Aim
To conduct a systematic review and meta‐analysis to evaluate the effect of carbohydrate restriction on glycaemic control in Type 2 diabetes.
Methods
We searched Medline, EMBASE and CINAHL for the ...period between 1976 and April 2018. We included randomized controlled trials comparing carbohydrate restriction with a control diet which aimed to maintain or increase carbohydrate intake, and that reported HbA1c as an outcome and reported the amount of carbohydrate consumed during or at the end of the study, with outcomes reported at ≥3 months.
Results
We identified 1402 randomized controlled trials, 25 of which met the inclusion criteria, incorporating 2132 participants for the main outcome. Definitions of low carbohydrate varied among the studies. The pooled effect estimate from meta‐analysis was a weighted mean difference of –0.09% 95% CI –0.27, 0.08 (P = 0.30); I2 72% (P <0.001), suggesting no effect on HbA1c of restricting the quantity of carbohydrate. A subgroup analysis of diets containing 50–130 g carbohydrate resulted in a pooled effect estimate of –0.49% 95% CI –0.75, –0.23 (P <0.001); I2 0% (P = 0.56), suggesting a clinically and statistically significant effect on HbA1c in favour of low‐carbohydrate diets in studies of ≤6 months’ duration.
Conclusions
There was no overall pooled effect on HbA1c in favour of restricting carbohydrate; however, restriction of carbohydrate to 50–130 g per day had beneficial effects on HbA1c in trials up to 6 months. Future randomized controlled trials should be of >12 months’ duration, assess pre‐study carbohydrate intake, use recognized definitions of low‐carbohydrate diets and examine reasons for non‐adherence to prescribed diets in greater detail.
What's new?
A large number of trials and systematic reviews have obtained conflicting results regarding the effect of restricting carbohydrate on glycaemic control.
The present study includes analysis of trials reporting adherence to carbohydrate‐restricted diets, showing this has no material impact on the outcome and bringing the evidence up to date by including more recent trials.
Clinicians should inform people with Type 2 diabetes that there are a number of effective dietary approaches for improving glycaemic control, which may include restricting carbohydrate to 50–130 g per day.
Background Short-term targeted treatment can potentially prevent fall asthma exacerbations while limiting therapy exposure. Objective We sought to compare (1) omalizumab with placebo and (2) ...omalizumab with an inhaled corticosteroid (ICS) boost with regard to fall exacerbation rates when initiated 4 to 6 weeks before return to school. Methods A 3-arm, randomized, double-blind, double placebo-controlled, multicenter clinical trial was conducted among inner-city asthmatic children aged 6 to 17 years with 1 or more recent exacerbations ( clincaltrials.gov # NCT01430403 ). Guidelines-based therapy was continued over a 4- to 9-month run-in phase and a 4-month intervention phase. In a subset the effects of omalizumab on IFN-α responses to rhinovirus in PBMCs were examined. Results Before the falls of 2012 and 2013, 727 children were enrolled, 513 were randomized, and 478 were analyzed. The fall exacerbation rate was significantly lower in the omalizumab versus placebo arms (11.3% vs 21.0%; odds ratio OR, 0.48; 95% CI, 0.25-0.92), but there was no significant difference between omalizumab and ICS boost (8.4% vs 11.1%; OR, 0.73; 95% CI, 0.33-1.64). In a prespecified subgroup analysis, among participants with an exacerbation during the run-in phase, omalizumab was significantly more efficacious than both placebo (6.4% vs 36.3%; OR, 0.12; 95% CI, 0.02-0.64) and ICS boost (2.0% vs 27.8%; OR, 0.05; 95% CI, 0.002-0.98). Omalizumab improved IFN-α responses to rhinovirus, and within the omalizumab group, greater IFN-α increases were associated with fewer exacerbations (OR, 0.14; 95% CI, 0.01-0.88). Adverse events were rare and similar among arms. Conclusions Adding omalizumab before return to school to ongoing guidelines-based care among inner-city youth reduces fall asthma exacerbations, particularly among those with a recent exacerbation.
Image-based brachytherapy is increasingly used for gynecologic malignancies. We report early outcomes of magnetic resonance imaging (MRI)-guided brachytherapy.
Consecutive patient cases with FIGO ...stage IB1 to IVA cervical cancer treated at a single institution were retrospectively reviewed. All patients received concurrent cisplatin with external beam radiation therapy along with interdigitated high-dose-rate intracavitary brachytherapy. Computed tomography or MRI was completed after each application, the latter acquired for at least 1 fraction. High-risk clinical target volume (HRCTV) and organs at risk were identified by Groupe Européen de Curiethérapie and European SocieTy for Radiotherapy and Oncology guidelines. Doses were converted to equivalent 2-Gy doses (EQD2) with planned HRCTV doses of 75 to 85 Gy.
