Japanese Elderly Diabetes Intervention Trial Research Articles

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 (< 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)

Functional categories based on cognition and activities of daily living predict all-cause mortality in older adults with diabetes mellitus: The Japanese Elderly Diabetes Intervention Trial.

Although the glycemic target in older diabetes patients is based on cognition, activities of daily living and multimorbidity in the Japanese guideline, evidence of the relationships is limited. Thus, we aimed to assess the relationship between functional category and mortality in older people with diabetes. We evaluated the data of 843 older diabetes patients in a 6-year prospective study, and the association between functional categories and all-cause mortality. The patients were divided into three functional categories based on cognition, instrumental activities of daily living and basic activities of daily living using the Mini-Mental State Examination, Tokyo Metropolitan Institute of Gerontology Index of Competence and Barthel Index at baseline, respectively (model 1). Those with multimorbidity (≥4 of 8 morbidities) were classified into category III (model 2). The functional category assessed using eight items from the Tokyo Metropolitan Institute of Gerontology Index of Competence and Barthel Index was also constructed (model 3). Hazard ratios and 95% confidence intervals were calculated in the Cox regression analysis using age, sex, body mass index, glycated hemoglobin level, total cholesterol level, estimated glomerular filtration rate and frequency of severe hypoglycemia as covariates. During the 6-year follow up, 64 incident mortalities occurred. The hazard ratios for mortality in categories II and III (as the reference of category I) were 1.83 (95% confidence interval 1.06-3.14, P=0.030) and 3.05 (95% confidence interval 1.12-8.26, P=0.029) after adjustment for covariates, respectively (model 1). Models 2 and 3 showed similar associations between functional category and mortality. The functional categories predicted all-cause mortality in older adults with diabetes. Geriatr Gerontol Int 2021; 21: 512-518.

Assessing the association between optimal energy intake and all-cause mortality in older patients with diabetes mellitus using the Japanese Elderly Diabetes Intervention Trial.

AimSelecting optimal energy intake during diet therapy for older patients with diabetes mellitus is difficult because of the large differences in physical function and comorbid diseases. In Japan, although requirements for total energy intake are calculated by multiplying a person's standard bodyweight (BW) by the amount of physical activity, evidence supporting the application of this method among older people is limited. Therefore, we aimed to assess optimal energy intake by evaluating the relationship between energy intake and mortality in older patients.MethodsWe evaluated data from a 6‐year prospective follow up of 756 older patients with diabetes mellitus, and the association between baseline nutrient intake and mortality. Total energy intake and nutrients were evaluated, and energy intake per actual BW was categorized into quartiles (Q). Cox regression analysis was used for statistical analyses. Energy intake per standard BW or age‐related target BW was statistically analyzed using the same protocol.ResultsAnalysis of energy intake per actual BW showed that hazard ratios for mortality was significantly higher in Q1 and Q4. Similar associations were found for energy intake per standard or target BW. Subgroup analysis showed that mortality rate was the lowest in Q2 in the young‐old population and in Q3 in the old‐old population.ConclusionsA U‐shaped relationship was observed between energy intake per BW and mortality in older patients with diabetes mellitus, which suggests that the optimal energy intake per actual or target BW should encompass a wide range to prevent malnutrition and excessive nutrition in these patients. Geriatr Gerontol Int 2020; 20: 59–65.

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..

Low intakes of carotene, vitamin B2 , pantothenate and calcium predict cognitive decline among elderly patients with diabetes mellitus: The Japanese Elderly Diabetes Intervention Trial.

