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See detailComparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial.
BEGIN Once Long Trial Investigators; RADERMECKER, Régis ULg

in Diabetic Medicine : A Journal of the British Diabetic Association (2013)

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See detailComparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial.
Begin once trial investigators; RADERMECKER, Régis ULg

in Diabetic Medicine : A Journal of the British Diabetic Association (2013)

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See detailPrognostic impact of electrocardiographic signs in patients with Type 2 diabetes and cardiovascular disease: results from the PROactive study
Pfister, R.; Cairns, R.; Erdmann, E. et al

in Diabetic Medicine : A Journal of the British Diabetic Association (2011), 28

Aims Although a resting electrocardiograph is broadly applied in clinical practice for evaluating patientswith Type 2 diabetes and cardiovascular disease, the independent prognostic relevance of ... [more ▼]

Aims Although a resting electrocardiograph is broadly applied in clinical practice for evaluating patientswith Type 2 diabetes and cardiovascular disease, the independent prognostic relevance of electrocardiographic signs has not thoroughly been examined. Methods Baseline 12-lead electrocardiographs available in 5231 of the 5238 participants of the PROactive trial were analysed for heart rate, heart rate corrected QT-interval, presence of atrial fibrillation ⁄ flutter, left axis deviation, right and left bundle branch block. The association of electrocardiographic signs with total mortality, the principal secondary composite endpoint (death, myocardial infarction and stroke) and serious adverse heart failure events was examined by Cox-regression analysis. Results Two hundred and twenty-three (4.3%) patients showed atrial fibrillation ⁄ flutter, 213 (4.1%) patients had right bundle branch block, 111 (2.1%) patients had left bundle branch block and 706 (13.5%) patients had left axis deviation. Mean cQT-interval was 418 ms ( 25 ms) and mean heart ratewas 72 ⁄min ( 14 ⁄ min). Inmultivariate adjusted analyses, heart rate and cQT-interval were significantly associated with mortality, the composite secondary endpoint and heart failure, whereas right and left bundle branch blockswere significantly associated with heart failure only. Left axis deviationwas associated with heart failure and atrial fibrillation ⁄ flutter was associated with mortality and heart failure in univariate but not multivariate analyses. Conclusion Easily assessable electrocardiographic signs such as heart rate, cQT-interval and bundle branch blocks were predictive for adverse outcome independently of multiple risk factor adjustment and should be considered in clinical care. [less ▲]

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See detailChanges in pulse pressure, heart rate and the pulse pressure x heart rate product during squatting in Type 1 diabetes according to age.
Philips, Jean-Christophe ULg; Marchand, Monique ULg; Scheen, André ULg

in Diabetic Medicine : A Journal of the British Diabetic Association (2010), 27(7), 753-61

AIMS: We assessed changes in pulse pressure and heart rate during a squatting test, as indirect markers of arterial stiffness and cardiovascular autonomic neuropathy, respectively, according to age and ... [more ▼]

AIMS: We assessed changes in pulse pressure and heart rate during a squatting test, as indirect markers of arterial stiffness and cardiovascular autonomic neuropathy, respectively, according to age and sex in patients with Type 1 diabetes mellitus. METHODS: We evaluated 160 diabetic patients, divided into four groups of 20 men and 20 women according to age (G1, 20-30 years old; G2, 31-40 years old; G3, 41-50 years old; and G4, 51-60 years old), and 160 non-diabetic matched control subjects. Each subject underwent a 3 min posture test (standing-squatting-standing) with continuous measurement of arterial blood pressure and heart rate by a Finapres device. Overall values throughout the test, baseline levels in initial standing position and squatting-induced changes in pulse pressure, heart rate and the pulse pressure x heart rate product were compared between diabetic patients and healthy control subjects. RESULTS: In the standing position, a greater increase in pulse pressure and lower reduction in heart rate with age led to a significantly higher pulse pressure x heart rate product in diabetic patients compared with control subjects. In the squatting position, a more marked pulse pressure increase in the absence of appropriate reduction in heart rate resulted in a greater rise in the pulse pressure x heart rate product in diabetic patients than in healthy subjects. No major differences were noted between the sexes, with the exception of a stronger relationship between pulse pressure and age in the female population with diabetes. Squatting-derived indices of cardiovascular autonomic neuropathy were also noted with increasing age in diabetic patients. CONCLUSIONS: The marked increase in the pulse pressure x heart rate product ('pulsatile stress') according to age, combined with cardiovascular autonomic neuropathy, may contribute to the higher cardiovascular risk of patients with Type 1 diabetes. [less ▲]

