Risk of Cardiovascular Events in Patients With Diabetes Mellitus on ß-Blockers.

Although the use of ß-blockers may help in achieving maximum effects of intensive glycemic control because of a decrease in the adverse effects after severe hypoglycemia, they pose a potential risk for the occurrence of severe hypoglycemia. This study aimed to evaluate whether the use of ß-blockers is effective in patients with diabetes mellitus and whether its use is associated with the occurrence of severe hypoglycemia. Using the ACCORD trial (Action to Control Cardiovascular Risk in Diabetes) data, we performed Cox proportional hazards analyses with a propensity score adjustment. The primary outcome was the first occurrence of a cardiovascular event during the study period, which included nonfatal myocardial infarction, unstable angina, nonfatal stroke, and cardiovascular death. The mean follow-up periods (±SD) were 4.6±1.6 years in patients on ß-blockers (n=2527) and 4.7±1.6 years in those not on ß-blockers (n=2527). The cardiovascular event rate was significantly higher in patients on ß-blockers than in those not on ß-blockers (hazard ratio, 1.46; 95% confidence interval, 1.24-1.72; P<0.001). In patients with coronary heart disease or heart failure, the cumulative event rate for cardiovascular events was also significantly higher in those on ß-blockers than in those not on ß-blockers (hazard ratio, 1.27; 95% confidence interval, 1.02-1.60; P=0.03). The incidence of severe hypoglycemia was significantly higher in patients on ß-blockers than in those not on ß-blockers (hazard ratio, 1.30; 95% confidence interval, 1.03-1.64; P=0.02). In conclusion, the use of ß-blockers in patients with diabetes mellitus was associated with an increased risk for cardiovascular events.

Trends in prevalence and management of diabetes and related vascular risks in Japanese adults: Japan National Health and Nutrition Surveys 2003-2012.

AIMS: To examine temporal changes in health system performance for the control of diabetes and related risks for vascular complications in Japan over a decade. METHODS: Data of 51,128 individuals aged ≥20years were obtained from the National Health and Nutrition Surveys in 2003-2012. Diabetes was defined as currently being treated by insulin or oral hypoglycaemic agents or having a glycated haemoglobin (HbA1c) level ≥6.5% (≥48mmol/mol). We estimated the prevalence and proportions of people with diabetes being treated and achieving target goals of HbA1c <7.0% (<53mmol/mol), blood pressure <130/80mmHg, and non-high-density lipoprotein cholesterol <130mg/dL. All estimates were age-standardized using the Japanese population in 2010. RESULTS: The age-standardized prevalence of diabetes remained constant at approximately 8% and was significantly higher in men (P<0.001) and in individuals age ≥65years (P<0.001) throughout the study period. The proportion of people with diabetes being treated significantly increased from 41.8% (95% confidence interval, 37.2-46.5%) in 2003 to 54.9% (51.9-57.8%) in 2012, and the proportion of those having controlled HbA1c significantly increased from 13.4% (10.3-17.3%) in 2003 to 28.8% (26.3-31.5%) in 2012. These two rates were significantly higher in age ≥65years compared with younger adults in most of the survey years (P<0.05). The control rates of blood pressure and non-high-density lipoprotein cholesterol remained around 20% and 30-40%, respectively. CONCLUSIONS: Diabetes management in Japan has improved over the past decade but is still inadequate for prevention of vascular complications.

Cluster-randomized trial to improve the quality of diabetes management: The study for the efficacy assessment of the standard diabetes manual (SEAS-DM).

