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Six-Month Outcomes After Transmetatarsal Amputation in Diabetic Patients: Predictive Utility of the SINBAD Classification.3 weeks agoThis study retrospectively reviewed 46 patients undergoing transmetatarsal amputation (TMA) between January 2017 and January 2023 to evaluate complication rates within 6 months and assess the predictive value of the SINBAD classification for re-amputation risk. Patients were categorised based on re-amputation occurrence, and clinical and demographic data were collected. Each case was evaluated using the SINBAD scoring system, with logistic regression used to assess associations. Among the patients, 28 (60.9%) experienced no re-amputation, while 18 (39.1%) underwent re-amputation. Baseline demographics and laboratory findings did not significantly differ between groups. The mean SINBAD score was significantly higher in the re-amputation group (3.67 vs. 2.29; p < 0.001), with logistic regression identifying SINBAD score as an independent predictor (OR 6.76; 95% CI: 2.18-21.02; p < 0.001). A SINBAD score of ≥ 4 was associated with a re-amputation rate of 90.9%. In conclusion, the SINBAD classification proves to be a simple and effective tool for predicting re-amputation post-TMA, facilitating risk stratification and surgical planning for diabetic foot ulcer patients.DiabetesCardiovascular diseasesAccessCare/ManagementAdvocacyEducation
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Evidence that atherosis of the spiral artery represents atherosclerotic lesions similar to those of native and transplant-induced atherosclerosis: implications for understanding the pathophysiology of obstetrical syndromes and long-term cardiovascular risk.3 weeks agoMothers who experience major obstetrical syndromes (ie, preeclampsia, spontaneous preterm birth, fetal growth restriction, fetal death, gestational diabetes mellitus) are at an increased risk for early death from cardiovascular disease. Atherosis of the spiral arteries has been observed in each of these syndromes. The lesion is characterized by subendothelial lipid-filled foam cells, fibrinoid necrosis, and leukocyte infiltration. We aimed to characterize the morphological feature of the lesion using multi-dimensional immunohistochemistry and to determine whether atherosis has features similar to native and transplant-induced atherosclerosis.
The objectives of the study were (a) to identify different cell types within atherosis lesions, (b) to determine whether the lesions had a phenotypic pattern of activation and inflammation, and (c) to ascertain whether atherosis resembles the lesions observed in the coronary arteries of patients with either native or transplant-induced atherosclerosis.
A retrospective case-control study was performed with and without atherosis. Basal plate samples (5.6 ± 0.9 per placenta) were studied immunohistochemically with antibodies specific for α-smooth muscle actin, cytokeratin, von Willebrand factor, fibrin (no fibrinogen), cluster of differentiation 68 (CD68), CD36, intercellular adhesion molecule-1 (ICAM-1/CD54), human leukocyte antigen-DR (HLA-DR), nuclear factor kappa B (NFκB), and C-reactive protein (CRP). Samples from hearts with atherosclerosis, native (n=10) and transplant-induced (n=10), and without atherosclerosis (n=10), were used for comparisons. Investigators examining microscopic sections were masked to clinical diagnoses. Statistical comparisons were performed using Fisher's exact (for discrete measures) and Kruskal-Wallis (for continuous measures) tests. Comparisons of continuous measures used the Wilcoxon Rank Sum test. Analysis of variance (ANOVA) assessed the means from subgroups.
1) We compared the cellular and immunopathologic features of 134 placentas with atherosis and 134 without atherosis; 2) histologic and immunopathologic analyses showed that atherotic lesions contain an average of a) 29.4% of foam cells; b) 30.6% of cells with lipid deposits (assessed by Oil Red O-positive cells); c) lack intra-arterial trophoblasts; d) 52.4% of smooth muscle cells; and e) 30.8% of macrophages (CD68-positive cells) which express the scavenger receptor CD36; and 3) atherotic lesions stained positive for ICAM-1 (48.4% of cells), HLA-DR (48% of cells), NFκB (endothelium and macrophages) (48.9% of cells), and CRP (17.6% of cells). Similar histopathologic and immunopathologic characteristics were identified in native and transplant-induced coronary atherosclerosis but not in control vessels.
Atherosis has similar morphologic and immunopathologic features as those observed in native and transplant-induced coronary atherosclerosis. These observations have implications in understanding the origin of atherosis and may explain why a subset of women with obstetrical syndromes are at an increased risk for cardiovascular disease later in life. We propose that the term atherosis be replaced with atherosclerosis of the spiral arteries.DiabetesCare/Management -
Instruments for measuring diabetic foot self-care behavior: a systematic review of measurement properties.3 weeks agoTo synthesize and critically evaluate the psychometric properties of patient-reported outcome measures (PROMs) designed to assess diabetic foot self-care behaviors.