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See detailLong-term glycaemic effects of pioglitazone compared with placebo as add-on treatment to metformin or sulphonylurea monotherapy in PROactive (PROactive 18)
Scheen, André ULg; Tan, M. H.; Betteridge, D. J. et al

in Diabetic Medicine : A Journal of the British Diabetic Association (2009)

Abstract Aims To assess the long-term glycaemic effects, concomitant changes in medications, and initiation of permanent insulin use (defined as daily insulin use for a period of ≥90 days, or ongoing use ... [more ▼]

Abstract Aims To assess the long-term glycaemic effects, concomitant changes in medications, and initiation of permanent insulin use (defined as daily insulin use for a period of ≥90 days, or ongoing use at death/final visit) with pioglitazone vs. placebo in diabetic patients receiving metformin or sulphonylurea monotherapy at baseline in the PROspective pioglitAzone Clinical Trial in macroVascular Events (PROactive). Methods In PROactive, patients with Type 2 diabetes and macrovascular disease were randomized to pioglitazone (force-titrated to 45 mg/day) or placebo, in addition to other existing glucose-lowering therapies. In a post-hoc analysis, we categorized patients not receiving insulin at baseline and treated by oral monotherapy into two main cohorts: addon to metformin alone (n = 514) and sulphonylurea alone (n = 1001). The follow-up averaged 34.5 months. Results There were significantly greater reductions in glycated haemoglobin (HbA1c) with pioglitazone than with placebo and more pioglitazone-treated patients achieved HbA1c targets, irrespective of the baseline oral glucose-lowering regimen and despite a decrease in the use of other glucose-lowering agents. Approximately twice as many in the placebo groups progressed to permanent insulin use than in the pioglitazone groups across the two cohorts: 3.4% for pioglitazone and 6.5% for placebo when added to metformin monotherapy and 6.3% and 14.8%, respectively, when added to sulphonylurea monotherapy. The overall safety of both dual therapies was good. Conclusions Intensifying an existing oral monotherapy regimen to a dual oral regimen by adding pioglitazone resulted in sustained improvements in glycaemic control and reduced progression to insulin therapy. The efficacy and safety of adding pioglitazone to either metformin monotherapy or sulphonylurea monotherapy were good. [less ▲]

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See detailLong-term glycaemic control with metformin– sulphonylurea–pioglitazone triple therapy in PROactive (PROactive 17)
Scheen, André ULg; Tan, M. H.; Betteridge, D. J. et al

in Diabetic Medicine : A Journal of the British Diabetic Association (2009), 26(10), 1033-1039

Aims We assessed the long-term glycaemic effects and the safety profile of triple therapy with the addition of pioglitazone vs. placebo in patients with Type 2 diabetes treated with combined ... [more ▼]

Aims We assessed the long-term glycaemic effects and the safety profile of triple therapy with the addition of pioglitazone vs. placebo in patients with Type 2 diabetes treated with combined metformin–sulphonylurea therapy in the PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive). Methods In a post-hoc analysis, we identified patients treated with metformin plus sulphonylurea combination therapy and not receiving insulin at baseline (n = 1314). In those patients, we compared the effects of pioglitazone (force-titrated to 45 mg⁄ day, n = 654) vs. placebo (n = 660) on glycated haemoglobin (HbA1c) reduction, concomitant changes in medications and initiation of permanent insulin use (defined as daily insulin use for a period of ‡ 90 days or ongoing use at death ⁄ final visit). Results Significantly greater reductions in HbA1c and greater proportions of patients with HbA1c at target were noted with pioglitazone vs, placebo, despite a decrease in the use of other oral glucose-lowering agents. Therewas an approximate twofold increase in progression to permanent insulin use in the placebo group vs. the pioglitazone group: 31.1 vs. 16.1%, respectively, when added to combination therapy. The overall safety of themetformin–sulphonylurea–pioglitazone triple therapy was good. Conclusions Intensifying an existing dual oral therapy regimen to a triple oral regimen by adding pioglitazone to the classical metformin–sulphonylurea combination resulted in sustained improvements in glycaemic control and reduced progression to insulin therapy. The advantages and disadvantages of adding pioglitazone instead of adding basal insulin should be assessed further. [less ▲]

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See detailContinuous glucose monitoring as a tool to identify hyperglycaemia in non-diabetic patients with acute coronary syndromes
RADERMECKER, Régis ULg; Sultan, A.; Piot, C. et al

in Diabetic Medicine : A Journal of the British Diabetic Association (2009), 26

Aim To explore the occurrence and the distribution of glucose excursions > 7.8 mmol/l by continuous glucose monitoring (CGM) in non-diabetic patients admitted with acute coronary syndrome (ACS). Methods ... [more ▼]

