Role of dietary intake and physical activity in reducing weight social inequalities among adolescents: an application of G-formula to PRALIMAP-INÈS trial.

Interventions aiming to reduce social inequalities of weight status in adolescents usually focus on lifestyle behaviours, but their effectiveness is limited. This study analysed the effect of achieving levels of dietary intake (DI) and/or physical activity (PA) guidelines on reducing social inequalities in weight status among adolescents. We included adolescents from the PRomotion de l'ALIMentation et de l'Activité Physique - INÉgalité de Santé (PRALIMAP-INÈS) trial with weight status data available at baseline and 1-year follow-up (n=1130). PA and DI were measured using the International Physical Activity Questionnaire and a validated food frequency questionnaire, respectively. We estimated the likelihood of a 1-year reduction in body mass index z-score (BMIz) and population risk difference (PRD) under hypothetical DI and PA levels and socioeconomic status using the parametric G-formula. When advantaged and less advantaged adolescents maintained their baseline DI and PA, we found social inequalities in weight status, with a PRD of a 1-year reduction in BMIz of -1.6% (-3.0%; -0.5%). These inequalities were not observed when less advantaged adolescents increased their proportion of achieving DI guidelines by 30% (PRD=2.2% [-0.5%; 5.0%]) unlike the same increase in PA (PRD= -3.9% [-6.8%; -1.3%]). Finally, social inequalities of weight status were not observed when levels of achievement of both PA and DI guidelines increased by 30% (PRD= 2.2% [-0.5%; 4.0%]). Enhancing DI rather than PA could be effective in reducing social inequalities in weight status among adolescents. Future interventions aiming to reduce these inequalities should mostly target DI to be effective.

Rôle et organisation des unités transversales d'éducation thérapeutique du patient dans les CHU et les CHR de France.

Introduction : The creation of transversal patient education units (UTEP), resources center to help Therapeutic Patient Education (TPE) teams in hospitals, was recommended in 2008 by the High Authority of Health and the French Society of Public Health.Purpose of research : To realize a national inventory of the UTEPs function (creation, governance, composition, missions, and funding).Method : This qualitative survey by semi-directional interviews was conducted by phone using an interview guide to the 29 UTEPs identified in the University or Regional Hospitals of France.Results : Twenty-four UTEPs (83%) responded. Since the law of 2009, except Besançon and Montpellier, these multidisciplinary teams coordinated mainly by a doctor have a total staff ranging from 0.5 to 5.5 full-time equivalents. Ten UTEPs have an institutional steering committee. They are mainly attached to a public health division. All UTEPs provide support missions for the TPE programs, coordination, and transversality. Fourteen carry out training ; eleven are involved in research and one lead TPE session. Eight UTEPs are involved at the level of the Territorial Hospital Grouping or the department. These differences condition variations in funding.Conclusions : The UTEPs are mostly well entrenched in their institution, recognized by TPE teams and directors. Their organizations, operations and funding are very varied according to the hospitals with common lines given by the regional health agency within the same large region.

Arterial and Cardiac Remodeling Associated With Extra Weight Gain in an Isolated Abdominal Obesity Cohort.

Introduction: This study aims to assess the changes in cardiovascular remodeling attributable to bodyweight gain in a middle-aged abdominal obesity cohort. A remodeling worsening might explain the increase in cardiovascular risk associated with a dynamic of weight gain. Methods: Seventy-five middle-aged subjects (56 ± 5 years, 38 women) with abdominal obesity and no known cardiovascular disease underwent MRI-based examinations at baseline and at a 6.1 ± 1.2-year follow-up to monitor cardiovascular remodeling and hemodynamic variables, most notably the effective arterial elastance (Ea). Ea is a proxy of the arterial load that must be overcome during left ventricular (LV) ejection, with increased EA resulting in concentric LV remodeling. Results: Sixteen obese subjects had significant weight gain (>7%) during follow-up (WG+), whereas the 59 other individuals did not (WG-). WG+ and WG- exhibited significant differences in the baseline to follow-up evolutions of several hemodynamic parameters, notably diastolic and mean blood pressures (for mean blood pressure, WG+: +9.3 ± 10.9 mmHg vs. WG-: +1.7 ± 11.8 mmHg, p = 0.022), heart rate (WG+: +0.6 ± 9.4 min-1 vs. -8.9 ± 11.5 min-1, p = 0.003), LV concentric remodeling index (WG: +0.08 ± 0.16 g.mL-1 vs. WG-: -0.02 ± 0.13 g.mL-1, p = 0.018) and Ea (WG+: +0.20 ± 0.28 mL mmHg-1 vs. WG-: +0.01 ± 0.30 mL mmHg-1, p = 0.021). The evolution of the LV concentric remodeling index and Ea were also strongly correlated in the overall obese population (p < 0.001, R2 = 0.31). Conclusions: A weight gain dynamic is accompanied by increases in arterial load and load-related concentric LV remodeling in an isolated abdominal obesity cohort. This remodeling could have a significant impact on cardiovascular risk.