A systematic search was conducted in PubMed, EMBASE, CINAHL, and Cochrane databases up to February 2024. Eligible studies included adults (≥18 years) with diabetes who could independently perform daily foot care, and only instruments assessing self-reported foot care practices were included. Studies were excluded if diabetes was not the primary condition, instruments were unrelated, or full-text data were unavailable. The methodological quality and measurement properties of these instruments were assessed using the COSMIN checklist and a modified GRADE approach.
Seven self-report instruments for assessing diabetic foot self-care were identified across 16 studies. The review found considerable variability in the methodological quality and psychometric robustness of the included PROMs. The Diabetic Foot Self-Care Questionnaire (DFSQ) consistently showed adequate content validity, structural validity, and internal consistency, and was validated across several cultural context.
Despite generally adequate psychometric properties, the evidence is limited by small and variable sample sizes, lack of longitudinal data, incomplete cross-cultural representation, and potential publication bias. Overall, the DFSQ demonstrated the most robust psychometric properties and recommended as a reliable and valid tool for assessing diabetic foot self-care behaviors in both research and clinical practice.DiabetesCare/Management -
Clinical characteristics and prognosis of pulmonary aspergillosis complicating interstitial lung diseases.3 weeks agoPulmonary aspergillosis can complicate interstitial lung diseases (ILDs) during immunosuppressive treatment. This study aimed to clarify the clinical characteristics and prognostic differences of pulmonary aspergillosis in patients with ILDs by disease subtypes.
Patients diagnosed with both ILDs and pulmonary aspergillosis were retrospectively analyzed at Nagasaki University Hospital between October 1, 2008, and March 31, 2022. Pulmonary aspergillosis was categorized as invasive pulmonary aspergillosis (IPA) or chronic pulmonary aspergillosis (CPA). CPA was further subdivided into simple pulmonary aspergilloma (SPA), chronic cavitary pulmonary aspergillosis (CCPA), and subacute invasive aspergillosis (SAIA). Clinical characteristics and prognostic outcomes were compared among the subtypes.
Fifty patients with both diseases were analyzed: 38 had CPA and 12 had IPA. All patients with IPA had a history of corticosteroid use and a significantly higher prevalence of diabetes mellitus than those with CPA. In contrast, honeycombing changes on chest computed tomography (CT) were more frequently observed in patients with CPA than in those with IPA. Kaplan-Meier analysis showed that patients with IPA had significantly higher mortality rates than those with CPA, and that among CPA subtypes, patients with SAIA had significantly higher mortality rates than those with SPA or CCPA. Univariate analysis showed that the presence of SAIA or IPA was significantly associated with 1-year mortality compared to other subtypes. The type of underlying ILD did not affect the prognosis.
Clinical characteristics and prognoses of pulmonary aspergillosis in patients with ILDs vary by subtype.DiabetesCare/Management -
Effects of mobile health management model on the prevention of gestational diabetes mellitus in pregnant women at risk of gestational diabetes: A randomized controlled trial.3 weeks agoGestational diabetes mellitus is a common pregnancy complication with rising incidence worldwide. Traditional interventions for gestational diabetes mellitus prevention often lack accessibility and personalization. Mobile health (mHealth) technologies, particularly smartphone apps, provide an innovative solution. They enable real-time, personalized care by tracking key health metrics, delivering user-specific dynamic feedback, and offering customized lifestyle plans. This approach addresses traditional limitations and presents a more effective, accessible gestational diabetes mellitus prevention strategy.
This study aimed to evaluate the effectiveness of a mobile health management model, based on a gestational diabetes prevention app, in preventing gestational diabetes mellitus and improving maternal and neonatal outcomes in pregnant women at risk of gestational diabetes mellitus.
In this randomized controlled trial, pregnant women at risk of gestational diabetes mellitus before 12 weeks of gestation were recruited from three tertiary hospitals in Beijing. Participants were randomly assigned to either a control group receiving standard care, or an intervention group receiving additional support via a mHealth model using the 'Better Pregnancy' app. A gestational diabetes mellitus risk group health management team was established, led by 3 diabetes specialist nurses, 1 doctor, 1 dietitian, 1 psychologist, and several volunteers. Outcomes included the incidence of gestational diabetes mellitus, oral glucose tolerance test values at 24 weeks of gestation, self-management ability, self-efficacy, perceived social support, pregnancy weight gain, delivery complications, and neonatal outcomes.
