[Show abstract][Hide abstract] ABSTRACT: In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn lead to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes-related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent shaving and clipping of the nails. No effective curative local therapies exist, and systemic agents are often withheld due to concerns for side effects and interactions.
The primary aim is to evaluate the efficacy of four sessions of Nd:YAG 1064 nM laser application on the one-year clinical and microbiological cure rate in a randomized, double-blind, sham-controlled design with blinded outcome assessment. Mandatory inclusion criteria are diagnosis of diabetes, risk factors for developing foot ulcers defined as a modified Simm's classification score 1 or 2 and either neuropathy or PAD. A total of 64 patients are randomized to intervention or sham treatment performed by a podiatrist.
This study will be the first double-blind study that investigates the effects of local laser therapy on onychomycosis, specifically performed in patients with diabetes with additional risk factors for foot complications.
Clinical trials.gov as NCT01996995 , first received 22 November 2013.
[Show abstract][Hide abstract] ABSTRACT: Combined data suggest a bimodal association of alanine aminotransferase (ALT) with mortality in the general population. Little is known about the association of ALT with mortality in patients with type 2 diabetes. We therefore investigated the association of ALT with all-cause, cardiovascular, and non-cardiovascular mortality in patients with type 2 diabetes.
A prospective study was performed in patients with type 2 diabetes, treated in primary care, participating in the Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC) study. Cox regression analyses were performed to determine associations of log2 -transformed baseline ALT with all-cause, cardiovascular, and non-cardiovascular mortality.
In 1,187 patients with type 2 diabetes (67±12 years, 45% female), ALT levels were 11 (8-16) U/l. During median follow-up for 11.1 (6.1-14.0) years, 553 (47%) patients died, with 238 (20%) attributable to cardiovascular causes. Overall, ALT was inversely associated with all-cause mortality (Hazard Ratio [HR] 0.81; 95% Confidence Interval [CI] 0.72-0.92), independently of potential confounders. This was less attributable to cardiovascular mortality (HR 0.87; 95% CI 0.72-1.05), than to non-cardiovascular mortality (HR 0.77; 95% CI 0.65-0.90). Despite the overall inverse association of ALT with mortality, it appeared that a bimodal association with all-cause mortality was present with increasing risk for levels of ALT above normal (P=0.003).
In patients with type 2 diabetes, low levels of ALT are associated with an increased risk of all-cause mortality, in particular non-cardiovascular mortality, compared to normal levels of ALT, while risk again starts to increase when levels are above normal. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.
European Journal of Clinical Investigation 06/2015; DOI:10.1111/eci.12474 · 2.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: We aimed to investigate whether adjustment for frailty influences the relationship of blood pressure with mortality in elderly patients with type 2 diabetes mellitus (T2DM).
Patients aged 60 years and older (n = 858) were selected from a prospective observational cohort study of primary care patients with T2DM. Frailty was defined as a score less than 80 on the subscale 'physical functioning' of the RAND-36 questionnaire. After median follow-up for 14 years, multivariate Cox regression analyses were performed to evaluate the association between blood pressure and (cardiovascular) mortality. Analyses were performed in strata according to the frailty level ('physical functioning' score <80 and ≥80) and were repeated for patients older than 75 years.
Frailty was highly prevalent in our study population; 629 out of 858 patients (73%) fulfilled the criterion. For patients aged at least 60 years, the hazard ratios (95% confidence interval) of a 10 mmHg increase in SBP and DBP for cardiovascular mortality in nonfrail patients were 1.38 (1.15-1.68%) and 1.60 (1.07-2.37%), respectively. No relationship was observed for frail patients. For the oldest frail elderly, the hazard ratios of SBP and DBP for all-cause mortality were 0.92 (0.87-0.98%) and 0.83 (0.73-0.93%), respectively. For the oldest nonfrail elderly, a positive relationship between SBP and all-cause mortality was observed.
Frailty modifies the relationship between blood pressure and mortality in elderly patients with T2DM. Higher blood pressure was related to increased cardiovascular mortality in nonfrail patients, even in the oldest elderly, and to lower all-cause mortality in frail patients.
