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Krebs J.D.,University of Otago | Krebs J.D.,Diabetes and Research Center | Elley C.R.,University of Auckland | Parry-Strong A.,University of Otago | And 6 more authors.
Diabetologia | Year: 2012

Aims/hypothesis To compare the effectiveness of low-fat high-protein and low-fat high-carbohydrate dietary advice on weight loss, using group-based interventions, among overweight people with type 2 diabetes. Study design Multicentre parallel (1:1) design, blinded randomised controlled trial. Methods Individuals with type 2 diabetes aged 30-75 years and a BMI >27 kg/m 2 were randomised, by an independent statistician using sequentially numbered sealed envelopes, to be prescribed either a low-fat high-protein (30% of energy as protein, 40% as carbohydrate, 30% as fat) or a low-fat highcarbohydrate (15% of energy as protein, 55%as carbohydrate, 30% as fat) diet. Participants attended 18 group sessions over 12 months. Primary outcomes were change in weight and waist circumference assessed at baseline, 6 and 12 months. Secondary outcomes were body fatness, glycaemic control, lipid profile, blood pressure and renal function. A further assessment was undertaken 12 months after the intervention. Research assessors remained blinded to group allocation throughout. Intention-to-treat analysis was performed. Results A total of 419 participants were enrolled (mean±SD age 58±9.5 years,BMI 36.6±6.5 kg/m 2 and HbA 1c 8.1±1.2% (65 mmol/mol)). The study was completed by 70%(294/419). No differences between groups were found in change in weight or waist circumference during the intervention phase or the 12-month follow-up. Both groups had lost weight (2-3 kg, p<0.001) and reduced their waist circumference (2-3 cm, p<0.001) by 12 months and largely maintained this weight loss for the following 12 months. By 6 months, the difference in self-reported dietary protein between groups was small (1.1%total energy; p<0.001). No significant differences between groups were found in secondary outcomes: body fatness, HbA 1c, lipids, blood pressure and renal function. There were no important adverse effects. Conclusions/interpretation In a 'real-world' setting, prescription of an energy-reduced low-fat diet, with either increased protein or carbohydrate, results in similar modest losses in weight and waist circumference over 2 years. Trial registration: Australia New Zealand Clinical Trials Register ACTRN12606000490572 Funding: The Health Research Council of New Zealand (06/337). © 2012 Springer-Verlag.

Elley C.R.,University of Auckland | Robinson E.,University of Auckland | Kenealy T.,University of Auckland | Bramley D.,Waitemata District Health Board | Drury P.L.,Auckland Diabetes Center
Diabetes Care | Year: 2010

OBJECTIVE - To derive a 5-year cardiovascular disease (CVD) risk equation from usual-care data that is appropriate for people with type 2 diabetes from a wide range of ethnic groups, variable glycemic control, and high rates of albuminuria in New Zealand. RESEARCH DESIGN AND METHODS - This prospective open-cohort study used primary-care data from 36,127 people with type 2 diabetes without previous CVD to derive a CVD equation using Cox proportional hazards regression models. Data from 12,626 people from a geographically different area were used for validation. Outcome measure was time to first fatal or nonfatal cardiovascular event, derived from national hospitalization and mortality records. Risk factors were age at diagnosis, diabetes duration, sex, systolic blood pressure, smoking status, total cholesterol-to-HDL ratio, ethnicity, glycated hemoglobin (A1C), and urine albumin-to-creatinine ratio. RESULTS - Baseline median age was 59 years, 51% were women, 55% were of non-European ethnicity, and 33% had micro- or macroalbuminuria. Median follow-up was 3.9 years (141,169 person-years), including 10,030 individuals followed for at least 5 years. At total of 6,479 first cardiovascular events occurred during follow-up. The 5-year observed risk was 20.8% (95% CI 20.3-21.3). Risk increased with each 1% A1C (adjusted hazard ratio 1.06 [95% CI 1.05-1.08]), when macroalbuminuria was present (2.04 [1.89-2.21]), and in Indo-Asians (1.29 [1.14-1.46]) and Maori (1.23 [1.14-1.32]) compared with Europeans. The derived risk equations performed well on the validation cohort compared with other risk equations. CONCLUSIONS - Renal function, ethnicity, and glycemic control contribute significantly to cardiovascular risk prediction. Population- appropriate risk equations can be derived from routinely collected data. © 2010 by the American Diabetes Association.

