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Aim: To investigate whether any reduction in all-cause mortality and cardiovascular disease morbidity was found over the decade in type 2 diabetes on real-world practice., Methods: A prospective observational study was performed by following two independent cohorts recruited in 2004 (n = 3286, Cohort 1) and 2014 (n = 3919, Cohort 2). The primary outcome was a composite of onset of cardiovascular disease and death. Cox proportional hazards analysis was used to explore any difference between Cohort 2 and Cohort 1 for the composite endpoints and cardiovascular disease after adjustment for covariates and accumulation of five risks (smoking, HbA1c, blood pressure, lipids, and albuminuria) outside target ranges., Results: During the 8-year follow-up, 391 (11.9%) and 270 (6.9%) primary outcomes, and 270 (8.2%) and 161 (4.1%) cardiovascular diseases occurred in Cohort 1 and Cohort 2, respectively. Cohort 2 (vs. Cohort 1) exhibited a significant risk reduction for composite endpoints (HR 0.73, 95% CI 0.62 to 0.86) and cardiovascular disease (HR 0.64, 95% CI 0.52 to 0.79), and similarly exhibited a significant reduction independent of the accumulation of the five risks., Conclusions: The significant reduction of Cohort 2 for cardiovascular disease independent of the baseline covariates suggests an integrated effect delivered by the recent treatment advances., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

Aims: To determine whether specific lipid parameters are better predictors of cardiovascular disease (CVD) in Japanese mild-to-moderate hypercholesterolemic patients with and without diabetes., Methods: Mildly or moderately hypercholesterolemic patients with no history of CVD received diet therapy or diet therapy plus pravastatin. In this post-hoc subanalysis, 5-year data from 3170 patients (668 diabetes, 2502 non-diabetes) on diet therapy alone were used to compare lipid parameters as predictors of CVD. We examined the data by tertiles, using hazard ratio (HR) per one-standard deviation (SD) increment (decrease for high-density lipoprotein cholesterol, HDL-C), χ(2) value, receiver operating characteristic curve analysis, and spline analysis., Results: In mild-to-moderate hypercholesterolemic patients with diabetes, increased total cholesterol (TC)/HDL-C, low-density lipoprotein cholesterol (LDL-C)/HDL-C and decreased HDL-C were strongly associated with increased incidence of CVD (tertile analysis). In non-diabetes, increased non-HDL-C, and LDL-C/HDL-C were significantly associated with increased incidence of CVD. A one-SD decrease in HDL-C and a one-SD increment in non-HDL-C, TC/HDL-C, and LDL-C/HDL-C were significantly associated with increased HRs for CVD in both diabetes and non-diabetes. Linear CVD risk increases were found for non-HDL-C in diabetes and for non-HDL-C and HDL-C in non-diabetes (spline analysis)., Conclusions: In mild-to-moderate hypercholesterolemia, CVD risk prediction by stratifications of single or combination of traditional lipid parameter values illustrates various patterns. Parameters including HDL-C are better predictors of cardiovascular risk than only using TC or LDL-C alone. Non-HDL-C could be the most useful lipid parameter to assess CVD risk, considering it is easy to calculate and less affected by food intake., (Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