Aim To explore the occurrence and the distribution of glucose excursions > 7.8 mmol/l by continuous glucose monitoring (CGM) in non-diabetic patients admitted with acute coronary syndrome (ACS). Methods Twenty-one non-diabetic patients without baseline hyperglycaemia admitted for ACS wore a continuous glucose monitoring system (CGMS) for a median period of 45.6 h. Occurrence and 24-h distribution of time spent with blood glucose > 7.8 mmol/l (TS > 7.8) were retrospectively investigated. Results CGMS data disclosed time spent > 7.8 in 17 patients, whereas only seven of them showed at least one capillary blood glucose test value above the threshold for the same time period. Glucose excursions were detectable earlier from CGMS data. Hyperglycaemia was detected most frequently in the morning, more than 2 h after breakfast. Conclusions CGM discloses early and frequent hyperglycaemia in non-diabetic patients with ACS. Intensive glucose monitoring during the morning time period is the most efficient in screening for hyperglycaemia and could be a valuable guide to initiating insulin therapy and to further investigate outcomes in ACS. [less ▲]

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See detailOrganization of a quality-assurance project in all Belgian multidisciplinary diabetes centres treating insulin-treated diabetes patients: 5 years' experience.
Debacker, Nathalie ULg; Nobels, F.; Vandenberghe, H. et al

in Diabetic Medicine : A Journal of the British Diabetic Association (2008), 25(2), 179-85

AIMS: To describe the IQED, a quality-assurance system started in 2001 in Belgian hospital-based multidisciplinary diabetes centres, and its effects on the quality of care. METHODS: The study was ... [more ▼]

AIMS: To describe the IQED, a quality-assurance system started in 2001 in Belgian hospital-based multidisciplinary diabetes centres, and its effects on the quality of care. METHODS: The study was conducted through four data collections (in 2001, 2002, 2004 and 2006). Approximately 120 diabetes centres provided data on a systematic random sample of 10% of their adult diabetic patients on at least two daily insulin injections. Data on patient characteristics, glycaemic control, cardiovascular risk, diabetes complications, follow-up procedures and treatment were obtained. Local quality promotion was encouraged by returning comprehensive feedback (benchmarks) and during information meetings. RESULTS: Nearly all diabetes centres (98-100%) participated. The pooled sample consisted of 9194 (32%) Type 1 and 19 828 (68%) Type 2 diabetes patients, with mean diabetes duration of 17 years and 14 years, prevalence of microvascular complications of 23% and 38% and prevalence of macrovascular complications of 9% and 26%, respectively. At the start, the quality of care was good in terms of risk-factor testing rates and moderate in terms of patients meeting goals for risk-factor management. At least 50% of the centres initiated quality-promoting initiatives. After 5 years, significant improvements were seen in risk-factor testing rates, apart from renal screening. Improvements in intermediate outcomes were less obvious, apart from an increase in patients reaching the targets for blood pressure and LDL cholesterol. CONCLUSIONS: It is feasible to implement a continuous quality-improvement project on a nationwide scale, with improvements particularly in process indicators. [less ▲]

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See detailFactors predictive of nephropathy in DCCT Type 1 diabetic patients with good or poor metabolic control
Zhang, Liying; Krzentowski, Georges; Albert, Adelin ULg et al

in Diabetic Medicine : A Journal of the British Diabetic Association (2003), 20(7), 580-585

Aims The study aim was to assess the time-related risk of developing diabetic nephropathy [albumin excretion rate (AER) greater than or equal to 40 mg/24 h] from baseline covariates in Type 1 diabetic ... [more ▼]

Aims The study aim was to assess the time-related risk of developing diabetic nephropathy [albumin excretion rate (AER) greater than or equal to 40 mg/24 h] from baseline covariates in Type 1 diabetic patients with either good or poor metabolic control (MC). Methods Based on material from the Diabetes Control and Complications Trial study (n = 1441), patients were considered as under good or poor MC if their HbA(1c) mean level up to last visit fell in the lowest (less than or equal to 6.9%) or highest (greater than or equal to 9.5%) quintile of the overall HbA(1c) distribution, respectively. Prevalence cases of nephropathy were excluded from the study. Survival analysis and Cox regression were applied to the data. Results Among patients with good MC (n = 277), 15% had developed nephropathy at the end of the study. Conversely, among patients with poor MC (n = 268), the proportion without the complication was 52%. When adjusting for MC, time to diabetic nephropathy was related to age (P < 0.0001), AER (P < 0.001), duration of diabetes (P < 0.005), body mass index (BMI) (P < 0.005), all at baseline, and to gender (P < 0.01). Patients with upper normal range AER levels, longer duration of diabetes and lower BMI were at higher risk, regardless of MC. The adverse effect of younger age on diabetic nephropathy was more marked in good than in poor MC. Although women tended to develop the complication more often under good MC, they appeared to be better protected under poor MC. Conclusions This study confirms occurrence of diabetic nephropathy under good MC and non-occurrence of the complication despite poor MC. It also demonstrates that some baseline covariates can affect, in a differential manner, time to diabetic nephropathy depending on MC. [less ▲]

