non-DM Cohort Research Articles

A phase II study of ME2136 (Asenapine Maleate) plus standard antiemetic therapy for patients, including diabetic patients, receiving cisplatin-based chemotherapy.

Olanzapine combined with the neurokinin-1 receptor antagonist, palonosetron and dexamethasone is the standard treatment for chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC). However, the use of olanzapine poses challenges in patients with diabetes mellitus (DM) due to the potential risk of hyperglycemia. ME2136, antipsychotic similar to olanzapine, is associated with a lower risk of hyperglycemia. This study investigated the antiemetic efficacy and safety of ME2136 for HEC. This single-arm phase 2 study examined the safety and efficacy of ME2136 5mg for 4days in combination with triplet-combination antiemetic therapy. Two cohorts were established for the safety assessment: DM and non-DM. Eligible patients had malignant tumors and were receiving cisplatin-based chemotherapy for the first time. The primary endpoint was the complete response (CR) rate, defined as the percentage of patients without vomiting and not requiring rescue medications in the delayed phase (24-120h). Between December 2020 and January 2022, 40 patients were enrolled, with 20 in each cohort. All patients were included in the safety analysis and 35 in the efficacy analysis. The CR rate in the delayed phase was 71.4% [60% CI 63.1-78.6%] for all patients, 66.7% in the DM cohort, and 76.5% in the non-DM cohort. No treatment-related adverse events ≥ grade 3, including hyperglycemia, were reported. ME2136, when combined with standard triplet-combination antiemetic therapy, is expected to exert similar antiemetic effects to the standard treatment for CINV due to HEC. Currently, ME2136-02 trial is underway to examine the safety and efficacy of triplet-combination antiemetic therapy and a 5-day treatment with ME2136. This study was registered with the Japan Registry of Clinical Trials (jRCT2041200071) on 10 December 2020. Clinical trial registration: This study was registered with the Japan Registry of Clinical Trials (jRCT2041200071) on 10 December 2020.

Association between quantitative flow ratio and clinical outcomes in multivessel disease STEMI patients with diabetes mellitus.

Among patients with multivessel disease and ST-elevation myocardial infarction (MVD-STEMI), complete revascularization (CR) has been shown with improved outcomes. However, it is controversial whether diabetes mellitus (DM) status affects the outcomes. Quantitative flow ratio (QFR), as a newer non-invasive tool for identifying functional coronary stenosis and determining the presence of functional CR (FCR), may open up a new perspective for studying the above issues. The aim of this retrospective study was to investigate an association between QFR-based FCR and clinical outcomes in MVD-STEMI patients under DM status. A total of 623 patients were included in the final analysis. The patients were divided into nonDM cohort and DM cohort. Within each cohort, patients were further stratified into functional CR (FCR) layer and functional incomplete revascularization (FIR) layer based on QFR assessment. The primary outcomes were 3-year major adverse cardiovascular events (MACEs), encompassing cardiac death, ischemia-driven revascularization (target vessel and non-target vessel), rehospitalization due to unstable angina pectoris, and non-fatal myocardial infarction. The incidence of MACEs was significantly lower in the FCR layer than in the FIR layer (12.6% vs 24.0%, log-rank P<0.001). In the nonDM cohort, the incidence of MACEs was also lower in the FCR layer than in the FIR layer (9.8% vs 18.5%, log-rank P = 0.032). Similar situations occurred in the DM cohort (16.1% vs 27.9%, log-rank P = 0.017). In addition, the multivariate Cox analysis showed that rSSQFR (QFR-derived residual SYNTAX score) was significantly associated with the increased risk of MACEs in the nonDM cohort (HR (95% CI) = 1.18 (1.10-1.26), P<0.001) and DM cohort (HR (95% CI) = 1.13 (1.09-1.18), P<0.001). ROC analysis showed adding rSSQFR into the model of clinical risk factors yielded a significant improvement in prediction of MACEs, especially in the DM cohort (AUC (95% CI) = 0.747 (0.675-0.819), P = 0.001) than in the nonDM cohort (AUC (95% CI) = 0.697 (0.602-0.791), P = 0.033). Furthermore, additional multivariate Cox analysis showed that rSSQFR was associated with the increased risk of MACEs in patients with moderate lesions (DS of 50%-89%) after procedure (HR (95% CI) = 1.16 (0.11-1.22), P<0.001). In patients with MVD-STEMI, the incidence of MACEs was lower in FCR than in FIR, and the decrease was particularly significant in the DM cohort. The association between QFR-derived rSSQFR and MACEs was independent of baseline characteristic differences, and rSSQFR provided higher prognostic predictive ability in DM cohort than in nonDM cohort. Additionally, QFR had the additional utility of identifying moderate residual lesions that require revascularization.

