Japan Diabetes Complications Research Articles

Dietary potassium intake and its interaction with sodium intake on risk of developing cardiovascular disease in persons with type 2 diabetes: The Japan Diabetes Complication and its Prevention Prospective study (JDCP study 12).

Many guidelines recommend increases in potassium intake. However, the relationship of dietary potassium intake with incident cardiovascular disease (CVD) has not been examined in those with type 2 diabetes (T2DM), including sodium acting antagonistically with potassium. We investigated these relationships in Japanese patients with T2DM. The investigation was part of the JDCP study, a nationwide prospective study begun in 2007. Analysed were 1477 persons with T2DM, 40-75 years of age, who completed a brief-type, self-administered Diet History Questionnaire at baseline. Primary outcome was a CVD event during the follow-up median 7 years (3.9-8.1 years). Hazard ratios (HRs) for CVD were estimated by Cox regression adjusted for confounders of daily potassium intake categorized by tertiles. Tertiles of sodium intake were also analysed. Mean daily potassium intake in tertiles was 1877, 2627 and 3532 mg, respectively, and significant associations were not shown between potassium intake and incidence of CVD. When HRs for CVD were stratified for potassium intake in tertiles (reference group, bottom tertile) and sodium intake (reference group, bottom tertile), potassium intake in the bottom tertile and sodium intake in the second and top tertiles were associated with significantly elevated HR for CVD (2.79 [1.02-7.63] and 3.92 [1.30-11.79], respectively). Low potassium intake in conjunction with high sodium intake was significantly associated with increased incident CVD in persons with T2DM. However, CVD incidence was not related to high potassium intake, regardless of sodium intake.

1372-P: Association between Fat Intake as the Percent of Total Energy and Incidence of Cardiovascular Disease in Persons with Type 2 Diabetes—Japan Diabetes Complication and Its Prevention Prospective Study (JDCP Study)

1372-P: Association between Fat Intake as the Percent of Total Energy and Incidence of Cardiovascular Disease in Persons with Type 2 Diabetes—Japan Diabetes Complication and Its Prevention Prospective Study (JDCP Study)

Prevalence and characteristics of diabetic symmetric sensorimotor polyneuropathy in Japanese patients with type 2 diabetes: The Japan Diabetes Complication and its Prevention Prospective study (JDCP study 10).

This study aimed to investigate the prevalence and characteristics of diabetic symmetric sensorimotor polyneuropathy (DSPN) in patients with type 2 diabetes registered in the Japan Diabetes Complication and its Prevention Prospective study. In the study, 6,338 patients with diabetes who had been treated by diabetes specialists were registered in 2007-2009. Of these, patients with type 2 diabetes who could be evaluated for DSPN were analyzed using the t-test, χ2 -test and logistic regression analyses. DSPN was diagnosed using the Simple Diagnostic Criteria for Diabetic Polyneuropathy proposed by the Diabetic Neuropathy Study Group in Japan. Of the total participants, 5,451 patients (mean age 61.4 years, duration of diabetes 10.8 years) were analyzed. Based on the criteria, 35.8% of patients were diagnosed with DSPN. The prevalence of sensory symptoms was 25.8%. The following factors increased the risk for DSPN: age (odds ratio[OR] 1.57, 95% confidence interval [CI] 1.42-1.73), duration of diabetes (OR 1.32, 95% CI 1.21-1.43), body mass index (OR 1.19, 95% CI 1.09-1.30), systolic blood pressure (OR 1.06, 95% CI 1.01-1.10), hemoglobin A1c (OR 1.15, 95% CI 1.09-1.22), biguanides (OR 1.22, 95% CI 1.06-1.39) and insulin therapy (OR 1.59, 95% CI 1.36-1.84). The following factors decreased the risk for DSPN: total cholesterol (OR 0.98, 95% CI 0.96-1.00) and exercise therapy (OR 0.85, 95% CI 0.73-0.98). The baseline survey clarified the prevalence and characteristics of DSPN in Japanese patients with type 2 diabetes. The survey also showed the risk factors of DSPN.

1381-P: Effect of Dietary Potassium Intake and Its Interaction with Sodium Intake on Risk of Developing Cardiovascular Disease (CVD) in Persons with Type 2 Diabetes (T2D)—Japan Diabetes Complication and Its Prevention Prospective Study (JDCP Study)