From 2007 to 2013, 128 patients, median 52 years of age, were treated. Predominant characteristics included stage IIB disease (58.6%) with a median tumor size of 5 cm, squamous histology (82.8%), and no radiographic nodal involvement (53.1%). Most patients (67.2%) received intensity modulated radiation therapy (IMRT) at a median dose of 45 Gy, followed by a median brachytherapy dose of 27.5 Gy (range, 25-30 Gy) in 5 fractions. At a median follow up of 24.4 months (range, 2.1-77.2 months), estimated 2-year local control, disease-free survival, and cancer-specific survival rates were 91.6%, 81.8%, and 87.6%, respectively. Predictors of local failure included adenocarcinoma histology (P<.01) and clinical response at 3 months (P<.01). Among the adenocarcinoma subset, receiving HRCTV D90 EQD2 ≥84 Gy was associated with improved local control (2-year local control rate 100% vs 54.5%, P=.03). Grade 3 or greater gastrointestinal or genitourinary late toxicity occurred at a 2-year actuarial rate of 0.9%.
This study constitutes one of the largest reported series of MRI-guided brachytherapy in North America, demonstrating excellent local control with acceptable morbidity. Dose escalation may be warranted when feasible for adenocarcinomas to offset the risk of local failure.
Sedentary behaviour is a public health concern that requires surveillance and epidemiological research. For such large scale studies, self-report tools are a pragmatic measurement solution. A large ...number of self-report tools are currently in use, but few have been validated against an objective measure of sedentary time and there is no comparative information between tools to guide choice or to enable comparison between studies. The aim of this study was to provide a systematic comparison, generalisable to all tools, of the validity of self-report measures of sedentary time against a gold standard sedentary time objective monitor.
Cross sectional data from three cohorts (N = 700) were used in this validation study. Eighteen self-report measures of sedentary time, based on the TAxonomy of Self-report SB Tools (TASST) framework, were compared against an objective measure of postural sitting (activPAL) to provide information, generalizable to all existing tools, on agreement and precision using Bland-Altman statistics, on criterion validity using Pearson correlation, and on data loss.
All self-report measures showed poor accuracy compared with the objective measure of sedentary time, with very wide limits of agreement and poor precision (random error > 2.5 h). Most tools under-reported total sedentary time and demonstrated low correlations with objective data. The type of assessment used by the tool, whether direct, proxy, or a composite measure, influenced the measurement characteristics. Proxy measures (TV time) and single item direct measures using a visual analogue scale to assess the proportion of the day spent sitting, showed the best combination of precision and data loss. The recall period (e.g. previous week) had little influence on measurement characteristics.
Self-report measures of sedentary time result in large bias, poor precision and low correlation with an objective measure of sedentary time. Choice of tool depends on the research context, design and question. Choice can be guided by this systematic comparative validation and, in the case of population surveillance, it recommends to use a visual analog scale and a 7 day recall period. Comparison between studies and improving population estimates of average sedentary time, is possible with the comparative correction factors provided.
Background In the nontransplant setting, acute kidney injury (AKI) may lead to chronic kidney disease (CKD) and end-stage renal disease, but the epidemiology of AKI in transplant recipients has not ...been characterized. The purpose of this study was to determine the incidence and consequences of AKI in kidney transplant recipients outside the peritransplant period and unrelated to acute rejection. Study Design Retrospective longitudinal cohort study. Setting & Participants 27,232 adult Medicare-insured transplant recipients with transplant survival of 6 months or longer in the US Renal Data System in 1995-2000. Predictors International Classification of Diseases, Ninth Revision, Clinical Modification ( ICD-9-CM ) hospital discharge diagnostic codes were used to identify AKI during the first 3 posttransplant years. Outcomes Transplant loss from any cause, mortality (death with a functioning transplant), and death-censored transplant loss. Measurements Estimated glomerular filtration rate calculated by the MDRD (Modification of Diet in Renal Disease) Study equation 6 months posttransplant. Results 3,066 (11.3%) patients had 4,181 hospitalizations with AKI, of which 14.8% required dialysis therapy. The incidence of AKI more than doubled during the study, and AKI was more frequent in patients with lower levels of transplant function. AKI was associated independently with increased risk of transplant loss from any cause (HR, 2.74; 95% CI, 2.56-2.92), death with a functioning transplant (HR, 2.36; 95% CI, 2.14-2.60), and death-censored transplant loss (HR, 3.17; 95% CI, 2.91-3.46). However, AKI-associated risks paradoxically were higher in patients with earlier CKD stage. Limitations Because of the limited sensitivity of ICD-9-CM codes for non–dialysis-requiring AKI events, the overall incidence of AKI likely is underestimated in this study. Conclusions We conclude that AKI is increasingly common and associated with transplant failure and death. Later CKD stage increases the risk of AKI, but AKI-associated risks of transplant failure were greater in those with higher levels of kidney function (earlier CKD stage).