The present study aimed to examine whether nutrient intakes predicted cognitive decline among elderly patients with diabetes mellitus. This study evaluated data from a 6-year prospective follow up of 237 elderly patients (aged ≥65 years) with diabetes mellitus, and the associations of baseline nutrient intakes with cognitive decline. Cognitive decline was defined as a ≥2-point decrease in the Mini-Mental State Examination (MMSE) score. Intakes of food and nutrients were assessed using a validated food frequency questionnaire, and were compared between patients with cognitive decline and intact cognition. Analysis of covariance and logistic regression analysis were used to compare the changes in the MMSE score during the follow up among intake tertile groups for each nutrient. Compared with men with intact cognition, the men with cognitive decline had lower baseline intakes of calcium, vitamin A, vitamin B2 , pantothenate, soluble fiber, green vegetables and milk. However, no significant associations between cognitive decline and nutrient intakes were observed among women. After adjusting for age, body mass index, glycated hemoglobin levels, history of severe hypoglycemia, previous stroke and baseline MMSE score, we found that cognitive decline was significantly associated with low intakes of carotene, vitamin B2 , pantothenate, calcium and green vegetables. Multiple logistic regression analysis showed that intakes of nutrients and green vegetables predicted cognitive decline after adjusting for age, body mass index, glycated hemoglobin levels, baseline MMSE score, and incident stroke during the follow up. These findings suggest that sufficient intakes of carotene, vitamin B2 , pantothenate, calcium and vegetables could help prevent cognitive decline among elderly men with diabetes mellitus. Geriatr Gerontol Int 2017; 17: 1168-1175.

Body mass index and mortality among Japanese patients with type 2 diabetes: pooled analysis of the Japan diabetes complications study and the Japanese elderly diabetes intervention trial.

Previous studies on the association between body mass index (BMI) and mortality in diabetes do not necessarily provide a comprehensive view in terms of the global population because of the exclusion of individuals with a BMI less than 18.5 kg/m(2). The objective of the study was to examine the association between BMI and mortality. We analyzed pooled data from 2 cohorts of 2620 Japanese patients with type 2 diabetes followed up for 6.3 years. Patients with a history of cardiovascular disease or cancer were excluded. The end point was all-cause mortality. Hazard ratios were estimated by Cox regression adjusted for age, smoking, leisure-time physical activity, and other confounders. An analysis using BMI categories of 14.4-18.5 (5.2%), 18.5-22.4 (37.3%), 22.5-24.9 (31.0%), and 25.0-37.5 kg/m(2) (26.6%) revealed no significant trend in mortality among patients with a BMI of 18.5 kg/m(2) or greater (trend P = .69). In contrast, the hazard ratio of patients with a BMI less than 18.5 kg/m(2) vs 22.5-24.9 kg/m(2) was 2.58 (95% confidence interval 1.38-4.84; P < .01). Exclusion of deaths in the first 4 years of follow-up decreased the hazard ratio only slightly. The lowest mortality rate was observed among patients with a BMI of 18.5-24.9 kg/m(2), and obesity had no benefits regarding mortality. Further research is needed in lean patients, especially among aging populations in East Asia.

New therapeutic strategy for Alzheimer's disease using antidiabetes agents.

New therapeutic strategy for Alzheimer's disease using antidiabetes agents.

4．ADL低下のリスクと対応策

The purpose of the present investigation was to explore the process towards functional disability and predicting factors in Japanese diabetic elderly. We recruited 317 older patients aged 65 or over among participants in the large-scale prospective study of the Japanese Elderly Diabetes Intervention Trial (J-EDIT). We analyzed the changes of daily life function prospectively for 6 years. Information about diabetes, blood examinations and complications was obtained, and basic activity of daily living (ADL) and instrumental ADL (IADL) were assessed by total Barthel index score and the Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG index), respectively. During 6 years of follow-up, 13.6% of subjects had developed a new ADL disability (bADL) and 38.3% had developed a new functional impairment assessed by TMIG index. In the 65-74 years age group, basic ADL decreased only in males, while females became functionally impaired. In 75-84 years age group, basic and IADL decreased in both men and women. Older age and metabolic syndrome negatively affected ADL, while baseline IADL impairment, cognitive dysfunction, physical inactivity, and insulin therapy were significant predictors of a future decline in the IADL. This study identified the disability process and prognostic factors, including the future decline of basic ADL and IADL in diabetic elderly patients. There are modifiable factors for ADL impairment, comprehensive treatment and care are required to keep Japanese diabetic elderly patients healthy in daily life functioning.