Many guidelines recommend increased potassium intake. However, the relationship between dietary potassium intake and incidence of CVD in persons with T2D has not been explored, nor is it known if this relationship varies with sodium intake in such persons. Therefore, we investigated these relationships as part of the JDCP study, a nationwide study launched in 2007. A total of 1477 persons with T2D aged 40-75 years completed a brief self-administered Diet History Questionnaire at baseline, and resultant data were analyzed. Primary outcome was the 7-year risk of a CVD event. Hazard ratios (HRs) for CVD according to tertiles of dietary potassium and sodium intake were estimated by Cox regression adjusted for confounders in addition to a stratified analysis of tertiles of sodium intake. Mean daily potassium and sodium intakes in tertiles 1 to 3 were 1.9, 2.6, and 3.5 g and 3.3, 4.2, and 5.3 g, respectively. HbA1c, BMI, triglycerides, and blood pressure were well controlled. No significant associations between potassium and sodium intakes and incidence of CVD were shown for the second and third tertiles relative to the first tertile (potassium: 0.64 [95% CI, 0.34-1.23] and 0.59 [0.28-1.25]; sodium: 1.02 [0.51-2.04] and 1.15 [0.58-2.30]). In the stratified analysis of tertiles of sodium intake, in the high sodium intake groups (T2 and T3) HRs for CVD in the high potassium intake group were significantly lower compared to the low potassium intake group (T2: 0.40 [0.12-1.35] and 0.06 [0.01-0.69]; T3: 0.23 [0.07-0.82] and 0.26 [0.07-0.88]). Associations of potassium intake with CVD in those with low sodium intake (T1) were not significant. Findings suggested that high potassium intake under high sodium intake is associated with a deceased incidence of CVD in persons with T2D although potassium intake under low sodium intake was not associated with incident CVD. Disclosure C.Horikawa: None. H.Shimano: None. J.Satoh: None. Y.Hayashino: Advisory Panel; Novo Nordisk A/S, Ono Pharmaceutical Co., Ltd., Speaker's Bureau; Boehringer Ingelheim Japan, Inc., Sumitomo Dainippon Pharma Co., Ltd., Santen, Daiichi Sankyo, Kowa Company, Ltd. N.Tajima: None. R.Nishimura: Speaker's Bureau; Sanofi K.K., Medicure Inc., Boehringer Ingelheim Inc., Takeda Pharmaceutical Company Limited, Kissei Pharmaceutical Co., Ltd., Novartis Pharma K.K., Eli Lilly Japan K.K., Novo Nordisk, Merck & Co., Inc., Abbott Japan Co., Ltd., Astellas Pharma Inc., Teijin Pharma Limited, Taisho Pharmaceutical Holdings Co., Ltd., Ono Pharmaceutical Co., Ltd., AstraZeneca. Y.Yamasaki: None. H.Sone: Research Support; Novo Nordisk, Astellas Pharma Inc., Kyowa Kirin Co., Ltd., Taisho Pharmaceutical Holdings Co., Ltd., Ono Pharmaceutical Co., Ltd., Eisai Co., Ltd., Takeda Pharmaceutical Co., Ltd. Jdcp study group: n/a. M.Takahara: None. N.Katakami: Speaker's Bureau; Abbott Japan Co., Ltd., Daiichi Sankyo, MSD, Mitsubishi Tanabe Pharma Corporation, Kowa Company, Ltd., Ono Pharmaceutical Co., Ltd., Novo Nordisk, Sumitomo Dainippon Pharma Co., Ltd., Bayer Inc., Lilly, Teijin Pharma Limited, Kyowa Kirin Co., Ltd., Boehringer Ingelheim Japan, Inc., Sanofi. Y.Takeda: None. M.Takeuchi: None. K.Fujihara: None. H.Suzuki: None. K.Tsuda: None. N.Yoshioka: None.

Causes of death in Japanese people with type 2 diabetes and factors associated with all-cause mortality from a large registry in Japan: the Japan Diabetes Complication and its prevention prospective (JDCP) study-9.

We aimed to estimate the causes of death and their incidence rates and risk factors for all-cause mortality in Japanese people with type 2 diabetes using baseline data from the Japan Diabetes Complication and its Prevention (JDCP) prospective study. We analyzed a multicenter prospective cohort of 5944 Japanese people with diabetes aged 40-74years. Causes of death were categorized as cardiac or cerebrovascular disease, malignancy, infectious disease, accident or suicide, sudden death of unknown cause, and other unknown causes. The Cox proportional hazards model was used to estimate the hazard ratio of all-cause mortality risk factors. The mean age was 61.4years, and 39.9% of the population was female. Overall, the mortality ratio per 100,000 person-years (95% confidence interval [CI]) was 515.3 (95% CI 445.1-596.9). Malignancies are the most common cause of death among people with type 2 diabetes, accounting for 46.9% of all deaths, followed by cardiac and cerebrovascular diseases at 11.7% and infectious diseases at 3.9%. Higher mortality risk was significantly associated with older age, lower body-mass index, alcohol intake, history of hypertension, and acute myocardial infarction (AMI). The frequency of causes of death in people with type 2 diabetes identified in this study was similar to that from a recent survey on causes of death conducted by the Japan Diabetes Society. A lower body-mass index, alcohol intake, history of hypertension, and AMI were found to be associated with an increased total risk of type 2 diabetes. The online version contains supplementary material available at 10.1007/s13340-023-00628-y.