Objective: Whether early stages of kidney dysfunction assessed by the estimated glomerular filtration rate from cystatin C measurements (eGFRCysC) rather than from creatinine measurements (eGFRCr) would more precisely reflect the risk of developing type 2 diabetes (T2D) has not been clarified. We compared the risk of developing T2D associated with renal dysfunction indicated by eGFRCysC or eGFRCr measurements., Methods: Studied were 2131 Japanese individuals without diabetes. Hazard ratios (HRs) for the development of T2D over 3-5 y were calculated across categories of eGFRCysC and eGFRCr, respectively., Results: Reduced levels of eGFRCysC were associated with a step-wise increase in the cumulative incidence rate of T2D (p=0.007). In comparison with the eGFRCysC >85th percentile group (≥ 117.4 ml/min/1.73 m(2)), the lowest group, which was the eGFRCysC <15th percentile group (<86.2 ml/min/1.73 m(2)), had an adjusted HR of 2.30 (95% CI 1.13, 4.68) for T2D. Compared with the eGFRCr >85th percentile group, the lowest eGFRCr group (<15th percentile) had an HR of 1.19 (0.63, 2.24) for T2D. However, individuals with eGFRCr <60 ml/min/1.73 m(2) had a significantly increased risk of T2D. Clustering of both low eGFRCysC and low eGFRCr further elevated the HR for T2D compared with the presence of either., Conclusions: Although eGFRCr in ranges indicating chronic kidney disease reflected an elevated risk of developing diabetes, earlier stages of kidney dysfunction indicated by reduced eGFRCysC, which could not be captured by reduced eGFRCr, would be a marker for an elevated risk of developing T2D., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims: Eradication of Helicobacter pylori (HP) is an effective approach to improve intestinal symptoms and prevent gastric cancer. However, there has been concern that the presence of diabetes reduces the effectiveness of antibiotics. We performed this meta-analysis to investigate the effect of diabetes on the risk of failing eradication in patients with diabetes., Methods: An electronic literature search was conducted using Biosis, MEDLINE, Embase, PASCAL, and SciSearch through November 30, 2012. Selected studies had to provide data on the number of individuals who received treatment for HP infection and on the failure of HP eradication in groups with and without diabetes. Two authors independently extracted relevant data., Results: Data were obtained from 8 eligible studies (693 total participants including 273 participants with diabetes). Overall, the pooled risk ratio (RR) of failing HP eradication for diabetic patients compared with non-diabetic participants was 2.19 [95%CI, 1.65-2.90] (P<0.001). Excluding the 2 studies that used a non-standard protocol for HP eradication, individuals with diabetes had a higher risk of failure of eradication compared to those without diabetes (RR=2.31 [95%CI, 1.72-3.11])., Conclusions: Current meta-analysis confirmed the higher risk of HP eradication failure in individuals with diabetes compared with those without diabetes, suggesting the necessity of prolonging treatment or developing a new regimen for HP eradication in patients with diabetes., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Although it is well known that the maternal prepregnancy BMI is a strong contributor to fetal growth, our results showed that a low postload glucose level, although within normal range, independent of maternal BMI was strongly associated with an increased risk of low birth weight births among Japanese mothers., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

To investigate the role of HDL-C in cardiovascular risk reduction, we evaluated using data from a diabetic population in a large clinical trial with pravastatin. A significant risk reduction in CVD was found only in diabetic patients who had both a reduction in LDL-C and an increase in HDL-C., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Objective: To evaluate the impact of HbA1c for diagnosis of diabetes and investigate whether cardiovascular risks profiles differ among individuals with diabetes diagnosed by HbA1c or fasting plasma glucose (FPG)., Methods: This cross-sectional study involved 26,884 participants (30.6% women; aged 20-91 years) without known diabetes. Subjects were categorized into 4 groups according to the presence or absence of FPG ≥7.0 mmol/L and/or HbA1c ≥6.5%, which were American Diabetes Association criteria. Oral glucose tolerance test data were not available., Results: Prevalence of undiagnosed diabetes was 3.6%. Of those individuals, 47.5% fulfilled both two criteria and 26.0% fulfilled only HbA1c criterion. Individuals with diabetes according to FPG ≥7.0 mmol/L alone were characterized as having poorly controlled hypertension while those with HbA1c ≥6.5% alone were characterized as older, female, and having lower blood pressure and γ-glutamyltransferase values. Persons with newly diagnosed diabetes by HbA1c had low HDL cholesterol and high LDL or non-HDL cholesterol levels., Conclusions: Introducing HbA1c into the diagnosis allowed detection of many previously undiagnosed cases of diabetes in Japanese individuals. Those diagnosed by FPG were characterized by hypertension and those diagnosed by HbA1c had unfavorable lipid profiles, reflecting an atherosclerotic trait., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

