Effect of urgent surgery within 8 hours compared to surgery between 8 and 24 hours on perioperative complications and neurological prognosis in patients older than 70 years with cervical spinal cord injury: a propensity score-matched analysis.

OBJECTIVE: This study aimed to investigate the effect of surgery within 8 hours on perioperative complications and neurological prognosis in older patients with cervical spinal cord injury by using a propensity score-matched analysis. METHODS: The authors included 87 consecutive patients older than 70 years who had cervical spinal cord injury and who had undergone posterior decompression and fusion surgery within 24 hours of injury. The patients were divided into two groups based on the time from injury to surgery: surgery within 8 hours (group 8 hours) and between 8 and 24 hours (group 8-24 hours). Following the preliminary study, the authors established a 1:1 matched model using propensity scores to adjust for baseline characteristics and neurological status on admission. Perioperative complication rates and neurological outcomes at discharge were compared between the two groups. RESULTS: Preliminary analysis of 87 prematched patients (39 in group 8 hours and 48 in group 8-24 hours) revealed that the motor index score (MIS) on admission was lower for lower extremities (12.3 ± 15.5 vs 20.0 ± 18.6, respectively; p = 0.048), and total extremities (26.7 ± 27.1 vs 40.2 ± 30.6, respectively; p = 0.035) in group 8 hours. In terms of perioperative complications, group 8 hours had significantly higher rates of cardiopulmonary dysfunction (46.2% vs 25.0%, respectively; p = 0.039). MIS improvement (the difference in scores between admission and discharge) was greater in group 8 hours for lower extremities (15.8 ± 12.6 vs 9.0 ± 10.5, respectively; p = 0.009) and total extremities (29.4 ± 21.7 vs 18.7 ± 17.7, respectively; p = 0.016). Using a 1:1 propensity score-matched analysis, 29 patient pairs from group 8 hours and group 8-24 hours were selected. There were no significant differences in baseline characteristics, neurological status on admission, and perioperative complications between the two groups, including cardiopulmonary dysfunction. Even after matching, MIS improvement was significantly greater in group 8 hours for upper extremities (13.0 ± 10.9 vs 7.8 ± 8.3, respectively; p = 0.045), lower extremities (14.8 ± 12.7 vs 8.3 ± 11.0, respectively; p = 0.044) and total extremities (27.8 ± 21.0 vs 16.0 ± 17.5, respectively; p = 0.026). CONCLUSIONS: Results of the comparison after matching demonstrated that urgent surgery within 8 hours did not increase the perioperative complication rate and significantly improved the MIS, suggesting that surgery within 8 hours may be efficient, even in older patients.

Transient Sinus Node Dysfunction Associated with Herpes Simplex Encephalitis.

Sinus arrest and inappropriate sinus bradycardia are sinus node dysfunction (SND), which cause loss of consciousness. Cardiac pacing is recommended in patients with symptoms, such as syncope or dizziness. Several conditions can induce these arrhythmias; however, whether or not intracranial infectious diseases, such as herpes simplex encephalitis (HSE), can cause secondary SND is unclear. We encountered a patient with sinus arrest and transient sinus bradycardia associated with HSE. Since cardiac pause was never monitored and the bradycardia improved after HSE treatment, HSE was suspected to be the cause of SND. Although the underlying mechanisms have not yet been completely elucidated, HSE may cause secondary SND.

Epidemic Preventive Management during the Coronavirus Disease 2019 Pandemic Is a Risk Factor for Delirium after Spinal Cord Injury Surgery.

