Predictors of Quality of Life and Other Patient-Reported Outcomes in the PANORAMA Multinational Study of People With Type 2 Diabetes.

OBJECTIVE: PANORAMA, a nine-country cross-sectional type 2 diabetes study, investigated factors associated with quality of life (QoL), health status, and other patient-reported outcome measures (PROMs). RESEARCH DESIGN AND METHODS: Patients were randomly or consecutively selected from primary/secondary care. PROMs included the Audit of Diabetes-Dependent Quality of Life (ADDQoL) (generic QoL item and average weighted impact [AWI] scores), Diabetes Treatment Satisfaction Questionnaire (DTSQ) (patient- and physician-completed), Hypoglycemia Fear Survey-II worry subscale, and the EuroQoL-5 Dimension visual analog scale (EQ-VAS) measuring patient-reported health. Multivariable linear regression analyses determined predictors of each PROM including patient characteristics, physician-reported adherence, complications, and glycosylated hemoglobin. RESULTS: In 5,813 patients, mean PROM scores indicated that generic QoL approximated "good" (0.93); perceived impact of diabetes on QoL was negative (AWI -1.69). Treatment satisfaction exceeded physicians' estimates (patient-reported: 29.76; physician-estimated: 27.75), but so did patients' perceived frequency of hypo-/hyperglycemia. Worry about hypoglycemia (13.27) was apparent. Intensifying treatments to three oral agents or insulin regimens predicted worse QoL (AWI P < 0.01). Insulin alone use predicted worse QoL (generic P < 0.02; AWI P < 0.001) and hypoglycemia worry (P < 0.007). No treatment had significant associations with EQ-VAS health status. CONCLUSIONS: Predictors for different PROMs differed markedly and provided insights for understanding and improving these important outcomes. Intensive treatment regimens had significant negative associations with all PROMs, except the EQ-VAS health status measure. The findings demonstrate the importance of measuring QoL alongside health status and other patient-reported outcomes when evaluating diabetes treatments with a view to protecting QoL and facilitating adherence and long-term glycemic control.

Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study.

INTRODUCTION: The objective of this subgroup analysis is to investigate the effectiveness of liraglutide in people with type 2 diabetes (T2D) treated within the primary care physician (PCP) and specialist care settings. METHODS: EVIDENCE is a prospective, observational study of 3152 adults with T2D recently starting or about to start liraglutide treatment in France. We followed patients in the PCP and specialist settings for 2 years to evaluate the effectiveness of liraglutide in glycemic control and body weight reduction. Furthermore, we evaluated the changes in combined antihyperglycemic treatments, the reasons for prescribing liraglutide, patient satisfaction, and safety of liraglutide in these two treatment settings. RESULTS: After 2 years of follow-up, 477 out of 1209 (39.0%) of PCP and 297 out of 1398 (21.2%) of specialist-treated patients still used liraglutide and maintained the glycated hemoglobin (HbA1c) target of <7.0%. Significant reductions from baseline were observed in both PCP- and specialist-treated cohorts in mean HbA1c (-1.22% and -0.8%, respectively), fasting plasma glucose (FPG) concentration (-39 and -23 mg/dL), body weight (-4.4 and -3.8 kg), and body mass index (BMI) (-1.5 and -1.4 kg/m2), all p < 0.0001. Reductions in HbA1c and FPG were significantly greater among PCP- compared with specialist-treated patients, p < 0.0001 for both. Patient treatment satisfaction was also significantly increased in both cohorts. Reported gastrointestinal adverse events were less frequent among PCP-treated patients compared with specialist-treated patients (4.5% vs. 16.1%). CONCLUSION: Despite differences in demography and clinical characteristics of patients treated for T2D in PCP and specialty care, greater reduction in HbA1c and increased glycemic control durability were observed with liraglutide in primary care, compared with specialist care. These data suggest that liraglutide treatment could benefit patients in primary care by delaying the need for further treatment intensification. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01226966. FUNDING: Novo Nordisk A/S.

Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study.

INTRODUCTION: The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. METHODS: This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up. RESULTS: At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA(1c) target. Mean (±SD) HbA(1c), fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%. CONCLUSION: The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. FUNDING: Novo Nordisk A/S. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01226966.