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See detailThe postprandial state and risk of cardiovascular disease.
Lefebvre, Pierre ULg; Scheen, André ULg

in Diabetic Medicine : A Journal of the British Diabetic Association (1998), 15 Suppl 4

Metabolism in man is regulated by complex hormonal signals and substrate interactions, and for many years the clinical focus has centred on the metabolic and hormonal picture after an overnight fast. More ... [more ▼]

Metabolism in man is regulated by complex hormonal signals and substrate interactions, and for many years the clinical focus has centred on the metabolic and hormonal picture after an overnight fast. More recently, the postprandial state, i.e. 'the period that comprises and follows a meal', has received more attention. The oral glucose tolerance test (OGTT), although highly non-physiological, has been used largely as a model of the postprandial state. Epidemiological studies have shown that, when 'impaired', oral glucose tolerance is associated with an increased risk of cardiovascular disease. Postprandial hyperlipidaemia has been investigated more recently in epidemiological, mechanistical and intervention studies, most of which indicate that high postprandial triglyceride levels, and particularly postprandial rich triglyceride remnants, constitute an increased risk for cardiovascular disease. Recent studies have shown that excessive postprandial glucose excursions are accompanied by oxidative stress and, less well known, activation of blood coagulation (increase in circulating D-dimers and prothrombin fragments). The mechanisms through which increased postprandial glucose levels and lipid concentrations may damage endothelial cells on blood vessel walls appear to be complex. These mechanisms include the activation of protein kinase C, increased expression of adhesion molecules, increased adhesion and uptake of leucocytes, increased production of proliferative substances such as endothelin, increased proliferation of endothelial cells, increased synthesis of collagen IV and fibronectin, and decreased production of nitric oxide (NO). In conclusion, the 'postprandial state' cumulatively covers almost half of the nycthemeral period, and its physiology involves numerous finely regulated motor, secretory, hormonal and metabolic events. Epidemiological and mechanistical studies have suggested that perturbations of the postprandial state are involved in cardiovascular disease. Correcting the abnormalities of the postprandial state must form part of the strategy for the prevention and management of cardiovascular diseases, particularly those that are associated with diabetes mellitus. [less ▲]

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See detailShort administration of metformin improves insulin sensitivity in android obese subjects with impaired glucose tolerance.
Scheen, André ULg; Letiexhe, Michel ULg; Lefebvre, Pierre ULg

in Diabetic Medicine : A Journal of the British Diabetic Association (1995), 12(11), 985-9

In a double-blind, randomized, cross-over study, the metabolic effects of a short treatment with metformin (2 x 850 mg day-1 for 2 days and 850 mg 1 h before evaluation) were compared to those of placebo ... [more ▼]

In a double-blind, randomized, cross-over study, the metabolic effects of a short treatment with metformin (2 x 850 mg day-1 for 2 days and 850 mg 1 h before evaluation) were compared to those of placebo in 15 obese subjects (BMI: 33.2 +/- 0.9 kg m-2), with abdominal distribution of adipose tissue and impaired glucose tolerance. An intravenous glucose tolerance test (0.3 g glucose kg-1) was performed after each period of treatment. Areas under the curve (AUC0-180 min) were calculated for plasma glucose, insulin, and C-peptide levels. Glucose tolerance was estimated by the coefficient of glucose assimilation (KG). Insulin sensitivity (SI) and glucose effectiveness (SG) indices were calculated using Bergman's minimal model. Insulin secretion rate (ISR) was determined by deconvolution of plasma C-peptide levels and insulin metabolic clearance rate (MCR) was estimated by dividing AUC 1SR by AUC insulin. Fasting plasma insulin levels were reduced after metformin (89.3 +/- 15.9 vs 112.4 +/- 24.3 pmol l-1; p = 0.04). AUC glucose, KG and SG were similar in both tests. However, AUC insulin was reduced (39.7 +/- 6.5 vs 51.8 +/- 10.4 nmol min l-1; p = 0.02), while SI (6.98 +/- 1.14 vs 4.61 +/- 0.42 10(-5) min-1 pmol-1 l; p = 0.03) and insulin MCR (715 +/- 116 vs 617 +/- 94 ml min-1 m-2; p = 0.03) were increased after metformin. The demonstration that metformin rapidly improves insulin sensitivity should encourage further research to evaluate the long-term effects of metformin in android obese subjects with impaired oral glucose tolerance. [less ▲]

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