Journal of Hypertension 06/2015; 33(6):1162-6. DOI:10.1097/HJH.0000000000000555 · 4.22 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The Perception of Self-Monitoring of Blood Glucose (P-SMBG) scale was developed and validated to assess perceptions of self-monitoring of blood glucose (SMBG) in insulin-treated patients with diabetes.
An initial 68-item version of the P-SMBG has been evaluated by a panel of professionals and patients. A sample of 375 patients tested the revised scale.
Factor analysis suggested a 19-item scale and a 2-factor structure, separating negatively and positively worded items. Cronbach's alpha was .84 and .72, and the intraclass correlation coefficient was .66 and .57, respectively for both factors. Item-total correlations were in the range of .23-.66. Convergent/divergent validity was confirmed for the negatively worded items.
The final P-SMBG scale (21 items) can be used to assess positive and negative perceptions of SMBG in insulin-treated patients with diabetes.
Journal of Nursing Measurement 04/2015; 2015(1):57-71. DOI:10.1891/1061-37184.108.40.206
[Show abstract][Hide abstract] ABSTRACT: The hormone somatostatin inhibits growth hormone release from the pituitary gland and is theoretically linked to diabetes and diabetes related complications. This study aimed to investigate the relationship between levels of the stable somatostatin precursor, N-terminal prosomatostatin (NT-proSST), with mortality in type 2 diabetes (T2DM) patients.
In 1,326 T2DM outpatients, participating in this ZODIAC prospective cohort study, Cox proportional hazards models were used to investigate the independent relationship between plasma NT-proSST concentrations with all-cause and cardiovascular mortality.
Median concentration of NT-proSST was 592 [IQR 450-783] pmol/L. During follow-up for 6 [3-10] years, 413 (31%) patients died, of which 176 deaths (43%) were attributable to cardiovascular causes. The age and sex adjusted hazard ratios (HRs) for all-cause and cardiovascular mortality were 1.48 (95%CI 1.14 - 1.93) and 2.21 (95%CI 1.49 - 3.28). However, after further adjustment for cardiovascular risk factors there was no independent association of log NT-proSST with mortality, which was almost entirely attributable to adjustment for serum creatinine. There were no significant differences in Harrell's C statistics to predict mortality for the models with and without NT-proSST: both 0.79 (95%CI 0.77 - 0.82) and 0.81 (95%CI 0.77 - 0.84).
NT-proSST is unsuitable as a biomarker for cardiovascular and all-cause mortality in stable outpatients with T2DM.
[Show abstract][Hide abstract] ABSTRACT: Zelfcontrole is een belangrijk hulpmiddel om strikte glucoseregulatie te bereiken. Er is echter geen overeenstemming over het gebruik van de 1e of 2e bloeddruppel bij de uitvoering van zelfcontrole.
[Show abstract][Hide abstract] ABSTRACT: In a recent issue of Diabetologia, Riefflin et al published the results of their investigation into the effects of glibenclamide (known as glyburide in the USA and Canada) on insulin secretion in patients at different levels of glucose control . We acknowledge that these results provide further evidence for the unique side-effect profile of glibenclamide. Unfortunately, in the discussion section, the results were repeatedly extrapolated to sulfonylureas as a class. For example, the final conclusion ends with ‘This emphasises the need for cautious titration when using sulfonylureas as second-line agents after metformin when attempting to maintain tight glucose control.’ The results of this study are largely confirmatory, given the overwhelming existing evidence that glibenclamide is associated with a higher risk of hypoglycaemia . This extrapolation completely ignores important and clinically relevant within-class differences among sulfonylureas. It is well known that of all the s ...
[Show abstract][Hide abstract] ABSTRACT: Patients with diabetes are at high risk of death prior to reaching end-stage renal disease, but most models predicting the risk of kidney disease do not take this competing risk into account. We aimed to compare the performance of Cox regression and competing risk models for prediction of early- and late-stage renal complications in type 2 diabetes.
Patients with type 2 diabetes participating in the observational ZODIAC study were included. Prediction models for (micro)albuminuria and 50% increase in serum creatinine (SCr) were developed using Cox regression and competing risk analyses. Model performance was assessed by discrimination and calibration.