Socioeconomic and behavioural factors associated with access to and use of Personal Health Records.

BACKGROUND: Access to and use of digital technology are more common among people of more advantaged socioeconomic status. These differences might be due to lack of interest, not having physical access or having lower intentions to use this technology. By integrating the digital divide approach and the User Acceptance of Information Technology (UTAUT) model, this study aims to further our understanding of socioeconomic factors and the mechanisms linked to different stages in the use of Personal Health Records (PHR): desire, intentions and physical access to PHR. METHODS: A cross-sectional online and in-person survey was undertaken in the areas of Lorraine (France), Luxembourg, Rhineland-Palatinate and Saarland (Germany), and Wallonia (Belgium). Exploratory factor analysis was performed to group items derived from the UTAUT model. We applied linear and logistic regressions controlling for country-level heterogeneity, health and demographic factors. RESULTS: A total of 829 individuals aged over 18 completed the questionnaire. Socioeconomic inequalities were present in the access to and use of PHR. Education and income played a significant role in individuals' desire to access their PHR. Being older than 65 years, and migrant, were negatively associated with desire to access PHR. An income gradient was found in having physical access to PHR, while for the subgroup of respondents who expressed desire to have access, higher educational level was positively associated with intentions to regularly use PHR. In fully adjusted models testing the contribution of UTAUT-derived factors, individuals who perceived PHRs to be useful and had the necessary digital skills were more inclined to use their PHR regularly. Social influence, support and lack of anxiety in using technology were strong predictors of regular PHR use. CONCLUSION: The findings highlight the importance of considering all stages in PHR use: desire to access, physical access and intention to regularly use PHRs, while paying special attention to migrants and people with less advantaged socioeconomic backgrounds who may feel financial constraints and are not able to exploit the potential of PHRs. As PHR use is expected to come with health benefits, facilitating access and regular use for those less inclined could reduce health inequalities and advance health equity.

Hospital practices for the implementation of patient partnership in a multi-national European region.

BACKGROUND: The extent to which patients are involved in their care can be influenced by hospital policies and interventions. Nevertheless, the implementation of patient participation and involvement (PPI) at the organisational (meso) level has rarely been assessed systematically. The aim of this study was to assess the occurrence of PPI practises in hospitals in Belgium, France, Germany and Luxembourg and to analyze if, and to what extent, the hospital vision and the presence of a patient committee influence the implementation of PPI practises. METHODS: A cross-sectional study was carried out using an online questionnaire in hospitals in the border regions of the four countries. The data were analyzed for differences between regions and the maturity of PPI development. RESULTS: Full responses were obtained from 64 hospitals. A wide range of practices were observed, the degree of maturity was mixed. A majority of hospitals promoted patient partnership in the hospital's philosophy of care statement. However, the implementation of specific interventions for PPI was not found uniformly and differences could be observed between the countries. CONCLUSIONS: Hospitals in the region seem to be motivated to include patients more fully, however, implementation of PPI interventions seems incomplete and only partially integrated into the general functioning of the hospitals. The implementation of the concept seems to be more mature in the francophone part of the region perhaps due, in part, to a more favourable political context.

Common sense model of self-regulation for understanding adherence and quality of life in type 2 diabetes with structural equation modeling.