Diabetes Mellitus and Acute Facial Palsy: A Nationwide Population-Based Study

Introduction: Acute facial palsy, characterized by sudden hemifacial weakness, significantly impacts an individual’s quality of life. Despite several predisposing factors identified for acute facial palsy, the specific relationship between diabetes mellitus (DM) and acute facial palsy has not been comprehensively explored in recent studies. The aim of the study was to assess the risk of acute facial palsy in patients with DM using a nationwide population sample cohort. Methods: DM cohort and non-DM cohort were built using the Korean National Health Insurance Service-Sample Cohort which represents the entire population of the Republic of Korea from January 2002 to December 2019. The DM cohort comprised 92,872 patients with a record of medication and a diagnosis of DM. Individuals who had facial palsy before the diagnosis of DM were excluded. A comparison cohort comprised 1,012,021 individuals without DM matched sociodemographically in a 1:4 ratio. The incidence of Bell’s palsy (BP) and Ramsay Hunt syndrome (RHS) were evaluated in both cohorts. The risk factors for acute facial palsy were also assessed. Results: Among the 92,868 patients in the DM cohort, the incidence rate (IR) of BP and RHS were 31.42 (confidence interval [CI], 30.24–32.63) and 4.58 per 10,000 person-years (CI, 4.14–5.05), respectively. Among the 371,392 individuals in the non-DM cohort, the IR of BP was 22.11 per 10,000 person-years (CI, 21.62–22.59) and the IR of RHS was 2.85 per 10,000 person-years (CI, 2.68–3.02). IR ratios for BP and RHS were 1.42 (CI, 1.36–1.48) and 1.61 (CI, 1.43–1.80). In multivariate analysis, DM (hazard ratio [HR] 1.428), age (HR 1.008), and high comorbidity score (HR 1.051) were associated with increased risk of BP, and male (HR 0.803) and living in metropolis (HR 0.966) decreased the risk of BP. And DM (HR 1.615), high comorbidity score (HR 1.078), and living in metropolis (HR 1.201) were associated with increased risk for RHS. Conclusion: This study suggests that patients with DM had an increased risk of acute facial palsy including BP and RHS.

Strong association of lumbar disk herniation with diabetes mellitus: a 12-year nationwide retrospective cohort study.

Despite reports on the association between diabetes mellitus (DM) and lumbar disk herniation (LDH), large-scale, nationwide studies exploring this relationship are lacking. We aimed to examine the profiles of DM in individuals with LDH and explore the potential mechanisms underlying the development of these disorders. This retrospective, population-based study was conducted between 2008 and 2019 using data from the National Health Insurance (NHI) research database in Taiwan. The primary outcome was the date of initial LDH diagnosis, death, withdrawal from the NHI program, or end of the study period. In total, 2,662,930 individuals with and 16,922,546 individuals without DM were included in this study; 719,068 matched pairs were established following propensity score matching (1:1 ratio) for sex, age, comorbidities, smoking, alcohol consumption, antihyperglycemic medications, and index year. The adjusted risk for developing LDH was 2.33-fold (95% confidence interval: 2.29-2.37; P<0.001), age-stratified analysis revealed a significantly greater risk of LDH in every age group, and both males and females were approximately twice as likely to develop LDH in the DM compared with non-DM cohort. Individuals with DM and comorbidities had a significantly higher risk of developing LDH than those without, and the serial models yielded consistent results. Treatment with metformin, sulfonylureas, meglitinides, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, or alpha-glucosidase inhibitors was associated with a more than 4-fold increased risk of LDH in the DM cohort. DM was strongly associated with the long-term development of LDH; over the 12-year follow-up period, the cumulative risk of LDH was significantly higher in patients with than without DM (log-rank P<0.001). DM is associated with an increased risk of LDH, and advanced DM may indicate a higher risk of LDH.

Impact of radiation therapy and alpha-fetoprotein level on survival outcomes for patients with hepatocellular carcinoma: a population-based study.

