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Takao T.,Institute for Adult Diseases | Matsuyama Y.,University of Tokyo | Yanagisawa H.,Jikei University School of Medicine | Kikuchi M.,Institute for Adult Diseases | Kawazu S.,Institute for Adult Diseases
Journal of Diabetes and its Complications | Year: 2014

Aims We aimed to evaluate the association between HbA1c variability and mortality due to all causes, cancer, and non-cancer in patients with type 2 diabetes independently of mean HbA1c levels. Methods We enrolled 754 patients with type 2 diabetes who first visited our hospital between 1995 and 1996, had been followed for at least 2 years, and had undergone four or more HbA1c determinations. Patients were followed through June 2012. The standard deviation (SD) or coefficient of variation (CV) was used as a measure of HbA1c variability. Risk of death was evaluated by multivariate Cox proportional hazard models. Results Through June 2012, 63 patients died. Hazard ratios (HRs) for all-cause mortality and non-cancer mortality including cardiovascular diseases (CVD) increased across tertiles of both HbA1cSD and HbA1cCV. HRs for cancer mortality did not increase across tertiles of either HbA1cSD or HbA1cCV. Using a stepwise regression method, both HbA1cSD and HbA1cCV predicted all-cause mortality, especially non-cancer mortality. In contrast, mean HbA1c predicted cancer mortality. Conclusions HbA1c variability is a predictor of all-cause mortality, especially non-cancer mortality including CVD, in patients with type 2 diabetes, independent of mean HbA1c level. In contrast, mean HbA1c, but not HbA1c variability, might predict cancer mortality. © 2014 Elsevier Inc.

Takao T.,Institute for Adult Diseases | Matsuyama Y.,University of Tokyo | Yanagisawa H.,Jikei University School of Medicine | Kikuchi M.,Institute for Adult Diseases | Kawazu S.,Institute for Adult Diseases
Journal of Diabetes and its Complications | Year: 2014

Objective To investigate whether visit-to-visit variability in systolic blood pressure (SBP) can predict development and progression of diabetic nephropathy and retinopathy in patients with type 2 diabetes mellitus (T2DM). Methods From 1995 through 1996, 664 T2DM patients visited our hospital for the first time and were subsequently examined 4 times or more and at least once annually. At first visit, 326 had normoalbuminuria, 644 had an estimated glomerular filtration rate (eGFR) of ≥ 45 ml/min/1.73 m2, 526 had no diabetic retinopathy and 609 had no severe non-proliferative diabetic retinopathy (NPDR). They were followed through June 2012, at the latest. Results Ninety patients developed microalbuminuria, 76 showed decrease of eGFR to < 45 ml/min/1.73 m2, 113 developed mild-moderate NPDR and 50 progression to severe NPDR. The unadjusted, age- and sex-adjusted and multivariate-adjusted hazard ratios for development and progression of nephropathy, but not retinopathy, increased across tertiles of the standard deviation (SD) of SBP. Both the SD and coefficient of variation (CV) of SBP were significant predictors of development and progression of nephropathy, but not retinopathy, independently of mean SBP. Conclusion Visit-to-visit SBP variability is an independent predictor of development and progression of diabetic nephropathy, but not retinopathy, in T2DM patients. © 2014 Elsevier Inc. All rights reserved.

Araneta M.R.G.,University of California at San Diego | Kanaya A.M.,University of California at San Francisco | Hsu W.C.,Harvard University | Chang H.K.,University of Hawaii at Manoa | And 11 more authors.
Diabetes Care | Year: 2015

OBJECTIVE: Asian Americans manifest type 2 diabetes at low BMI levels but may not undergo diagnostic testing for diabetes if the currently recommended BMI screening cut point of ≥25 kg/m2 is followed. We aimed to ascertain an appropriate lower BMI cut point among Asian-American adults without a prior diabetes diagnosis. RESEARCH DESIGN AND METHODS: We consolidated data from 1,663 participants, ages ≥45 years, without a prior diabetes diagnosis, from population- and community-based studies, including the Mediators of Atherosclerosis in South Asians Living in America study, the North Kohala Study, the Seattle Japanese American Community Diabetes Study, and the University of California San Diego Filipino Health Study. Clinical measures included a 2-h 75-g oral glucose tolerance test, BMI, and glycosylated hemoglobin (HbA1c). RESULTS: Mean age was 59.7 years, mean BMI was 25.4 kg/m2, 58% were women, and type 2 diabetes prevalence (American Diabetes Association 2010 criteria) was 16.9%. At BMI ≥25 kg/m2, sensitivity (63.7%), specificity (52.8%), and Youden index (0.16) values were low; limiting screening to BMI ≥25 kg/m2 would miss 36% of Asian Americans with type 2 diabetes. For screening purposes, higher sensitivity is desirable to minimize missing cases, especially if the diagnostic test is relatively simple and inexpensive. At BMI ≥23 kg/m2, sensitivity (84.7%) was high in the total sample and by sex and Asian-American subgroup and would miss only ∼15% of Asian Americans with diabetes. CONCLUSIONS: The BMI cut point for identifying Asian Americans who should be screened for undiagnosed type 2 diabetes should be <25 kg/m2, and ≥23 kg/m2 may be the most practical. © 2015 by the American Diabetes Association.