OBJECTIVES: The objective of the present study was to test the Common Sense Model of self-regulation (CSM) for its relevance for improving adherence and quality of life in type 2 diabetes. METHODS: A sample of 253 patients with type 2 diabetes was recruited. They completed questionnaires about their perceptions regarding diabetes, coping strategies, therapeutic adherence and quality of life. Their HbA1c levels were also collected. Structural equation modeling (SEM) was used to check the adequacy of our theoretical model (CSM) with the patient data. RESULTS: The final model indicated that perceptions were directly and indirectly related to health outcomes through coping strategies and adequately matched the data (χ2 / df = 561/ 220 = 2.55; RMSEA = 0.08; PCFI = 0.66; PGFI = 0.70). Moreover, the model appeared to be identical for both types of treatment (oral and injectable). CONCLUSIONS: Illness perceptions and coping strategies, or, more specifically, how patients accept disease and think they are able to manage it, significantly affect therapeutic adherence and quality of life in type 2 diabetes. PRACTICE IMPLICATIONS: These results pave the way for developing psychological treatments aimed at improving patient acceptance and internal resources (e.g. use of autobiographical memory, Acceptance and Commitment Therapy).

Physical activity rather than sedentary behaviour is socially determined in French adolescents with overweight and obesity.

Social differences in prevalence of overweight and obesity among adolescents, known as the weight social gradient, could be explained by differences in behaviours between social classes. This study examined the respective association of physical activity (PA), sedentary behaviour (SB) and weight status with adolescents' socioeconomic status. We used cross-sectional data for 1935 adolescents (13-18 years old) with overweight or obesity who participated in the PRALIMAP-INÉS (PRomotion de l'ALImentation et de l'Activité Physique - INÉgalités de Santé) trial conducted in northeastern France between 2012 and 2015. Adolescents completed the International Physical Activity Questionnaire for PA and SB and the Family Affluence Scale for socioeconomic status. Weight status was assessed by the body mass index (BMI) and BMI z-score. Social gradient of weight status, PA and SB were described according to the Family Affluence Scale (slopes) and evidenced by the linear trend test (p). Adolescents' socioeconomic status was positively associated with PA practice (frequency, vigorous PA and leisure-time PA), but there was no association with their SB. The results confirmed a significant weight social gradient: BMI (ß = 0.37, p < .0001) and BMI z-score (ß = 0.07, p = .0001). The weight social gradient in adolescents was mostly associated with PA (5.7% to 8.1%) rather than SB (2.7% to 5.7%). Nearly 14% of BMI z-scores could be related to a combined PA and SB effect. PA was found an important factor of weight social gradient in adolescence. Actions aimed at preventing weight social inequalities among adolescents could include PA promotion as lever. CLINICAL TRIALS REGISTRY AND NUMBER: ClinicalTrials.gov (NCT01688453).

Effectiveness of a socially adapted intervention in reducing social inequalities in adolescence weight. The PRALIMAP-INÈS school-based mixed trial.

BACKGROUND: A high prevalence of overweight/obesity among low socioeconomic status adolescents contributes to health inequalities. However, evidence-based interventions for reducing social inequalities in adolescent weight are lacking. We aimed to investigate whether strengthened care management for adolescents with low socioeconomic status has an equivalent effect in reducing overweight as standard care management in adolescents with high status. METHODS: PRALIMAP-INÈS was a multicentre trial including 35 state-run high and middle schools in the north-eastern France. A population-based sample of 1639 adolescents aged 13-18 years with screened and clinically confirmed overweight/obesity were proposed for inclusion and divided into two groups by the Family Affluence Scale score: advantaged (score > 5), receiving standard care management (A.S) and less-advantaged randomly assigned to two groups (1:2 ratio): standard care management (LA.S) and standard and strengthened care management (LA.S.S). Interventions were based on the proportionate universalism principle: universal standard care for all groups and proportionate care for the LA.S.S group. Main outcome was body mass index z-score (BMIz) assessed before and 1 year after inclusion. RESULTS: A total of 1419 adolescents were included and 1143 followed up at 1 year: 649 in A.S, 158 in LA.S and 336 in LA.S.S groups. BMIz decreased significantly for boys (-0.11 [95% CI, -0.13 to -0.08]; p < 0.0001) and girls (-0.05 [-0.08 to -0.03]; p < 0.0001). No equivalence between LA.S.S and A.S groups was evidenced. For girls, the trend to superiority for LA.S.S was confirmed by the more favourable change (-0.06 [-0.11 to -0.01]; p = 0.01) observed on superiority analysis, with no differential change for boys (0.02 [-0.03 to 0.08]; p = 0.41). CONCLUSIONS: A public health school-based intervention using the proportionate universalism principle may be effective in not worsening or even reducing overweight social inequalities in adolescents, especially for girls. Overcoming social barriers may help health professionals dealing with the burden and inequalities of overweight in adolescents.