The use of radiation therapy (RT) in hepatocellular carcinoma (HCC) remains a matter for debate. Recently published research indicate that advanced RT techniques may improve survival in patients with HCC. This study aimed to evaluate this hypothesis in a large-scale retrospective cohort. The effect of alpha-fetoprotein (AFP) was taken into account because of its important role in the prognosis of HCC. The Surveillance, Epidemiology, and End Results (SEER) database was queried for adults patients diagnosed 2010-2019 with HCC (≥ 18 years). The study population was divided into four groups: Non-radiation & AFP-positive (reference), Non-radiation & AF-negative, Radiation & AFP-positive, Radiation & AFP-negative. Distant metastasis (DM) was used as a stratification factor. Differences in 5-year overall survival (OS) of the four groups were assessed using the Kaplan-Meier method. Univariate and multivariable Cox proportional hazards model were used to estimate unadjusted and adjusted hazard ratios (HR). A total of 34,656 patients were eligible for this analysis, including 21,084 (60.8%), 8,449 (24.4%), 3,810 (11.0%) and 1,313 (3.8%) in the Non-radiation & AFP-positive, Non-radiation & AF-negative, Radiation & AFP-positive and Radiation & AFP-negative groups, respectively. Median OSs of the four groups were 3, 4, 5 and 11 months in the DM cohort, and 12, 28, 15, and 28 months in the Non-DM cohort. Patients in the Radiation & AFP - group had the best OS and patients in the Non-radiation & AFP + group had the worst OS (adjusted HR [95% confidence interval (CI)]: 0.497 [0.399-0.619] in the DM cohort, and 0.405 [0.372-0.441] in the Non-DM cohort). Radiation & AFP + also showed improved survival compared with the reference group (adjusted HR [95%CI]: 0.725 [0.657-0.801] in the DM cohort, and 0.630 [0.600-0.661] in the Non-DM cohort). This population-based cohort study confirmed a significant improvement in overall survival with radiation therapy in HCC. AFP-negative patients benefit the most from RT. Superior OS of radiation therapy and AFP-negative status persisted even in patients with complex metastasis patterns. Our data suggest that radiation may provide an alternative modality for unresectable HCC.

Risk and dose-response relationship of diabetes mellitus for endophthalmitis after cataract surgery in a nationwide cohort study in Taiwan.

To investigate the risk of endophthalmitis after cataract surgery in patients with diabetes mellitus (DM) and evaluate the dose-response relationship. This retrospective cohort study enrolled patients who underwent bilateral cataract surgeries from 2000 to 2017 in Taiwan National Health Insurance Research Database. The endophthalmitis rates within 3 months after cataract surgery were compared between DM and non-DM cohorts using a generalised estimating equation. The diabetes complications severity index (DSCI) score was adopted to assess the dose-response effect on the endophthalmitis rate. A total of 883 398 patients (1 766 796 eyes) were included. Patients with DM had an increased risk of endophthalmitis after cataract surgery than patients without DM (0.261% vs. 0.242%, adjusted odds ratio = 1.09, 95% confidence interval = 1.03-1.16). The higher endophthalmitis rate in the DM group than in the non-DM group remains after excluding those with prior vitrectomy or intravitreal injection (IVI), and took IVI between the cataract surgery and endophthalmitis (p = 0.0156, 0.0048, and 0.0139). There was a significant dose-response relationship on the likelihood of endophthalmitis in DM patients when DCSI score >10. The endophthalmitis rate is highest among DM complications in patients with metabolic disorders (0.342%). DM was a risk factor for endophthalmitis after cataract surgery after adjusting for age, sex, common systemic disorders, and excluding those with prior vitrectomy or IVI and having IVI between cataract surgery and endophthalmitis. A dose-response relationship was noted in DM patients with a DCSI score >10.

Five-Year Outcomes after Paclitaxel Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Diabetic and Chronic Limb-Threatening Ischemia Cohorts: IN.PACT Global Study Post Hoc Analysis