1178-P: Current Situations in Dietary Intake and Physical Activity in Japanese Patients with Type 2 Diabetes: JDCP Study

Medical nutrition therapy and exercise therapy are the cornerstones of treatment for patients with type 2 diabetes; however, there has not been a nationwide study on the actual dietary intake and physical activity status of patients since the 2000s. We aimed to clarify this in Japanese patients with type 2 diabetes using data from the Japan Diabetes Complication and its Prevention prospective (JDCP) , a nationwide study launched in 2007. A total of 1,992 patients with type 2 diabetes, aged 40-75 years, completed either the Brief-type, self-administered Diet History Questionnaire (1,643 patients) or International Physical Activity Questionnaire (1,834 patients) , and their data were analyzed in this study. Mean daily energy intake for all participants was 1686.8 kcal/day, and the mean proportions of carbohydrate, protein, and fat comprising total energy intake were 60.2, 16.2, and 23.6%, respectively. The patients in this study had similar energy and nutrient intake status to patients in the 1996 Japan Diabetes Complications Study; however, Japanese patients still had higher carbohydrate and lower fat consumption than patients with diabetes in Western countries. Only 10.5 % of the patients had equal to or more than 20 g/day of dietary fiber and 7.5% consumed less than 6 g of salt. Weekly physical activities of male and female patients were 2344.5±2700.9 and 1948.3±2209.3 METs·min/week in women, respectively (p <0.001) . As for exercise, 31.0% of patients did not do it habitually; this was particularly noticeable in female patients and patients under the age of 65. BMI increased from 22.7 to 24.1 kg/m2 in men and 23.2 to 24.8 kg/m2 in women from 1996 to 2007, respectively. The reason for this increment is suggested to be due to energy intake remaining unchanged despite a decrease in physical activity level. The balance between dietary energy intake and energy expenditure based on physical activity has become more important in Japanese patients with type 2 diabetes in recent years. Disclosure C.Horikawa: None. K.Tsuda: None. J.Satoh: None. Y.Hayashino: None. N.Tajima: None. R.Nishimura: Speaker's Bureau; Abbott Diabetes, Astellas Pharma Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck & Co., Inc., Novo Nordisk, Ono Pharmaceutical Co., Ltd., Sanofi, Taisho Pharmaceutical Holdings Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited, Terumo Corporation. H.Sone: Research Support; Astellas Pharma Inc., Eisai Co., Ltd., Kyowa Kirin Co., Ltd., Novo Nordisk, Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Holdings Co., Ltd., Takeda Pharmaceutical Company Limited. Funding Japan Diabetes Society

1179-P: Secular Trends in Dietary Intake Over a Five-Year Period in People with Type 2 Diabetes in Japan: Japan Diabetes Complications Study (JDCS)

To provide effective medical nutrition therapy (MNT) , it is necessary to consider dietary intake, which can change over time. This longitudinal study analyzed changes in the dietary intakes of Japanese patients with type 2 diabetes over a 5-year period. The JDCS is a nationwide study of Japanese patients with type 2 diabetes conducted in 1996. Participants were aged 40-70 years from outpatient clinics in 59 universities and general hospitals. Analyzed were 922 responders to a dietary survey assessed by the Food Frequency Questionnaire based on food groups at baseline and 5 years after registration. Paired samples t-test was used for analysis. Over a 5-year period, patients with type 2 diabetes maintained almost the same body mass index (BMI) (baseline: 22.9±3.0; 5 years later: 22.8±3.0 kg/m2) . Differences in energy intake, fat-to-energy ratio, and carbohydrate-to-energy ratio were small although significant. Neither the mean intake of fiber nor salt met the required intake for MNT for persons with diabetes both at baseline and after 5 years. As for food groups, there was a significant decrease in intakes of vegetables, seaweed, soybeans/soy products, and milk/dairy products. Details are shown in the Table. Results showed that Japanese patients with type 2 diabetes need to pay special attention to dietary fiber intake and salt intake on an ongoing basis. Disclosure C.Horikawa: None. R.Aida: None. C.Kamada: None. K.Fujihara: None. S.Tanaka: None. A.Araki: None. Y.Yoshimura: None. Y.Akanuma: None. H.Sone: Research Support; Astellas Pharma Inc., Eisai Co., Ltd., Kyowa Kirin Co., Ltd., Novo Nordisk, Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Holdings Co., Ltd., Takeda Pharmaceutical Company Limited. Funding Japan Society for the Promotion of Science (19H04028)

Secular Trends in Dietary Intake over a 20-Year Period in People with Type 2 Diabetes in Japan: A Comparative Study of Two Nationwide Registries; Japan Diabetes Complications Study (JDCS) and Japan Diabetes Clinical Data Management Study (JDDM).