Introduction: Epidemic preventive management during the coronavirus disease 2019 (COVID-19) pandemic may have negatively impacted perioperative outcomes in patients with traumatic spinal cord injury (SCI). However, little is known about the relationship between epidemic preventive management and delirium after traumatic SCI. Here, we clarified the predictors of delirium after SCI surgery. Methods: We retrospectively analyzed 231 patients (mean age, 66 years) who underwent SCI surgery between 2017 and 2021. Patients were categorized into the delirium and non-delirium groups. Preoperative characteristics and laboratory data related to the occurrence of delirium were assessed. During the study period, we continued early surgical intervention. However, early rehabilitation intervention was not performed in the hospital rehabilitation room from May 2020 due to epidemic preventive management, which involved performing rehabilitation on the bed for 8 days postoperatively. Results: Postoperatively, 33 (14.3%) patients experienced delirium. Univariate analysis showed that age (p<0.01), presence of a psychiatric disorder (p<0.05), dementia (p<0.05), serum albumin (p<0.05) and hemoglobin (p<0.01) levels, American Society of Anesthesiologists classification score (p<0.05), and treatment during the COVID-19 pandemic (p<0.01) differed significantly in the delirium and non-delirium groups. Multivariate logistic regression analysis showed that an age ≥73 years (odds ratio [OR], 15.78; 95% confidence interval [CI], 4.54-54.80; p<0.01), treatment during the COVID-19 pandemic (OR, 3.85; 95% CI, 1.61-9.22; p<0.01), and psychiatric disorder (OR, 29.38; 95% CI, 5.63-153.43; p<0.01) were associated with delirium. Conclusions: Our comprehensive preventive management during the COVID-19 pandemic was identified as one of the risk factors for delirium after SCI surgery. Patients with preventive management should be cautioned regarding the risk of delirium.

The Impact of Diffuse Idiopathic Skeletal Hyperostosis on Nutritional Status, Neurological Outcome, and Perioperative Complications in Patients with Cervical Spinal Cord Injury.

This retrospective study aimed to investigate the characteristics of patients with cervical spinal cord injuries (CSCI) with diffuse idiopathic skeletal hyperostosis (DISH). We included 153 consecutive patients with CSCI who underwent posterior decompression and fusion surgery. The patients were divided into two groups based on the presence of DISH. Patient characteristics, neurological status on admission, nutritional status, perioperative laboratory variables, complications, neurological outcomes at discharge, and medical costs were compared between the groups. The DISH group (n = 24) had significantly older patients (72.1 vs. 65.9, p = 0.036), more patients with low-impact trauma (62.5% vs. 34.1%, p = 0.009), and a lower preoperative prognostic nutritional index on admission (39.8 vs. 42.5, p = 0.014) than the non-DISH group (n =129). Patients with DISH had significantly higher rates of ventilator management (16.7% vs. 3.1%, p = 0.022) and pneumonia (29.2% vs. 8.5%, p = 0.010). There was no significant difference in medical costs and neurological outcomes on discharge. Patients with CSCI and DISH were older, had poor nutritional status, and were prone to postoperative respiratory complications, while no differences were found between the neurological outcomes of patients with CSCI with and without DISH.

Complications Associated with Preventive Management to Reduce the Risk of COVID-19 Spread After Surgery for Spinal Cord Injury.

BACKGROUND: Preventive management to reduce the risk of coronavirus disease-2019 (COVID-19) spread led to delays in active rehabilitation, which may have negatively impacted the outcomes of patients with traumatic spinal cord injury (SCI). Therefore, the aim of this study was to clarify the influence of preventive management on the rate of perioperative complications after surgical treatment for SCI. METHODS: This single-center retrospective study examined the cases of 175 patients who had SCI surgery between 2017 and 2021. We could not continue early rehabilitation interventions starting on April 30, 2020, because of our preventive management to reduce the risk of COVID-19 spread. Using a propensity score-matched model, we adjusted for age, sex, American Spinal Injury Association impairment scale score at admission, and risk factors for perioperative complications described in previous studies. Perioperative complication rates were compared between the COVID-19 pandemic and prepandemic groups. RESULTS: Of the 175 patients, 48 (the pandemic group) received preventive management. The preliminary analysis revealed significant differences between the unmatched pandemic and prepandemic groups with respect to age (75.0 versus 71.2 years, respectively; p = 0.024) and intraoperative estimated blood loss (152 versus 227 mL; p = 0.013). The pandemic group showed significant delays in visiting the rehabilitation room compared with the prepandemic group (10 versus 4 days from hospital admission; p < 0.001). There were significant differences between the pandemic and prepandemic groups with respect to the rates of pneumonia (31% versus 16%; p = 0.022), cardiopulmonary dysfunction (38% versus 18%; p = 0.007), and delirium (33% versus 13%; p = 0.003). With a propensity score-matched analysis (C-statistic = 0.90), 30 patients in the pandemic group and 60 patients in the prepandemic group were automatically selected. There were significant differences between the matched pandemic and prepandemic groups with respect to the rates of cardiopulmonary dysfunction (47% versus 23%; p = 0.024) and deep venous thrombosis (60% versus 35%; p = 0.028). CONCLUSIONS: Even with early surgical intervention, late mobilization and delays in active rehabilitation during the COVID-19 pandemic increased perioperative complications after SCI surgery. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Efficacy of a machine learning-based approach in predicting neurological prognosis of cervical spinal cord injury patients following urgent surgery within 24 h after injury.