2．動脈硬化性血管障害のリスクと対応策

2．動脈硬化性血管障害のリスクと対応策

Factors associated with progression of diabetic nephropathy in Japanese elderly patients with type 2 diabetes: Sub‐analysis of the Japanese Elderly Diabetes Intervention Trial

Diabetic nephropathy is a serious complication in patients with type 2 diabetes. The aim of this study was to explore the factors associated with the progression of this complication in elderly patients with type 2 diabetes. This retrospective study of a subgroup of patients registered with the Japanese Elderly Diabetes Intervention Trial included 621 Japanese patients with type 2 diabetes mellitus (age ≥ 65 years, 346 with normoalbuminuria, 190 with microalbuminuria and 85 with overt proteinuria). Multivariate Cox proportional hazard regression model with a backward stepwise procedure was applied to select factors with significant effects on worsening of nephropathy stage and the doubling of serum creatinine. During the follow up (median 52 months), 21% of patients progressed from normoalbuminuria and microalbuminuria to a worse nephropathy stage. Aging, female sex and high-density lipoprotein cholesterol were identified as independent and significant factors that worsen nephropathy stage. Also, 6.1% of patients showed doubling of serum creatinine during follow up. A positive history of cardiovascular disease, hyperuricemia and conventional therapy were identified as significant factors involved in the doubling of serum creatinine. The cumulative incidence of the doubling of serum creatinine was significantly lower in the intensive therapy group than the conventional therapy group (P = 0.016), although that of progression of nephropathy stage was similar in the two groups. We identified several factors associated with the progression of diabetic nephropathy in elderly patients with type 2 diabetes. The results suggest that multiple risk factor intervention seems important in preventing deterioration of renal dysfunction.

Risk factors for a 6‐year decline in physical disability and functional limitations among elderly people with type 2 diabetes in the Japanese elderly diabetes intervention trial

Type 2 diabetes increases the risk of disability. The purpose of this study was to clarify the explanatory factors for disability in Japanese diabetic elderly. The 6-year decline in physical disability and functional limitations was investigated among 317 elderly people with type 2 diabetes recruited in a large-scale prospective study of the Japanese Elderly Diabetes Intervention Trial. Information about diabetes, blood examinations and complications was obtained, and basic activities of daily living (ADL) and instrumental ADL (IADL) were assessed by total score of the Barthel index and the Tokyo Metropolitan Institute of Gerontology Index of Competence, respectively. After 6 years of follow up, 13.6% of patients had developed a new ADL disability and 38.3% had developed a new functional impairment. In the 65-74 years age group, basic ADL decreased only in males, whereas females became functionally impaired. In the 75-84 years age group, basic and IADL decreased in both males and females. Older age and metabolic syndrome were prognostic for impairment of basic ADL, whereas baseline IADL problems, lower cognitive function, physical inactivity and insulin therapy were significant predictors of a future decline in the IADL. This study identified several factors predicting the future decline of basic ADL and IADL in diabetic elderly patients, and provided a conceptual framework that might help to clarify the pathways leading to disability. Because the specific causes of each functional problem are modifiable, comprehensive treatment and care are needed to allow Japanese diabetic elderly patients to have more favorable living conditions.

Lower physical activity, but not excessive calorie intake, is associated with metabolic syndrome in elderly with type 2 diabetes mellitus: The Japanese elderly diabetes intervention trial

A decline in physical activity has been shown to be associated with metabolic syndrome (MetS), leading to cardiovascular events. However, this is difficult to manage well in the elderly with multiple atherosclerotic risk factors. In this study, we investigated the correlation between physical activity and clinical parameters in the presence and absence of MetS in Japanese elderly subjects with type 2 diabetes mellitus (T2DM). In addition, we determined which factor, calorie intake or physical activity, mainly contributes to the prevalence of MetS. Cross-sectional analysis of 846 consecutive Japanese elderly (408 men and 438 women, mean age 68.7 years) was carried out at the time of enrolment (2000-2002) in the Japanese Elderly Diabetes Intervention Trial. Their level of physical activity was evaluated using the Baecke questionnaire, consisting of three components: work, sports and leisure. Total activity score (TAS) as the sum of each activity score was divided into four quartiles (Q1 to Q4). After adjustment for age and sex, there was a positive association of TAS with high-density lipoprotein cholesterol, although no significant correlation between other lipid parameters and TAS was found. In addition, fasting plasma glucose, insulin level and physical measurements, such as waist circumference, waist/hip ratio and body mass index, were inversely associated with TAS. Although no correlation between TAS and cognitive function Mini-Mental State Examination was found, TAS was positively associated with instrumental ADL and negatively associated with geriatric depression score (GDS), suggesting that a decline in physical activity in the elderly is associated with depressed mood rather than a decline of cognitive function. Total calorie intake appeared to increase according to TAS; however, this did not reach statistical significance. In a subanalysis comparing the presence and absence of MetS, the TAS grade in the MetS group was significantly lower than that in the non-MetS group, although there was no significant difference in total calorie intake between the groups. These results showed that lower physical activity, but not excessive calorie intake, is independently associated with the prevalence of MetS in the elderly with T2DM. In our routine work, encouraging physical activity might contribute to preventing MetS and subsequent atherosclerotic disease in the elderly, rather than strict management of abnormal laboratory parameters using multiple drugs.