Effectiveness of a type 2 diabetes prevention program combining FINDRISC scoring and telephone-based coaching in the French population of bakery/pastry employees.

BACKGROUND/OBJECTIVES: Preventive actions targeting the risk of type 2 diabetes mellitus (T2D) and deployed from the workplace are scarce. This study aimed to measure this T2D risk in a large sample of the bakery/pastry employees in France and to assess the effectiveness of a telephone coaching program in participants with the highest risk. SUBJECTS/METHODS: A screening survey using the FINDRISC score was conducted by phone among the employees. Those with a moderate risk (score ≥ 12 and <15; body mass index ≥ 25 kg/m2) or high/very high risk (score ≥ 15) were invited to participate in a 6-month coaching program including 6 monthly interviews together with a final evaluation interview three months later. The effects and impact were evaluated using 8 questions on dietary knowledge/behavior as well as the GPAQ (physical activity) and SF-12 (quality of life) questionnaires. RESULTS: There were 19,951 employees eligible for screening (age: 38.0 ± 13.5 years, men 49.6%, mean FINDRISC score 5.9 ± 4.4). A high/very high score was found in 4% of individuals. Overall, 1,348 (among 2,018) eligible employees agreed to participate in the coaching program, 630 of whom participated in all interviews. Of the latter, dietary knowledge/behavior (+1.60) and quality of life (+1.83) improved (P < 0.0001), with a favorable trend for physical activity (+0.06, P = 0.0756). Dietary knowledge/behavior continued to improve in the 581 completers (+0.17, P = 0.0001). CONCLUSIONS: This two-step prevention program associating T2D risk estimation and a 6-month telephone coaching was deployed in the French craft bakery/pastry sector with significant adhesion. Such program appears beneficial for enhancing knowledge and mobilizing skills associated with T2D prevention.

Measuring adolescents' weight socioeconomic gradient using parental socioeconomic position.

Background: There is an evidence of social inequalities in weight status in adolescence but the diversity of family socioeconomic status (SES) indicators can lead to discrepant findings. We aimed to identify how combination of family SES indicators can help measuring weight socioeconomic gradient (WSG) among adolescents. Methods: Cross-sectional data from 2113 adolescents (13-18 years old) of the PRALIMAP-INÈS trial were used. Multiple SES indicators and assessment of weight status including body mass index (BMI), waist circumference (WC), waist-to-height ratio (WHtR) and self-perception of overweight were used. We used principal component analysis (PCA) followed by structural equation models to identify SES dimensions. A dimension normalized score was calculated ranging from 1 to 10 (a high score corresponding to high SES). Linear regression models (linear trend test) were used to assess the WSG. Results: Three SES dimensions were identified: (i) 'Family social status', (ii) 'Family education level' and (iii) 'Family income level'. BMI was significantly lower in highly advantaged compared with highly less advantaged [-1.64 (-2.39; -0.89) for family social dimension, -0.86 (-1.37; -0.36) for family education level and -2.35 (-3.65; -1.05) for family income level]. Similar results were observed for all weight indicators excepted for self-perception of overweight status. Socially less advantaged adolescents perceived themselves less fat than they were. Conclusion: Although WSG was evident in adolescence, association between SES and weight status differed according to objective or perceived weight indicators. The proposed SES dimension can be applied in other field and future studies are needed to confirm our findings.

Reducing social inequalities in access to overweight and obesity care management for adolescents: The PRALIMAP-INÈS trial protocol and inclusion data analysis.