Background: In order to provide effective dietary guidance, it is necessary to consider dietary intake, which can change over time. This study analyzed changes in the diet of Japanese patients with type 2 diabetes over a 20-year period. Methods: We compared the results of two dietary surveys that used the food frequency questionnaire format. The first was conducted in 1996 by the Japan Diabetes Complications Study (JDCS) (n = 1509; males 53.3%), and the second in 2014–2018 by the Japan Diabetes Clinical Data Management Study (JDDM) (n = 1145; males 65.6%). Both are nationwide representative registries of outpatients with type 2 diabetes in Japan. Results: Over a 20-year period, both men and women with type 2 diabetes had a significant increase in body mass index (BMI). Nonetheless, there was only a small change in energy intake. Conversely, there was a significant increase in fat intake and thus in the fat-to-energy ratio. With regard to food groups, there was a significant increase in meat intake and a decrease in the intake of fish, soybeans/soy products, vegetables, and fruits, with a particularly significant decrease in vegetables. Conclusions: Even in Japan, an industrialized country with a stable socioeconomic environment, there were many significant changes in the dietary intake of patients with type 2 diabetes over the 20-year period.

Different impacts of metabolic profiles on future risk of cardiovascular disease between diabetes with and without established cardiovascular disease: the Japan diabetes complication and its prevention prospective study 7 (JDCP study 7)

AimsMost risk calculators that predict future cardiovascular disease (CVD) by baseline profiles are originally developed for primary prevention, but some studies applied the calculators to secondary prevention. We compared the impact of baseline profiles on the future CVD risk between patients with diabetes with and without a CVD history.MethodsWe analyzed a multicenter prospective cohort of 6338 Japanese patients with diabetes aged 40–74 years, including those with (n = 634) and without a CVD history (n = 5704). The future risk of CVD was investigated using the competing risk model, with adjustment for non-cardiovascular mortality.ResultsDuring the median follow-up of 6.9 years, 413 CVD events were observed. The 8-year cumulative incidence rates of CVD were 21.5% and 7.2% in patients with and without a CVD history, respectively. A higher systolic blood pressure and lower high-density lipoprotein cholesterol levels were independently associated with a future CVD risk in patients without a CVD history (both P < 0.05), whereas they were not associated in those with a CVD history. The P values for interaction were 0.040 and 0.005, respectively. The male sex, an older age, a longer duration of diabetes, higher hemoglobin A1c levels, and higher low-density lipoprotein cholesterol levels were common independent risk factors regardless of CVD history (all P < 0.05).ConclusionsThe prognostic impact of metabolic profiles on CVD risk would not be identical between patients with and without a CVD history, suggesting that it might be inappropriate to apply CVD risk calculators developed for primary prevention to patients with a CVD history.

Developing a health economic model for Asians with type 2 diabetes based on the Japan Diabetes Complications Study and the Japanese Elderly Diabetes Intervention Trial

IntroductionCost-effectiveness analyses are becoming increasingly important in Japan following the introduction of a health technology assessment scheme. The study objective was to develop an economic model to evaluate the cost-effectiveness...

371-P: Impact of Sodium Intake on the Risk of Cardiovascular Disease in Patients with Type 2 Diabetes: Analysis of Data from the Japan Diabetes Complications Study and the Japanese Elderly Diabetes Intervention Trial

Excessive sodium intake is regarded as a crucial factor related to developing and worsening of cardiovascular disease (CVD). However, epidemiological studies on this topic in patients with type 2 diabetes are sparse. We investigated the associations between sodium intake and CVD risk in Japanese patients with type 2 diabetes from the analysis of pooled data from two nation-wide prospective longitudinal studies. Data were analyzed on 2428 individuals whose dietary intake at baseline was assessed by the Food Frequency Questionnaire based on food groups. Primary outcome was the 6-year risk of a CVD event. Cox regression analyses estimated hazard ratios (HRs) for dietary intake adjusted for age, gender, body mass index, HbA1c, smoking, energy intake, and other confounders. Mean sodium intake in quartiles ranged from 2494 mg to 6166 mg/day and more than three-quarters of participants had sodium intake more than the recommended dietary allowance by American Diabetes Association (&amp;lt; 2300 mg/day). After adjustment for confounders, HRs for CVD in patients with sodium intake in the 2nd, 3rd, and 4th quartiles compared with sodium intake in the 1st quartile were analyzed, and no significant differences were shown between sodium intake and CVD [Q2: 0.77 (95%CI, 0.48-1.23); Q3: 1.03 (0.65-1.63); and Q4: 1.31 (0.80-2.14), trend p = 0.131]. Results of subgroup analysis according to age showed that patients aged 39 through 59 years in the higher quartiles of sodium intake compared with the 1st quartile had a significantly higher incidence of CVD [Q2: 1.37 (0.57-3.33); Q3: 1.68 (0.70-4.03); and Q4: 4.16 (1.63-10.58), trend p = 0.004]. However, no significant association between sodium intake and CVD in participants aged over 60 years. Findings indicated that high sodium intake is associated with elevated incidence of CVD in younger patients with type 2 diabetes. Disclosure C. Horikawa: None. H. Sone: Research Support; Self; Astellas Pharma Inc., Eisai Co., Ltd., Kyowa Kirin Co., Ltd., Novo Nordisk, Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co. R. Aida: None. S. Tanaka: None. C. Kamada: None. Y. Yoshimura: None. R. Kodera: None. K. Fujihara: None. T. Moriya: None. A. Araki: None. Funding Japan Society for the Promotion of Science (19H04028)

