Insulin monotherapy compared with the addition of oral glucose-lowering agents to insulin for people with type 2 diabetes already on insulin therapy and inadequate glycaemic control.

BACKGROUND: It is unclear whether people with type 2 diabetes mellitus on insulin monotherapy who do not achieve adequate glycaemic control should continue insulin as monotherapy or can benefit from adding oral glucose-lowering agents to the insulin therapy. OBJECTIVES: To assess the effects of insulin monotherapy compared with the addition of oral glucose-lowering agents to insulin monotherapy for people with type 2 diabetes already on insulin therapy and inadequate glycaemic control. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and reference lists of articles. The date of the last search was November 2015 for all databases. SELECTION CRITERIA: Randomised controlled clinical trials of at least two months' duration comparing insulin monotherapy with combinations of insulin with one or more oral glucose-lowering agent in people with type 2 diabetes. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias, extracted data and evaluated overall quality of the evidence using GRADE. We summarised data statistically if they were available, sufficiently similar and of sufficient quality. We performed statistical analyses according to the statistical guidelines in the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: We included 37 trials with 40 treatment comparisons involving 3227 participants. The duration of the interventions ranged from 2 to 12 months for parallel trials and two to four months for cross-over trials.The majority of trials had an unclear risk of bias in several risk of bias domains. Fourteen trials showed a high risk of bias, mainly for performance and detection bias. Insulin monotherapy, including once-daily long-acting, once-daily intermediate-acting, twice-daily premixed insulin, and basal-bolus regimens (multiple injections), was compared to insulin in combination with sulphonylureas (17 comparisons: glibenclamide = 11, glipizide = 2, tolazamide = 2, gliclazide = 1, glimepiride = 1), metformin (11 comparisons), pioglitazone (four comparisons), alpha-glucosidase inhibitors (four comparisons: acarbose = 3, miglitol = 1), dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) (three comparisons: vildagliptin = 1, sitagliptin = 1, saxagliptin = 1) and the combination of metformin and glimepiride (one comparison). No trials assessed all-cause mortality, diabetes-related morbidity or health-related quality of life. Only one trial assessed patients' treatment satisfaction and showed no substantial differences between the addition of either glimepiride or metformin and glimepiride to insulin compared with insulin monotherapy.Insulin-sulphonylurea combination therapy (CT) compared with insulin monotherapy (IM) showed a MD in glycosylated haemoglobin A1c (HbA1c) of -1% (95% confidence interval (CI) -1.6 to -0.5); P < 0.01; 316 participants; 9 trials; low-quality evidence. Insulin-metformin CT compared with IM showed a MD in HbA1c of -0.9% (95% CI -1.2 to -0.5); P < 0.01; 698 participants; 9 trials; low-quality evidence. We could not pool the results of adding pioglitazone to insulin. Insulin combined with alpha-glucosidase inhibitors compared with IM showed a MD in HbA1c of -0.4% (95% CI -0.5 to -0.2); P < 0.01; 448 participants; 3 trials; low-quality evidence). Insulin combined with DPP-4 inhibitors compared with IM showed a MD in HbA1c of -0.4% (95% CI -0.5 to -0.4); P < 0.01; 265 participants; 2 trials; low quality evidence. In most trials the participants with CT needed less insulin, whereas insulin requirements increased or remained stable in participants with IM.We did not perform a meta-analysis for hypoglycaemic events because the included studies used different definitions.. In most trials the insulin-sulphonylurea combination resulted in a higher number of mild episodes of hypoglycaemia, compared to the IM group (range: 2.2 to 6.1 episodes per participant in CT versus 2.0 to 2.6 episodes per participant in IM; low-quality evidence). Pioglitazone CT also resulted in more mild to moderate hypoglycaemic episodes compared with IM (range 15 to 90 episodes versus 9 to 75 episodes, respectively; low-quality evidence. The trials that reported hypoglycaemic episodes in the other combinations found comparable numbers of mild to moderate hypoglycaemic events (low-quality evidence).The addition of sulphonylureas resulted in an additional weight gain of 0.4 kg to 1.9 kg versus -0.8 kg to 2.1 kg in the IM group (220 participants; 7 trials; low-quality evidence). Pioglitazone CT caused more weight gain compared to IM: MD 3.8 kg (95% CI 3.0 to 4.6); P < 0.01; 288 participants; 2 trials; low-quality evidence. Metformin CT was associated with weight loss: MD -2.1 kg (95% CI -3.2 to -1.1), P < 0.01; 615 participants; 7 trials; low-quality evidence). DPP-4 inhibitors CT showed weight gain of -0.7 to 1.3 kg versus 0.6 to 1.1 kg in the IM group (362 participants; 2 trials; low-quality evidence). Alpha-glucosidase CT compared to IM showed a MD of -0.5 kg (95% CI -1.2 to 0.3); P = 0.26; 241 participants; 2 trials; low-quality evidence.Users of metformin CT (range 7% to 67% versus 5% to 16%), and alpha-glucosidase inhibitors CT (14% to 75% versus 4% to 35%) experienced more gastro-intestinal adverse effects compared to participants on IM. Two trials reported a higher frequency of oedema with the use of pioglitazone CT (range: 16% to 18% versus 4% to 7% IM). AUTHORS' CONCLUSIONS: The addition of all oral glucose-lowering agents in people with type 2 diabetes and inadequate glycaemic control who are on insulin therapy has positive effects on glycaemic control and insulin requirements. The addition of sulphonylureas results in more hypoglycaemic events. Additional weight gain can only be avoided by adding metformin to insulin. Other well-known adverse effects of oral glucose-lowering agents have to be taken into account when prescribing oral glucose-lowering agents in addition to insulin therapy.