We recorded self-reported eating patterns in 172 Japanese men and women who were subsequently followed for 3 years for the occurrence of impaired glucose tolerance (IGT). Incidence of IGT was significantly higher in those who reported eating fast. Self-reported eating fast is a potent risk factor for development of IGT., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Aims: To clarify risk factors predictive of glucose intolerance in later pregnancy., Methods: We prospectively studied 509 pregnant women who visited the obstetrics clinic in Tokyo prior to week 13 of gestation, between September 2008 and January 2010. Biochemical parameters were measured in fasting plasma samples collected at week 8.0 ± 2.0 of gestation. A 50 g glucose challenge test (GCT) was performed between weeks 26 and 29: plasma glucose levels ≥ 7.8 mmol/l 1h after ingestion indicated a positive GCT. Logistic regression was performed, adjusting for relevant covariates., Results: We identified 114 patients with positive GCTs, including 8 with gestational diabetes mellitus (GDM). After correcting for baseline body mass index, only the homeostasis model assessment of insulin resistance value remained a significant predictor of GCT positivity (OR 2.07; 1.21-3.55). We identified threshold values of fasting plasma glucose (FPG) ≥ 3.66 mmol/l and fasting plasma insulin (FPI) ≥ 36.69 pmol/l as indicative of a higher risk of positive GCT (OR 2.38; 1.49-3.80)., Conclusions: First trimester FPI levels improve the predictive ability of FPG level on subsequent GCT positivity., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Aim: To investigate the efficacy of continuing glimepiride in combination with basal-prandial insulin therapy in type 2 diabetes., Methods: An open crossover study was performed with arms of discontinuation and continuation of glimepiride in 25 subjects with mean diabetes duration of 17 years and 5 years of insulin treatment combined with glimepiride plus metformin. At entry and at the end of each 3-month arm, meal tolerance tests were performed for measurements of blood glucose and C-peptide., Results: In terms of between-treatment differences (discontinuation vs. continuation arm of glimepiride) during meal tolerance tests performed at the ends of arms, significant increases in plasma glucose were seen on the discontinuation arm at 0-, 30-, and 60-min, while significant decreases in serum C-peptide were observed at 60- and 120-min. A1C values of the discontinuation arm significantly increased (from 6.6 ± 0.6 at baseline to 7.7 ± 0.8 at 3-months, p<0.0001). Increases in A1C were closely correlated with decreases in area under the curve of meal-stimulated serum C-peptide (r=-0.61, p<0.0001)., Conclusions: Since endogenous insulin secretion is more physiological than subcutaneous insulin injection, continuing glimepiride may remain beneficial, partly through enhancing insulin secretion, in individuals with a long duration of diabetes and basal-prandial insulin therapy., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Although, weight loss is associated with improved glycemic control in diabetic patients, the relationships between patient weight, daily energy intake (EI), and glycemic or other control status have been poorly investigated. Baseline characteristics of the Japan Diabetes Complications Study, a representative cohort of Japanese diabetic patients, were used for quartile analysis stratified according to patient body mass index (BMI) and EI. Despite a 1.4-fold discrepancy in BMI between the highest and the lowest quartiles, no significant linear trend in HbA(1C) levels or EI between quartiles was seen, although, waist/hip ratio, blood pressure, total cholesterol and triglycerides increased and HDL cholesterol decreased with the increase in BMI. Quartile analysis, according to EI, revealed a 1.8-fold elevation in EI between the lowest and the highest quartile. Nevertheless, the differences in patient BMI between the lowest and the highest quartile were no more than 3% and there were no significant linear trends among the four quartiles in most parameters including HbA(1C), blood pressure, serum lipids. These results revealed only very limited cross-sectional correlations among BMI, EI and other parameters suggesting that it is necessary to consider much wider variations in ideal weight and optimal dietary prescription when making assessments of diabetic patients.

The medical criteria for initiating insulin therapy, based on clinical profiles of type 2 diabetic patients, have not yet been clearly established. We explored various parameters with 48 type 2 diabetic patients who were taking oral hypoglycemic medication. Among parameters, body mass index (BMI), the fasting plasma glucose level (FPG), and plasma chloride concentration were identified by forward-stepwise discriminant analysis as parameters that can discriminate between patients who were and those who were not undergoing insulin therapy. In combination, these parameters correctly diagnosed 86.4% of the patients who were undergoing insulin therapy, and 84.6% of those who were not undergoing insulin therapy. Further, we observed significant correlations between plasma chloride concentrations and either plasma sodium or organic acid concentrations, suggesting that impaired insulin action may reduce plasma chloride concentrations through changes in plasma sodium and organic acid metabolism. Our results suggest that plasma chloride concentration is a possible new indicator of insulin insufficiency.