We aimed to develop a machine learning (ML) model for predicting the neurological outcomes of cervical spinal cord injury (CSCI). We retrospectively analyzed 135 patients with CSCI who underwent surgery within 24 h after injury. Patients were assessed with the American Spinal Injury Association Impairment Scale (AIS; grades A to E) 6 months after injury. A total of 34 features extracted from demographic variables, surgical factors, laboratory variables, neurological status, and radiological findings were analyzed. The ML model was created using Light GBM, XGBoost, and CatBoost. We evaluated Shapley Additive Explanations (SHAP) values to determine the variables that contributed most to the prediction models. We constructed multiclass prediction models for the five AIS grades and binary classification models to predict more than one-grade improvement in AIS 6 months after injury. Of the ML models used, CatBoost showed the highest accuracy (0.800) for the prediction of AIS grade and the highest AUC (0.90) for predicting improvement in AIS. AIS grade at admission, intramedullary hemorrhage, longitudinal extent of intramedullary T2 hyperintensity, and HbA1c were identified as important features for these prediction models. The ML models successfully predicted neurological outcomes 6 months after injury following urgent surgery in patients with CSCI.

Paravertebral foramen screw fixation for posterior cervical spine surgery: clinical case series.

OBJECTIVE: The goal of this study was to clarify the clinical utility of paravertebral foramen screws (PVFSs) and to determine intraoperative indicators for appropriate screw placement during posterior cervical fusion surgery to improve its safety. METHODS: The authors included data from 46 patients (29 men and 17 women, mean age 61.7 years) who underwent posterior cervical spine surgery with 94 PVFSs. Of the 94 PVFSs, 77 were used in C6, 9 in C3, 5 in C4, and 3 in C5. According to the cervical lateral radiographic view, the authors divided the 94 PVFSs into 3 groups as follows: a longer group, in which the tip of PVFS was located anteriorly from the line of the posterior wall of the vertebral body (> +0 mm); an intermediate group, in which the screw tip was located up to 2 mm posteriorly to the posterior wall of the vertebral body (-2 to 0 mm); and a shorter group, in which the screw tip was located more than 2 mm posteriorly (< -2 mm). The accuracy of screw placement was assessed using CT imaging in the axial plane, and the proportion of screws penetrating a vertebral foramen or a transverse foramen was compared between the 3 groups. Screw loosening was defined as a lucent zone around the screw evaluated on cervical radiography at 1 year after surgery. Complications related to PVFS insertion and revision surgery related to PVFS were evaluated. RESULTS: The authors classified 25 PVFSs into the longer group, 43 into the intermediate group, and 26 into the shorter group. The proportion of screws penetrating a vertebral foramen was largest in the shorter group, and the proportion penetrating a transverse foramen was largest in the longer group. Screw loosening was confirmed for 3 of 94 PVFSs. One PVFS inserted in C6 unilaterally within a long construct from C2 to C7 showed loosening, but it did not cause clinical symptoms. Revision surgery was required for 2 PVFSs inserted in C3 bilaterally as the lower instrumented vertebra in occiput-cervical fusion because they pulled out. There was no neurovascular complication related to PVFS insertion. CONCLUSIONS: PVFSs are useful for posterior cervical fusion surgery as alternative anchor screws, and the line of the posterior wall of the cervical body on lateral fluoroscopic images is a potential intraoperative reference to indicate an appropriate trajectory for PVFSs.