A total of 246 pregnant women at risk of gestational diabetes mellitus were enrolled, including 124 in the control group and 122 in the intervention group. Compared to the control group, the intervention group had a lower incidence of gestational diabetes mellitus (18.9 % vs. 33.9 %), lower glucose tolerance test values (fasting: 4.47 ± 0.36 vs. 4.61 ± 0.51, 1-hour postprandial: 7.74 ± 1.54 vs. 8.29 ± 1.82, 2-hour postprandial: 6.85 ± 1.28 vs. 7.32 ± 1.64), and lower HbA1c levels (4.81 ± 0.32 vs. 4.98 ± 0.35). The intervention group also had reduced insulin use (0 % vs. 8.3 %) and hospitalizations rate due to poor blood glucose control (2.1 % vs. 14.5 %). Besides, the intervention group showed improved general self-efficacy, self-management, and perceived social support scores than the control group (P < 0.05). Multivariate logistic regression analysis showed that the intervention significantly reduced the risk of gestational diabetes mellitus (OR = 0.424, 95 % CI: 0.217-0.827, P = 0.012). Higher pre-pregnancy BMI and history of gestational diabetes mellitus were identified as risk factors for gestational diabetes mellitus incidence.
The mHealth management model significantly reduced fasting and postprandial blood glucose, HbA1c levels, and gestational diabetes mellitus incidence in pregnant women at risk of gestational diabetes mellitus, while improving self-efficacy, social support, and self-management abilities. Additionally, the intervention was associated with a significant reduction in the hospitalization rate due to poor blood glucose control. However, its impact on certain maternal and neonatal outcomes, such as gestational weight gain and neonatal hypoglycemia rates, remains inconclusive. Limitations include potential selection bias and reliance on self-reported data. Future research should further explore the long-term impact of this model on maternal and infant health.
This study was registered at the Chinese Clinical Trial Registry (ChiCTR2200057889) on March 20, 2022, and participant recruitment was initiated in August 2022. Social media abstract: Mobile health model reduces gestational diabetes risk and improves maternal & neonatal outcomes in at-risk pregnant women.DiabetesCare/Management -
Association between the Geriatric Nutritional Risk Index and mild cognitive impairment in elderly patients with type 2 diabetes mellitus.3 weeks agoBackgroundDiabetes increases the risk of mild cognitive impairment (MCI). The Geriatric Nutritional Risk Index (GNRI) is an objective indicator for assessing malnutrition risk, and aging and malnutrition are closely associated with MCI. However, the relationship between GNRI and MCI in older type 2 diabetes mellitus (T2DM) remains unclear.ObjectiveTo investigate the correlation between GNRI and MCI in elderly patients with T2DM.MethodsIn this cross-sectional study, 366 T2DM patients aged ≥ 60 years were divided into MCI and normal cognitive function (NCF) group according to the Montreal Cognitive Assessment (MoCA). Nutritional status was evaluated by calculating GNRI levels. GNRI levels and MoCA scores were compared between two groups, and correlation and regression analysis were performed to explore the association between GNRI and MCI.ResultsThe GNRI level in the MCI group was significantly lower than that in the NCF group (p < 0.05) and positively correlated with MoCA scores (r = 0.783, p < 0.001). MCI prevalence increased progressively with decreasing GNRI levels. After adjusting for confounders, the odds of MCI were significantly higher in the 92 ≤ GNRI ≤ 98 and GNR < 92 groups compared to GNRI < 98 (p < 0.05). Binary logistic regression identified that after adjusting for age, education level, body mass index, HbA1c, HOMA-IR, 25(OH)D and DR, GNRI as an independent protective factor for T2DM with MCI (OR = 0.783, 95%CI 0.648-0.874, p < 0.001).ConclusionsLower GNRI levels are associated with increased risk of MCI in elderly T2DM patients; GNRI is a potential predictor of MCI. Assessing nutritional status of elderly with T2DM facilitates the early clinical recognition of MCI.DiabetesDiabetes type 2Care/Management