BACKGROUND: Despite social inequalities in overweight/obesity prevalence, evidence-based public health interventions to reduce them are scarce. The PRALIMAP-INÈS trial aimed to investigate whether a strengthened-care management for adolescents with low socioeconomic status has an equivalent effect in preventing and reducing overweight as a standard-care management for high socioeconomic status adolescents. METHODS: PRALIMAP-INÈS was a mixed, prospective and multicenter trial including 35 state-run schools. It admitted overweight or obese adolescents, age 13-18 years old, for 3 consecutive academic years. One-year interventions were implemented. Data were collected before (T0), after (T1) and post (T2) intervention. Among 2113 eligible adolescents who completed questionnaires, 1639 were proposed for inclusion and 1419 were included (220 parental refusals). Two groups were constituted according to the Family Affluence Scale (FAS) score: the less advantaged (FAS≤5) were randomly assigned to 2 groups in a 2/1 ratio. The 3 intervention groups were: advantaged with standard-care management (A.S, n = 808), less advantaged with standard-care management (LA.S, n = 196), and less advantaged with standard and strengthened-care management (LA.S.S, n = 415). The standard-care management was based on the patient education principle and consisted of 5 collective sessions. The strengthened-care management was based on the proportionate universalism principle and consisted of activities adapted to needs. INCLUSION RESULTS: The written parental refusal was less frequent among less advantaged and more overweight adolescents. A dramatic linear social gradient in overweight was evidenced. DISCUSSION: The PRALIMAP-INÈS outcomes should inform how effectively a socially adapted public health program can avoid worsening social inequalities in overweight adolescents attending school. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01688453).

[Cross-border evaluation of needs for training in therapeutic education of the patient for the management in type 2 diabetes and obesity: Survey by method of nominal group with healthcare professionals]. / Étude transfrontalière des besoins de formation en éducation thérapeutique du patient pour la prise en charge du diabète de type 2 et de l'obésité : enquête par groupes nominaux auprès des professionnels de santé.

INTRODUCTION: The design of continuous training programs in therapeutic patient education (ETP) should be inspired by needs shown by the professionals concerned in terms of mobilization or acquisition of skills in this domain. The objective of this study is to analyze needs expressed by healthcare professionals (HP) involved in patients' management presenting a type 2 diabetes (T2D) and/or obesity and to compare them with the existing recommendations. METHODS: One hundred and five PS (general practitioners, dietitians and nurses) of 3 frontier regions of French-speaking European countries (France, Belgium and Grand duchy of Luxembourg) were questioned in 12 monodisciplinary groups according to the technique of the nominal group. Needs expressed by the participants were classified in the categories of the reference table of skills to dispense TPE (National Institute for Health Prevention and Education [INPES], 2013). RESULTS/DISCUSSION: Among needs expressed by HP, 52 % of the votes targeted relational skills, 10 % of the skills relative to the biomedical techniques, 20 % of the skills relative to the educational techniques and 11 %, those of organization and the coordination. Seven percent of the proposals were out of the categories of the INPES. Results do not allow to establish profiles of skills according to the studied region or profession. The recognition of the TPE by the French legislation does not seem to influence in a major way the data. CONCLUSION: The needs expressed by PS in the context of this study are focused on the relation HP/patient that is the heart of the TPE. It would however be necessary to raise awareness among HP in the acquisition of the other skills which concern in particular the animation of group, the interprofessional coordination, the consideration of the environment or more generally the procedures.

Comprehensive MRI analysis of early cardiac and vascular remodeling in middle-aged patients with abdominal obesity.

OBJECTIVES: To determine, using a comprehensive MRI investigation, prevalence and vascular correlates of early left-ventricular concentric remodeling in middle-aged patients with abdominal obesity. Left-ventricular and vascular remodeling are commonly associated with hypertension, but little is known for abdominal obesity patients, a population with definite increase in cardiovascular risk and high rates of further developments of hypertension and of the metabolic syndrome. METHODS: Seventy middle-aged abdominal obesity patients (56 ±â€Š5 years, 49% women, 69% with body mass index > 30 kg/m), who had no additional cardiovascular risk factor except for untreated stage 1 hypertension (16%), and 40 controls underwent MRI for detecting concentric remodeling (increase in left-ventricular mass/end-diastolic volume ratio) and identifying potential determinants, including arterial compliance indexes [aortic pulse wave velocity and total arterial compliance (TAC)] and total peripheral vascular resistances (TPVRs). RESULTS: Twenty abdominal obesity patients (29%) had concentric remodeling (concentric remodeling+), whereas 50 did not (concentric remodeling-). Concentric remodeling+ patients were mostly men (85%), they frequently had stage 1 hypertension (45%) and few had left-ventricular hypertrophy (20%). When adjusted for sex, there was a step-by-step decline in TAC between controls (mean ±â€ŠSEM: 2.10 ±â€Š0.06 ml/mmHg), concentric remodeling- (1.82 ±â€Š0.06 ml/mmHg) and concentric remodeling+ (1.42 ±â€Š0.09 ml/mmHg, P < 0.005 for inter-group comparisons) and TPVRs were lower than controls for concentric remodeling- (14.7 ±â€Š0.5 vs. 16.8 ±â€Š0.5 ml/mmHg, P = 0.005) but not for concentric remodeling+ (17.5 ±â€Š0.7 mmHg/min per l). CONCLUSIONS: Concentric remodeling is frequently documented by MRI in the middle-aged men with abdominal obesity and in association with a decrease in TAC no longer counter-balanced by a decrease in TPVR, suggesting a remodeling from proximal to peripheral vasculature.