Continuous local antibiotic perfusion for patients with surgical site infection after instrumented spinal surgery; a novel technique to retain the implants.

OBJECTIVES: To describe the novel technique of continuous local antibiotic perfusion (CLAP) for a surgical site infection (SSI) after instrumented spinal surgery. METHODS: CLAP was applied to 4 continuous patients at our institution who developed SSI after instrumented spinal surgery. RESULTS: All 4 patients were successfully treated and the infection was controlled. The implant was retained in all patients. The duration of CLAP ranged from 2 to 3 weeks. The blood level of the antibiotic used (gentamicin) at 1 week after the initiation of CLAP did not increase in any patient. No other adverse events occurred in any patient. Dramatic improvements in laboratory parameters, including the white blood cell (WBC) counts and C-reactive protein (CRP) levels were seen in every patient at 1 week after the initiation of CLAP. CONCLUSIONS: CLAP controlled the infection without severe adverse events in all 4 patients, and the implants were retained. Despite its cost and the discomfort of patients, CLAP may become an option for the treatment of SSIs after instrumented spinal surgery. A large number of case series are needed to verify the efficacy of CLAP for patients with SSIs after instrumented spinal surgery.

A Pilot Study of Intervention With a Mobile Application Visualizing the Macronutrient Content for Type 2 Diabetes at a Japanese Center.

BACKGROUND: Estimating the nutritional content of food is essential for self-management in people with type 2 diabetes mellitus, but it is a difficult skill to learn. The aim of this study was to investigate how diabetes management was impacted by the ability of patients to search for items they ate from a database of 26,300 different foods, and to visualize nutritional intake using the Japanese mobile application (app) "Calomeal." METHODS: This was a single-arm, single-center, pilot study. Eighteen outpatients with type 2 diabetes mellitus used the "Calomeal" app for 3 months. The primary endpoint was change in hemoglobin A1c (HbA1c). Secondary endpoints were changes in body weight (BW), lipid parameters, and quality of life scores. RESULTS: The baseline characteristics of the study subjects were as follows: age: 53.4 ± 7.8 years; male/female ratio: 11/7; HbA1c: 7.9 (7.58 - 8.23)%; and body mass index (BMI): 25.17 (21.63 - 28.59) kg/m2. Significant reductions in HbA1c and BMI were observed over 3 months (HbA1c: 7.9 (7.58 - 8.23)% to 7.6 (7.3 - 8.23)%, P = 0.0410; BMI: 25.17 (21.63 - 28.59) to 24.54 (21.57 - 27.81) kg/m2, P = 0.0057). Reductions in HbA1c and BMI both correlated with decreased carbohydrate intake estimated by the mobile app. CONCLUSIONS: Japanese patients who used their smartphones to visualize their nutritional intake using the "Calomeal" app demonstrated improved short-term glycemic control and BMI. Although the validity of the results should be tested in future randomized controlled trials, this approach may be a clinical option for improving self-management in Japanese patients with type 2 diabetes mellitus.

Correlation between osteoarthritis of the atlantoaxial facet joint and a high-riding vertebral artery.

BACKGROUND: A high-riding vertebral artery (HRVA) is an intraosseous anomaly that narrows the trajectory for C2 pedicle screws. The prevalence of a HRVA is high in patients who need surgery at the craniovertebral junction, but reports about HRVAs in subaxial cervical spine disorders are limited. We sought to determine the prevalence of HRVAs among patients with subaxial cervical spine disorders to elucidate the potential risk for VA injury in subaxial cervical spine surgery. METHODS: We included 215 patients, 94 were with a main lesion from C3 to C7 (subaxial group) and 121 were with a main lesion from T1 to L5 (thoracolumbar group). A HRVA was defined as a maximum C2 pedicle diameter of < 3.5 mm on axial CT. The sex, age of patients, body mass index (BMI), osteoarthritis of the atlantoaxial (C1-2) facet joints, and prevalence of a HRVA in the 2 groups were compared and logistic regression was used to identify the factors correlated with a HRVA. RESULTS: The patients in the subaxial group were younger than those in the thoracolumbar group, but their sex and BMI did not differ significantly between the 2 groups. The mean osteoarthritis grade of the C1-2 facet joints of patients in the subaxial group was significantly higher than that in those in the thoracolumbar group. A HRVA was found in 26 patients of 94 (27.7 %) in the subaxial group and in 19 of 121 (15.7 %) in the thoracolumbar group. The prevalence of a HRVA in the subaxial group was significantly higher and osteoarthritis of C1-2 facet joints correlated significantly with a HRVA. CONCLUSIONS: The prevalence of a HRVA in patients with subaxial cervical spine disorders is higher than in those without and osteoarthritis of the C1-2 facet joints is correlated with a HRVA.