Lower physical activity is a strong predictor of cardiovascular events in elderly patients with type 2 diabetes mellitus beyond traditional risk factors: The Japanese elderly diabetes intervention trial

It is well known that a decline in physical activity is associated with lifestyle-related diseases including cardiovascular (CV) events. However, little is known about the association between physical activity and CV events in elderly patients, because recent accumulating reports have mainly dealt with middle-aged populations. In this study, we investigated the correlation between physical activity and CV events in Japanese elderly patients with type 2 diabetes mellitus (T2DM). A total of 938 Japanese elderly patients with T2DM (447 men and 491 women, mean age 71.9 years) enrolled (2000-2002) in the Japanese Elderly Diabetes Intervention Trial (J-EDIT) were used in this study. Physical activity consisting of three components, work, sports and leisure-time, of their lifestyle was evaluated using the Baecke questionnaire at baseline. Total activity score (TAS) as a sum of each activity score was divided into four quartiles (Q1 to Q4). During a follow-up period of 65.2 months, 165 events and 71 deaths in total occurred. Higher TAS grade was associated with reduced risk of all events (hazard ratios: 0.82, 0.77 and 0.54 in Q2, Q3 and Q4, respectively) with statistical significance. Even after multivariate adjustment for covariates, higher TAS grade was a strong predictor of all events, and the prediction by TAS of cerebrovascular events was more effective than that of cardiac events. In contrast, all-cause mortality gradually decreased according to TAS grade; however, no statistical significance was found. Among the four grades of TAS, no significant change in several parameters, such as profiles of lipid and glucose metabolism, blood pressure, physical measurements, cognitive function and depression scale, was found throughout the follow-up period, suggesting that the higher level of physical activity itself was associated with the risk reduction of primary events. Lower physical activity is a strong and independent predictor of all CV events in the elderly with T2DM beyond traditional risk factors. In addition to strict management of each atherosclerotic risk factor, engagement with patients to augment and maintain the level of physical activity in their lifestyle is also essential in clinical practice.

Effective prevention of cardiovascular disease and diabetes‐related events with atorvastatin in Japanese elderly patients with type 2 diabetes mellitus: Adjusting for treatment changes using a marginal structural proportional hazards model and a rank‐preserving structural failure time model