Current level of glycaemic control and its associated factors in patients with type 2 diabetes across Europe: data from the PANORAMA study.

OBJECTIVE: To provide an update on glycaemic control in European patients with type 2 diabetes based on data from the nine-country, cross-sectional PANORAMA study (NCT00916513). DESIGN: Post-hoc analysis to report the number of patients achieving/not achieving glycaemic goal (HbA(1c) <7%). PATIENTS: Patients were randomly or consecutively selected from physician practices in nine countries. Eligible patients were aged ≥40 years, diagnosed with type 2 diabetes >1 year prior to study entry, and had an available medical record of >1 year. MEASUREMENTS: All data were collected at a single visit, including HbA1c measurement using a common device (A1CNow). Bivariate and multivariate analyses were used to investigate factors associated with not reaching glycaemic goal. RESULTS: Of 5817 patients enrolled (aged 65·9 ± 10·4 years, 53·7% male), 37·4% had an HbA(1c) ≥7%; (range 25·9% in The Netherlands to 52·0% in Turkey). In adjusted multivariate analyses, higher individual glycaemic target, younger age, poor physician-reported patient adherence to lifestyle/medication, longer diabetes duration, increasing treatment regimen complexity and physician-reported patient's unwillingness to intensify treatment were associated with not achieving goal. However, bivariate analyses also found gender, socioeconomic factors, body mass index, rate of complications and hypoglycaemia to be associated with not achieving goal. CONCLUSIONS: In PANORAMA, 37·4% of patients enrolled were not at glycaemic goal. Factors relating to patient characteristics, physician selection of individualized HbA1c target and diabetes itself (longer duration, more complex treatment) were strongly associated with not achieving goal. Further studies are warranted to explore these associations and evaluate strategies for improving glycaemic control.

[Type 2 diabetes in France: epidemiology, trends of medical care, social and economic burden]. / Le diabète de type 2 en France : épidémiologie, évolution de la qualité de la prise en charge, poids social et économique. Entred 2007.

Between 2001 and 2007, treatments for type 2 diabetes have increased and therapeutic choices have improved. However glycemic control remains insufficient. Cardiovascular risk control has widely increased. Statins, hypertensive and antithrombotic treatments are more often prescribed. Blood pressure and LDL cholesterol levels have decreased whatever age. However, progress remains possible, especially regarding blood pressure control. Obesity has increased between 2001 and 2007 to reach 41% whereas the frequency of dietetic visits has decreased. Insulin therapy (more than obesity) determines the frequency of dietetic visits: dietetic care happens too late. Important improvements of the quality of follow-up are observed. However, fundus exams and more specifically albuminuria measurement remain insufficiently performed and their progression is too slow, as well as the podiatric examination. Only 10% of people with type 2 diabetes have an endocrinology visit, which has been stable between 2001 and 2007. Information expectations of people with type 2 diabetes are strong, especially for diet. Education demand is lower but more important for people who have already benefited. This improvement of medical care leads to an increase in the cost of reimbursements. The consequences of diabetes, more than the disease itself, alter the quality of life.

Medication adherence in type 2 diabetes: the ENTRED study 2007, a French Population-Based Study.

BACKGROUND: Adherence to prescribed medications is a key dimension of healthcare quality. The aim of this large population-based study was to evaluate self-reported medication adherence and to identify factors linked with poor adherence in patients with type 2 diabetes in France. METHODOLOGY: The ENTRED study 2007, a French national survey of people treated for diabetes, was based on a representative sample of patients who claimed reimbursement for oral hypoglycaemic agents and/or insulin at least three times between August 2006 and July 2007, and who were randomly selected from the database of the two main National Health Insurance Systems. Medication adherence was determined using a six-item self-administered questionnaire. A multinomial polychotomous logistic regression model was used to identify factors associated with medication adherence in the 3,637 persons with type 2 diabetes. PRINCIPAL FINDINGS: Thirty nine percent of patients reported good medication adherence, 49% medium adherence and 12% poor adherence. The factors significantly associated with poor adherence in multivariate analysis were socio-demographic factors: age <45 years, non-European geographical origin, financial difficulties and being professionally active; disease and therapy-related factors: HbA(1c)>8% and existing diabetes complications; and health care-related factors: difficulties for taking medication alone, decision making by the patient only, poor acceptability of medical recommendations, lack of family or social support, need for information on treatment, reporting no confidence in the future, need for medical support and follow-up by a specialist physician. CONCLUSIONS: In a country with a high level of access to healthcare, our study demonstrated a substantial low level of medication adherence in type 2 diabetic patients. Better identification of those with poor adherence and individualised suitable recommendations remain essential for better healthcare management.