Prevalence of albuminuria and renal dysfunction, and related clinical factors in Japanese patients with diabetes: The Japan Diabetes Complication and its Prevention prospective study5.

Aims/IntroductionTo clarify the prevalence of albuminuria and renal dysfunction, and related factors in Japanese patients with diabetes, we analyzed the baseline data of the Japan Diabetes Complication and its Prevention prospective study.Materials and MethodsWe used the data of 355 patients with type 1 diabetes and 5,194 patients with type 2 diabetes to evaluate the prevalence of albuminuria and renal dysfunction, and related factors. A binomial logistic regression analysis was used to investigate independent contributing factors for estimated glomerular filtration rate <60 mL/min/1.73 m2 or albuminuria.ResultsThe prevalence of microalbuminuria and macroalbuminuria was 15.2% (54/355) and 3.1% (11/355) in type 1 diabetes patients, and 25.0% (1,298/5,194) and 5.1% (265/5,194) in type 2 diabetes patients, respectively. The proportion of renal dysfunction (estimated glomerular filtration rate <60 mL/min/1.73 m2) was 9.9% (35/355) in type 1 diabetes patients, and 15.3% (797/5,194) in type 2 diabetes patients. The proportion of patients with renal dysfunction with normoalbuminuria was 7.3% (26/355) for type 1 diabetes patients, and 9.0% (467/5,194) for type 2 diabetes patients. The factors related to albuminuria in type 2 diabetes patients were glycated hemoglobin, hypertension, age, duration of diabetes, body mass index and estimated glomerular filtration rate. In contrast, factors to related renal dysfunction were age, duration of diabetes, dyslipidemia, hypertension, body mass index, male sex and albuminuria.ConclusionsWe showed the recent prevalence of albuminuria and renal dysfunction, and related factors in Japanese type 1 and type 2 diabetes patients using the baseline data of the Japan Diabetes Complication and its Prevention prospective study. The current results suggest that renal disease in patients with type 2 diabetes is heterogeneous, and different mechanisms might be involved in albuminuria and deterioration of renal function.

Vitamin B6 intake and incidence of diabetic retinopathy in Japanese patients with type 2 diabetes: analysis of data from the Japan Diabetes Complications Study (JDCS).

Although vitamin B6 has been suspected to prevent the progression of diabetic retinopathy, evidence of this in patients with type 2 diabetes based on longitudinal studies is sparse. This study investigated the relationship between vitamin B6 intake and the incidence of diabetic retinopathy in Japanese patients with type 2 diabetes. The study was part of an examination of a nationwide cohort of patients with type 2 diabetes aged 40-70years with HbA1c ≥ 48mmol/mol. After excluding nonresponders to a dietary survey using the Food Frequency Questionnaire based on food groups, 978 patients were analyzed. Primary outcome was the 8-year risk of a diabetic retinopathy event, and Cox regression analyses estimated hazard ratios (HRs) for retinopathy according to vitamin B6 intake adjusted for age, gender, body mass index, HbA1c, smoking, energy intake, and other confounders. Mean vitamin B6 intake in quartiles ranged from 1.1 to 1.6mg/day, and half of the participants had vitamin B6 intake below the recommended daily dietary allowance according to dietary reference intakes in Japanese adults (men 1.4mg/day; women 1.2mg/day). After adjusting for confounders, HRs for diabetic retinopathy in the 2nd, 3rd, and 4th quartile groups of vitamin B6 intake compared with the 1st quartile group were 1.17 (95% confidence interval 0.81-1.69, p = 0.403), 0.88 (0.58-1.34, p = 0.550), and 0.50 (0.30-0.85, p = 0.010), respectively. Findings suggested that high vitamin B6 intake was associated with a lower incidence of diabetic retinopathy in Japanese with type 2 diabetes.