To assess the preventive effect of atorvastatin on cardiovascular disease and on diabetes-related events in elderly type 2 diabetic patients enrolled in the Japanese Elderly Diabetes Intervention Trial (J-EDIT). Data were obtained from 1173 patients aged 65-84 years who were enrolled in the J-EDIT. Patients were followed prospectively for 6 years to determine the effects of atorvastatin on serum cholesterol levels, and cardiovascular and diabetes-related events. Because the study protocol allowed atorvastatin to be prescribed according to the clinical needs of each patient, we regarded the J-EDIT data as if they came from a cohort study. We adjusted for clinical characteristics during the study as time-dependent confounders using two methods, inverse-probability-of-treatment (IPT) weighting and g-estimation method. The total follow-up period was 5310.8 person-years (5.7 years of median follow up), during which 202 patients received atorvastatin treatment. Atorvastatin was associated with moderate reductions in cholesterol levels: 24.2 mg/dL for total cholesterol, 22.9 mg/dL for low-density lipoprotein (LDL) cholesterol and 24.3 mg/dL for non-high-density lipoprotein cholesterol at the first post-treatment year. As a result, the proportion of patients who achieved targeted levels of LDL cholesterol clearly increased after atorvastatin treatment. Eight patients in 476.6 person-years among atorvastatin-treated and 113 untreated patients in 4721.4 person-years had cardiovascular events (the composite end-point of fatal/non-fatal myocardial infarction, angina pectoris, coronary intervention, and fatal/non-fatal cerebrovascular disease); hazard ratio (HR) = 0.48, 95% confidence interval (CI) = 0.19-1.16, P = 0.10, and HR = 0.32, 95% CI = 0.05-1.87, P = 0.21 from IPT weighting and g-estimation method, respectively. Furthermore, seven in 475.0 person-years among atorvastatin-treated and 149 untreated patients in 4682.4 person-years had diabetes-related events (the composite end-point of sudden death, renal failure death, death as a result of hyperglycemia or hypoglycemia, diabetic gangrene and congestive heart failure in addition to cardiovascular event); HR = 0.30, 95% CI = 0.12-0.77, P = 0.01, and HR = 0.40, 95% CI = 0.09-0.89, P = 0.03 from IPT weighting and g-estimation method, respectively. When cardiovascular events were further differentiated into coronary vascular and cerebrovascular events, atorvastatin especially decreased the cerebrovascular risk. The use of atorvastatin to lower cholesterol levels in elderly Japanese patients with type 2 diabetes mellitus appears to reduce the risk of cardiovascular and diabetes-related events.

Optimal energy distribution of carbohydrate intake for Japanese elderly patients with type 2 diabetes: The Japanese Elderly Intervention Trial

In diet therapy for diabetes, optimal energy intake and the energy distribution of macronutrients (protein : fat : carbohydrate [PFC] energy ratio) are important. We aimed to clarify the correlation between the PFC energy ratio and metabolic parameters including glycated hemoglobin A1c (HbA1c) and triglycerides in Japanese elderly patients with type 2 diabetes mellitus aged 65 years or older. Participants were 1173 diabetic patients aged 65 years or older with serum HbA1c level of >/=7.4% enrolled in the Japanese Elderly Diabetes Intervention Trial (J-EDIT). The participants were divided into four groups by the percentage of total energy intake (%E) of carbohydrate (C1: less than 55%E, C2: 55%E or more and less than 60%E, C3: 60%E or more and less than 65%E, and C4: 65%E or more). Relations of %E of carbohydrate to HbA1c and other metabolic parameters, energy intake and nutritional intake were examined. Furthermore, the subjects were divided into four categories by HbA1c levels by quartile method (Q1: less than 7.90%, Q2: 7.90% or more and less than 8.30%, Q3: 8.30% or more and less than 8.80%, Q4: 8.80% or more). Relations of HbA1c to other metabolic parameters, energy intake and nutritional intake were examined. The mean HbA1c levels in the four groups were C1: 8.40%, C2: 8.50%, C3: 8.41% and C4: 8.36% in men, and C1: 8.51%, C2: 8.47%, C3: 8.35% and C4: 8.52% in women, respectively. There were no significant differences and linear trend in HbA1c levels across groups. The mean triglyceride levels were in the range of 122-128 mg/dL in men from C1 to C3, although it was significantly higher in C4 (177 mg/dL). The mean triglyceride levels were in the range of 128-136 mg/dL in women from C1 to C3, although it was significantly higher in Q4 (150 mg/dL). Amounts of protein and fat intakes decreased with an increase of %E of carbohydrate, although amount of carbohydrate intake did not change significantly. As a result, %E of protein and fat, and energy intake decreased in both men and women with an increase in %E of carbohydrate. Among the four quartiles divided by HbA1c levels, there were no significant differences in energy intake and PFC energy ratio. The present study suggests that, within the range studied, the carbohydrate energy ratio has no correlation with HbA1c levels. However, serum triglyceride levels increased and high-density lipoprotein cholesterol levels decreased significantly, with an increase of %E of carbohydrate in men, and the same tendencies were observed in women. Furthermore, in patients with 65%E or more of carbohydrate, serum triglyceride levels exceeded 150 mg/dL, which is the recommended treatment target for diabetic patients. These results suggest that the ideal %E of carbohydrate for Japanese elderly type 2 diabetes is less than 65. The lower limit of %E of carbohydrate could not be determined from the present study.