Best J.D.,University of Melbourne | Drury P.L.,Auckland Diabetes Center | Davis T.M.E.,University of Western Australia | Taskinen M.-R.,University of Helsinki | And 5 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - Glycemic control in type 2 diabetes generally worsens over time, requiring intensification of therapy. The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial provided the opportunity to observe glycemic control in a real-world setting. We assessed the adequacy of metformin, sulfonylureas, and insulin to maintain glycemic control and their effects on weight. RESEARCH DESIGNANDMETHODS - Diabetes control was measured at baseline and yearly for a median of 5 years in the 4,900 patients from the nonintervention arm of this study allocated to placebo. RESULTS - Median HbA 1c was 6.9% at baseline and increased by an average of 0.22% over 5 years (P < 0.001). Median weight was 86.3 kg at baseline and decreased by 0.4 kg over 5 years (P = 0.002). Baseline therapy was lifestyle measures only in 27%, oral agents without insulin in 59%, and insulin in 14%(7%also taking oral agents). Over 5 years, insulin use increased to 32% (21% also taking oral agents). Use of oral agents remained similar at 56%. Only 2% of patients at baseline and 4% after 5 years were taking oral agents other than metformin or sulfonylureas. Initiation of insulin therapy in 855 patients produced a sustained reduction of HbA 1c from a median of 8.2 to 7.7%, with a weight gain of 4.6 kg over 5 years. CONCLUSIONS - With intensification of traditional therapies, glycemic control deteriorated very little over 5 years in a large cohort of type 2 diabetes. However, the requirement for insulin therapy doubled, at the expense of significant weight gain and risk of hypoglycemia. © 2012 by the American Diabetes Association.

Drury P.L.,Auckland Diabetes Center | Drury P.L.,University of Sydney | Ting R.,University of Sydney | Zannino D.,University of Sydney | And 11 more authors.
Diabetologia | Year: 2011

Aims/hypothesis: We investigated effects of renal function and albuminuria on cardiovascular outcomes in 9,795 low-risk patients with diabetes in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Methods: Baseline and year 2 renal status were examined in relation to clinical and biochemical characteristics. Outcomes included total cardiovascular disease (CVD), cardiac and non-cardiac death over 5 years. Results: Lower estimated GFR (eGFR) vs eGFR ≥90 ml min-1 1.73 m-2 was a risk factor for total CVD events: (HR [95% CI] 1.14 [1.01-1.29] for eGFR 60-89 ml min -1 1.73 m-2; 1.59 [1.28-1.98] for eGFR 30-59 ml min -1 1.73 m-2; p< 0.001; adjusted for other characteristics). Albuminuria increased CVD risk, with microalbuminuria and macroalbuminuria increasing total CVD (HR 1.25 [1.01-1.54] and 1.19 [0.76-1.85], respectively; p=0.001 for trend) when eGFR ≥90 ml min-1 1.73 m-2. CVD risk was further modified by renal status changes over the first 2 years. In multivariable analysis, 77% of the effect of eGFR and 81% of the effect of albumin:creatinine ratio were accounted for by other variables, principally low HDL-cholesterol and elevated blood pressure. Conclusions/interpretation: Reduced eGFR and albuminuria are independent risk factors for cardiovascular events and mortality rates in a low-risk population of mainly European ancestry. While their independent contributions to CVD risk appear small when other risk factors are considered, they remain excellent surrogate markers in clinical practice because they capture risk related to a number of other characteristics. Therefore, both should be considered when assessing prognosis and treatment strategies in patients with diabetes, and both should be included in risk models. © Springer-Verlag 2010.

Elley C.R.,University of Auckland | Robinson T.,University of Auckland | Moyes S.A.,University of Auckland | Kenealy T.,University of Auckland | And 4 more authors.
Diabetes Care | Year: 2013

OBJECTIVE Diabetes has become the leading cause of end-stage renal disease (ESRD). Renal risk stratification could assist in earlier identification and targeted prevention. This study aimed to derive risk models to predict ESRD events in type 2 diabetes in primary care. RESEARCH DESIGN AND METHODSdThe nationwide derivation cohort included adultswith type 2 diabetes fromthe New Zealand Diabetes Cohort Study initially assessed during 2000-2006 and followed until December 2010, excluding those with pre-existing ESRD. The outcome was fatal or nonfatal ESRD event (peritoneal dialysis or hemodialysis for ESRD, renal transplantation, or death from ESRD). Risk models were developed using Cox proportional hazards models, and their performance was assessed in a separate validation cohort. RESULTSdThe derivation cohort included 25,736 individuals followed for up to 11 years (180,497 person-years; 86% followed for≤5 years). At baseline, mean age was 62 years, median diabetes duration 5 years, and median HbA1c 7.2 (55 mmol/mol); 37% had albuminuria; and median estimated glomerular filtration rate (eGFR) was 77 mL/min/1.73 m2. There were 637 ESRD events (2.5%) during follow-up. Models that included sex, ethnicity, age, diabetes duration, albuminuria, serum creatinine, systolic blood pressure, HbA1c, smoking status, and previous cardiovascular disease status performed well with good discrimination and calibration in the derivation cohort and the validation cohort (n = 5,877) (C-statistics 0.89-0.92), improving predictive performance compared with previous models. CONCLUSIONSdThese 5-year renal risk models performed very well in two large primary care populations with type 2 diabetes. More accurate risk stratification could facilitate earlier intervention than using eGFR and/or albuminuria alone. © 2013 by the American Diabetes Association.

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