Impact of UKPDS risk estimation added to a first subjective risk estimation on management of coronary disease risk in type 2 diabetes - An observational study.

AIMS: To investigate the impact of the UKPDS risk engine on management of CHD risk in T2DM patients. METHODS: Observational study among 139 GPs. Data from 933 consecutive patients treated with a maximum of two oral glucose lowering drugs, collected at baseline and after twelve months. GPs estimated the CHD risk themselves and afterwards they calculated this with the UKPDS risk engine. Under- and overestimation were defined as a difference >5 percentage points difference between both calculations. The impact of the UKPDS risk engine was assessed by measuring differences in medication adjustments between the over-, under- and accurately estimated group. RESULTS: In 42.0% the GP accurately estimated the CHD risk, in 32.4% the risk was underestimated and in 25.6% overestimated. Mean difference between the estimated (18.7%) and calculated (19.1%) 10 years CHD risk was -0.36% (95% CI -1.24 to 0.52). Male gender, current smoking and total cholesterol level were associated with underestimation. Patients with an subjectively underestimated CHD risk received significantly more medication adjustments. Their UKPDS 10 year CHD risk did not increase during the follow-up period, contrary to the other two groups of patients. CONCLUSIONS: The UKPDS risk engine may be of added value for risk management in T2DM.

What follow-up care and self-management support do patients with type 2 diabetes want after their first acute coronary event? A qualitative study.

AIMS: Despite diabetes patients' efforts to control their disease, many of them are confronted with an acute coronary event. This may evoke depressive feelings and self-management may be complicated. According to the American Diabetes Association, the transition from hospital to home after an acute coronary event (ACE) is a high-risk time for diabetes patients; it should be improved. Before developing an intervention for diabetes patients with an ACE in the period after discharge from hospital, we want to gain a detailed understanding of patients' views, perceptions and feelings in this respect. METHODS: Qualitative design. Two semi-structured focus groups were conducted with 14 T2DM patients (71% male, aged 61-77 years) with a recent ACE. One focus group with partners (67% male, aged 64-75 years) was held. All interviews were transcribed verbatim and analyzed by two independent researchers. RESULTS: Patients believed that coping with an ACE differs between patients with and without T2DM. They had problems with physical exercise, sexuality and pharmacotherapy. Patients and partners were neither satisfied with the amount of information, especially on the combination of T2DM and ACE, nor with the support offered by healthcare professionals after discharge. Participants would appreciate tailored self-management support after discharge from hospital. CONCLUSIONS: Patients with T2DM and their partners lack tailored support after a first ACE. Our findings underpin the ADA recommendations to improve the transition from hospital to home. The results of our study will help to determine the exact content of a self-management support program delivered at home to help this specific group of patients to cope with both conditions.

Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital - design and development of a randomised controlled trial.