Dietary pattern and mortality in Japanese elderly patients with type 2 diabetes mellitus: Does a vegetable‐ and fish‐rich diet improve mortality? An explanatory study

To assess the effect of dietary patterns on all deaths and diabetes-related deaths in the Japanese Elderly Diabetes Intervention Trial (J-EDIT). We investigated relationships between that of overall mortality and dietary pattern, and diabetes-related deaths and dietary pattern as observed among 912 registered cases of the J-EDIT study, which is a prospective follow-up study of elderly Japanese type 2 diabetic patients. Factor analysis with the factor number 3 led to deriving three dietary patterns (healthy type, snack type and greasy type). The relationship between these patterns and overall mortality or diabetes-related death was investigated. Although not statistically significant, there was a lower tendency of overall mortality and diabetes-related deaths for the healthy type dietary pattern. When the tendencies of overall mortality were analyzed for "young-old," who are younger than 75 years-of age, and "old-old" of over 75 years-of-age, the mortality rate for the greasy type and healthy type dietary patterns were nearly the same and higher than the snack type dietary pattern in young-old. In contrast, in old-old, a higher mortality rate was reported for the greasy type dietary pattern and a lower mortality rate was reported for the healthy type dietary pattern. The hazard ratio by Cox regression analysis for greasy type to healthy type in old-old was 3.03 (P = 0.04, CI 1.07-8.57). Furthermore, in old-old, as vegetable consumption increased, the lower the tendency foroverall mortality, and the more fish that was consumed, the overall mortality significantly decreased (P = 0.020) in the tertile. The greasy type dietary pattern with an increased amount of sugar, fat and meat led to poor life prognosis for elderly Japanese type 2 diabetic patients. The healthy type dietary pattern rich in vegetable and fish, which is similar to the Mediterranean diet and Dietary Approach to Stop Hypertension diet, was suggested to improve life prognosis.

Relations of nutritional intake to age, sex and body mass index in Japanese elderly patients with type 2 diabetes: The Japanese Elderly Diabetes Intervention Trial

To determine the status of nutritional intake in elderly Japanese patients with type 2 diabetes aged 65 years or older, and to clarify relations of nutritional intake to age, sex and body mass index (BMI). Clinical parameters and nutritional intake were investigated and compared in 912 (417 men, 495 women) elderly Japanese patients with type 2 diabetes registered to the Japanese Elderly Diabetes Intervention Trial. The mean daily energy intake of patients was 1802 kcal in men and 1661 kcal in women, respectively. The energy intakes per kilogram of standard bodyweight in both sexes and the energy intakes per kilogram of present bodyweight in men increased significantly with age. The protein : fat : carbohydrate (PFC) energy ratio (%E) was 15.2:25.4:59.5 in men, and 15.7:25.8:58.6 in women, respectively. Grain, oil, alcohol and soft drink intakes were higher in men than in women. Potato, fruit and green vegetable intakes were higher in women than in men. Fruit intake showed a significant age-related increase in men. In women, there was an age-related significant decrease of meat intake. An increase of BMI correlated with a significant increase in bodyweight, waist circumference, hip circumference, waist-to-hip ratio, triglycerides and diastolic blood pressure. The mean energy intake of three BMI groups, lean (BMI < 18.5 kg/m(2)), normal (18.5 kg/m(2) </= BMI < 25 kg/m(2) ) and obese (25 kg/m(2) </= BMI), were 1625, 1796 and 1839 kcal in men, and 1655, 1647 and 1685 kcal in women, respectively. However, BMI-related increase of energy intake did not reach statistically significant levels in both sexes. Energyintake per kilogram of present bodyweight decreased as BMI increased in both sexes. Energy intake per kilogram of standard bodyweight increased significantly as BMI increased in men only, but not in women. There were no differences in PFC energy ratios among the three BMI groups. In contrast, intake of soft drinks in men increased significantly as BMI increased. In women, intakes of alcohol and soft drink increased significantly as BMI increased. An increased energy intake per kilogram of standard bodyweight correlated with increase of BMI in men, but not in women. Intakes of soft drinks in both sexes and alcohol in women correlated with increase of BMI. These results suggest there are sex differences in the pathogenesis of obesity in elderly type 2 diabetic patients from an aspect of nutritional intake.

