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Gerstein H.C.,McMaster University | Bosch J.,McMaster University | Dagenais G.R.,University of Quebec | Diaz R.,Estudios Clinicos Latino America | And 8 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: The provision of sufficient basal insulin to normalize fasting plasma glucose levels may reduce cardiovascular events, but such a possibility has not been formally tested. METHODS: We randomly assigned 12,537 people (mean age, 63.5 years) with cardiovascular risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes to receive insulin glargine (with a target fasting blood glucose level of ≤95 mg per deciliter [5.3 mmol per liter]) or standard care and to receive n-3 fatty acids or placebo with the use of a 2-by-2 factorial design. The results of the comparison between insulin glargine and standard care are reported here. The coprimary outcomes were nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes and these events plus revascularization or hospitalization for heart failure. Microvascular outcomes, incident diabetes, hypoglycemia, weight, and cancers were also compared between groups. RESULTS: The median follow-up was 6.2 years (interquartile range, 5.8 to 6.7). Rates of incident cardiovascular outcomes were similar in the insulin-glargine and standard-care groups: 2.94 and 2.85 per 100 person-years, respectively, for the first coprimary outcome (hazard ratio, 1.02; 95% confidence interval [CI], 0.94 to 1.11; P = 0.63) and 5.52 and 5.28 per 100 person-years, respectively, for the second coprimary outcome (hazard ratio, 1.04; 95% CI, 0.97 to 1.11; P = 0.27). New diabetes was diagnosed approximately 3 months after therapy was stopped among 30% versus 35% of 1456 participants without baseline diabetes (odds ratio, 0.80; 95% CI, 0.64 to 1.00; P = 0.05). Rates of severe hypoglycemia were 1.00 versus 0.31 per 100 person-years. Median weight increased by 1.6 kg in the insulin-glargine group and fell by 0.5 kg in the standard-care group. There was no significant difference in cancers (hazard ratio, 1.00; 95% CI, 0.88 to 1.13; P = 0.97). CONCLUSIONS: When used to target normal fasting plasma glucose levels for more than 6 years, insulin glargine had a neutral effect on cardiovascular outcomes and cancers. Although it reduced new-onset diabetes, insulin glargine also increased hypoglycemia and modestly increased weight. Copyright © 2012 Massachusetts Medical Society.

Bosch J.,McMaster University | Gerstein H.C.,McMaster University | Dagenais G.R.,University of Quebec | Diaz R.,Estudios Clinicos Latino America | And 8 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown. METHODS: In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here. RESULTS: During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P = 0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups. CONCLUSIONS: Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. Copyright © 2012 Massachusetts Medical Society.

Ramachandran A.,India Diabetes Research Foundation | Riddle M.C.,Oregon Health And Science University | Kabali C.,Hamilton Health Sciences | Gerstein H.C.,McMaster University
Diabetes Care | Year: 2012

OBJECTIVE - A1C measurement has advantages over measures of plasma glucose. Few studies have evaluated the A1C-fasting plasma glucose (FPG) relationship and whether oral antidiabetes drugs (OADs) and ethnic or geographic variations affect the relationship. Baseline A1C and FPG data from the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial participants were analyzed to 1) elucidate the relationship between A1C and FPG in people with moderate dysglycemia (A1C 5.6-9.0% [38-75 mmol/mol]) and additional risk factors for cardiovascular disease, 2) determine whether this relationship is altered by use of an OAD, and 3) study whether geographic and ethnic differences exist. RESEARCH DESIGN AND METHODS - Analysis was performed of 12,527 participants with dysglycemia or early type 2 diabetes recruited in North America, South America, Europe, Australia, and Asia who comprised white, Latin American, Asian, black, and other ethnicities. The A1C-FPG relationships were analyzed using cubic B spline curves in all participants and in subgroups not using an OAD or using an OAD and comprising persons of different ethnic or geographic origin. RESULTS - A strong relationship between FPG in the range of 5.6-9.0 mmol/L and the corresponding A1C was seen across different geographic regions and ethnic groups. A smaller increase in A1C per unit increase in FPG occurred for persons taking an OAD versus those not taking an OAD. CONCLUSIONS - The strong relationship between A1C and FPG in moderate dysglycemia is not significantly affected by ethnic or geographic differences. Use of an OAD alters the relationship and should be considered when interpreting A1C level. © 2012 by the American Diabetes Association.

Agency: Cordis | Branch: FP7 | Program: MC-IAPP | Phase: FP7-PEOPLE-2011-IAPP | Award Amount: 809.24K | Year: 2011

DiaBSmart project aims to generate, transfer and exchange the clinical, academic and production knowledge between the partners to create a new generation of diabetic footwear through a newly developed patient assessment system.The transfer of knowledge(TOK) between various sectors ensures that the need of patients is considered and transferred effectively to product development using a scientific approach.The objectives include:(1) the design and development of an integrated system of DIABetic foot assessment (2) to validate the newly developed system using experimental methods (3) to develop a suitable material to meet the mechanical and clinical requirements (4) to evaluate the mechanical and clinical effectiveness of material choice in reducing the potential risk of foot complications.The Numerical, Experimental and Mathematical Analyses system will integrate all aspects of diabetic footwear including; clinical and biomechanical assessment, material choice and aesthetic design.Proposed interdisciplinary, intersectorial approach is unique and brings together the expertise from research institutions, industry and clinics. TOK between these sectors will ensure the synergy and efficient use of information in patient assessment, monitoring, product development and customisation in an objective manner.This project while enhancing the knowledge base in diabetic assessment; will have a clear impact on new product development leading to both clinical and economic benefits. The products include a new generation of integrated SMART /multi material midsoles and/or orthoses for diabetic footwear.Properties of the materials will be optimised with a view to minimise/ redistribute the pressure and hence the stress on the soft tissue in the critical plantar areas of the foot.Whilst significantly affecting the course of the disease, the products will aim to reduce the risk of limb loss in patients with diabetes,the most frequent cause of non-traumatic lower-limb amputations.

Ramachandran A.,India Diabetes Research Foundation | Snehalatha C.,India Diabetes Research Foundation | Ma R.C.W.,Chinese University of Hong Kong
Diabetes Research and Clinical Practice | Year: 2014

According to the recent estimates by the International Diabetes Federation (IDF), South East-Asia (SEA) Region consisting of India, Sri Lanka, Bangladesh, Bhutan, Mauritius and Maldives, is home to more than 72 million adults with diabetes in 2013 and is expected to exceed 123 million in 2035. Nearly 95% of people with diabetes have type 2 diabetes (T2DM). Although type 1 diabetes (T1DM) is relatively rare in these countries, its prevalence is also rising. Furthermore, a large number (24.3 million) of people also have impaired glucose tolerance (IGT). Several characteristic differences are seen in the clinical and immunological presentation of these people when compared with their European counterparts.A sharp increase in the prevalence of T2DM has been observed in the SEA Region, both in urban and rural areas, which is mostly associated with the lifestyle transitions towards urbanisation and industrialisation. Evidence suggests that a large portion of T2DM may be preventable by lifestyle modification. However, morbidity and early mortality occur as a result of inadequate healthcare facilities for early detection and initiation of therapy, as well as suboptimal management of diabetes and associated morbidities. This is largely preventable by primary prevention of diabetes and enhancing awareness about the disease among the public and the healthcare providers. There is an urgent need for concerted efforts by government and non-governmental sectors to implement national programmes aimed at prevention, management and surveillance of the disease. © 2013 Elsevier Ireland Ltd.

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