AIMS/INTRODUCTION: 'The Standard Diabetes Manual' has been developed by clinical researchers from multiple major institutions in Japan, such as the National Center for Global Health and Medicine, as a comprehensive disease management program, including collaboration between primary care physicians (PCPs) and specialist services. The present study evaluated the efficacy of the manual as a quality improvement strategy in diabetes care by PCPs. MATERIALS AND METHODS: A total of 42 PCPs in eight domestic districts of the Japan Medical Association were allocated to either the intervention group or the control group in a cluster-randomized design. The PCPs in both groups were provided with a copy of the Diabetes Treatment Guide published by the Japan Diabetes Society, and the PCPs in the intervention group additionally received a copy of the manual and a 30-min relevant seminar at the inception of the intervention. The primary end-point was the adherence to the following performances as quality indicators: evaluation of retinopathy, and urinary albumin excretion measurements and serum creatinine measurements, as recommended by the Japan Medical Association. RESULTS: A total of 416 patients were enrolled by 36 PCPs. During the 1-year follow-up period, the proportion of PCPs who adhered to recommendation-concordant measurements of urinary albumin excretion was significantly higher in the intervention group than in the control group (adherence: 17.9% vs 5.3%, P = 0.016). The other parameters were not statistically different between the two groups. CONCLUSIONS: Implementation of 'The Standard Diabetes Manual' potentially leads to an improved quality of diabetes management by PCPs.

Factors complicating the diabetes management of visitors to Japan: advices from a Japanese National Center for overseas medical staff.

Linguistic, cultural, and geographical differences might challenge the management of diabetes patients travelling in a culturally and linguistically homogeneous country. This article presents an instructive case and identifies various factors that can help in effective diabetes management of such cases. A Russian female patient aged 23 came to Japan and visited our hospital for a second opinion regarding glycemic control. She was diagnosed with type 1 diabetes at age three and started insulin injections and diet therapy with carbohydrate counting methods. Her HbA1c level was 11.0% with multiple daily insulin injections. She showed neuropathy, nephropathy, and blindness due to her progressed retinopathy. Because of the language barrier, suggestions for lifestyle modification were not effectively conveyed to the patient. We analyzed possible barriers to effective diabetes management in such foreign patients. In addition to language barriers and difficulties in diet therapy, dissimilar diabetes treatment guidelines, inadequate healthcare insurance, and stress-inducing conditions can be barriers to effective diabetes management. Foreign diabetes patients might face several barriers in effective management while travelling in Japan. Use of medical interpreters, adequate medical insurance, and trained medical staff will help in overcoming these barriers.

Effects of telephone-delivered lifestyle support on the development of diabetes in participants at high risk of type 2 diabetes: J-DOIT1, a pragmatic cluster randomised trial.

OBJECTIVES: To examine the effects of telephone-delivered lifestyle coaching on preventing the development of type 2 diabetes mellitus (T2DM) in participants with impaired fasting glucose (IFG). DESIGN: Cluster randomised trial. SETTING: 40 groups from 17 healthcare divisions in Japan: companies (31), communities (6) and mixed settings (3). PARTICIPANTS: Participants aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/L were invited from the 17 healthcare divisions. RANDOMISATION: The groups were then randomly assigned to an intervention or a control arm by independent statisticians according to a computer-generated list. INTERVENTION: The intervention arm received a 1-year telephone-delivered intervention provided by three private lifestyle support centres (at different frequencies: low-frequency (3 times), middle-frequency (6 times) and high-frequency (10 times) support calls). The intervention and control arms both received self-help devices such as a weight scale and pedometer. OUTCOMES: Participants were followed up using data from annual health check-ups and a questionnaire regarding lifestyle. The primary outcome was the development of T2DM defined as FPG ≥ 7.0 mmol/L, the diagnosis of diabetes, or use of an antidiabetic drug, confirmed by referring to medical cards. RESULTS: Of 14,473 screened individuals, participants were enrolled in either the intervention (n = 1240) arm or control (n = 1367) arm. Overall, the HR for the development of T2DM in the intervention arm during 5.5 years was 1.00 (95% CI 0.74 to 1.34). In the subanalysis, the HR was 0.59 (95% CI 0.42 to 0.83) in the subgroup that received phone calls the most frequently, compared with the control arm. A limitation of the study includes a lack of blinding. CONCLUSIONS: High-frequency telephone-delivered lifestyle support could effectively prevent T2DM in participants with IFG in a primary healthcare setting, although low-frequency and middle-frequency phone calls did not. TRIAL REGISTRATION NUMBER: This trial has been registered with the University Hospital Medical Information Network (UMIN000000662).