BACKGROUND: Type 2 diabetes mellitus patients with an acute coronary event (ACE) experience decreased quality of life and increased distress. According to the American Diabetes Association, discharge from the hospital is a time of increased distress for all patients. Tailored support specific to diabetes is scarce in that period. We developed an intervention based on Bandura's Social Cognitive Theory, Leventhal's Common Sense Model, and results of focus groups. The aim of this study is to evaluate the effectiveness of the intervention to reduce distress in type 2 diabetes patients who experienced a first ACE. METHODS: Randomised controlled trial. Two hundred patients are recruited in thirteen hospitals. A diabetes nurse visits the patients in the intervention group (n = 100) at home within three weeks after discharge from hospital, and again after two weeks and two months. The control group (n = 100) receives a consultation by telephone. The primary outcome is diabetes-related distress, measured with the Problem Areas in Diabetes (PAID) questionnaire. Secondary outcomes are well-being, health status, anxiety, depression, HbA1c, blood pressure and lipids. Mediating variables are self-management, self-efficacy and illness representations. Outcomes are measured with questionnaires directly after discharge from hospital and five months later. Biomedical variables are obtained from the records from the primary care physician and the hospital. Differences between groups in change over time are analysed according to the intention-to-treat principle. The Holm-Bonferroni correction is used to adjust for multiplicity. DISCUSSION: Type 2 diabetes patients who experience a first ACE need tailored support after discharge from the hospital. This trial will provide evidence on the effectiveness of a supportive intervention in reducing distress in these patients. TRIAL REGISTRATION: NCT01801631.

Satisfaction of well-controlled type 2 diabetes patients with three-monthly and six-monthly monitoring.

BACKGROUND: Patient's satisfaction with monitoring frequency is of interest when implementing six-monthly monitoring for well-controlled type 2 diabetes patients. Here we want to determine the satisfaction of well-controlled type 2 diabetes patients with either three-monthly or six-monthly diabetes monitoring and their future preference. METHODS: Survey among 2215 well-controlled type 2 diabetes patients (not using insulin, HbA1c ≤58 mmol/mol, systolic blood pressure ≤145 mmHg and total cholesterol ≤5.2 mmol/l) who participated in the EFFIMODI study, a randomised controlled patient-preference equivalence trial. At baseline, participants were asked whether they had a strong preference for three-monthly or six-monthly monitoring or not. If not, they were randomised to either three-monthly or six-monthly monitoring, while the others were monitored according to their preference. After eighteen months, all participants were asked whether they were satisfied with the monitoring frequency and about their future preference. Patient characteristics associated with satisfaction were also examined. RESULTS: Most patients (70.8%) would like to continue their monitoring frequency. Patients from the preference groups were more often satisfied than randomised patients (92.7% and 88.1%, respectively) and patients monitored three-monthly were more often satisfied than patients monitored six-monthly (93.5% and 88.5%, respectively). Higher age, better physical health, less diabetes-related distress, higher diabetes treatment satisfaction and less perceived hyper- and hypoglycaemias were associated with a higher monitoring satisfaction. CONCLUSIONS: Most well-controlled type 2 diabetes patients were satisfied with their monitoring frequency and would like to continue it. Although the satisfaction for three-monthly monitoring was slightly higher, the satisfaction with six-monthly monitoring was still rather high (88.5%). TRIAL REGISTRATION: Current controlled trials ISRCTN93201802.

Process evaluation of podiatric treatment of patients with forefoot pain.

BACKGROUND: Foot pain is a common problem for people aged 50 and over and occurs more often in women than in men. About 60% of the foot problems are forefoot problems and slightly more than half of these patients seek medical help, mainly in the form of podiatric care. Podiatric treatment of forefoot problems is known to be heterogeneous. The aims of the present study are to describe the podiatric treatment of patients with forefoot pain and to evaluate the podiatric examination and treatment using an expert panel. METHOD: We invited twenty-five randomly selected subjects with forefoot problems who had received podiatric treatment in a pragmatic randomised clinical trial to participate in an analysis of their treatment by an expert panel. The panel retrospectively established the cause of the foot problem as well as the therapeutic goals and evaluated the treatment. These findings were compared to those reported by the treating podiatrist. RESULTS: Two fundamentally different approaches were found in approach of podiatric examination; a functional approach (n =13) and a non-functional approach (n =12). In nine cases the expert panel agreed with the cause recorded by the podiatrist. In five other cases the expert panel concluded that the treatment of the podiatrist was not consistent with the cause of the problem recorded by the podiatrist. Of the 10 patients for whom the podiatrist had recorded to have given shoe advice, only two were able to recollect the proper advice. Three patients did not remember receiving advice at all. CONCLUSION: In this study almost half of the podiatrists worked according to a non-functional approach where the other half (like the expert panel) chose a functional strategy that analyses the underlying problem. Fundamental differences in treatment plans and thus heterogeneous treatments could be a consequence.