PANORAMA: a European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus--study design.

AIM: Type-2 diabetes mellitus (T2DM) is a major cause of disability reaching epidemic proportions worldwide. The disease burden of T2DM is commonly characterised using health status measures, but few European-wide data are available concerning patients' views of their quality of life (QoL) and other patient-reported outcomes (PROs). Despite evidence supporting benefits of glycaemic control, many patients are currently not treated to recommended HbA(1c) targets (<7%). Consequently, the prevalence of T2DM-related chronic complications remains high, impacting negatively on patients' health status. Hypoglycaemia is a side effect associated with some antidiabetes medications that may also diminish QoL and treatment satisfaction. The aim of the PANORAMA study (NCT00916513) is to evaluate QoL and other PROs in patients with T2DM. It will investigate the association between these variables, the different diabetes treatment regimens used and levels of glycaemic control achieved across Europe. This report describes the rationale for conducting the PANORAMA study, and the study design. METHODS: PANORAMA is an observational, multicentre, multinational, cross-sectional study. Approximately 5000 patients with T2DM currently treated with diet, oral antidiabetes agents and/or injectables (insulin and/or glucagon-like peptide-1 [GLP-1] analogues), ≥1-year follow up, will be randomly selected from a representative sample of mainly primary care practices across nine countries. Patient demographics; HbA(1c) level (standardised measurement); PROs, including QoL (ADDQoL), health status (EQ-5D), treatment satisfaction (DTSQ) and fear of hypoglycaemia (HFS-II); disease-related variables; health-economic variables; physician demographics and physician-reported outcomes will be collected. DISCUSSION: The large-scale, European-wide PANORAMA study is designed to evaluate QoL and other PROs in patients with T2DM.

Trends in the quality of care for elderly people with type 2 diabetes: the need for improvements in safety and quality (the 2001 and 2007 ENTRED Surveys).

AIM: This study aimed to characterize the sociodemographic data, health status, quality of care and 6-year trends in elderly people with type 2 diabetes. METHODS: This study used two French cross-sectional representative surveys of adults of all ages with all types of diabetes (Entred 2001 and 2007), which combined medical claims, and patient and medical provider questionnaires. The 2007 data in patients with type 2 diabetes aged 65 years or over (n=1766) were described and compared with the 2001 data (n=1801). RESULTS: Since 2001, obesity has increased (35% in 2007; +7 points since 2001) while written nutritional advice was less often provided (59%; -6 points). Mean HbA(1c) (7.1%; -0.2%), blood pressure (135/76 mmHg; -4/-3 mmHg) and LDL cholesterol (1.04 g/L; -0.21 g/L) declined, while the use of medication increased: at least two OHAs, 34% (+4 points); OHA(s) and insulin combined, 10% (+4 points); antihypertensive treatment, 83% (+4 points); and statins 48% (+26 points). Severe hypoglycaemia remained frequent (10% had an event at least once a year). The overall prevalence of complications increased. Renal complications were not monitored carefully enough (missing value for albuminuria: 42%; -4.5 points), and 46% of those with a glomerular filtration rate less than 60 mL/min/1.73 m² were taking metformin. CONCLUSION: Elderly people with type 2 diabetes are receiving better quality of care and have better control of cardiovascular risk factors than before. However, improvement is still required, in particular by performing better screening for complications. In this patient population, it is important to carefully monitor the risks for hypoglycaemia, hypotension, malnutrition and contraindications related to renal function.