Olfactory dysfunction predicts the development of dementia in older patients with type 2 diabetes.

AIMS: Olfactory dysfunction is associated with the transition from normal cognition to dementia in persons without type 2 diabetes. This study aimed to investigate whether olfactory dysfunction could be an early marker of future dementia in older patients with type 2 diabetes. METHODS: This exploratory study included 151 older Japanese outpatients with type 2 diabetes who did not have a diagnosis of probable dementia at baseline. A multivariate logistic regression model was used to determine whether Open Essence (OE) test score at baseline is associated with the development of probable dementia. RESULTS: Over 3 years, approximately 9% of the study subjects developed probable dementia. Subjects with olfactory dysfunction at baseline developed probable dementia more frequently than those without. Multivariate logistic regression showed that lower OE test score, higher age, lower Mini-Mental State Examination (MMSE) score, higher total protein concentration, and more frequent use of a sulfonylurea are significantly associated with the development of probable dementia. Stepwise multivariate regression analysis demonstrated that change in OE test score over 3 years is significantly associated with change in MMSE score. CONCLUSIONS: Our study suggested that olfactory dysfunction precedes the development of probable dementia in older patients with type 2 diabetes.

Effects of Synbiotic Supplementation on Chronic Inflammation and the Gut Microbiota in Obese Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Study.

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.

Methotrexate-related lymphoproliferative disorder of the lumbar spine origin presenting with severe low-back pain: case report.

The use of methotrexate (MTX) to treat rheumatoid arthritis (RA) is increasing. Recently, MTX-associated lymphoproliferative disorder (MTX-LPD) has been frequently reported as lymphoma occurring during MTX therapy. The authors report their experience with a relatively rare case of MTX-LPD presenting in the lumbar spine. The patient, a 73-year-old woman who experienced low-back pain while receiving MTX therapy for RA, was suspected of having developed MTX-LPD based on her medical history, images of the L1 vertebra, and transpedicular biopsy results. One week after discontinuing MTX, the patient's low-back pain reportedly improved. The woman was diagnosed with MTX-LPD based on histopathological findings. MTX discontinuation alone coincided with spontaneous tumor regression. Because MTX-LPD can occur in tissues other than lymph nodes, such as in bones and joints, it is a disease that should be considered when diagnosing spinal tumors in patients receiving MTX therapy.

One year follow-up after a randomized controlled trial of a 130 g/day low-carbohydrate diet in patients with type 2 diabetes mellitus and poor glycemic control.

BACKGROUND & AIMS: Recently, we conducted a prospective randomized controlled trial (RCT) showing that a 6-month 130g/day low-carbohydrate diet (LCD) reduced HbA1c and BMI more than a calorie restricted diet (CRD). [1] To assess whether the benefits of the LCD persisted after the intensive intervention, we compared HbA1c and BMI between the LCD and CRD groups at 1 year after the end of the 6-month RCT. METHODS: Following the end of the 6-month RCT, patients were allowed to manage their own diets with periodic outpatient visits. One year later, we analyzed clinical and nutrition data. RESULTS: Of the 66 participants in the original study, 27 in the CRD group and 22 in the LCD group completed this trial. One year after the end of the original RCT, the carbohydrate intake was comparable between the groups (215 [189-243]/day in the CRD group and 214 (176-262) g/day in the LCD group). Compared with the baseline data, HbA1c and BMI were decreased in both groups (CRD: HbA1c -0.4 [-0.9 to 0.3] % and BMI -0.63 [-1.20 to 0.18] kg/m2; LCD: HbA1c -0.35 [-1.0 to 0.35] % and BMI -0.77 [-1.15 to -0.12] kg/m2). There were no significant differences in HbA1c and BMI between the groups. CONCLUSIONS: One year after the diet therapy intervention, the beneficial effect of the LCD on reduction of HbA1c and BMI did not persist in comparison with CRD. However, combining the data of both groups, significant improvements in HbA1c and BMI from baseline were observed. Although the superiority of the LCD disappeared 1 year after the intensive intervention, these data suggest that well-constructed nutrition therapy programs, both CRD and LCD, were equally effective in improving HbA1c for at least 1 year. TRIAL REGISTRATION: University Hospital Medical Information Network (UMIN) ID000010663.