Differences between diabetes patients who are interested or not in the use of a patient Web portal.

OBJECTIVE: A patient Web portal allows patients to access their personal health record through the Internet. It may improve diabetes outcomes, but the adoption is unsatisfactory. We examined the differences between patients with and without a login in order to optimize its use. PATIENTS AND METHODS: A survey was conducted among patients from 62 general practices and one outpatient clinic that all use a diabetes Web portal. Between November 2011 and March 2012 questionnaires were sent to 1,500 patients with and 3,000 patients without a login. Patient groups were stratified according to type of diabetes. Demographic and diabetes-related variables were analyzed with multivariable regression analysis. RESULTS: The total response rate was 67%. Fewer than 50% of the patients did request a login. Among 128 patients with type 1 diabetes mellitus, those with a login (89.8%) were younger and more frequently treated by an internist. In 1,262 patients with type 2 diabetes mellitus, fewer patients had a log-in (41.0%), and the likelihood of having a login was independently associated with younger age, male gender, higher educational level, treatment by an internist, longer duration of diabetes, and polypharmacy (all P<0.001). CONCLUSIONS: Patients with type 1 diabetes request a login more frequently than patients with type 2 diabetes, and patients with a login are strikingly different than patients without. The healthcare provider seems to play an important role in patients' Web utilization. Simply promoting use of electronic healthcare methods does not make sense. It is important to address disparities between patient groups to optimize the use of a Web portal.

Six-monthly diabetes monitoring of well-controlled patients: experiences of primary care providers.

AIMS: To examine experiences of primary care providers with six-monthly diabetes monitoring of well-controlled patients. METHODS: This study was part of the EFFIMODI study, examining whether six-monthly monitoring of well-controlled (HbA1c ≤58 mmol/mol, systolic blood pressure ≤145 mmHg and total cholesterol ≤5.2 mmol/l) type 2 diabetes patients results in equivalent cardiometabolic control compared to three-monthly monitoring. Primary care providers completed a questionnaire about their experiences with six-monthly diabetes monitoring, whether they want to continue six-monthly monitoring and for which type of patients six-monthly monitoring is sufficient. RESULTS: Of 163 questionnaires, 157 (96.3%) were completed and returned. Only 14 (8.9%) primary care providers were negative about the six-monthly monitoring and 102 (65.0%) would like to continue six-monthly monitoring. Primary care providers disagreed about patients' ability to determine their own monitoring frequency and whether six-monthly monitoring was suitable for all well-controlled type 2 diabetes patients. Practical concerns emerged such as the inability to declare healthcare costs and the unsuitability of electronic health record systems. CONCLUSIONS: Almost two out of three primary care providers would like to continue six-monthly monitoring of well-controlled type 2 diabetes patients. However, some diabetes care providers should be convinced and some practical concerns should be solved.

Defining and improving quality management in Dutch diabetes care groups and outpatient clinics: design of the study.

BACKGROUND: Worldwide, the organisation of diabetes care is changing. As a result general practices and diabetes teams in hospitals are becoming part of new organisations in which multidisciplinary care programs are implemented. In the Netherlands, 97 diabetes care groups and 104 outpatient clinics are working with a diabetes care program. Both types of organisations aim to improve the quality of diabetes care. Therefore, it is essential to understand the comprehensive elements needed for optimal quality management at organisational level. This study aims to assess the current level of diabetes quality management in both care groups and outpatient clinics and its improvement after providing feedback on their quality management system and tailored support. METHODS/DESIGN: This study is a before-after study with a one-year follow-up comparing the levels of quality management before and after an intervention to improve diabetes quality management. To assess the status of quality management, online questionnaires were developed based on current literature. They consist of six domains: organisation of care, multidisciplinary teamwork, patient centeredness, performance management, quality improvement policy and management strategies. Based on the questionnaires, respondents will receive feedback on their score in a radar diagram and an elucidating table. They will also be granted access to an online toolbox with instruments that proved to be effective in quality of care improvement and with practical examples. If requested, personal support in implementing these tools will be available. After one year quality management will be measured again using the same questionnaire. DISCUSSION: This study will reveal a nationwide picture of quality management in diabetes care groups and outpatient clinics in the Netherlands and evaluate the effect of offering tailored support. The operationalisation of quality management on organisational level may be of interest for other countries as well.