Tanaka S.,Kyoto University | Iimuro S.,University of Tokyo | Yamashita H.,Yamagata University | Katayama S.,Saitama University | And 6 more authors.
Diabetes Care | Year: 2013

OBJECTIVE-To develop and validate a risk engine that calculates the risks of macro- and microvascular complications in type 2 diabetes. RESEARCH DESIGNANDMETHODS-We analyzed pooled data from two clinical trials on 1,748 Japanese type 2 diabetic patients without diabetes complications other than mild diabetic retinopathy with a median follow-up of 7.2 years. End points were coronary heart disease (CHD), stroke, noncardiovascular mortality, overt nephropathy defined by persistent proteinuria, and progression of retinopathy. We fit a multistate Cox regression model to derive an algorithm for prediction. The predictive accuracy of the calculated 5-year risks was cross-validated. RESULTS-Sex, age, HbA1c, years after diagnosis, BMI, systolic blood pressure, non-HDL cholesterol, albumin-to-creatinine ratio, atrial fibrillation, current smoker, and leisure-time physical activity were risk factors for macro- and microvascular complications and were incorporated into the risk engine. The observed-to-predicted (O/P) ratios for each event were between 0.93 and 1.08, and Hosmer-Lemeshow tests showed no significant deviations between observed and predicted events. In contrast, the UK Prospective Diabetes Study (UKPDS) risk engine overestimated CHD risk (O/P ratios: 0.30 for CHD and 0.72 for stroke). C statistics in our Japanese patients were high for CHD, noncardiovascular mortality, and overt nephropathy (0.725, 0.696, and 0.767) but moderate for stroke and progression of retinopathy (0.636 and 0.614). By combining macro- and microvascular risks, the classification of low- and high-risk patients was improved by a net reclassification improvement of 5.7% (P = 0.02). CONCLUSIONS-The risk engine accurately predictsmacro- and microvascular complications and would provide helpful information in risk classification and health economic simulations. © 2013 by the American Diabetes Association.

Onishi Y.,Institute for Adult Diseases | Ono Y.,Internal Medicine | Rabol R.,Novo Nordisk AS | Endahl L.,Novo Nordisk AS | Nakamura S.,Internal Medicine
Diabetes, Obesity and Metabolism | Year: 2013

Aims: This phase 3, 26-week, open-label, treat-to-target trial investigated the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in insulin-naïve Japanese adults with type 2 diabetes. Methods: Subjects were randomized to once-daily injections of IDegAsp (n=147) or insulin glargine (IGlar) (n=149), both ±≤2 oral antidiabetic treatments. IDegAsp was given before the largest meal at the discretion of each subject (and maintained throughout the trial); IGlar was dosed according to label. Both insulins were titrated to a target prebreakfast self-measured plasma glucose of 3.9 to <5.0mmol/l. Results: After 26weeks, mean HbA1c was 7% with IDegAsp and 7.3% with IGlar; superiority of IDegAsp to IGlar was shown (estimated treatment difference, ETD; IDegAsp-IGlar: -0.28% points [-0.46; -0.10]95% CI, p<0.01). At end-of-trial, mean fasting plasma glucose (FPG) was similar for IDegAsp and IGlar (5.7 vs. 5.6mmol/l; ETD IDegAsp-IGlar: 0.15mmol/l [-0.29; 0.60]95% CI, p=NS). IDegAsp was associated with numerically lower rates of overall confirmed (27%) and nocturnal confirmed hypoglycaemia (25%) versus IGlar (estimated rate ratio IDegAsp/IGlar: 0.73 [0.50; 1.08]95% CI, p=NS, and 0.75 [0.34; 1.64]95% CI, p=NS, respectively). Mean daily insulin doses were similar between groups at end-of-trial (both: 0.41U/kg) as were the increases in body weight from baseline (both: 0.7kg). Adverse event profiles were similar between groups. Conclusions: IDegAsp provided superior long-term glycaemic control compared to IGlar, with similar FPG and doses and numerically lower rates of overall and nocturnal hypoglycaemia (p=NS). © 2013 Blackwell Publishing Ltd.

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