Safety and efficacy of metformin up-titration in Japanese patients with type 2 diabetes mellitus treated with vildagliptin and low-dose metformin.

BACKGROUND: This study investigated the safety and efficacy of metformin up-titration in Japanese patients with type 2 diabetes mellitus treated with vildagliptin (100 mg/day) and low-dose metformin (500 or 750 mg/day). RESEARCH DESIGN AND METHODS: Fifty patients were randomly allocated to the control group (maintaining the initial low-dose of metformin) and the dose increase group (up-titrating of metformin to 1,500-2,250 mg/day) for 24 weeks. The primary outcome was change in HbA1c from baseline to 24 weeks. RESULTS: Among the 25 patients allocated to the dose increase group, four patients were not able to complete the study protocol because of gastrointestinal symptoms. HbA1c in the dose increase group was significantly but modestly lower than in the control group (change in HbA1c: 0.22 ± 0.57 vs. -0.15 ± 0.58%, group comparison, P < 0.05). The dose increase group did not gain weight during the study period, and no hypoglycemic events were reported in both groups. The rate of gastrointestinal symptoms in the dose increase group was profoundly higher than in the control group (32 vs. 0%, P < 0.01). CONCLUSIONS: In Japanese patients with type 2 diabetes treated with vildagliptin and low-dose metformin, metformin up-titration significantly but modestly improved glycemic control without hypoglycemia and weight gain.

[A Case of Cardiopulmonary Arrest due to Difficult Mask Ventilation and Difficult Laryngoscopy in the Ward after Operation: A Case Report].

A 77-year-old man with paroxysmal atrial fibrillation and hypertrophic obstructive cardiomyopathy was scheduled for cervical laminoplasty. He was predicted difficult mask ventilation combined with difficult laryn- goscopy (CICV) because of short thyromental distance. After induction of general anesthesia, we attempted tracheal intubation using McGRATHO and Gum-elastic Bougie and the intubation was successful. After opera- tion, in ward, atrial fibrillation occurred. Because anti- arrhythmic agents were not effective, cardioversion was planned. While under sedation, his breathing stopped. The attending physician could not ventilate with mask and intubate with Macintosh laryngoscope. The patient went into cardiopulmonary arrest After successful intubation using McGRATH? and Gum- elastic Bougie by anesthesiologist The attending physi- cian did not recognize CICV. We should convey infor- mation of CICV surely and perform education about difficult airway management.

Synthesis of Tricyclic Benzazocines by Aza-Prins Reaction.

The aza-Prins reaction of 3-vinyltetrahydroquinolines with aldehydes proceeded smoothly in the presence of hydrogen halides, and the tricyclic benzazocine derivatives were isolated in good to high yields. The reaction would proceed through the formation and cyclization of the iminium ion intermediate.

A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control.

