hospitalization, 23 of 99 patients who had no constipation before hospitalization developed new-onset constipation. Among the 29 patients with constipation before hospitalization, 9 showed worsening constipation. Overall, 52 patients (41% of all subjects) had constipation, and 32 (25% of all subjects) were diagnosed with deterioration in defecation status. In univariate logistic regression analyses, patient age, albuminuria, diabetic peripheral neuropathy, AST, eGFR, HbA1c, and baPWV were significantly associated with deterioration in defecation status. In the multivariate logistic regression analyses, albuminuria was the only factor that showed a significant association with the deterioration of defecation status after hospitalization. Conclusion Constipation is highly prevalent among hospitalized patients with type 2 diabetes. Paying attention to albuminuria is useful for facilitating an appropriate response to the deterioration of defecation status in patients with type 2 diabetes after hospitalization.

We retrospectively examined the benefits and disadvantages of addingimeglimin to metformin therapy in patients with type 2 diabetes. Ninety-four patients with type 2diabetes who had been administered imeglimin were included in the safety analysisset (SAS). Sixty-four patients who had been treated with imeglimin for over 6 months were included in the full analysis set (FAS). The primary outcome wasthe change in HbA1c levels in the FAS. The secondary outcomes were gastrointestinaladverse events (AEs) in the SAS and changes in body weight and FIB-4 in theFAS. In the SAS, gastrointestinal AEsoccurred in 15 of 40 (38%) metformin users and 6 of 54 (11%) non-users. In the FAS, HbA1c levels were significantlyreduced in both metformin users (n = 27, baseline, 8.5 ± 1.1%;6 months, 7.7 ± 1.2%)and non-users (n = 37, baseline, 8.0 ± 0.9%; 6 months,7.4 ± 0.9%).While body weight (from 72.0 ± 20.5 kg to 70.9 ± 20.8 kg) and FIB-4 (from 1.27 ± 0.57to 1.17 ± 0.49) significantly decreased in metformin users, they did notsignificantly differ in non-users. Adding imeglimin to metformin therapy demonstratedfavorable reductions in HbA1c, body weight, and FIB-4 in patients with type 2diabetes, although it was associated with the incidence of gastrointestinalAEs. UMIN000055241.

Aim: Changes in FIB‐4 levels after the initiation of luseogliflozin therapy were compared between patients with type 2 diabetes according to the presence or absence of alcohol consumption.Methods: A total of 192 patients with type 2 diabetes who continued luseogliflozin therapy for over 12 months were retrospectively investigated. The primary outcome was the change in FIB‐4. The secondary outcomes were changes in HbA1c, body weight, and serum albumin concentration. A current drinker was defined as an individual consuming >20 g ethanol equivalent/day. Patients were classified according to their risk of developing liver fibrosis into the low‐risk (FIB‐4 < 1.3) and intermediate/high‐risk (FIB‐4 ≥ 1.3) groups.Results: In the low‐risk group, while FIB‐4 increased dramatically from 0.91 ± 0.30 at the baseline to 1.14 ± 0.34 at 12 months in drinkers (n = 27), non‐drinkers (n = 79) showed no significant change (0.87 ± 0.22–0.91 ± 0.26). In the intermediate/high‐risk group (n = 63), although the FIB‐4 in drinkers (n = 23) showed no significant change (2.18 ± 1.00–2.16 ± 0.93), it significantly decreased from 2.10 ± 0.87 to 1.80 ± 0.68 in non‐drinkers (n = 63). In both the low‐ and intermediate/high‐risk groups, HbA1c and body weight significantly decreased in both drinkers and non‐drinkers. Serum albumin concentrations significantly increased in both drinkers and non‐drinkers in the low‐risk group. Although serum albumin concentration did not significantly change in drinkers, it dramatically increased in non‐drinkers in the intermediate/high‐risk group.Conclusions: HbA1c levels and body weight decreased in patients with type 2 diabetes after initiating luseogliflozin therapy, regardless of drinking habits. However, it is desirable to limit alcohol consumption when considering its effects on liver fibrosis.