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Is "Perfect" the Enemy of the "Good?": Insights from the Lifestyle Behaviors and Health Status of Americans with Type 2 Diabetes.3 weeks agoPersons with Type 2 diabetes mellitus (T2DM, ~ 38.1 million Americans) are at risk of poor health, cardiovascular disease (CVD) and chronic kidney disease (CKD) if their disease is poorly controlled. T2DM control requires disease self-management through adequate physical activity and optimum diet. We evaluated the physical activity and diet patterns of the US T2DM population against the American Diabetes Association and clinical practice guideline norms, and their associations with health outcomes. Using a cross-sectional, observational study design, we studied the US T2DM population's physical activity and fruit/vegetable intake (independent variables), and their associations with three health outcomes, self-rated health (from the SF-36 question on experienced health status, categorized as excellent/very good/good vs. fair/poor), CVD-free status, and CKD-free status. We used pooled data from the Behavioral Risk Factor Surveillance Surveys (2015, 2017 and 2019) on adults aged 30-75 years with T2DM (defined as diabetes mellitus diagnosed after age 30). Physical activity categories were inactive, insufficiently active, sufficiently active, highly active, and fruit/vegetable intake categories, ≤ 2, 3-4, and ≥ 5 daily servings. We used hierarchical logistic regression, adjusting for demographic variables (age, sex, race), and potentially confounding factors, diabetes severity (disease duration, insulin use), chronic comorbidity, overweight/obese, smoking, alcohol overuse, having a regular healthcare provider, and having health insurance. Missing data were coded as a separate category. We conducted a subgroup analysis of those with ≥ 10 years of disease duration. Among 119,298 respondents with T2DM (52.1% female, mean age 62.1 years, 94% insured), 36.9% were physically inactive and 16.2% insufficiently active, 52.6% consumed ≤ 2 daily servings of fruit/vegetables, 57% reported excellent-good health, 24.7% had CVD, and 9.7% had CKD. Physical activity showed a dose-dependent association with self-rated health (reference group, physically inactive; adjusted OR for insufficiently active 1.77 (95%CI 1.71-1.83), sufficiently active, 2.33 (2.24-2.43), highly active, 2.63 (2.54-2.72)), as did fruit/vegetable intake [reference group ≤ 2 daily servings; OR for 3-4 servings, 1.12 (1.09-1.16), and ≥ 5 servings, 1.13 (1.08-1.17)]. Physical activity was associated with being CKD-free (ORs, 1.29 (1.22-1.37), 1.50 (1.40-1.60), 1.52 (1.44-1.60, respectively), and being CVD-free (1.31 (1.25-1.37), 1.34 (1.28-1.41, and 1.37(1.31-1.42), respectively). Fruit/vegetable intake was not associated with CVD. CKD outcome was not studied due to dietary restrictions of CKD patients. Subgroup analyses (53,925 respondents) showed similar results. Over a third of the US T2DM population and the subgroup with long-term T2DM were physically inactive, a sixth were insufficiently active, and over half had negligible fruit/vegetable intake. On the positive side, even limited physical activity and fruit-vegetable intake were associated with substantial health benefits including subjective quality of life (self-rated health) compared to physically inactive/negligible fruit-vegetable intake. Our findings call for disease self-management research focused on physician communication for patient empowerment to enable incremental improvements, however modest.DiabetesDiabetes type 2Care/Management
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A Multicenter, Prospective, Observational, and Single-Arm Interventional Study of Mirogabalin in Diabetic Peripheral Neuropathic Pain: Rationale and Design of Dia-NeP.3 weeks agoThe exact prevalence of and recent changes in diabetic polyneuropathy (DPN) and diabetic peripheral neuropathic pain (DPNP) in Japan are unclear. The oral gabapentinoid, mirogabalin besylate (mirogabalin), is effective with a good safety profile for DPNP with moderate-to-severe pain (numerical rating scale [NRS] scores ≥ 4). However, clinical evidence for mild pain (NRS scores ≤ 3) is unclear. The Dia-NeP study aims to examine: (1) the prevalences of DPN and DPNP and background factors in patients with type 2 diabetes mellitus (T2DM); and (2) the efficacy and safety of mirogabalin in patients with DPNP, including those with mild pain.
The Dia-NeP study is a multicenter, prospective study consisting of two parts, a baseline survey and an interventional study, to be conducted from March 2025 to August 2026 in patients with T2DM in Japan. The baseline survey is the observational study investigating the epidemiology of DPN and DPNP, and the interventional study is an exploratory, single-arm, open-label study of 12-week mirogabalin treatment. Of patients with T2DM enrolled in the baseline survey, those diagnosed with DPNP who have an NRS score for pain ≥ 1 will be included in the interventional study. The target sample size is 1000 to 3000 patients for the baseline survey and 100 for the interventional study.