The "Test Your Memory" test performs better than the MMSE in a population without known cognitive dysfunction.

AIM: To examine the relation of performance on the self-administered Test Your Memory test (TYM) and the Mini-Mental State Examination (MMSE) with a comprehensive neuropsychological assessment in a population sample including people with modest cognitive decrements. METHODS: Eighty-six participants (aged 56-77 years), without known cognitive dysfunction, performed a neuropsychological assessment including MMSE, and were asked to fill out the TYM. The relation between both the TYM and the MMSE and a neuropsychological assessment was examined by means of correlation analyses, area under the ROC curves for discriminating between a "normal" and "modest decrements"(≥1SD below the sample mean) group, and Bland-Altman plots. RESULTS: Correlation with the full neuropsychological assessment was significantly stronger for the TYM than the MMSE (r=0.78 versus r=0.55; Steiger's Z=2.66, p<0.01). The TYM showed an area under the ROC-curve of 0.88 (95% CI 0.80 to 0.97) for differentiating between "normal" and "modest decrements" compared with 0.71 (0.53 to 0.90) for the MMSE. Bland-Altman plots showed limits of agreement for the TYM of -1.10 to 1.10 and for the MMSE of -1.39 to 1.38. CONCLUSIONS: The TYM showed good correlation with a neuropsychological assessment, performed better in discriminating between variations of cognition and showed more agreement with a neuropsychological assessment than the MMSE.

Computerized decision support systems in primary care for type 2 diabetes patients only improve patients' outcomes when combined with feedback on performance and case management: a systematic review.

PURPOSE: Computerized decision support systems (CDSSs) are often part of a multifaceted intervention to improve diabetes care. We reviewed the effects of CDSSs alone or in combination with other supportive tools in primary care for type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: A systematic literature search was conducted for January 1990-July 2011 in PubMed, Embase, and the Cochrane Database and by consulting reference lists. Randomized controlled trials (RCTs) in general practice were selected if the interventions consisted of a CDSS alone or combined with a reminder system and/or feedback on performance and/or case management. The intervention had to be compared with usual care. Two pairs of reviewers independently abstracted all available data. The data were categorized by process of care and patient outcome measures. RESULTS: Twenty RCTs met inclusion criteria. In 14 studies a CDSS was combined with another intervention. Two studies were left out of the analysis because of low quality. Four studies with a CDSS alone and four studies with a CDSS and reminders showed improvements of the process of care. CDSS with feedback on performance with or without reminders improved the process of care (one study) and patient outcome (two studies). CDSS with case management improved patient outcome (two studies). CDSS with reminders, feedback on performance, and case management improved both patient outcome and the process of care (two studies). CONCLUSIONS: CDSSs used by healthcare providers in primary T2DM care are effective in improving the process of care; adding feedback on performance and/or case management may also improve patient outcome.

One year follow-up of patients with screen-detected metabolic syndrome in primary care: an observational study.

BACKGROUND: Early detection and appropriate treatment of metabolic syndrome (MetS) can modify cardiometabolic risk factors and prevent cardiovascular disease. Optimal screening outcomes require follow-up management of MetS. OBJECTIVE: To investigate the natural course of events in the first year after positive screening for MetS in primary care with regard to follow-up behavior, medication prescription and lifestyle changes. METHODS: Screening of 1721 apparently healthy primary care patients (20-70 years old) detected 473 new MetS cases. These people were asked to contact their general practice for subsequent advice and treatment. Data about follow-up behavior of the screening participants and prescription of cardiovascular medication were collected from the electronic medical file, and changes in lifestyle were collected by the practice nurse. RESULTS: Of the 424 participants with screen-detected MetS for whom data about follow-up were available, 306 (72.2%) spontaneously contacted the practice. Antihypertensive, lipid-lowering and blood glucose-lowering medications were prescribed in 21.5%, 21.2% and 1.9% of the participants, respectively. Half of the participants for whom data about self-reported lifestyle changes were available reported to have increased their physical activity; 16.9% of the smokers quit smoking. Average weight loss was 2.1kg. CONCLUSIONS: Screening for MetS followed by the advice to contact the general practice for lifestyle counseling and treatment had a substantial spontaneous follow-up. Although the changes in physical activity, weight loss and smoking abstinence are promising, further research will have to demonstrate whether they are sustainable.