Possible discrepancy of HbA1c values and its assessment among patients with chronic renal failure, hemodialysis and other diseases.

BACKGROUND: Glycated hemoglobin (HbA1c) and glycated albumin (GA) are frequently used as glycemic control markers. However, these markers are influenced by alterations in hemoglobin and albumin metabolism. Thus, conditions such as anemia, chronic renal failure, hypersplenism, chronic liver diseases, hyperthyroidism, hypoalbuminemia, and pregnancy need to be considered when interpreting HbA1c or GA values. Using data from patients with normal albumin and hemoglobin metabolism, we previously established a linear regression equation describing the GA value versus the HbA1c value to calculate an extrapolated HbA1c (eHbA1c) value for the accurate evaluation of glycemic control. In this study, we investigated the difference between the measured HbA1c and the eHbA1c values for patients with various conditions. METHODS: Data sets for a total of 2461 occasions were obtained from 731 patients whose HbA1c and GA values were simultaneously measured. We excluded patients with missing data or changeable HbA1c levels, and patients who had received transfusions or steroids within the previous 3 months. Finally, we included 44 patients with chronic renal failure (CRF), 10 patients who were undergoing hemodialysis (HD), 7 patients with hematological malignancies and a hemoglobin level of less than 10 g/dL (HM), and 12 patients with chronic liver diseases (CLD). RESULTS: In all the groups, the eHbA1c values were significantly higher than the measured HbA1c values. The median difference was 0.75 % (95 % CI 0.40-1.10 %, P for the difference is <0.001) in the CRF group, 0.80 % (95 % CI 0.30-1.65 %, P for the difference is 0.041) in the HD group, 0.90 % (95 % CI 0.90-1.30 %, P for the difference is 0.028) in the HM group, and 0.85 % (95 % CI 0.40-1.50 %, P for the difference is 0.009) in the CLD group. CONCLUSIONS: We found that the measured HbA1c values were lower than the eHbA1c values in each of the groups.

Predictors for cecal insertion time: the impact of abdominal visceral fat measured by computed tomography.

BACKGROUND: Several factors affect the risk for longer cecal insertion time. OBJECTIVE: The aim of this study was to identify the predictors of longer insertion time and to evaluate the effect of visceral fat measured by CT. DESIGN: This is a retrospective observational study. PATIENTS: Outpatients for colorectal cancer screening who underwent colonoscopies and CT were enrolled. Computed tomography was performed in individuals who requested cancer screening and in those with GI bleeding. MAIN OUTCOME MEASURES: Information on obesity indices (BMI, visceral adipose tissue, and subcutaneous adipose tissue area), constipation score, history of abdominal surgery, poor preparation, fellow involvement, diverticulosis, patient discomfort, and the amount of sedation used was collected. RESULTS: The cecal insertion rate was 95.2% (899/944), and 899 patients were analyzed. Multiple regression analysis showed that female sex, lower BMI, lower visceral adipose tissue area, lower subcutaneous adipose tissue area, higher constipation score, history of surgery, poor bowel preparation, and fellow involvement were independently associated with longer insertion time. When obesity indices were considered simultaneously, smaller subcutaneous adipose tissue area (p = 0.038), but not lower BMI (p = 0.802) or smaller visceral adipose tissue area (p = 0.856), was associated with longer insertion time; the other aforementioned factors remained associated with longer insertion time. In the subanalysis of normal-weight patients (BMI <25 kg/m), a smaller subcutaneous adipose tissue area (p = 0.002), but not a lower BMI (p = 0.782), was independently associated with a longer insertion time. Longer insertion time had a positive correlation with a higher patient discomfort score (ρ = 0.51, p < 0.001) and a greater amount of midazolam use (ρ = 0.32, p < 0.001). LIMITATIONS: This single-center retrospective study includes a potential selection bias. CONCLUSIONS: In addition to BMI and intra-abdominal fat, female sex, constipation, history of abdominal surgery, poor preparation, and fellow involvement were predictors of longer cecal insertion time. Among the obesity indices, high subcutaneous fat accumulation was the best predictive factor for easier passage of the colonoscope, even when body weight was normal.