[Nonsurgical management of obesity in adults]. / Prise en charge de l'obésité de l'adulte.

General practitioners are placed in an ideal position to manage obesity. First, they have to consider the motivation of the obese patient to change his habits. When the patient is not motivated to loss weight, their role is to identify and treat co-morbidities, to evaluate the risk related to the obesity and to establish a therapeutic diagnosis to evaluate motivation and ability to change. If the patient is motivated, the therapeutic choices have to be adapted individually to each patient. An inadequate management may not only result in a failure but may increase obesity. The objectives in obesity treatment are to achieve weight loss in order to reduce health risk as far as possible, to maintain that weight loss, to restore quality of life. Goals and methods must be realistic. Even a modest weight loss (5-10 % of initial weight) will improve health indices in an obese patient. Dietary treatment and physical activity are fundamental to the management of obesity. Compliance with the diet is the major problem, especially during the phase of weight maintenance after the excess weight loss has been lost. Initial weight reduction depends on the level of energy deficit and weight maintenance on compliance to a low fat diet and a physical activity programme. Cognitive behavioural approaches should be an integral part of the management of a chronic disease. This treatment is very useful to improve body image, self-esteem, management of stress and control of disordered eating patterns. A psychotherapeutic approach is often necessary, especially when the obesity is psycho-determined. Obesity drugs should be used for carefully selected patients, as an adjunct to diet therapy and lifestyle modifications, under medical supervision.

Sympathetic-leptin relationship in obesity: effect of weight loss.

Obese patients have high plasma leptin concentrations that do not induce the expected responses on weight regulation, suggesting a leptin resistance in obesity. Elevated leptin levels are also thought to be related to a high sympathetic nervous system (SNS) activity. This effect could be preserved, lowered, or even abolished in obesity. We planned to investigate the possible association in a longitudinal study. Ninety-five normotensive healthy women, aged 40.4 +/- 11.4 years and body mass index of 33.2 +/- 2.3 kg/m(2), were studied. Baseline leptin, fat mass, and heart rate variability were measured and included in a 6-month longitudinal study. Body composition was measured by dual-energy x-ray absorption. Time domain heart rate variability, QT dynamicity, and spectral components on ambulatory electrocardiographs were analyzed. Dietary advice was given by a dietitian to the patient (maximum caloric reduction of 30%), and subjects were randomized in 3 treatment groups: sibutramine 10 mg, sibutramine 20 mg, or placebo. At baseline, low frequencies (LF) and the LF-high frequencies (HF) ratio, mainly related to the SNS, were negatively correlated to leptin concentration (r = -0.30, P = .002 and r = -0.36, P < .001) and to the leptin-fat mass ratio (r = -0.28, P = .004 and r = - 0.33, P = .0007), thus explaining 38% of the LF variance and 33% of the LF/HF variance. Diastolic blood pressure was also negatively correlated to leptin concentrations (-0.20, P = .04) and to the leptin-fat mass ratio (-0.22, P = .022). In contrast, no consistent correlations between leptin and the time domain components related to vagal activity were observed. At 6 months, after completion of the weight loss program, LF significantly decreased (-7.7% +/- 7.9%, P < .001), whereas HF was higher than the initial value (+20% +/- 5.2%). The leptin-fat mass ratio remained negatively correlated to the LF (r = -0.34, P = .030) and to LF/HF (r = -0.35, P = .021) values, explaining 21% of the LF variation. None of the pairwise comparisons between the 2 sibutramine groups and the placebo group were statistically significant for heart rate variability. High leptin concentration is associated with low indexes of cardiac SNS activity and with a lower diastolic blood pressure in normotensive obese women. Our results imply therefore that the relationship between leptin and the autonomic nervous system is disturbed in normotensive obese subjects.