Mild depressive symptoms do not influence cognitive functioning in patients with type 2 diabetes.

Type 2 diabetes (T2DM) is associated both with cognitive decrements and depressive symptoms. Since depression in itself has been associated with cognitive decrements we aimed to investigate the influence of depressive symptoms on the relation between T2DM and cognitive functioning. Data were derived from three independent studies on cognitive functioning in patients with T2DM (n=366) and controls without diabetes (n=204), two with longitudinal and one with only cross-sectional assessments. Depressive symptoms were measured with self-report inventories (CES-D or BDI-II). The composite z-score of the domains memory, information-processing speed, and attention and executive function was the primary cognitive outcome measure. Mixed linear regression analyses were used in a stepped approach to compare cognitive functioning between (1) patients with T2DM and controls (cross-sectionally and longitudinally), (2) participants with and without depressive symptoms, separately for patients and controls, and (3) patients and controls after adjustment for depressive symptoms. In addition the mediating effect of depressive symptoms was assessed with a bootstrapping technique. Depressive symptoms were present in 11% of the patients with T2DM and in 7% of controls (p=0.15). Cognitive performance in patients with T2DM was worse than in controls (overall difference composite z-score -0.13). However, T2DM was not associated with accelerated cognitive decline over three years of follow-up relative to controls. Controls with depressive symptoms performed worse than those without depressive symptoms, although not statistically significant. Performance in patients with T2DM with and without depressive symptoms was similar. Adjustment for depressive symptoms and estimation of the mediating effect showed that the difference between patients and controls was not mediated by depressive symptoms. In conclusion, the modest cognitive decrements that are associated with T2DM are not due to the presence of mild depressive symptoms.

Impact of self-reported comorbidity on physical and mental health status in early symptomatic osteoarthritis: the CHECK (Cohort Hip and Cohort Knee) study.

OBJECTIVE: To describe the relationship between comorbidity (absolute number as well as the presence of specific comorbidities) and pain, physical functioning and mental health status of participants with early symptomatic OA of the hip or knee. METHODS: In the Netherlands, a prospective 10-year follow-up study was initiated by the Dutch Arthritis Association in participants with early symptomatic OA of the hip or knee: CHECK (Cohort Hip and Cohort Knee), which consists of 1002 individuals. At baseline, linear regression analysis was used to determine the influence of comorbidity on the outcome variables: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, WOMAC physical functioning, Medical Outcomes Study Short Form 36 (SF-36) Physical Component Summary and Mental Component Summary. RESULTS: Of 979 subjects, 67% reported one or more comorbidities. After controlling for age, gender, social status and severity of radiographic OA (Kellgren and Lawrence score), back disorders have the largest effect on WOMAC pain and physical functioning, and one of the largest effects on physical status of SF-36, besides obesity. Mental status was negatively influenced by the additional presence of duodenal ulcer, thyroid disease, and migraine or chronic headache. CONCLUSION: In early stage of OA, the presence of additional problems in the musculoskeletal system and of obesity have a negative effect on pain and physical health status. Also mental status is affected in early symptomatic OA by the presence of specific comorbidities. Comorbidity should be assessed and treated to improve the burden of illness in patients with early symptomatic OA.

Both cardiovascular and non-cardiovascular comorbidity are related to health status in well-controlled type 2 diabetes patients: a cross-sectional analysis.