The Prevalence and Characteristics of Diabetic Polyneuropathy in Japanese Type 2 Diabetic Patient

This study aims to investigate the prevalence and characteristics of diabetic polyneuropathy (DPN) in type 2 diabetic patients registered in the Japan Diabetes Complication and its Prevention Prospective (JDCP) study. In the JDCP study, 6,338 diabetic patients who had been treated by diabetes specialists were registered in 2007-9. Of these, 5,451 patients with type 2 diabetes (61.4 years-old, duration of diabetes 10. 8 years, BMI 24.5 and HbA1c 7.42%) who could be evaluated for DPN were analyzed by using t-test, chi-square test and logistic regression analysis. The diagnosis of DPN was performed by using simple diagnostic criterion for diabetic polyneuropathy proposed by Diabetic Neuropathy Study Group in Japan. This criterion should meet two or more of the following three items: 1) sensory symptoms (SS) considered to be due to DPN, 2) bilaterally decreased or absent Achilles tendon reflex (ATR) and 3) decreased vibratory perception threshold (VPT) in bilateral medical malleoli. The prevalence of positive SS, bilaterally decreased/absent ATR and symmetric decrease in VPT were 25.8%, 40.9% and 48.1%, respectively. Based on simple diagnostic criterion, DPN was observed in 35.8% of the total. The decrease/absence of bilateral ATR showed high sensitivity (87.2%) and specificity (84.8%) in the diagnosis of DPN. In the group with DPN, we investigated the odds ratio (OR) of covariates for neuropathy and found that the age (OR 1.58, p&amp;lt;0.001), the duration of diabetes (OR 1.32, p&amp;lt;0.001), BMI (OR 1.20, p&amp;lt;0.001), T-cho (OR 0.98, p&amp;lt;0.05), insulin therapy (OR 1.62, p&amp;lt;0.001), systolic blood pressure (OR 1.06, p&amp;lt;0.01), HbA1c (OR 1.17, p&amp;lt;0.001), oral administration of biguanide (OR 1.19, p&amp;lt;0.01) and exercise therapy (OR 0.83, p&amp;lt;0.05) showed significant. Baseline survey of the JDCP study, the prevalence of DPN in type 2 diabetic patients was similar to that reported previously, suggesting the possibility that the evaluation of bilateral ATR is useful for the diagnosis of DPN. Disclosure H. Kamiya: Other Relationship; Self; MSD K.K., Ono Pharmaceutical Co., Ltd., Sanofi K.K., AstraZeneca, Astellas Pharma KK, Eli Lilly and Company, Novartis Pharma K.K., Dainippon Sumitomo Pharma Co., Ltd, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Ltd.. A. Watarai: None. M. Baba: None. R. Nishimura: Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Astellas Pharma US, Inc., Eli Lilly and Company, Abbott, Medtronic, MSD K.K., Novo Nordisk A/S, Sanofi, Takeda Development Center Asia, Pte. Ltd., Kissei Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd.. N. Tajima: None. J. Nakamura: Other Relationship; Self; Astellas Pharma US, Inc., AstraZeneca, Ono Pharmaceutical Co., Ltd., MSD K.K., Kyowa Hakko Kirin Co., Ltd., Kowa Pharmaceuticals America, Inc., Sanofi K.K., Taisho Pharmaceutical Co., Ltd., Takeda Development Center Asia, Pte. Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly and Company, Novartis Pharma K.K., Pfizer Inc..

Developing a Health Economic Model for Asians with Type 2 Diabetes Based on the Japan Diabetes Complications Study and the Japanese Elderly Diabetes Intervention Trial

Cost-effectiveness analyses (CEAs) are becoming increasingly important in Japan following the introduction of the pilot-based health technology assessment (HTA) from April 2016. Although health economic (HE) models for type 2 diabetes (T2D) have been developed, most models are not generalizable to patients in Asia whose risk factor profiles are different from Caucasians, since they are based on risk equations derived from the United Kingdom Prospective Diabetes Study (UKPDS). The objective was to develop a HE model for T2D using risk equations validated in Japanese patients (JJ Risk Engine) designed to meet the criteria in the guidelines of the Ministry of Health, Labour and Welfare in Japan. The model cohort is defined by patient characteristics and four risk factors (HbA1c, BMI, blood pressure and cholesterol), and treatment effects on macro and micro vascular complications and mortality are applied as risk factor modification over specified duration. In addition to outcomes included in the JJ Risk Engine, end-stage renal disease, amputation, hypoglycemia, utilities and costs were incorporated in the model using data available in the literature. The HE model estimates risks of macro and microvascular complications, cost of complications and treatments, quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER). Deterministic and probabilistic sensitivity analyses can be conducted for assessment of uncertainty. Simulation settings related to e.g., time horizon, treatment duration, and discount rates can be varied. This HE model offers an opportunity for decision-makers to assess the long-term cost-effectiveness of interventions in Asian patients with T2D. Disclosure S. Tanaka: None. J. Langer: Employee; Self; Novo Nordisk Pharma Ltd.. Stock/Shareholder; Self; Novo Nordisk A/S. T. Morton: Consultant; Self; Novo Nordisk Inc. L. Wilkinson: Employee; Self; Novo Nordisk A/S. S. Tanaka: None. R. Kawasaki: None. T. Moriya: None. C. Horikawa: None. R. Aida: None. A. Araki: None. H. Sone: Research Support; Self; Novo Nordisk Inc., Eli Lilly and Company, MSD K.K., Chugai Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Development Center Asia, Pte. Ltd., Daiichi Sankyo Company, Limited, Ono Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Sanofi, Kowa Pharmaceuticals America, Inc., Eisai Inc..