Accuracy of an electrochemical sensor for measuring capillary blood ketones by fingerstick samples during metabolic deterioration after continuous subcutaneous insulin infusion interruption in type 1 diabetic patients.

OBJECTIVE: This study was designed to test the accuracy of capillary ketonemia for diagnosis of ketosis after interruption of insulin infusion. RESEARCH DESIGN AND METHODS: A total of 18 patients with type 1 diabetes treated by external pump were studied during pump stop for 5 h. Plasma and capillary ketonemia and ketonuria were determined every hour from 7:00 A.M. (time 0 min = T0) to 12:00 P.M. (time 300 min = T300). Plasma beta-hydroxybutyrate (beta-OHB) levels were measured by an enzymatic end point spectrophotometric method, and capillary beta-OHB levels were measured by an electrochemical method (MediSense Optium meter). Ketonuria was measured by a semiquantitative test (Ketodiastix). Positive ketosis was defined by a value of >/=0.5 mmol/l for ketonemia and >/=4 mmol/l (moderate) for ketonuria. RESULTS: After stopping the pump, concentrations of beta-OHB in both plasma and capillary blood increased significantly at time 60 min (T60) compared with T0 (P < 0.001), reaching maximum levels at T300 (1.30 +/- 0.49 and 1.23 +/- 0.78 mmol/l, respectively). Plasma and capillary beta-OHB values were highly correlated (r = 0.94, P < 0.0001). For diagnosis of ketosis, capillary ketonemia has a higher sensitivity and negative predictive value (80.4 and 82.5%, respectively) than ketonuria (63 and 71.8%, respectively). For plasma glucose levels >/=250 mg/dl, plasma and capillary ketonemia were found to be more frequently positive (85 and 78%, respectively) than ketonuria (59%) (P = 0.017). The time delay to diagnosis of ketosis was significantly higher for ketonuria than for plasma ketonemia (212 +/- 67 vs. 140 +/- 54 min, P = 0.0023), whereas no difference was noted between plasma and capillary ketonemia. CONCLUSIONS: The frequency of screening for ketosis and the efficiency of detection of ketosis definitely may be improved by the use of capillary blood ketone determination in clinical practice.

Evolution of analytical performance in portable glucose meters in the last decade.

OBJECTIVE: To assess and compare the technical accuracy of portable glucose meters during the last decade. RESEARCH DESIGN AND METHODS: One-thousand preprandial (pre) and postprandial (post) capillary whole-blood glucose values measured with meters owned mainly by diabetic patients were compared with a single laboratory method yearly from 1989 to 1999. A total of 21,950 capillary measurements and their corresponding laboratory reference values were analyzed at our clinic. RESULTS: The lowest mean absolute difference was found in 1989 (pre: 2 +/- 22 mg/dl, post: 9 +/- 31 mg/dl) (mean +/- SD). The highest mean absolute difference was observed in 1993 (pre: 31 +/- 33 mg/dl) and 1996 (post: 50 +/- 35 mg/dl). The highest mean relative deviation was observed in 1990 (pre: 16.4%) and 1996 (post: 20.6%). The highest percentage of readings that were within a 5% deviation limit were observed in 1998 (pre: 44.5%) and in 1997 (post: 36.7%). Based on blood glucose levels within +/-5 and +/-10% of laboratory values, the technical accuracy of meters was similar for 1989 and 1999 (P = 0.27 and 0.52, respectively). The percentage of pre values in zone A of Clarke's error grid analysis was >90% in 1989, 1997, 1998, and 1999. CONCLUSIONS: The analytical performance of glucose meters decreased between 1990 and 1996 but was restored between 1997 and 1999. Nevertheless, our data suggest that the technical accuracy of glucose meters has not significantly improved during the last decade. Complementary studies taking into account the preanalytical improvements of the recent meters, as well as their calibration method, appear necessary.

Clinical performance of CGMS in type 1 diabetic patients treated by continuous subcutaneous insulin infusion using insulin analogs.