BACKGROUND: Type 2 diabetes patients have a decreased health-related quality of life compared to healthy persons, especially regarding physical functioning and well-being. Health-related quality of life is even lower in type 2 diabetes patients when other diseases co-exist. In contrast to earlier studies, we assessed the associations between the number and type of comorbidities and health status in well-controlled type 2 diabetes patients, in whom treatment goals for HbA1c, blood pressure and cholesterol had been reached. Approximately one in five type 2 diabetes patients belongs to this group. METHODS: Cross-sectional analysis was performed in 2086 well-controlled (HbA1c ≤58 mmol/mol, systolic blood pressure ≤145 mmHg, total cholesterol ≤5.2 mmol/l and not using insulin) type 2 diabetes patients in general practice. Both number and type (cardiovascular and non-cardiovascular) of comorbidities were determined for each patient. Health status was assessed with the questionnaires Short Form-36 (SF-36) and EuroQol (EQ). The SF-36 generates eight dimensions of health and a Physical and Mental Component Score (PCS and MCS), scale: 0-100. The EQ consists of two parts: EQ-5D and EQ Visual Analogue Scale. Multivariable linear regression analysis was used to assess if number and type of comorbidities were associated with health status. RESULTS: Well-controlled type 2 diabetes patients with comorbidities had a much lower health status, with a decrease ranging from -1.5 for the MCS to -26.3 for role limitations due to physical problems, compared to those without. Health status decreased when the number of comorbidities increased, except for mental health, role limitations due to emotional problems, MCS and both EQ measures. In patients with both cardiovascular and non-cardiovascular comorbidity, physical functioning, role limitations due to physical problems and PCS were significantly lower than in patients with only cardiovascular comorbidity. Physical functioning was also lower compared to patients with only non-cardiovascular comorbidity. CONCLUSIONS: Even acceptable values of HbA1c, blood pressure and cholesterol in type 2 diabetes patients are not necessarily related with a good health status. We have shown that comorbidities have a large impact on health status. Physicians may take into account patient's health status and integrate the impact of comorbidities into diabetes care.

Remission of screen-detected metabolic syndrome and its determinants: an observational study.

BACKGROUND: Early detection and treatment of the metabolic syndrome may prevent diabetes and cardiovascular disease. Our aim was to assess remission of the metabolic syndrome and its determinants after a population based screening without predefined intervention in the Netherlands. METHODS: In 2006 we detected 406 metabolic syndrome cases (The National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) definition) among apparently healthy individuals with an increased waist circumference. They received usual care in a primary care setting. After three years metabolic syndrome status was re-measured. We evaluated which baseline determinants were independently associated with remission. RESULTS: The remission rate among the 194 participants was 53%. Baseline determinants independently associated with a remission were the presence of more than three metabolic syndrome components (OR 0.46) and higher levels of waist circumference (OR 0.91), blood pressure (OR 0.98) and fasting glucose (OR 0.60). CONCLUSIONS: In a population with screen-detected metabolic syndrome receiving usual care, more than half of the participants achieved a remission after three years. This positive result after a relatively simple strategy provides a solid basis for a nation-wide implementation. Not so much socio-demographic variables but a higher number and level of the metabolic syndrome components were predictors of a lower chance of remission. In such cases, primary care physicians should be extra alert.

Advanced glycation end products measured by skin autofluorescence in a population with central obesity.

Accumulation of advanced glycation end products (AGEs) is enhanced by chronic hyperglycemia and oxidative stress and this process may contribute to the pathogenesis of vascular disease. Skin autofluorescence (AF), a measure of accumulation of AGEs in skin collagen, is associated with vascular disease in patients with diabetes.   Because central obesity enhances oxidative stress people with central obesity might already have increased accumulation of AGEs before diabetes or cardiovascular disease become manifest. To test this hypothesis, we compared the distribution of skin AF and its association with clinical and biochemical parameters in individuals with and without central obesity. Skin AF was measured by a validated AGE Reader in 816 persons with and 431 persons without central obesity, aged 20-70 y. Mean skin AF increased with age and smoking and was higher in centrally obese individuals compared with non-obese individuals (p = 0.001, after adjustment for age and smoking p = 0.13). Mean skin AF in the subgroups without central obesity and without other risk factors (n = 106), central obesity without other risk factors (n = 74) and central obesity with other risk factors (n = 742) was 1.63 ± 0.37, 1.74 ± 0.44 and 1.87 ± 0.43 AU, respectively (p for trend < 0.001, after adjustment for age and smoking p for trend = 0.12). In the group with central obesity age, current smoking, alcohol consumption, waist circumference, creatinine clearance and hs-CRP were independently associated with skin AF (R(2) = 29.4%). Waist circumference hardly contributed to the explained variance. The relationship between waist circumference and skin AF is not as obvious as we hypothesized.

High-sensitivity C-reactive protein to detect metabolic syndrome in a centrally obese population: a cross-sectional analysis.

