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AbstractObjectiveTo determine the efficacy and safety of low carbohydrate diets (LCDs) and very low carbohydrate diets (VLCDs) for people with type 2 diabetes.DesignSystematic review and meta-analysis.Data sourcesSearches of CENTRAL, Medline, Embase, CINAHL, CAB, and grey literature sources from inception to 25 August 2020.Study selectionRandomized clinical trials evaluating LCDs (<130 g/day or <26% of a 2000 kcal/day diet) and VLCDs (<10% calories from carbohydrates) for at least 12 weeks in adults with type 2 diabetes were eligible.Data extractionPrimary outcomes were remission of diabetes (HbA1c <6.5% or fasting glucose <7.0 mmol/L, with or without the use of diabetes medication), weight loss, HbA1c, fasting glucose, and adverse events. Secondary outcomes included health related quality of life and biochemical laboratory data. All articles and outcomes were independently screened, extracted, and assessed for risk of bias and GRADE certainty of evidence at six and 12 month follow-up. Risk estimates and 95% confidence intervals were calculated using random effects meta-analysis. Outcomes were assessed according to a priori determined minimal important differences to determine clinical importance, and heterogeneity was investigated on the basis of risk of bias and seven a priori subgroups. Any subgroup effects with a statistically significant test of interaction were subjected to a five point credibility checklist.ResultsSearches identified 14 759 citations yielding 23 trials (1357 participants), and 40.6% of outcomes were judged to be at low risk of bias. At six months, compared with control diets, LCDs achieved higher rates of diabetes remission (defined as HbA1c <6.5%) (76/133 (57%) v 41/131 (31%); risk difference 0.32, 95% confidence interval 0.17 to 0.47; 8 studies, n=264, I2=58%). Conversely, smaller, non-significant effect sizes occurred when a remission definition of HbA1c <6.5% without medication was used. Subgroup assessments determined as meeting credibility criteria indicated that remission with LCDs markedly decreased in studies that included patients using insulin. At 12 months, data on remission were sparse, ranging from a small effect to a trivial increased risk of diabetes. Large clinically important improvements were seen in weight loss, triglycerides, and insulin sensitivity at six months, which diminished at 12 months. On the basis of subgroup assessments deemed credible, VLCDs were less effective than less restrictive LCDs for weight loss at six months. However, this effect was explained by diet adherence. That is, among highly adherent patients on VLCDs, a clinically important reduction in weight was seen compared with studies with less adherent patients on VLCDs. Participants experienced no significant difference in quality of life at six months but did experience clinically important, but not statistically significant, worsening of quality of life and low density lipoprotein cholesterol at 12 months. Otherwise, no significant or clinically important between group differences were found in terms of adverse events or blood lipids at six and 12 months.ConclusionsOn the basis of moderate to low certainty evidence, patients adhering to an LCD for six months may experience remission of diabetes without adverse consequences. Limitations include continued debate around what constitutes remission of diabetes, as well as the efficacy, safety, and dietary satisfaction of longer term LCDs.Systematic review registrationPROSPERO CRD42020161795.

The aim of this study was to investigate the effects of 24-week synbiotic supplementation on chronic inflammation and the gut microbiota in obese patients with type 2 diabetes. We randomized 88 obese patients with type 2 diabetes to one of two groups for 24 weeks: control or synbiotic (Lacticaseibacillus paracasei strain Shirota (previously Lactobacillus casei strain Shirota) and Bifidobacterium breve strain Yakult, and galactooligosaccharides). The primary endpoint was the change in interleukin-6 from baseline to 24 weeks. Secondary endpoints were evaluation of the gut microbiota in feces and blood, fecal organic acids, high-sensitivity C-reactive protein, lipopolysaccharide-binding protein, and glycemic control. Synbiotic administration for 24 weeks did not significantly affect changes in interleukin-6 from baseline to 24 weeks (0.35 ± 1.99 vs. −0.24 ± 1.75 pg/mL, respectively). Relative to baseline, however, at 24 weeks after synbiotic administration there were positive changes in the counts of Bifidobacterium and total lactobacilli, the relative abundances of Bifidobacterium species such as Bifidobacterium adolescentis and Bifidobacterium pseudocatenulatum, and the concentrations of acetic and butyric acids in feces. No significant changes in inflammatory markers were found in the synbiotic group compared to the control group. However, synbiotic administration at least partially improved the gut environment in obese patients with type 2 diabetes.