PurposeTo summarize the 5-year outcomes of drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with diabetes mellitus (DM) or chronic limb-threatening ischemia (CLTI) compared to non-DM and intermittent claudication (IC).MethodsThe IN.PACT Global study was a real-world prospective, multicenter, international, single-arm study that enrolled 1535 participants. Post hoc analyses were conducted for participants with DM (n = 560) versus non-DM (n = 842) and CLTI (n = 156) versus IC (n = 1246). Assessments included freedom from clinically driven target lesion revascularization (CD-TLR) through 60 months, a composite safety outcome (freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and freedom from CD-target vessel revascularization within 60 months), and major adverse events (MAEs).ResultsKaplan–Meier estimates of 60-month freedom from CD-TLR were 67.7% and 70.5% (p = 0.25) in the DM and non-DM cohorts; and 60.7% and 70.5% (p = 0.006) in the CLTI and IC cohorts. The Kaplan–Meier 60-month composite safety outcomes were 65.1% DM versus 68.9% non-DM (p = 0.12); 53.2% CLTI versus 69.1% IC (p < 0.001). Between DM and non-DM, MAE rates were not significantly different through 60 months except for all-cause mortality which was higher in DM (23.8% versus 16.6%; p < 0.001). Participants with CLTI had a higher cumulative incidence of major target limb amputation (6.8% versus 1.1%; p < 0.001) and all-cause mortality (37.4% versus 17.4%; p < 0.001) through 60 months compared to IC.ConclusionsIn this real-world study, 5-year reintervention rates following DCB angioplasty were similar between DM and non-DM, but mortality rates were expectedly higher in patients with DM. Reintervention, mortality, and amputation rates were all higher in CLTI patients compared to IC, which is consistent with the known frailty of this patient population.Level of EvidenceLevel 3, Non-randomized controlled cohort/follow-up study

Severe hypoglycaemia in adults presenting to a hospital emergency department: Clinical characteristics, comorbidities, and mortality outcomes.

To determine the clinical characteristics, risk factors and mortality outcomes associated with severe hypoglycaemia (SH) treated at a hospital emergency department. Adult patients presenting with SH to the Northern General Hospital, Sheffield, UK over a 44-month period were assessed for clinical characteristics, coexisting comorbidities and mortality outcomes, including cause of death, and analysed by age of diabetes onset, below and above age 40 years. Factors that predicted mortality were determined. A total of 619 episodes of SH occurred in 506 individuals. Most had type 1 (T1D; n = 172 [34.0%]) or type 2 diabetes (T2D; n = 216 [42.7%]), but several attendees did not have diabetes (non-DM; n = 110 [21.7%]). Irrespective of age of diabetes onset, patients with T2D had more socioeconomic deprivation and comorbidities (P < 0.005). SH was uncommon in those with young-onset T2D, who constituted 7.2% of all episodes in diabetes. Hospital admission was high (60%-75%). The T2D cohort had the longest inpatient stay (median 5 days, vs. 2 and 3 days for the T1D and non-DM cohorts, respectively). Survival after the index SH episode was lower and mortality was higher in the non-DM (39.1%) and T2D (38.0%) cohorts than the T1D cohort (13.3%; all P < 0.05), with a median time to death of 13, 113 and 465 days, respectively. Most deaths (78%-86%) were from non-cardiovascular causes. Charlson index predicted mortality and poor survival in T1D and T2D (both P < 0.05). Severe hypoglycaemia requiring emergency hospital treatment is associated with non-cardiovascular deaths and exerts a disproportionately greater impact on mortality in people with T2D and those without diabetes. Multimorbidity is an important risk factor for SH and increases mortality risk.

Comparable Short-Term Weight Loss and Safety of Endoscopic Sleeve Gastroplasty in Diabetic and Non-diabetic Patients.

Endoscopic sleeve gastroplasty (ESG) is a highly effective endo bariatric procedure. Data on outcomes of ESG in patients with diabetes mellitus (DM) compared to non-diabetics are limited. We aim to assess differences in clinical outcomes of ESG in DM patients in North America. We used the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program database from 2016 to 2021 to identify all DM patients who underwent ESG as the primary procedure for weight loss. A 1:1 propensity score matched cohort of non-DM patients served as controls. Patient characteristics, clinical outcomes, and complications were compared and analyzed. Adult patients with Class I obesity and above were included. After matching, 310 DM and non-DM patients that underwent ESG were compared. The median % BMI decrease (3.3% vs. 3.1%, P = 0.62) and median total body weight loss (%TBWL) (4.3% vs. 4%, P = 0.75) in 30days were similar in the DM compared to non-DM cohorts. A similar proportion of patients with major adverse events (AEs) were presentafter ESG in the DM (1.6% vs. 1.3%, P = 0.74) compared to the non-DM cohort. The DM cohort had more patients with 30-day readmissions (3.2% vs. 1.9%, P = 0.08) than the non-DM cohort. %TBWL was similar in patients with HbA1c < 9% compared to ≥ 9%, (4.3% each, P = 0.33) with comparable AEs. ESG is a safe procedure in DM patients, without an increase in AEs, and it shows similar short-term weight loss compared to non-DM patients.