BACKGROUND: People with central obesity have an increased risk for developing the metabolic syndrome, type 2 diabetes and cardiovascular disease. However, a substantial part of obese individuals have no other cardiovascular risk factors, besides their obesity. High sensitivity C-reactive protein (hs-CRP), a marker of systemic inflammation and a predictor of type 2 diabetes and cardiovascular disease, is associated with the metabolic syndrome and its separate components. We evaluated the use of hs-CRP to discriminate between centrally obese people with and without the metabolic syndrome. METHODS: 1165 people with central obesity but without any previous diagnosis of hypertension, dyslipidemia, diabetes or cardiovascular disease, aged 20-70 years, underwent a physical examination and laboratory assays to determine the presence of the metabolic syndrome (NCEP ATP III criteria). Multivariable linear regression analyses were performed to assess which metabolic syndrome components were independently associated with hs-CRP. A ROC curve was drawn and the area under the curve was calculated to evaluate whether hs-CRP was capable to predict the presence of the metabolic syndrome. RESULTS: Median hs-CRP levels were significantly higher in individuals with central obesity with the metabolic syndrome (n = 417; 35.8%) compared to individuals with central obesity without the metabolic syndrome (2.2 mg/L (IQR 1.2-4.0) versus 1.7 mg/L (IQR 1.0-3.4); p < 0.001). Median hs-CRP levels increased with an increasing number of metabolic syndrome components present. In multivariable linear regression analyses, waist circumference and triglycerides were the only components that were independently associated with hs-CRP after adjusting for smoking, gender, alcohol consumption and the other metabolic syndrome components. The area under the ROC curve was 0.57 (95%-CI 0.53-0.60). CONCLUSIONS: Hs-CRP has limited capacity to predict the presence of the metabolic syndrome in a population with central obesity.

Intensive multifactorial treatment and cognitive functioning in screen-detected type 2 diabetes--the ADDITION-Netherlands study: a cluster-randomized trial.

AIM: To assess whether an intensive multifactorial treatment can reduce cognitive decrements and cognitive decline in screen-detected type 2 diabetes. METHODS: The multinational ADDITION-study, a cluster-randomized parallel group trial in patients with screen-detected type 2 diabetes, compared the effectiveness of intensive multifactorial treatment (IT; lifestyle advice and strict regulation of metabolic parameters) with routine care (RC) on cardiovascular outcome. In The Netherlands randomization was stratified according to practice organization. Allocation was concealed from patients. The present study assessed the effect of IT on cognition through two neuropsychological assessments (NPA) on two occasions. The assessments took place three and six years after the start of the intervention. Non-diabetic controls served as reference group. The first NPA was performed in 183 patients (IT: 97; RC: 86) and 69 controls. The second NPA was performed in 135 patients (IT: 71; RC: 64) and 55 controls. Primary outcome was a composite score, including the domains memory, information-processing speed and attention and executive function. Comparisons between the treatment groups were performed with multi-level analyses. RESULTS: The first NPA showed no differences between the treatment groups (mean difference composite z-score: 0.00; 95%-CI -0.16 to 0.16; IT vs RC). Over the next three years cognitive decline in the diabetic groups was within the range of the reference group and did not differ between the treatment arms (difference decline between diabetic groups -0.12; -0.24 to 0.01; IT vs RC). CONCLUSIONS: Six years of IT in screen-detected type 2 diabetes had no benefit on cognitive functioning over RC.

Diabetes: glycaemic control in type 2 (drug treatments).

INTRODUCTION: Diabetes mellitus is a progressive disorder of glucose metabolism. It is estimated that about 285 million people between the ages of 20 and 79 years had diabetes worldwide in 2010, or 5% of the adult population. Type 2 diabetes may occur with obesity, hypertension, and dyslipidaemia (the metabolic syndrome), which are powerful predictors of cardiovascular disease. Without adequate blood-glucose-lowering treatment, blood glucose levels may rise progressively over time in people with type 2 diabetes. Microvascular and macrovascular complications may develop. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of blood-glucose-lowering medications in adults with type 2 diabetes? We searched: Medline, Embase, The Cochrane Library, and other important databases up to February 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 194 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: alpha-glucosidase inhibitors (AGIs), combination treatment (single, double, and triple), dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogues, insulins (including conventional [human] and analogue, different regimens, different length of action), meglitinides, metformin, sulphonylureas, and thiazolidinediones.