Aims/Introduction We evaluated the effect of the MiniMed™ 770G, an insulin pump using hybrid closed‐loop technology, on blood glucose management and quality of life in Japanese people with type 1 diabetes. Materials and Methods This was a 52‐week, prospective, observational study. Fifty Japanese people with type 1 diabetes switched from the MiniMed™ 640G to 770G, and we analyzed the continuous glucose monitoring data of 24 subjects who used auto mode throughout the study. We also analyzed the scores of the Diabetes Therapy‐Related Quality of Life questionnaire completed by 26 auto‐mode users before and after the treatment change. Results The baseline time in range 70–180 mg/dL was 67.3 (54.8–78.4)%, with a significant improvement beginning 8 weeks after the switch and lasting until 52 weeks. The baseline time below range <70 mg/dL was 1.9 (0.6–3.6)%, with a significant increase at week 8; however, the mean value was less than 4% throughout the study period. On the other hand, the number of blood glucose measurements significantly increased. While there was no significant difference in the overall change in the total Diabetes Therapy‐Related Quality of Life score, there was a significant decrease in the treatment satisfaction score. Conclusions Use of the MiniMed™ 770G improved continuous glucose monitoring metrics. However, treatment satisfaction decreased, probably due to the increased frequency of blood glucose monitoring necessary to maintain auto mode. Use of the MiniMed™ 770G improved continuous glucose monitoring metrics. However, treatment satisfaction decreased, probably due to the increased frequency of blood glucose monitoring necessary to maintain auto mode.

Purpose To evaluate the 2-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema (DME) in the YOSEMITE Japan subgroup. Study design YOSEMITE/RHINE (NCT03622580/NCT03622593) subgroup analysis: global, multicenter, randomized, double-masked, active-comparator–controlled, phase 3 faricimab trials. Methods Patients were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W) and per treat-and-extend (T&E) dosing, or aflibercept 2.0 mg Q8W. Outcomes were assessed through year 2 for the YOSEMITE Japan subgroup (N = 60) and the pooled YOSEMITE/RHINE global cohort (N = 1891). Results In the YOSEMITE Japan subgroup, 21, 19, and 20 patients were randomized to faricimab Q8W, faricimab T&E, and aflibercept Q8W, respectively (632, 632, and 627 patients in the pooled YOSEMITE/RHINE cohort). Vision gains and anatomic improvements with faricimab at year 1 were maintained over 2 years and were generally consistent between groups. Mean best-corrected visual acuity changes from baseline at year 2 (weeks 92–100 average) for the YOSEMITE Japan subgroup were +12.5, +9.0, and +5.0 letters in the faricimab Q8W, faricimab T&E and aflibercept Q8W arms, respectively (+10.8, +10.4, and +10.3 letters in the pooled YOSEMITE/RHINE cohort). At week 96, 61.1% of the YOSEMITE Japan subgroup and 78.1% of the pooled YOSEMITE/RHINE cohort were on ≥ Q12W dosing. Faricimab was well-tolerated with a safety profile comparable with aflibercept. Conclusion Faricimab up to Q16W offered durable vision gains and anatomic improvements up to 2 years in patients with DME in the YOSEMITE Japan subgroup. Outcomes were generally consistent with the pooled YOSEMITE/RHINE cohort.