BACKGROUND & AIMS: The usefulness of low-carbohydrate diet (LCD) for Japanese patients with type 2 diabetes mellitus (T2DM) has not been fully investigated. Therefore, we compared the effectiveness and safety of LCD with calorie restricted diet (CRD). METHODS: This prospective, randomized, open-label, comparative study included 66 T2DM patients with HbA1c >7.5% even after receiving repeated education programs on CRD. They were randomly allocated to either the 130g/day LCD group (n = 33) or CRD group (n = 33). Patients received personal nutrition education of CRD or LCD for 30 min at baseline, 1, 2, 4, and 6 months. Patients of the CRD group were advised to maintain the intake of calories and balance of macronutrients (28× ideal body weight calories per day). Patients of the LCD group were advised to maintain the intake of 130 g/day carbohydrate without other specific restrictions. Several parameters were assessed at baseline and 6 months after each intervention. The primary endpoint was a change in HbA1c level from baseline to the end of the study. RESULTS: At baseline, BMI and HbA1c were 26.5 (24.6-30.1) and 8.3 (8.0-9.3), and 26.7 (25.0-30.0) kg/m2 and 8.0 (7.6-8.9) %, in the CRD and LCD, respectively. At the end of the study, HbA1c decreased by -0.65 (-1.53 to -0.10) % in the LCD group, compared with 0.00 (-0.68 to 0.40) % in the CRD group (p < 0.01). Also, the decrease in BMI in the LCD group [-0.58 (-1.51 to -0.16) kg/m2] exceeded that observed in the CRD group (p = 0.03). CONCLUSIONS: Our study demonstrated that 6-month 130 g/day LCD reduced HbA1c and BMI in poorly controlled Japanese patients with T2DM. LCD is a potentially useful nutrition therapy for Japanese patients who cannot adhere to CRD. This trial was registered at http://www.umin.ac.jp/english/ (University Hospital Medical Information Network: study ID number 000010663).

Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial.

OBJECTIVES: To assess the effect of treatment guidance based on data from a continuous glucose monitoring (CGM) device on glycaemic control, and patient satisfaction, in patients with type 2 diabetes mellitus (T2DM). METHODS: Patients with poorly-controlled T2DM treated with insulin were randomly assigned to the intervention or nonintervention group. Continuous blood-glucose levels were recorded for 4-5 days using a CGM device on three separate occasions during the 8-month study period. The intervention group received treatment guidance based on the CGM data; the nonintervention group received advice based on blood glucose and glycosylated haemoglobin (HbA1c) levels. RESULTS: A total of 34 patients were enrolled in the study. The mean ± SD baseline HbA1c was 8.2 ± 1.2% in the intervention group and 8.2 ± 0.9% in the nonintervention group. At the study end, there was no significant difference in the change from baseline of HbA1c between the two groups. There was also no significant difference in the change from baseline in the Diabetes Treatment Satisfaction Questionnaire score between the two groups. CONCLUSIONS: The present study did not demonstrate that treatment guidance using retrospective CGM data was effective for improving glycaemic control and therapeutic satisfaction in Japanese patients with T2DM.

Switching from Twice-Daily Basal Insulin Injections to Once-Daily Insulin Degludec Injection for Basal-Bolus Insulin Regimen in Japanese Patients with Type 1 Diabetes: A Pilot Study.

The aim of this study was to investigate the efficacy of insulin degludec used for basal-bolus insulin regimen after switching from twice-daily basal insulin in Japanese patients with type 1 diabetes mellitus. The subjects were 22 type 1 diabetes patients treated with basal-bolus insulin regimen with twice-daily basal insulin. Basal insulin was switched to once-daily injection of insulin degludec with 10% dose reduction. HbA1c and fasting plasma glucose (FPG) were measured before and 12 weeks after switching. The frequency of hypoglycemic episodes, standard deviation (SD) of blood glucose, and mean of daily difference (MODD) were evaluated by continuous glucose monitoring (CGM) before and 4 weeks after switching. HbA1c and FPG before and 12 weeks after switching were comparable (HbA1c 8.5 ± 1.4 versus 8.7 ± 1.6%, P = 0.28; FPG 203.2 ± 81.2 versus 206.5 ± 122.4 mg/dL, P = 0.91). The frequency of hypoglycemia during nighttime was not significantly different at 4 weeks after switching (14.4 ± 17.0 versus 11.1 ± 15.0%, P = 0.45). In addition, SD and MODD before and 4 weeks after switching were also comparable. In conclusion, glycemic control under once-daily insulin degludec injection was almost comparable to that under twice-daily basal insulin injections in Japanese type 1 diabetes patients. This study was registered with ID: UMIN000010474.