Effects of total and green vegetable intakes on glycated hemoglobin A1c and triglycerides in elderly patients with type 2 diabetes mellitus: The Japanese Elderly Intervention Trial

Many reports have shown that vegetable intake is effective in inhibiting the onset and progression of diabetes mellitus, although the amount of vegetable intake required to be effective remains as unclear. The present study therefore aimed to clarify the relationship between the amount of vegetable intake and glycated hemoglobin A1c (HbA1c) and other metabolic parameters using male Japanese type 2 diabetic patients aged 65 years or older as subjects. Participants were 417 male type 2 diabetic patients aged 65 years or older enrolled in the Japanese Elderly Diabetes Intervention Trial. Dietary intakes were measured by using the Food Frequency Questionnaires method. The patients were divided into five groups by their daily total vegetable intake (A1: ~100 g, A2: 100~150 g, A3: 150~200 g, A4: 200~300 g, A5: 300 g~), and compared HbA1c and other metabolic parameters. Furthermore, the relationship between daily green vegetable intake and HbA1c and other metabolic parameters were examined among five groups divided by quintile methods. There were significant decreases in HbA1c, triglycerides and waist circumference with an increase of total vegetable intake. A significant decrease of HbA1c levels was observed in patients with a daily total vegetable intake of 150 g or more. Furthermore, there was a significant decrease of serum triglyceride levels in patients with a total vegetable intake of 200 g or more. HbA1c levels showed a decreasing tendency with the increase of green vegetable intake, and HbA1c levels in the Q1 group (green vegetable intake: less than 40 g) was significantly higher than those in the other four groups (anovaP = 0.025). In addition, there were significant decreases of body mass index, triglyceride levels and waist circumference with the increase of green vegetable intake. Triglyceride levels decreased significantly from the Q3 group (green vegetable intake: 70 g or more) to the Q5 group (green vegetable intake: 130 g or more; anovaP = 0.016). In the group with a lower intake of total vegetables and green vegetables, the protein energy ratio decreased significantly. As a result, the fat energy ratio and energy intake tended to increase with the decrease of total and green vegetable intakes. Furthermore, intake of grains, sweets and alcoholic beverages increased with the decrease of total vegetable intake. In contrast, intake of nuts, potatoes, sugar, legumes, fruit, seaweed and fish increased with the increase of total vegetable intake Daily total vegetable intake of 200 g or more, and green vegetable intake of 70 g or more correlated with improved control of HbA1c and triglyceride levels in elderly type 2 diabetes patients through achieving a well-balanced diet.

Long‐term multiple risk factor interventions in Japanese elderly diabetic patients: The Japanese Elderly Diabetes Intervention Trial – study design, baseline characteristics and effects of intervention

To evaluate long-term, multiple risk factor intervention on physical, psychological and mental prognosis, and development of complications and cardiovascular disease in elderly type 2 diabetes patients. Our randomized, controlled, multicenter, prospective intervention trial included 1173 elderly type 2 diabetes patients who were enrolled from 39 Japanese institutions and randomized to an intensive or conservative treatment group. Glycemic control, dyslipidemia, hypertension, obesity, diabetic complications and atherosclerotic disease were measured annually. Instrumental activity of daily living, cognitive impairment, depressive symptoms and diabetes burden were assessed at baseline and 3 years. There was no significant difference in clinical or cognitive parameters at baseline between the two groups. The prevalence of low activities of daily living, depressive symptoms and cognitive impairment was 13%, 28% and 4%, respectively, and was similar in the two groups. A small, but significant difference in HbA1c between the two groups was observed at 1 year after the start of intervention (7.9% vs 8.1%, P < 0.05), although this significant difference was not observed after the second year. With the exception of coronary revascularization, there was no significant difference in fatal or non-fatal events between the two groups. Composite events were also similar in the two groups. This study showed no significant differences in fatal or non-fatal events between intensive and conventional treatment. The present study might clarify whether treatment of risk factors influences function and quality of life in elderly diabetic patients.