Factors associated with non-proliferative diabetic retinopathy in patients with type 1 and type 2 diabetes: the Japan Diabetes Complication and its Prevention prospective study (JDCP study 4).

This study aims to identify associations of non-proliferative diabetic retinopathy (NPDR) in the Japan Diabetes Complication and its Prevention prospective (JDCP) study, a nation-wide study capturing real-world practice for diabetes in Japan. We recruited patients with type 1 and type 2 diabetes mellitus aged between 40 and 75years from 464 hospitals and clinics. Seven thousand and seven hundred patients fulfilled the inclusion criteria, and 5852 patients were included for this specific analysis. Multiple logistic regression models were used to identify associated factors of NPDR. Of the 363 patients with type 1 diabetes, 83 patients (22.8%) had NPDR; there were significant associations of duration of diabetes and high-density lipoprotein cholesterol with the presence of NPDR. Of the 5489 patients with type 2 diabetes, 1515 (27.6%) had NPDR. Female, duration of diabetes, lifetime maximum body weight, treatment types, systolic blood pressure, and the number of oral hypoglycemic agents (OHA) and antihypertensive drug were associated with increased odds of having NPDR. Diastolic BP, body mass index, alcohol intake, and the number of lipid-lowering drugs were associated with lower odds of having NPDR. Statin and fibrate use was associated with lower odds of having NPDR; this association was confirmed in the model adjusting for the propensity score for taking fibrate or statin (odds ratio 0.80, 95% confidence interval 0.70-0.92; p = 0.002). There was a potential protective association of lipid-lowering medication (statin or fibrate) and statin use and the presence of NPDR in patients with type 2 diabetes in the JDCP study.

Meat intake and incidence of cardiovascular disease in Japanese patients with type 2 diabetes: analysis of the Japan Diabetes Complications Study (JDCS).

Excessive meat intake has been researched as a major cause of cardiovascular disease (CVD) among healthy adults, but data on this topic in Asian patients with diabetes are sparse. The quantity and variety of available meats vary widely between Asian and Western countries. As part of a nationwide cohort study we investigated the relationship between meat intake and incidence of CVD in Japanese patients with type 2 diabetes aged 40-70 years with HbA1c ≥ 6.5%. Analyzed were 1353 responders to a baseline dietary survey assessed by the Food Frequency Questionnaire based on food groups. Primary outcome was the 8-year risk of a CVD event, including coronary heart disease (CHD) and stroke. Cox regression analyses estimated hazard ratios (HRs) for dietary intake adjusted for age, gender, body mass index, HbA1c, smoking, energy intake, and other confounders. Mean meat intake in quartiles ranged from 9.9 to 97.7g/day. After adjusting for confounders, HRs of CHD in the 2nd, 3rd, and 4th quartiles for meat intake compared with the 1st quartile were 2.84 (95% confidence interval 1.29-6.24, p = 0.01), 3.02 (1.36-6.70, p < 0.01), and 2.99 (1.35-6.65, p = 0.01), respectively. In two groups according to meat intake, patients consuming ≥ 20g/day of meat had a 2.94-fold higher risk of CHD than those consuming < 20g/day (p < 0.01). There was no significant association of stroke with meat intake. An elevated incidence of CHD in Japanese patients with type 2 diabetes was associated with high meat intake.