Hemoglobin A1c and fasting plasma glucose levels as predictors of retinopathy at 10 years: the French DESIR study.

OBJECTIVE: To evaluate the predictive values of hemoglobin A(1c) (HbA(1c)) and fasting plasma glucose (FPG) for retinopathy 10 years after the baseline examination. METHODS: Seven hundred men and women from the DESIR (Data From an Epidemiological Study on the Insulin Resistance Syndrome) Study underwent evaluation for retinopathy using a nonmydriatic digital camera. During the preceding 9 years, 235 had diabetes mellitus (treated or FPG level of ≥126 mg/dL at least once), 227 had an impaired FPG level (110-125 mg/dL) at least once, and 238 always had glucose levels within reference limits (<110 mg/dL). RESULTS: Compared with those without retinopathy, the 44 participants with retinopathy at 10 years had higher baseline mean (SD) levels of FPG (130 [49] vs 106 [22] mg/dL) and HbA(1c) (6.4% [1.6%] vs 5.7% [0.7%]) (both, P < .001). The frequency of retinopathy at 10 years, standardized according to the distribution of glycemia across the entire DESIR population, was 3.6%. In our population, FPG levels of 108 and 116 mg/dL had positive predictive values of 8.4% and 14.0%, respectively, for retinopathy at 10 years; HbA(1c) levels of 6.0% and 6.5% had positive predictive values of 6.0% and 14.8%, respectively. After 10 years of follow-up, retinopathy was equally frequent in participants with impaired FPG levels and in those who became diabetic during the study (8.6% and 6.7%, respectively), lower than in those with diabetes at baseline (13.9%). CONCLUSION: Because the positive predictive values for retinopathy increase sharply from 108 mg/dL for FPG and from 6.0% for HbA(1c) levels, these thresholds are proposed to identify those at risk of retinopathy 10 years later.

Mean and yearly changes in blood pressure with age in the metabolic syndrome: the DESIR study.

Systolic and diastolic blood pressure (SBP; DBP) increase with age, but after 45 years of age, the yearly change in DBP (ΔDBP) tends to be smaller in comparison with the yearly change in SBP (ΔSBP), which increases with age. The effect of the metabolic syndrome (MetS) on this yearly change has never been explored. In a 9-year longitudinal cohort Data from an Epidemiologic Study on the Insulin Resistance syndrome (DESIR) study, we examined 1308 men and 1325 women, aged 30-65 years, who had never been treated for hypertension. SBP and DBP were measured at four examinations 3 years apart, and pulse pressure (PP) and yearly changes (ΔSBP, ΔDBP and ΔPP) were calculated. SBP and PP increased with age to a higher degree in patients with the MetS. In men and women with the MetS, DBP remained nearly constant, but in those without the MetS, DBP increased. After adjusting for baseline values, ΔSBP and ΔPP increased by 0.5 mm Hg per year for every additional 10 years from baseline. These correlations with age were similar for men and women, and the yearly change was always higher than in those with the MetS. In contrast, ΔDBP increased very slowly until 50 years of age and then decreased similarly for those with and without the MetS. The increase in PP with age, a marker of vascular aging, was determined to begin earlier in the present study than has been shown in the past, and the MetS amplified this effect. This new aspect of the MetS might modify clinical management leading to earlier drug treatment, particularly in regard to both endothelial dysfunction and increased arterial stiffness.

Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT).