During a total follow-up period of 10 years, 183 out of 640 patients (28.6%) with normoalbuminuria developed (micro)albuminuria, and 22 patients (3.4%) died without developing (micro)albuminuria (i.e. experienced the competing event). Seventy-nine out of 1,143 patients (6.9%) reached the renal end point of 50% increase in SCr, while 219 (19.2%) died without developing the renal end point. Performance of the Cox and competing risk models predicting (micro)albuminuria was similar and differences in predicted risks were small. However, the Cox model increasingly overestimated the risk of increase in SCr in presence of a substantial number of competing events, while the performance of the competing risk model was quite good.
In this study, we demonstrated that, in case of substantial numbers of competing events, it is important to account for the competing risk of death in renal risk prediction in patients with type 2 diabetes.
PLoS ONE 03/2015; 10(3):e0120477. DOI:10.1371/journal.pone.0120477 · 3.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This study described the incidence and prevalence of type 1 diabetes in children in The Netherlands in 2010-2011 and to compare these results with earlier studies.
This was a retrospective nationwide cohort study of Dutch children aged 14 years or younger. Patients were identified using health insurance reimbursement registries for hospital care and invoices for insulin. In The Netherlands, all children with diabetes are treated by hospital-based paediatricians and healthcare for all Dutch citizens is covered by law.
The incidence of type 1 diabetes almost doubled between 1978-1980 and 2010-2011, from 11.1 to 21.4 per 100,000. In the youngest age group, who were under five years, the incidence rate doubled between 1996 and 1999 and remained stable after that. There were no relevant incidence differences between the sexes. The overall prevalence of type 1 diabetes in The Netherlands during 2009-2011 was 143.6 (95% confidence interval 141.1-146.2) per 100,000 children and was similar for boys and girls.
The incidence of type 1 diabetes in children in The Netherlands almost doubled between 1978-1980 and 2010-2011, but the incidence in children under five years appeared to stablise between 1996 and 1999. There were no statistical differences between the sexes. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.
[Show abstract][Hide abstract] ABSTRACT: Describe the incidence, prevalence and survival of patients needing renal replacement therapy (RRT) for end-stage renal disease (ESRD) due to diabetes mellitus (DM)-related glomerulosclerosis or nephropathy (diabetic nephropathy, DN) in the Netherlands.
Using the national registry for RRT (RENINE-registry), data of all Dutch individuals initiating RRT for ESRD and having DN as primary diagnosis in the period 2000-2012 were obtained.
Observational study in the Netherlands.
Patients with ESRD needing RRT for DN.
Age and gender adjusted incidence and prevalence of RRT for DN in the period 2000-2012. In addition, trends in time and patient's survival were examined.
The prevalence of DM in the general population increased from approximately 466 000 in 2000 to 815 000 in 2011. The number of individuals who started RRT with DN as primary diagnosis was 17.4 per million population (pmp) in 2000 and 19.1 pmp in 2012, with an annual percentage change (APC) of 0.8% (95% CI -0.4 to 2.0). For RRT due to type 1 DN, the incidence decreased from 7.3 to 3.5 pmp (APC -4.8%, 95% CI -6.5 to -3.1) while it increased for type 2 DN from 10.1 to 15.6 pmp (APC 3.1%, 95% CI 1.3 to 4.8). After 2009, the prevalence of RRT for DN remained stable (APC 1.0%, 95% CI -0.4 to 2.5). Compared to the period 2000-2004, patients initiating RRT and dialysis in 2005-2009 had better survival, HRs 0.8 (95% CI 0.7 to 0.8) and 0.8 (95% CI 0.7 to 0.9), respectively, while survival after kidney transplantation remained stable, HR 0.8, 95% CI 0.5 to 1.1).
Over the last decade, the incidence of RRT for DN was stable, with a decrease in RRT due to type 1 DN and an increase due to type 2 DN, while survival increased.
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
BMJ Open 01/2015; 5(1):e005624. DOI:10.1136/bmjopen-2014-005624 · 2.06 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background
Previous studies have shown that the carpal tunnel syndrome seems to occur more frequently in patients with diabetes mellitus and might be associated with the duration of diabetes mellitus, microvascular complications and degree of glycaemic control. Primary aim was to determine if type 2 diabetes can be identified as a risk factor for carpal tunnel syndrome after adjusting for possible confounders. Furthermore, the influence of duration of diabetes mellitus, microvascular complications and glycaemic control on the development of carpal tunnel syndrome was investigated.