The primary endpoint is the change from baseline in the NRS score at week 12 in the interventional study. The safety endpoint is adverse events. This study will not only show the latest prevalence of DPN and DPNP in Japan, but is also the first study to investigate the efficacy and safety of mirogabalin in patients with DPNP having mild pain, as well as moderate-to-severe pain, and is expected to provide useful evidence for future DPN and DPNP treatment.
Japan Registry of Clinical Trials (jRCTs031240623, registered 20/January/2025, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs031240623 ).DiabetesDiabetes type 2Care/Management -
Gliptin-Induced Bullous Pemphigoid: Are Statins and Angiotensin Receptor Blockers the Cause?3 weeks agoRecently, dipeptidyl peptidase 4 inhibitors (DPP4i), a group of drugs used for the treatment of diabetes mellitus, have been associated with an increased risk of bullous pemphigoid (BP). Several studies previously found clinical and laboratory differences between patients with gliptin-induced BP and conventional BP, and some authors accept DPP4i-induced BP as a separate entity. In this retrospective study, we aimed to compare clinical and laboratory characteristics, comorbidities, and medications used simultaneously with gliptins in these two groups of BP.
Patients with the diagnosis of BP hospitalized in our clinic between 2010 and 2023 were included in this retrospective cross-sectional study. Demographic, clinical, laboratory data, comorbidities, and additional medications were recorded for each patient. Patients were divided into DPP4i-associated and conventional BP groups, and the data were compared between the two groups.
A total of 105 patients with BP, of which 11 were DPP4i-associated, were included. There was no statistically significant difference in age, age at onset, gender distribution, lesion distribution, histopathological, and laboratory findings between the two groups. The median use of DPP4i before BP onset was 3 months (1-12). Disease and follow-up duration were shorter in the gliptin-associated group. DPP4i-induced patients had a higher frequency of severe disease and presentation with a prebullous phase. Cardiovascular disorders, hypertension, hyperlipidemia, the use of angiotensin receptor blockers (ARB), and statins were significantly higher in the gliptin-using patients.
This is one of the first studies to compare demographic, clinical, and laboratory characteristics of patients with gliptin-induced and conventional BP. Our results suggest gliptin-associated BP may present with more severe disease. Hyperlipidemia, ARB, and statin use may be associated with DPP4i-induced BP. Although larger studies are warranted to confirm this association, we believe these findings should be kept in mind while choosing patients to treat with gliptins.DiabetesCare/Management -
Protective Effects of Eugenia uniflora Red Fruit on Brain in a Rat Model of Type 2 Diabetes: Mechanistic Insights.3 weeks agoThe current study aimed to evaluate the in-vitro toxicity and in-vivo antidiabetic effects of a standardized extract from Eugenia uniflora (E. uniflora) fruit, comparing its efficacy to metformin (Met), a widely used anti-hyperglycemic drug. First, toxicity of the extract was determined by MTT assay in 3T3 cell line and primary astrocyte culture. Then Wistar rats were divided into four groups: I- Control, II- type 2 diabetes mellitus (T2DM), III- T2DM + Met and IV- T2DM + E. uniflora. To induce T2DM, groups II, III and IV received a high fat diet (HFD) for 3 weeks followed by a single intraperitoneal (i.p.) dose of streptozotocin (STZ, 35 mg/kg). Animals of group I received normal diet and vehicle (i.p.). Group III received Met (250 mg/kg) and group IV received E. uniflora (200 mg/kg) intragastric pathway, once a day, throughout all experimental protocol. Animals from the groups I and II received water in the same volume. Results showed that cell viability was not affected. In-vivo, E. uniflora and Met prevented the change in serum levels of glucose, cholesterol, LDL, triglyceride and interleukin-6. Furthermore, extract and Met improved oxidative stress markers and antioxidant enzyme activity in the brain (cerebral cortex, hippocampus, striatum). Furthermore, extract enhanced the downstream insulin signaling pathway, including insulin receptor substrate 1, forkhead box protein O-3a, as well as activated the nuclear factor erythroid 2-related factor 2 in the cerebral cortex. This study indicates that E. uniflora extract may have potential in preventing complications associated with T2DM; nevertheless, additional studies are required to confirm these effects and establish their clinical significance.DiabetesDiabetes type 2Care/Management