In this paper, we present results from the weak-lensing shape measurement GRavitational lEnsing Accuracy Testing 2010 (GREAT10) Galaxy Challenge. This marks an order of magnitude step change in the ...level of scrutiny employed in weak-lensing shape measurement analysis. We provide descriptions of each method tested and include 10 evaluation metrics over 24 simulation branches.
GREAT10 was the first shape measurement challenge to include variable fields; both the shear field and the point spread function (PSF) vary across the images in a realistic manner. The variable fields enable a variety of metrics that are inaccessible to constant shear simulations, including a direct measure of the impact of shape measurement inaccuracies, and the impact of PSF size and ellipticity, on the shear power spectrum. To assess the impact of shape measurement bias for cosmic shear, we present a general pseudo-C
ℓ formalism that propagates spatially varying systematics in cosmic shear through to power spectrum estimates. We also show how one-point estimators of bias can be extracted from variable shear simulations.
The GREAT10 Galaxy Challenge received 95 submissions and saw a factor of 3 improvement in the accuracy achieved by other shape measurement methods. The best methods achieve sub-per cent average biases. We find a strong dependence on accuracy as a function of signal-to-noise ratio, and indications of a weak dependence on galaxy type and size. Some requirements for the most ambitious cosmic shear experiments are met above a signal-to-noise ratio of 20. These results have the caveat that the simulated PSF was a ground-based PSF. Our results are a snapshot of the accuracy of current shape measurement methods and are a benchmark upon which improvement can be brought. This provides a foundation for a better understanding of the strengths and limitations of shape measurement methods.
Background. Anal cancer is one of the most common cancers affecting individuals infected with human immunodeficiency virus (HIV), although few have evaluated rates separately for men who have sex ...with men (MSM), other men, and women. There are also conflicting data regarding calendar trends. Methods. In a study involving 13 cohorts from North America with follow-up between 1996 and 2007, we compared anal cancer incidence rates among 34 189 HIV-infected (55% MSM, 19% other men, 26% women) and 114 260 HIV-uninfected individuals (90% men). Results. Among men, the unadjusted anal cancer incidence rates per 100 000 person-years were 131 for HIV-infected MSM, 46 for other HIV-infected men, and 2 for HIV-uninfected men, corresponding to demographically adjusted rate ratios (RRs) of 80.3 (95% confidence interval CI, 42.7—151.1) for HIV-infected MSM and 26.7 (95% CI, 11.5—61.7) for other HIV-infected men compared with HIV-uninfected men. HIV-infected women had an anal cancer rate of 30/100 000 person-years, and no cases were observed for HIV-uninfected women. In a multivariable Poisson regression model, among HIV-infected individuals, the risk was higher for MSM compared with other men (RR, 3.3; 95% CI, 1.8—6.0), but no difference was observed comparing women with other men (RR, 1.0; 95% CI, 0.5—2.2). In comparison with the period 2000—2003, HIV-infected individuals had an adjusted RR of 0.5 (95% CI, .3—.9) in 1996—1999 and 0.9 (95% CI, .6—1.2) in 2004—2007. Conclusions. Anal cancer rates were substantially higher for HIV-infected MSM, other men, and women compared with HIV-uninfected individuals, suggesting a need for universal prevention efforts. Rates increased after the early antiretroviral therapy era and then plateaued.
We report the detection of a single burst from the first-discovered repeating fast radio burst (FRB) source, FRB 121102, with the Canadian Hydrogen Intensity Mapping Experiment (CHIME) telescope, ...which operates in the frequency band 400-800 MHz. The detected burst occurred on 2018 November 19 and its emission extends down to at least 600 MHz, the lowest frequency detection of this source yet. The burst, detected with a significance of 23.7 , has fluence 12 3 Jy ms and shows complex time and frequency morphology. The 34 ms width of the burst is the largest seen for this object at any frequency. We find evidence of subburst structure that drifts downward in frequency at a rate of −3.9 0.2 MHz ms−1. Our best fit tentatively suggests a dispersion measure of 563.6 0.5 pc cm−3, which is 1% higher than previously measured values. We set an upper limit on the scattering time at 500 MHz of 9.6 ms, which is consistent with expectations from the extrapolation from higher-frequency data. We have exposure to the position of FRB 121102 for a total of 11.3 hr within the FWHM of the synthesized beams at 600 MHz from 2018 July 25 to 2019 February 25. We estimate on the basis of this single event an average burst rate for FRB 121102 of 0.1-10 per day in the 400-800 MHz band for a median fluence threshold of 7 Jy ms in the stated time interval.
We report a case of chronic traumatic paraplegia in which epidural electrical stimulation (EES) of the lumbosacral spinal cord enabled (1) volitional control of task-specific muscle activity, (2) ...volitional control of rhythmic muscle activity to produce steplike movements while side-lying, (3) independent standing, and (4) while in a vertical position with body weight partially supported, voluntary control of steplike movements and rhythmic muscle activity. This is the first time that the application of EES enabled all of these tasks in the same patient within the first 2 weeks (8 stimulation sessions total) of EES therapy.
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