Retrospective, case–control study using data from electronic patient charts from the Isala (Zwolle, the Netherlands). All patients diagnosed with carpal tunnel syndrome in the period from January 2011 to July 2012 were included and compared with a control group of herniated nucleus pulposus patients.
A total of 997 patients with carpal tunnel syndrome and 594 controls were included. Prevalence of type 2 diabetes was 11.5% in the carpal tunnel syndrome group versus 7.2% in the control group (Odds Ratio 1.67 (95% confidence interval 1.16-2.41)). In multivariate analyses adjusting for gender, age and body mass index, type 2 diabetes was not associated with carpal tunnel syndrome (OR 0.99 (95% CI 0.66-1.47)). No differences in duration of diabetes mellitus, microvascular complications or glycaemic control between groups were detected.
Although type 2 diabetes was more frequently diagnosed among patients with carpal tunnel syndrome, it could not be identified as an independent risk factor.
[Show abstract][Hide abstract] ABSTRACT: Aims: Continuous intraperitoneal insulin infusion (CIPII) is a last-resort treatment option for patients with type 1 diabetes mellitus (T1DM) who fail to reach adequate glycaemic control with subcutaneous (SC) insulin therapy. Aim was to compare the long-term effects of CIPII and SC insulin therapy among patients with T1DM in poor glycaemic control. Methods: Patients in which CIPII was initiated in 2006 were compared with a control group of T1DM patients who continued SC therapy. Linear mixed models were used to calculate differences between the baseline (2006) and final (2013) measurements within and between groups. Results: A total of 95 patients of which 21 were using CIPII and 74 using SC insulin were included. Within the CIPII group, the number of hypoglycaemic episodes decreased with -5 (95% CI -8 to -3) per 2 weeks while it remained stable among SC patients. Over time, only the number of hypoglycaemic episodes decreased more with CIPII as compared to SC insulin treatment (difference: -6 (95% CI -9 to -4)). There were no differences between treatment groups regarding clinical parameters and quality of life scores over time. Pump or catheter dysfunction led to ketoacidosis in 6 patients: 2 using CIPII and 4 SC insulin. Conclusions: After 7 years of follow-up, there is a persistent decline of hypoglycaemic events among CIPII treated T1DM patients. Besides less hypoglycaemic episodes with CIPII therapy, there are no differences between long-term CIPII and SC insulin therapy.
Diabetes Research and Clinical Practice 09/2014; 106(2). DOI:10.1016/j.diabres.2014.08.018 · 2.54 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: IMPORTANCE Device-guided breathing (DGB) is recommended by the American Heart Association for its blood pressure-lowering effects. Most previous studies that showed beneficial effects on blood pressure had low methodological quality and only investigated short-term blood pressure effects. OBJECTIVE To assess the efficacy of DGB on blood pressure in a meta-analysis of individual patient data from blinded, randomized controlled trials with an active control group. DATA SOURCES MEDLINE, EMBASE, clinicaltrials.gov, and the Cochrane Library. STUDY SELECTION Included were randomized studies of at least 4 weeks' duration, with a single-or double-blind design and an active control group. Bias was assessed with the Cochrane risk of bias tool, and analyses were performed with linear mixed models. DATA EXTRACTION AND SYNTHESIS Articles were searched in MEDLINE (using PubMed), EMBASE, and the Cochrane Library. MAIN OUTCOMES AND MEASURES Office blood pressure. RESULTS From the 15 selected abstracts, 5 studies were suitable for inclusion. Individual patient data from 2 of 5 studies were not provided. The effect of DGB on office systolic blood pressure compared with music therapy or a sham device was 2.2 mm Hg (95% CI, -2.7 to 7.0) in favor of the control group; DGB did not significantly lower office diastolic blood pressure (0.2 mm Hg [95% CI, -2.8 to 3.1] in favor of DGB). CONCLUSIONS AND RELEVANCE All trials included in the analysis had a short follow-up period; therefore, no recommendations could be made regarding hypertension treatment. Treatment with DGB did not significantly lower office blood pressure compared with a sham procedure or music therapy.
JAMA Internal Medicine 09/2014; 174(11). DOI:10.1001/jamainternmed.2014.4336 · 13.25 Impact Factor