Need for improving immunization status and preventive care in diabetes mellitus patients.

The incidence and the comorbidities, such as infectious diseases (e.g. pneumonia or influenza) of diabetes mellitus are increasing. Therefore, the purpose of this study is to investigate immunization status and preventive care in diabetes mellitus patients. Two groups from the Austrian health interview survey 2014 were identified, acohort of diabetes mellitus (DM) individuals (n = 678) and anon-diabetes mellitus (non-DM) cohort (n = 15,093). The frequencies of doctors' visits, preventive care and immunization status were compared. Furthermore, the study population was divided by age (> 50years, < 50years) and differences between > 50years old DM with < 50years old DM and the > 50years old DM and > 50years old Non-DM cohort were investigated. In the DM cohort ahigher frequency of influenza immunization (13.3% vs. 7.1%, p < 0.001), doctor visits (89.4% vs. 75.4%, p < 0.001), and preventive care, such as colonoscopy (11.2% vs. 6.8%, p < 0.001) and hemoccult tests (32.6% vs. 22.1%, p < 0.001) was observed. Even though older DM individuals have ahigher risk for complications, the > 50 years DM cohort has similar frequencies of colonoscopy, hemoccult test and immunization against influenza and TBE (tick-borne encephalitis) compared to > 50 years Non-DM. Although the > 50 years old DM cohort had ahigher frequency of doctors' visits, they still had lower frequencies of mammography and dentists' visits compared to > 50 years old Non-DM. In comparison to the < 50 years old DM cohort, the > 50 years DM cohort was related to lower intact immunization status of tetanus, diphtheria, Polio and TBE. Still a higher frequency of intact immunization of pneumococcus, influenza and doctors' visits in the > 50years old DM cohort compared to the < 50years old DM cohort can be reported. Preventive care and immunization status in the DM cohort just differ slightly from the general cohort but still should be improved.

Effects of diabetes mellitus on post-intervention coronary physiological assessment derived by quantitative flow ratio in patients with coronary artery disease underwent percutaneous coronary intervention

AimsTo compare the prognostic implication of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) assessment in patients with and without diabetes enrolled in the all-comers, multicenter, randomized controlled PANDA III trial. MethodsAll treated vessels in PANDA III trial were retrospectively assessed for post-PCI QFR. Vessels with available post-PCI QFR were further stratified into DM and non-DM cohorts, and prognostic performance of post-PCI QFR was compared in 2 cohorts. The primary outcome was 2-year vessel-oriented composite endpoint (VOCE), defined as composite of vessel-related cardiac death, vessel-related non-procedural myocardial infarction, and ischemia-driven target vessel revascularization. ResultsOf 2,989 treated vessels, 2,227 (74.5%) with available post-PCI QFR were included, while 548 were presence of DM and 1,679 were not. The performance of post-PCI QFR to predict 2-year VOCE were moderate in both DM (area under the curve [AUC] 0.77, 95% confidence interval [CI]: 0.68 to 0.87) and non-DM cohorts (AUC 0.74, 95% CI: 0.67 to 0.82), while between-cohorts AUC difference was not significant (ΔAUC 0.03, P = 0.65). After multivariate adjustment, vessels with suboptimal post-PCI QFR results (≤0.92) were associated with higher risk of 2-year VOCE in both DM (adjusted HR 6.24, 95% CI: 2.40 to 16.2) and non-DM cohorts (adjusted HR 5.92, 95% CI: 3.28 to 10.7) without significant interaction (P for interaction 0.91). ConclusionsThis study, the first to directly compare clinical value of post-PCI QFR assessments in patients with and without DM, showed that a higher post-PCI QFR value was associated with improved long-term prognosis regardless of the presence of DM.Clinical Trial Registration Information URL: https://www.clinicaltrials.gov; Unique identifier: NCT02017275.