OBJECTIVE: The purpose of this study was to compare effects of insulin detemir once daily versus twice a day in a basal-bolus insulin regimen. RESEARCH DESIGN AND METHODS: In this open-label, 7-month study, 520 patients with type 1 diabetes were randomly assigned to receive detemir once daily or twice daily with mealtime insulin aspart. Insulin doses were titrated over 1 month, with patients followed up over the subsequent 3 months. Thereafter, patients were able to switch from one regimen to the other, with an additional nonrandomized 3-month follow-up, to a total of 7 months. The primary end point was A1C at 4 months, with noninferiority defined as a difference <0.4% between groups. RESULTS: A1C at 4 months was 8.1 +/- 0.9 versus 8.0 +/- 1.0% with once- and twice-daily detemir, respectively, with an adjusted between-group difference of 0.12% (95% CI -0.01 to 0.25%), showing noninferiority for once-daily dosing. Similar results were found in the per protocol population. Improvement in A1C was similar in both groups (-0.4 +/- 0.8 vs. -0.5 +/- 0.8%; P = 0.09, NS) but with differences in the 7-point glucose profile. Detemir doses were lower (29 +/- 18 vs. 39 +/- 20 units/day, P < 0.001), but aspart doses were higher (34 +/- 17 vs. 26 +/- 14 IU/day, P < 0.001) with once-daily detemir. At 7 months, A1C decreased slightly in patients switched from once-daily to twice-daily administration (8.2 +/- 0.8 vs. 8.0 +/- 0.8%; P = 0.34, NS) in association with increased total insulin doses (P < 0.05), but A1C increased in those switched from twice-daily to once-daily administration (7.2 +/- 0.9 vs. 7.6 +/- 0.8%, P < 0.05) in association with decreased doses (P < 0.05). CONCLUSIONS: Although some individuals may benefit from twice-daily dosing, the most suitable routine starting schedule for detemir in a basal-bolus regimen for type 1 diabetes is once-daily injection.

The Data from an Epidemiologic Study on the Insulin Resistance Syndrome Study: the change and the rate of change of the age-blood pressure relationship.

OBJECTIVE: Systolic blood pressure (SBP) and diastolic blood pressure (DBP) increase significantly until around 55 years, when SBP increases, DBP decreases. Whether the rates of change of SBP and DBP with age exhibit a similar dissociation has never been investigated. DESIGN AND PARTICIPANTS: The Data from an Epidemiologic Study on the Insulin Resistance Syndrome Study (D.E.S.I.R.), a 9-year longitudinal study included 2278 men and 2314 women, 30-65 years and SBP, DBP, and other cardiometabolic risk factors were determined every 3 years. RESULTS: Both SBP and DBP increased with age, more rapidly in women than in men. SBP and DBP were higher in the presence of risk factors (except smoking) but the increases with age were similar. For the rates of change, whereas DeltaSBP increased linearly with age, DeltaDBP declined as early as 45 years. This finding was not influenced by sex, menopause or other risk factors but was significantly attenuated in the presence of hypertension at baseline, whether treated or not, and mainly in men. CONCLUSION: DBP increases with age between 30 and 60 years, DeltaDBP tends to be markedly reduced as early as 45 years, in contrast with DeltaSBP. Consequences for the understanding of vascular aging and antihypertensive therapy remain to be explored.

Predicting diabetes: clinical, biological, and genetic approaches: data from the Epidemiological Study on the Insulin Resistance Syndrome (DESIR).

OBJECTIVE: To provide a simple clinical diabetes risk score and to identify characteristics that predict later diabetes using variables available in the clinic setting as well as biological variables and polymorphisms. RESEARCH DESIGN AND METHODS: Incident diabetes was studied in 1,863 men and 1,954 women, 30-65 years of age at baseline, with diabetes defined by treatment or by fasting plasma glucose >or=7.0 mmol/l at 3-yearly examinations over 9 years. Sex-specific logistic regression equations were used to select variables for prediction. RESULTS: A total of 140 men and 63 women developed diabetes. The predictive clinical variables were waist circumference and hypertension in both sexes, smoking in men, and diabetes in the family in women. Discrimination, as measured by the area under the receiver operating curves (AROCs), were 0.713 for men and 0.827 for women, a little higher than for the Finish Diabetes Risk (FINDRISC) score, with fewer variables in the score. Combining clinical and biological variables, the predictive equation included fasting glucose, waist circumference, smoking, and gamma-glutamyltransferase for men and fasting glucose, BMI, triglycerides, and diabetes in family for women. The number of TCF7L2 and IL6 deleterious alleles was predictive in both sexes, but after including the above clinical and biological variables, this variable was only predictive in women (P < 0.03) and the AROC statistics increased only marginally. CONCLUSIONS: The best clinical predictor of diabetes is adiposity, and baseline glucose is the best biological predictor. Clinical and biological predictors differed marginally between men and women. The genetic polymorphisms added little to the prediction of diabetes.