Background Incomplete clinical trials for pediatric drug development result in a lack of adequate scientific evidence for providing appropriate medication to pediatric populations; this is especially true for Japan. Thus, using the European Clinical Trials Database (EudraCT), this study aimed to identify the factors related to the study design and administration that lead to incompletion of clinical trials that included pediatric patients. Methods We focused on clinical trials that included patients under the age of 18 registered in the database, named as the European Clinical Trials Database between January 1, 2014, and December 31, 2018. Two groups of trials were identified: “all cases completed” and “not all cases completed,” reflecting whether they were completed in all participating countries/regions or not. To identify the factors of the occurrence of “not all cases completed,” a logistic regression analysis was performed to calculate the odds ratios and 95% confidence intervals. In total, 142 clinical trials (95 “all cases completed” and 47 “not all cases completed”) were analyzed. Results The logistic regression analysis showed the number of countries in which a clinical trial was conducted to be the only significant factor (odds ratio: 1.3; 95% confidence interval: 1.1-1.5); this was identified as the primary factor for the occurrence of “not all cases completed” in the clinical trials that included pediatric patients. Conclusion Our findings suggest that the feasibility of clinical trials that include pediatric patients, such as whether the countries in which the trial is to be conducted are suitable, must be considered prior to the trial.

Introduction Depressive tendencies associated with difficulty in the treatment of type 1 diabetes (T1D) could hinder appropriate intervention. Factors related to depressive tendencies in Japan remain unclear, though recent advances in medication may have affected them. Materials and methods Three hundred and fifty‐two Japanese patients with T1D registered in the Juntendo‐Aso Type 1 Diabetes (JAT‐1) Cohort Study were divided into two groups based on depressive tendencies assessed with the Beck Depression Inventory‐II score. We compared background characteristics of the patients between the groups and also analyzed additional clinical factors and quality of life scores. Results The patients with a Beck Depression Inventory‐II score ≧14 (35.5%) are classified as having depressive tendencies. Compared to the individuals without depressive characteristics, those with depressive tendencies had significantly higher proportions of females, welfare recipients, and shift workers; a higher proportion of individuals with microvascular complications; higher diastolic pressure; eating out or taking out food more frequently for dinner; lower protein intake; and higher scores in the total score of diabetes‐related problem domains and Pittsburgh Sleep Quality Index. Multiple regression analysis revealed that diastolic blood pressure, welfare recipient status, total score of diabetes‐related problem domains (PAID), and Pittsburgh Sleep Quality Index were significantly associated factors with BDI‐II score, and the PAID score showed the strongest association. Conclusions This study revealed that diabetes‐specific psychological burden, evaluated with the PAID score, is strongly associated with depressive tendencies. Routine use of the PAID could support the strategies to prevent depression in people with type 1 diabetes by identifying those at risk. We are conducting the Juntendo‐Aso Type 1 Diabetes cohort study, which is a prospective, 5‐year observational study of 352 adults with T1D in Japan. We used baseline data from the Beck Depression Inventory‐II scores and various clinical factors to investigate the prevalence of depression tendencies and their correlates.

Background Given the increasing number of dementia patients worldwide, a new method was developed for machine learning models to identify the ‘latent needs’ of patients and caregivers to facilitate patient/public involvement in societal decision making. Methods Japanese transcribed interviews with 53 dementia patients and caregivers were used. A new morpheme selection method using Z-scores was developed to identify trends in describing the latent needs. F-measures with and without the new method were compared using three machine learning models. Results The F-measures with the new method were higher for the support vector machine (SVM) (F-measure of 0.81 with the new method and F-measure of 0.79 without the new method for patients) and Naive Bayes (F-measure of 0.69 with the new method and F-measure of 0.67 without the new method for caregivers and F-measure of 0.75 with the new method and F-measure of 0.73 without the new method for patients). Conclusion A new scheme based on Z-score adaptation for machine learning models was developed to predict the latent needs of dementia patients and their caregivers by extracting data from interviews in Japanese. However, this study alone cannot be used to assign significance to the adaptation of the new method because of no enough size of sample dataset. Such pre-selection with Z-score adaptation from text data in machine learning models should be considered with more modified suitable methods in the near future.