Increase in homeostasis model assessment of insulin resistance (HOMA-IR) had a strong impact on the development of type 2 diabetes in Japanese individuals with impaired insulin secretion: the Saku study.

Our aim was to assess the impact of increase in homeostasis model assessment of insulin resistance (HOMA-IR) on the development of type 2 diabetes in Japanese individuals with impaired insulin secretion (IIS). This study included 2,209 participants aged 30-69 without diabetes at baseline who underwent comprehensive medical check-ups between April 2006 and March 2007 at Saku Central Hospital. Participants were classified into eight groups according to the combination of baseline IIS status (non-IIS and IIS) and category of HOMA-IR change between the baseline and follow-up examinations (decrease, no change/small increase, moderate increase, and large increase). Type 2 diabetes was determined from fasting and 2 h post-load plasma glucose concentrations at the follow-up examination between April 2009 and March 2011. At baseline, 669 individuals (30.3%) were classified as having IIS. At follow-up, 74 individuals developed type 2 diabetes. After adjusting for confounding factors including baseline HOMA-IR values, the multivariable-adjusted odds ratios (95% confidence intervals) for type 2 diabetes in the non-IIS with a decrease (mean change in HOMA-IR: -0.47), non-IIS with a moderate increase (mean change in HOMA-IR: 0.28), non-IIS with a large increase (mean change in HOMA-IR: 0.83), IIS with a decrease (mean change in HOMA-IR: -0.36), IIS with no change/small increase (mean change in HOMA-IR: 0.08), IIS with a moderate increase (mean change in HOMA-IR: 0.27), and IIS with a large increase (mean change in HOMA-IR: 0.73) groups, relative to the non-IIS with no change/small increase (mean change in HOMA-IR: 0.08) group were 0.23 (0.04, 1.11), 1.22 (0.26, 5.72), 2.01 (0.70, 6.46), 1.37 (0.32, 4.28), 3.60 (0.83, 15.57), 5.24 (1.34, 20.52), and 7.01 (1.75, 24.18), respectively. Moderate and large increases in HOMA-IR had a strong impact on the development of type 2 diabetes among individuals with IIS in this Japanese population.

Effects of walking on medical cost: A quantitative evaluation by simulation focusing on diabetes.

AIMS/INTRODUCTION: Recently, the prevalence of lifestyle-related disease has increased, and its associated medical costs have become considerable. Although walking is thought to prevent lifestyle-related disease, few studies have evaluated its effect on medical costs in Japanese subjects. We aimed at evaluating the effect of walking on medical costs by simulation mainly focusing on diabetes in the Japanese population. MATERIALS AND METHODS: A Markov model focusing on diabetes was constructed. As complications of diabetes, 'dialysis', 'ischemic heart disease' and 'stroke' were included. The model has four states: 'non-diabetes', 'diabetes', 'dialysis' and 'dead', and 'ischemic heart disease' and 'stroke' were included as events that occurred in each state. The effect of walking was included as changing the rate of transition and incident rates of events. RESULTS: After 10 years, the numbers of subjects with diabetes were 4.3 and 7.3% lower for daily increase of 3,000 and 5,000 steps, respectively. The numbers of cases of ischemic heart disease and stroke also decreased. Lower medical costs were also seen according to the daily increase in steps. In 10 years, the total medical costs were 5.2 and 8.4% lower for 3,000 and 5,000 steps increase, respectively. The cost reduction associated with a daily increase of 3,000 steps walked was calculated as ¥0.00146 for each step. CONCLUSIONS: Walking is one of the most common and accessible forms of exercises. The present results suggested that walking reduced the medical costs associated with lifestyle-related disease, which will have a large impact on health policy.

Adult mortality attributable to preventable risk factors for non-communicable diseases and injuries in Japan: a comparative risk assessment.