COVID-19 mortality risk assessments for individuals with and without diabetes mellitus: Machine learning models integrated with interpretation framework

This research develops machine learning models equipped with interpretation modules for mortality risk prediction and stratification in cohorts of hospitalised coronavirus disease-2019 (COVID-19) patients with and without diabetes mellitus (DM). To this end, routinely collected clinical data from 156 COVID-19 patients with DM and 349 COVID-19 patients without DM were scrutinised. First, a random forest classifier forecasted in-hospital COVID-19 fatality utilising admission data for each cohort. For the DM cohort, the model predicted mortality risk with the accuracy of 82%, area under the receiver operating characteristic curve (AUC) of 80%, sensitivity of 80%, and specificity of 56%. For the non-DM cohort, the achieved accuracy, AUC, sensitivity, and specificity were 80%, 84%, 91%, and 56%, respectively. The models were then interpreted using SHapley Additive exPlanations (SHAP), which explained predictors’ global and local influences on model outputs. Finally, the k-means algorithm was applied to cluster patients on their SHAP values. The algorithm demarcated patients into three clusters. Average mortality rates within the generated clusters were 8%, 20%, and 76% for the DM cohort, 2.7%, 28%, and 41.9% for the non-DM cohort, providing a functional method of risk stratification.

Diabetes mellitus is associated with an increased incidence of aortic valve stenosis.

Background:The prognosis of patients with diabetes mellitus (DM) is particularly determined by vascular comorbidities. A recent theory implies that DM could also promote aortic valve stenosis (AS). The present study investigates this association in a large collective of outpatients.Methods:This retrospective cohort study compared the incidence of AS in patients with an initial diagnosis of type 2 DM and a matched non-DM cohort in 809 general and diabetologist practices in Germany between January 2005 and December 2018. Cox regression models were performed to study the association between type 2 DM and AS incidence.Results:A total of 78,805 patients with type 2 DM and 78,805 patients without diabetes were analysed. Diabetes patients were more frequently diagnosed with obesity (52% vs 21%). Four percent of patients with and three percent of without diabetes were diagnosed with AS (p < 0.001). Diabetes was significantly associated with an increased incidence of AS (HR: 1.36, p < 0.001). This association was higher in men (HR: 1.41) versus women (HR: 1.30). The strongest association was observed in young patients (18–50 years, HR: 2.35, p < 0.001).Conclusion:In our study, diabetes patients had a higher incidence of aortic stenosis during their disease course.

Effects of diabetes mellitus on the rate of carpal tunnel release in patients with carpal tunnel syndrome

The objective of this study was to evaluate the effects of diabetes mellitus (DM) on the rate of carpal tunnel release (CTR) using a large nationwide cohort in Korea and to identify risk factors, including comorbidities and socioeconomic status (SES), associated with CTR. Patients with a primary or secondary diagnosis of carpal tunnel syndrome (CTS; ICD-10 code: G560) were selected and divided into two groups according to the presence of DM. A Cox proportional hazard model was used to assess the rate of CTR between the two groups. To evaluate the influence of demographic factors, comorbidities, and SES on CTR, multivariate Cox proportional hazard regression models were used to adjust for confounding variables. In total, 12,419 patients with CTS were included in the study: 2487 in DM cohort and 9932 in non-DM cohort. DM duration was negatively related with the rate of CTR (HR = 0.89, 95% CI 0.87–0.91) in CTS patients with DM. The rate of CTR was decreased in patients with DM compared to those without DM in the unadjusted model; however, after adjusting for comorbidities, DM had no significant effect on the rate of CTR. Female sex (HR = 1.50, 95% CI 1.36–1.67) correlated with the rate of CTR, and an inverse relationship between the number of comorbidities and CTR was found (p < 0.001) irrespective of DM. Diabetic polyneuropathy (DPN) was not associated with CTR, and we did not find any factors correlating with CTR in DPN patients. We found that CTS patients with more comorbidities or combined with a longer duration of DM were undertreated in real-word practice. Actual outcomes of CTR in CTS patents with various comorbidities should be investigated in future studies for optimal management of CTS.