Severe hypoglycaemia is a major predictor of incident diabetic retinopathy in Japanese patients with type 2 diabetes

AimHypoglycaemia is a common complication in diabetes patients. However, its relationship with retinopathy has not been well documented in patients with type 2 diabetes (T2D). This study aimed to investigate the associations between hypoglycaemia and the incidence and progression of diabetic retinopathy (DR). MethodsIn this longitudinal cohort study, which was part of the Japan Diabetes Complications Study (JDCS), adult patients with T2D were recruited at 59 diabetes clinics across Japan. Their history of hypoglycaemia was assessed by standardized self-reported questionnaires. Severe hypoglycaemia was defined as having at least one episode with coma requiring an outpatients visit or hospitalization. Adjusted hazard ratios (HRs) for incidence and progression of DR over 8 years of follow-up were determined. ResultsOf 1221 patients without DR, 127 (10.4%) had experienced non-severe hypoglycaemia within the previous year, whereas 10 (0.8%) reported severe hypoglycaemia episodes. During the 8-year follow-up involving 8492 person-years, 329 patients developed DR. In 410 patients with prevalent DR, the adjusted HRs for incident DR were 4.35 (95% CI: 1.98–9.56; P<0.01) and, for progression of DR, 2.29 (95% CI: 0.45–11.78; P=0.32) with severe hypoglycaemia. ConclusionHaving a history of severe hypoglycaemia was one of the strongest predictors of incident DR in patients with T2D, with a fourfold increased risk. Identifying patients with greater risks of DR based on their history of hypoglycaemia may help to personalize risk evaluation in patients with diabetes.

Association between all-cause mortality and severity of depressive symptoms in patients with type 2 diabetes: Analysis from the Japan Diabetes Complications Study (JDCS)

ObjectiveThe aims of this study are to confirm whether the excess mortality caused by depressive symptoms is independent of severe hypoglycemia in patients with type 2 diabetes mellitus (T2DM) and to evaluate the association between all-cause mortality and degrees of severity of depressive symptoms in Japanese patients with T2DM. MethodsA total of 1160 Japanese patients with T2DM were eligible for this analysis. Participants were followed prospectively for 3years and their depressive states were evaluated at baseline by the Center for Epidemiologic Studies Depression Scale (CES-D). Cox proportional hazards model was used to evaluate the relative risk of all-cause mortality and was adjusted by possible confounding factors, including severe hypoglycemia, all of which are known as risk factors for both depression and mortality. ResultsAfter adjustment for severe hypoglycemia, each 5-point increase in the CES-D score was significantly associated with excess all-cause mortality (hazard ratio 1.69 [95% CI 1.26–2.17]). The spline curve of HRs for mortality according to total CES-D scores showed that mortality risk was slightly increased at lower scores but was sharply elevated at higher scores. ConclusionA high score on the CES-D at baseline was significantly associated with all-cause mortality in patients with T2DM after adjusting for confounders including severe hypoglycemia. However, only a small effect on mortality risk was found at relatively lower levels of depressive symptoms in this population. Further research is needed to confirm this relationship between the severity of depressive symptoms and mortality in patients with T2DM.

Is the Proportion of Carbohydrate Intake Associated with the Incidence of Diabetes Complications?-An Analysis of the Japan Diabetes Complications Study.

The appropriate proportions of macronutritional intake have been controversial in medical nutritional therapy for diabetes, and evidence of the effects of carbohydrate consumption on diabetes complications in prospective settings is sparse. We investigated the relationships between proportions of carbohydrate intake as the % of total energy and diabetes complications in a nationwide cohort of Japanese patients with type 2 diabetes aged 40–70 years with hemoglobin A1c ≥6.5%. The analysis was of 1516 responders to a baseline dietary survey assessed by the Food Frequency Questionnaire based on food groups. Primary outcomes were times to overt nephropathy, diabetic retinopathy, and cardiovascular disease (CVD) after 8 years. Hazard ratios (HRs) for proportions of carbohydrate intake were estimated by Cox regression adjusted for confounders. High carbohydrate intake was significantly related to higher intakes of grain, fruits, and sweets/snacks and lower intakes of soybean and soy products, vegetables, seaweed, meat and processed meat, fish and processed fish, eggs, milk and dairy products, oil, and alcoholic beverages. During the eight-year follow-up, there were 81, 275, and 129 events of overt nephropathy, diabetic retinopathy, and CVD, respectively. After adjustment for confounders, HRs for complications in patients with carbohydrate intake in the second or third tertiles (51.0%–56.4% and ≥56.5%, respectively) compared with carbohydrate intake in the first tertile (<50.9%, referent) were analyzed. No significant associations were shown in the second and third tertiles relative to first tertile (overt nephropathy: 1.05 (95% Confidence Interval, 0.54–2.06) and 0.98 (0.40–2.44); diabetic retinopathy: 1.30 (0.90–1.88) and 1.30 (0.78–2.15); and CVD: 0.95 (0.55–1.63) and 1.37 (0.69–2.72)). By exploring potentially nonlinear relationships, trends for the incidence of diabetes complications according to proportions of carbohydrate intake were not clearly shown. Findings suggested that proportions of carbohydrate intake were not associated with the incidence of diabetes complications among type 2 diabetes patients in Japan.