Monitoring the obesity epidemic in France: the Obepi surveys 1997-2006.

The objective of the study was to describe the prevalences of obesity in French adults over a 9-year period. Mailed questionnaire surveys, in 1997, 2000, 2003, and 2006, sampled 20,000 representative French households by the method of quotas. Weight, height, and waist circumference were reported by all members of the selected households > or = 18-years. Obesity was defined according to the WHO criteria, BMI > 30 kg/m2. The prevalence of adult obesity increased progressively from 8.6% (95% confidence interval: 8.2-8.8) in 1997 to 13.1% (12.7-13.5) in 2006. The increase affected all ages, socioeconomic strata, and regions. Although the prevalence of obesity increased in parallel in men and women from 1997 to 2003, the rate of increase was lower in men between 2003 and 2006. These surveys showed a sharp increase in the prevalence of obesity in France in recent years contrasting with a stable prevalence in the 1980s. The results of the first Obepi surveys prompted the French government to implement a Nutrition and Health National Plan in 2001. Regular monitoring of obesity prevalence in France and neighboring countries is needed to compare future trends.

Gamma-glutamyltransferase activity and development of the metabolic syndrome (International Diabetes Federation Definition) in middle-aged men and women: Data from the Epidemiological Study on the Insulin Resistance Syndrome (DESIR) cohort.

OBJECTIVE: Among hepatic enzymes, gamma-glutamyltransferase (GGT) is the main predictor of type 2 diabetes incidence, although it has not been shown that GGT predicts pre-diabetes states. Our aim was to study the association of GGT with the development of the metabolic syndrome (MetS). RESEARCH DESIGN AND METHODS: We analyzed the 3-year data from the Data from Epidemiological Study on the Insulin Resistance Syndrome prospective cohort of 1,656 men and 1,889 women without MetS at baseline, according to the International Diabetes Federation definition. RESULTS: Over 3 years, 309 participants developed the MetS. After adjustment for age, alcohol intake, physical activity, smoking habits, and alanine aminotransferase (ALT), the odds ratios for incident MetS increased across baseline GGT quartiles (1, 1.96, 2.25, and 3.81 in men, P < 0.03; and 1, 1.23, 1.80, and 1.58 in women, P < 0.05). After additional adjustment for insulin resistance markers (fasting insulin or homeostasis model assessment of insulin resistance index), the association was attenuated and the linear relation no longer significant in both sexes (P = 0.08, P = 0.16). However, men in the highest in comparison to the lowest quartile of GGT retained a significant risk for incident MetS. In women, there was no longer a significant risk. GGT was significantly associated with the 3-year incidence of individual components of the MetS. The incidence of the MetS also increased with ALT, but after adjustment on GGT this association remained significant only in women. CONCLUSIONS: GGT, a predictor of type 2 diabetes, was associated with a risk of incident MetS. This association was mainly related with insulin resistance but was independent of other confounding factors.

Association of glucose metabolism, smoking and cardiovascular risk factors with incident peripheral arterial disease: the DESIR study.

AIMS: We determined the 6-year incidence of peripheral arterial disease (PAD) in a French population and assessed the association of glucose metabolism, smoking, cardiovascular risk factors and physical activity with incident PAD. METHODS: Participants from the French Data from a Epidemiological Study on the Insulin Resistance Syndrome (DESIR) were studied. Participants analysed were 30-65 years (at baseline) and had complete data (n=3805) after 6 years of follow-up. Diabetes was diagnosed according to the 1999 WHO criteria on the basis of fasting plasma glucose results or previous diagnosis of diabetes mellitus. The ankle brachial pressure index (ABPI) and a claudication question were used to classify PAD. RESULTS: The 6-year incidence of PAD (defined by ABPI<0.9 and or claudication present) among those with normal fasting glucose (NFG) and free of PAD at baseline was 5.1%. Among those with impaired fasting glucose (IFG) at baseline the incidence of PAD was 4.9% and among those with diabetes mellitus at baseline the incidence of PAD was 9.8%. The incidence of PAD among those who maintained NFG over 6 years was 4.7% and among those who progressed to diabetes over 6 years was 10.2%. Those who progressed from NFG or IFG to diabetes over 6 years were twice as likely to develop PAD compared to those who maintained NFG over 6 years, after adjustment for age and sex (OR (95% CI), 2.22 (1.12-4.42)). Independent risk factors for incident PAD using baseline population characteristics were diabetes (OR (95% CI) 2.11 (1.25-3.55)), systolic BP 122-135mmHg 1.06 (0.70-1.60), >135mmHg 1.54 (1.04-2.27) and current smoking 1.60 (1.10-2.34) after multivariate adjustment for age, sex, cholesterol, triglycerides and waist circumference. CONCLUSIONS: This French study shows that those who progress to diabetes are twice as likely to develop PAD, compared to those who maintain NFG. Peripheral arterial disease is a treatable condition and more aggressive management of atherosclerotic risk factors could reduce the numbers of people who develop PAD.