BACKGROUND: The population of Japan has achieved the longest life expectancy in the world. To further improve population health, consistent and comparative evidence on mortality attributable to preventable risk factors is necessary for setting priorities for health policies and programs. Although several past studies have quantified the impact of individual risk factors in Japan, to our knowledge no study has assessed and compared the effects of multiple modifiable risk factors for non-communicable diseases and injuries using a standard framework. We estimated the effects of 16 risk factors on cause-specific deaths and life expectancy in Japan. METHODS AND FINDINGS: We obtained data on risk factor exposures from the National Health and Nutrition Survey and epidemiological studies, data on the number of cause-specific deaths from vital records adjusted for ill-defined codes, and data on relative risks from epidemiological studies and meta-analyses. We applied a comparative risk assessment framework to estimate effects of excess risks on deaths and life expectancy at age 40 y. In 2007, tobacco smoking and high blood pressure accounted for 129,000 deaths (95% CI: 115,000-154,000) and 104,000 deaths (95% CI: 86,000-119,000), respectively, followed by physical inactivity (52,000 deaths, 95% CI: 47,000-58,000), high blood glucose (34,000 deaths, 95% CI: 26,000-43,000), high dietary salt intake (34,000 deaths, 95% CI: 27,000-39,000), and alcohol use (31,000 deaths, 95% CI: 28,000-35,000). In recent decades, cancer mortality attributable to tobacco smoking has increased in the elderly, while stroke mortality attributable to high blood pressure has declined. Life expectancy at age 40 y in 2007 would have been extended by 1.4 y for both sexes (men, 95% CI: 1.3-1.6; women, 95% CI: 1.2-1.7) if exposures to multiple cardiovascular risk factors had been reduced to their optimal levels as determined by a theoretical-minimum-risk exposure distribution. CONCLUSIONS: Tobacco smoking and high blood pressure are the two major risk factors for adult mortality from non-communicable diseases and injuries in Japan. There is a large potential population health gain if multiple risk factors are jointly controlled.

What has made the population of Japan healthy?

People in Japan have the longest life expectancy at birth in the world. Here, we compile the best available evidence about population health in Japan to investigate what has made the Japanese people healthy in the past 50 years. The Japanese population achieved longevity in a fairly short time through a rapid reduction in mortality rates for communicable diseases from the 1950s to the early 1960s, followed by a large reduction in stroke mortality rates. Japan had moderate mortality rates for non-communicable diseases, with the exception of stroke, in the 1950s. The improvement in population health continued after the mid-1960s through the implementation of primary and secondary preventive community public health measures for adult mortality from non-communicable diseases and an increased use of advanced medical technologies through the universal insurance scheme. Reduction in health inequalities with improved average population health was partly attributable to equal educational opportunities and financial access to care. With the achievement of success during the health transition since World War 2, Japan now needs to tackle major health challenges that are emanating from a rapidly ageing population, causes that are not amenable to health technologies, and the effects of increasing social disparities to sustain the improvement in population health.

Development of a database of health insurance claims: standardization of disease classifications and anonymous record linkage.

BACKGROUND: Health insurance claims (ie, receipts) record patient health care treatments and expenses and, although created for the health care payment system, are potentially useful for research. Combining different types of receipts generated for the same patient would dramatically increase the utility of these receipts. However, technical problems, including standardization of disease names and classifications, and anonymous linkage of individual receipts, must be addressed. METHODS: In collaboration with health insurance societies, all information from receipts (inpatient, outpatient, and pharmacy) was collected. To standardize disease names and classifications, we developed a computer-aided post-entry standardization method using a disease name dictionary based on International Classification of Diseases (ICD)-10 classifications. We also developed an anonymous linkage system by using an encryption code generated from a combination of hash values and stream ciphers. Using different sets of the original data (data set 1: insurance certificate number, name, and sex; data set 2: insurance certificate number, date of birth, and relationship status), we compared the percentage of successful record matches obtained by using data set 1 to generate key codes with the percentage obtained when both data sets were used. RESULTS: The dictionary's automatic conversion of disease names successfully standardized 98.1% of approximately 2 million new receipts entered into the database. The percentage of anonymous matches was higher for the combined data sets (98.0%) than for data set 1 (88.5%). CONCLUSIONS: The use of standardized disease classifications and anonymous record linkage substantially contributed to the construction of a large, chronologically organized database of receipts. This database is expected to aid in epidemiologic and health services research using receipt information.