197 Amniotic fluid levels in pregnancies affected by diabetes

While diabetes is recognized as a risk factor for polyhydramnios (PH), the distribution of amniotic fluid levels (AF) among pregnancies affected by diabetes (DM) is inadequately studied in contemporary populations. We sought to compare the distribution of AF levels, as well as rates and severity of PH, between DM and non-DM cohorts. We performed a retrospective cohort study of non-anomalous singleton gestations who had an ultrasound examination (USE) in the 3rd trimester at any of 17 academically affiliated ultrasound units. All USE were performed by RDMS. Pregnancies were separated into those with and without DM (both gestational and pregestational). We computed gestational age specific AFI and DVP centiles for both groups following logarithmic transformation of the AF measurements. Rates of PH, both overall and by gradations of severity were compared between groups for AFI and DVP using logistic regression. PH was defined according to SMFM guidelines. Rates of PH were determined on a per pregnancy basis, and a diagnosis of PH at any gestational age was considered a positive finding. There were 71,893 USE of singleton pregnancies with recorded AFI and DVP. Of these, 8,275 (11.5%) had a fetal anomaly and were excluded. The final study group consisted of 63,618 USE from 28,070 pregnancies. There were 4,225 (15.1%) pregnancies with DM and 23,845 (84.9%) without DM. The AFI and DVP were significantly higher in the diabetic cohort between 28-36 weeks with no significant differences at 37 weeks or greater (Figure 1; DVP not shown). Using AFI, the rate of PH was 10.5% vs 3.8% (OR 2.95; 95% CI 2.62-3.32) for pregnancies with vs without DM, respectively. Using DVP, the rate of PH was 13.9% vs 5.4% (OR 2.84; 95% CI 2.56-3.15). A breakdown by severity, method of measurement, and type of DM is shown in Figure 2. Within our study population, pregnancies affected by DM had increased levels of AF between 28-36 weeks. Rates of polyhydramnios are nearly 3x higher in pregnancies affected by DM and vary by DM classification.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

The Impact of Diabetes Mellitus on the Second Primary Malignancies in Colorectal Cancer Patients

IntroductionAll colorectal cancer (CRC) survivors have an increased risk of developing second primary malignancies (SPMs). The association between diabetes mellitus (DM) and the risk of cancer is well known. However, the role of DM and its therapy in the development of SPMs in CRC patients is not well described.MethodsIn this single-institutional retrospective analysis we identified 1,174 colorectal carcinoma patients, median follow-up 10.1 years, (median age 63 years, 724 men). All patients over 18 years with histologically confirmed CRC who were admitted in the period 1.1. 2003- 31.12.2013 and followed-up till 31.12. 2018 at the Masaryk Memorial Cancer Institute (MMCI) were screened for eligibility. The exclusion criteria were CRC diagnosed at autopsy, lost to follow-up and high risk of development of SPMs due to hereditary cancer syndrome. Tumours are considered multiple primary malignancies if arising in different sites and/or are of a different histology or morphology group. Comparisons of the basic characteristics between the patients with SPM and the patients without SPM were performed as well as comparison of the occurrence of SPMs by the site of diagnosis between the DM and non-DM cohorts and survival analyses.ResultsA SPM was diagnosed in 234 (20%) patients, DM in 183 (15%) patients. DM was diagnosed in 22.6% of those with SPM vs. in 13.8% of those without SPM (p=0.001). The most common types of SPMs in DM patients were other CRC, kidney, lung, bladder and nonmelanoma skin cancer, but only carcinoma of the liver and bile duct tracts was significantly more common than in the group without DM. Although breast cancer was the second most common in the group with DM, its incidence was lower than in the group without DM, as well as prostate cancer. A significantly higher incidence of SPMs was found in older CRC patients (≥ 65 years) and in those with lower stage colon cancer and DM. No significant difference in DM treatment between those with and without a SPM was observed including analysis of type of insulin.ConclusionCRC patients with diabetes mellitus, especially those with older age, and early stages of colon cancer, should be screened for second primary malignancies more often than the standard population. Patients without DM have longer survival. According to the occurrence of the most common second malignancies, a clinical examination, blood count, and ultrasound of the abdomen is appropriate, together with standard breast and colorectal cancer screening, and lung cancer screening under certain conditions, and should be recommended in CRC survivors especially in patients with intercurrent DM, however the necessary frequency of screening remains unclear.

Ticagrelor or Prasugrel in Patients With Acute Coronary Syndromes and DiabetesMellitus.

The aim of this study was to assess the efficacy and safety of ticagrelor versus prasugrel in patients with diabetes mellitus (DM) presenting with acute coronary syndromes (ACS) in whom invasive therapy was planned. The efficacy and safety of ticagrelor versus prasugrel in patients with ACS with DM undergoing invasive treatment remain unknown. This pre-specified analysis of the ISAR-REACT (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) 5 trial included 892 patients with ACS with DM and 3,124 patients with ACS without DM randomized to prasugrel or ticagrelor. The primary endpoint was a composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding (both assessed 12months after randomization). The primary endpoint occurred in 51 patients (11.2%) in the ticagrelor group and 55 patients (13.0%) in the prasugrel group in the DM cohort (hazard ratio: 0.84; 95% confidence interval: 0.58 to 1.24; p=0.383) and in 132 patients (8.6%) in the ticagrelor group and 81 patients (5.2%) in the prasugrel group in the non-DM cohort (hazard ratio: 1.70; 95% confidence interval: 1.29 to 2.24; p<0.001). There was a significant treatment arm-by-diabetic status interaction (pint=0.0035). Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 27 patients (6.9%) in the ticagrelor group and 19 patients (5.5%) in the prasugrel group (p=0.425) in the DM cohort and in 68 patients (5.2%) in the ticagrelor group and 60 patients (4.6%) in the prasugrel group in the non-DM cohort (p=0.500). DM seems to affect the efficacy of ticagrelor and prasugrel in patients with ACS. In patients with DM, the efficacy of ticagrelor was comparable with that of prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome [ISAR-REACT 5]; NCT01944800).