Use of HbA1c in predicting progression to diabetes in French men and women: data from an Epidemiological Study on the Insulin Resistance Syndrome (DESIR).

OBJECTIVE: Early identification of subjects at high risk for diabetes is essential, and random HbA(1c) (A1C) may be more practical than fasting plasma glucose (FPG). The predictive value of A1C, in comparison to FPG, is evaluated for 6-year incident diabetes. RESEARCH DESIGN AND METHODS: From the French cohort study Data from an Epidemiological Study on the Insulin Resistance Syndrome (DESIR), 1,383 men and 1,437 women, aged 30-65 years, were volunteers for a routine health check-up. Incident diabetes was defined by FPG >or=7.0 mmol/l or treatment by antidiabetic drugs. Multivariate logistic regression models were used to predict diabetes at 6 years. Receiver operating characteristic curves compared the predictive values of A1C and FPG. RESULTS: At 6 years, 30 women (2.1%) and 60 men (4.3%) had developed diabetes. Diabetes risk increased exponentially with A1C in both sexes (P < 0.001). After stratifying on FPG, A1C predicted diabetes only in subjects with impaired fasting glucose (IFG) (FPG >or=6.10 mmol/l): the odds ratio (95% CI) for a 1% increase in A1C was 7.20 (3.00-17.00). In these subjects, an A1C of 5.9% gave an optimal sensitivity of 64% and specificity of 77% to predict diabetes. CONCLUSIONS: A1C predicted diabetes, even though the diagnosis of diabetes was based on FPG, but it was less sensitive and specific than FPG. It could be used as a test if fasting blood sampling was not available or in association with FPG. In subjects with IFG, A1C is better than glucose to evaluate diabetes risk, and it could be used to select subjects for intensive early intervention.

Weight, the metabolic syndrome, and coronary heart disease in type 2 diabetes: associations among a national French sample of adults with diabetes-the ENTRED study.

The authors examined whether obesity alone or as part of the metabolic syndrome (MS) increases coronary heart disease (CHD) risk in type 2 diabetes mellitus (T2DM) among 2970 adults aged 30-79 years in a French national sample. MS was defined as T2DM plus self-report of 2 or more of the following: body mass index >30 kg/m(2), diagnosed hypertension, or diagnosed dyslipidemia. A subsample with physician-reported data (n =841) was further classified with measured hypertension and dyslipidemia. Weight distribution included normal (21%), overweight (42%), and obese (37%). A 20% increased odds of CHD was estimated for every 5-kg/m(2) body mass index increase (P=.0001). MS was associated with a more than 2-fold higher risk of CHD compared with T2DM without MS (P<.0001, multivariate-adjusted [both samples]). With MS stratified by high-density lipoprotein cholesterol (<1.5 vs > or =1.5 mmol/L), compared with no MS, the odds ratio for CHD was 2.8 (normal-level high-density lipoprotein MS; 95% confidence interval, 1.8-4.5) and 1.5 (high-level high-density lipoprotein MS; 95% confidence interval, 0.8-2.9). The authors suggest that obesity alone--and particularly when the MS is present--increases CHD risk in patients with T2DM. High levels of high-density lipoprotein may modify this relationship.