OBJECTIVE: Performance criteria have been established for in vitro blood glucose monitoring, particularly for the self-monitoring of blood glucose using glucose meters. Devices intended for use in the future, such as the continuous glucose monitoring system (CGMS), should satisfy similar criteria, particularly in diabetic patients under intensive therapy. RESEARCH DESIGN AND METHODS: The analysis was conducted on 18 type 1 diabetic patients (not controlled, HbA(1c) >7.5%) treated by external pump using insulin analogs. Each patient received a glucose sensor for 3 days during his/her hospitalization and was instructed in its operation. Medtronic criteria were used to determine the accuracy of the CGMS. In addition, the data were analyzed according to American Diabetes Association (ADA) criteria, Clarke Error Grid analysis, and method of residuals, with the glucose oxidase method using a Beckman analyzer used as the reference method. Specificity and sensitivity were evaluated from the viewpoint of accuracy in the detection of hypoglycemia. For nine patients, two glucose sensors were simultaneously inserted into an abdominal site to determine the reproducibility of the system. RESULTS-Among the 33 glucose sensors inserted, 6 (18%) were nonfunctional. The mean duration of CGMS recording was 63 +/- 12 h. From all of the 692 sets of data that paired glucose readings and CGMS, the coefficients of correlation ranged from 0.87 to 0.92 and the mean absolute error ranged from 12.8 to 15.7%. The time experienced in hypoglycemia (<55 mg/dl) was reported at 86 +/- 62 min/day. Only 39% of the CGMS values satisfied the ADA precision criteria to within +/-10%, and 19% of these values satisfied the future ADA precision criteria of accuracy to within +/-5%. The means of difference method showed that the CGMS slightly underestimated the plasma glucose values (mean = -12 mg/dl). Error grid analysis showed only 77% of the glucose sensor values were in zone A, and 98.9% were in zones A and B. Two values fell in zone C and a single value fell in zone D. The sensitivity and specificity of the CGMS to detect hypoglycemia were 33 and 96%, respectively. A total of 6666 paired sensor values were recorded with a coefficient of correlation of 0.84 with a coefficient of variation of 8.25%. CONCLUSIONS: CGMS could be useful in routine clinical practice to provide much more information on the glucose profile than intermittent self-monitoring of blood glucose (SMBG). However, CGMS cannot be used as a replacement for glucose meters because it does not satisfy the conventional performance goals set down for in vitro glucose measurements and could therefore lead to clinically incorrect treatment decisions.

The benefits of metformin therapy during continuous subcutaneous insulin infusion treatment of type 1 diabetic patients.

OBJECTIVE: This study was designed to assess the insulin-sparing effect of oral administration of metformin along with a continuous subcutaneous insulin infusion (CSII) for the treatment of type 1 diabetic patients. RESEARCH DESIGN AND METHODS: A total of 62 patients (25 women and 37 men) were studied in a monocenter, randomized, double-blind placebo-controlled study, comparing metformin (850 mg b.i.d.) with placebo in association with CSII during a 6-month period. RESULTS: Treatment with metformin was associated with a reduction in daily insulin requirements between V0 and V6 of -4.3 +/- 9.9 units (-7.8 +/- 18%) compared with an increase with placebo treatment of 1.7 +/- 8.3 units (2.8 +/- 12.7%) (P = 0.0043). A decrease in basal requirement of insulin was also observed in patients treated with metformin of -2.6 +/- 3.2 units (-7.9 +/- 23.8%) compared with an increase with placebo treatment of 1.9 +/- 5.7 units (8.8 +/- 27.1%) (P = 0.023). HbA(1c) remained unchanged in treatment with metformin and placebo between V0 and V6. The number of hypoglycemic events (<60 mg/dl) was similar in both groups. Significant reductions of total cholesterol (P = 0.04) and LDL cholesterol (P = 0.05) were observed in patients treated with metformin. Gastrointestinal events, including diarrhea and abdominal pain, were reported in three patients in the metformin group who discontinued the trial. Mild or moderate gastrointestinal side effects were also reported in eight patients treated with metformin and two patients treated with placebo (P = 0.069). CONCLUSIONS: Metformin was found to be a safe insulin-sparing agent, when used in combination with CSII for the treatment of type 1 diabetes.