A risk stratification scoring system for new-onset atrial fibrillation after ischemic stroke: A National cohort study.

Atrial fibrillation (AF) is a major independent risk factor of stroke and anticoagulation therapy is needed in patients with AF after ischemic stroke. However, the detection rate of AF is low after ischemic stroke. Developing a prediction model for newly diagnosed AF after ischemic stroke will help to assess the subclinical AF.We identified 98,103 patients with diabetes mellitus (DM) and 261,893 patients without DM, who were not AF history and admitted for newly ischemic stroke from the National Health Insurance Research Database in Taiwan. The prediction model for 3-year incidence of AF after ischemic stroke was derived from multivariate logistic regression and also the accuracy rate of the prediction model was compared with CHA2DS2-VASC and CHADS2 scores as a reference.Four thousand nine hundred seventy six patients in the DM cohort and 16,127 patients in the non-DM cohort developed AF during 3 years of follow-up. The variables in the point-based prediction model for non-DM patients (range: -3-28), included age, heart failure, coronary artery disease, gout, obstructive pulmonary disease, hypertension, female, and statin use, while those for DM patients (range: -2-30) included age, heart failure, coronary artery disease, chronic kidney disease, hypertension, obstructive pulmonary disease, and statin use. Compared to the CHADS2 and CHA2DS2-VASc scoring systems, this scoring system was better at predicting 3-year risk of AF after ischemic stroke in both cohorts.This model might be useful in evaluating the benefit of insertable cardiac monitor implantation and anticoagulation agents in individual patients after ischemic stroke.

Impact of type 2 diabetes on postoperative outcome after hip fracture: nationwide population-based study in Taiwan

SummaryThe impact of diabetes mellitus (DM) on hip fracture (HFx) is still controversial. We used nationwide population-based data in Taiwan to observe postoperative outcomes of HFx in patients with type...

The Effects of Perioperative Dexamethasone on Glycemic Control and Postoperative Outcomes

Objective: Perioperative glucocorticoids are commonly given to reduce pain and nausea in patients undergoing surgery. However, the glycemic effects of steroids and the potential effects on morbidity and mortality have not been systematically evaluated. This study investigated the association between perioperative dexamethasone and postoperative blood glucose, hospital length of stay (LOS), readmission rates, and 90-day survival. Methods: Data from 4,800 consecutive orthopedic surgery patients who underwent surgery between 2000 and 2016 within a single health system were analyzed retrospectively. Results: Patients with and without diabetes mellitus (DM) who were given a single dose of dexamethasone had higher rates of hyperglycemia during the first 24 hours after surgery as compared to those who did not receive dexamethasone (hazard ratio [HR] was 1.81, and 95% confidence interval [CI] was [1.46, 2.24] for the DM cohort; HR 2.34, 95% CI [1.66, 3.29] for the nonDM cohort). LOS was nearly 1 day shorter in patients who received dexamethasone (geometric mean ratio [GMR] 0.79, 95% CI [0.75, 0.83] for patients with DM; GMR 0.75, 95% CI [0.72, 0.79] for patients without DM), and there was no difference in 90-day readmission rates. In patients without DM, dexamethasone was associated with a higher 90-day overall survival (99.07% versus 96.90%; P = .004). Conclusion: In patients with and without DM who undergo orthopedic surgery, perioperative dexamethasone was associated with a transiently higher risk of hyperglycemia. However, dexamethasone treatment was associated with a shorter LOS in patients with and without DM, and a higher overall 90-day survival rate in patients without DM, compared to patients who did not receive dexamethasone. Abbreviations: BMI = body mass index; CAD = coronary artery disease; CI = confidence interval; DM = diabetes mellitus; GMR = geometric mean ratio; HR = hazard ratio; IV = intravenous; LOS = length of stay; POD = postoperative day.