PurposeIntraoperative injury to the popliteal artery (PA) should be avoided during total knee arthroplasty (TKA). This study was performed to clarify the preoperative localization of the PA and the patient factors that impact its localization as a preventive measure.MethodsNinety-seven patients (110 knees; 18 men, 79 women) with osteoarthritis who underwent primary TKA were retrospectively reviewed. Preoperative sagittal magnetic resonance imaging was used to measure the distance between the PA and the closest point at three levels: the femoral epicondyle (DPF), the tibial articular surface (DPAS), and the posterior tibial cortex (DPT). All variables are expressed in millimeters as median (interquartile range).ResultsThe median distance was 10.35 (7.90–12.34) mm for DPF, 6.32 (5.12–8.57) mm for DPAS, and 3.76 (2.28–5.26) mm for DPT. Body height and weight showed weak correlations with DPF (r = 0.324, p < 0.001 and r = 0.207, p = 0.03, respectively). DPF was smaller in women [9.82 (7.64–12.23) mm] than in men [11.27 (10.26–12.75) mm] (p = 0.004). A larger flexion angle and range of motion showed a weak negative correlation with DPT (r =  − 0.282, p = 0.003 and r =  − 0.236, p = 0.016, respectively). Multiple regression analysis revealed that DPF was related to body height (β = 0.341, p < 0.001) and that DPT was related to the flexion angle (β =  − 0.264, p = 0.005).ConclusionsSpecial attention should be paid to women with a small physique on the femoral side and/or patients with a large flexion angle on the tibial side as a strategy to prevent PA-related complications.

The FreeStyle Libre Flash Glucose Monitoring System allows users to obtain sensor glucose values by scanning with the reader or their mobile phone. We report a case of a 59‐year‐old man with type 1 diabetes mellitus who developed diabetic ketoacidosis due to a sensor defect. After replacing the sensor with a new one, the glucose value shown in the device was much lower than usual, which made him consider that he was hypoglycemic. Accordingly, he reduced his insulin dose and eventually developed diabetic ketoacidosis. He was unaware of the discrepancy due to the lack of self‐monitoring of his blood glucose, although he was educated to do. In sum, glucose monitoring with the FreeStyle Libre is helpful; however, it is necessary to remind the patient that a sensor defect leading to a severe complication frequently happens.

Background: A high proportion of type 2 diabetes cases are associated with host genetic and environmental factors. During the past decade, microorganisms that inhabit the gut have emerged as contributors to the pathogenesis of obesity and type 2 diabetes. Therefore, manipulation of the human gut microbiota will provide essential clues regarding new therapeutic targets for diabetes. Summary: Several studies have established the presence of gut dysbiosis in patients with type 2 diabetes mellitus, even though there are some differences among the studies that could be explained by differences in ethnicity, diet, and methodology. Gut dysbiosis affects the quality and quantity of short-chain fatty acids and secondary bile acids that act as signaling molecules in energy, glucose, and lipid metabolism. In addition, gut dysbiosis affect intestinal permeability. In particular, a high-fat diet can lead to changes in the gut microbiota that strongly reduce intestinal permeability due to the malfunction of tight junction proteins, such as occludin and ZO-1 [ 1 ]. The formation of leaky gut results in increased plasma levels of lipopolysaccharide, which activate Toll-like receptor 4 and result in innate and adaptive immune responses [ 2 ]. Key messages: Gut dysbiosis play an important role in the pathogenesis of obesity and diabetes, for example, via chronic low-grade inflammation. Normalizing gut dysbiosis could be a new approach to overcome diseases of insulin resistance, such as diabetes mellitus.