Aims
To determine the impact of gender on glycaemic control and hypoglycaemia in insulin‐naïve patients with type 2 diabetes (T2DM).
Methods
Data were pooled from six randomized clinical trials of ...insulin glargine or NPH insulin in insulin‐naïve, inadequately controlled patients. Female n = 1251; mean glycated haemoglobin (HbA1c) level 8.99%, age 56.91 years, diabetes duration 9.84 years and male patients (n = 1349; mean HbA1c 8.9%, age 57.47 years, diabetes duration 10.13 years) were started on and treated with insulin glargine or NPH insulin for 24–36 weeks. HbA1c and fasting blood glucose levels, percent achieving HbA1c target of <7% and insulin dose change were recorded.
Results
For both men and women, HbA1c levels were significantly reduced over time (p < 0.001); a significantly greater HbA1c reduction was observed in men than in women (−1.36 vs. −1.22; p = 0.002). Significantly fewer women achieved target HbA1c of <7% (p < 0.001). At the study end, women had a significantly higher insulin dose/kg than men (0.47 vs. 0.42 U/kg; p < 0.001). The incidence rates of severe and severe nocturnal hypoglycaemia were significantly higher in women (3.28% vs. 1.85%; p < 0.05 and 2.24% vs. 0.59%; p < 0.001, respectively). Women were more likely to experience severe hypoglycaemia odds ratio (OR) 1.80; 95% confidence interval (CI) 1.08, 3.00; p = 0.02 and severe nocturnal hypoglycaemia (OR: 3.80; 95% CI 1.72, 8.42; p = 0.001).
Conclusions
These observations confirm studies that found a smaller improvement in HbA1c and greater hypoglycaemia in women during insulin treatment. Physicians should be aware of the need to determine and closely monitor dosing, particularly in women, to optimize the balance between glycaemic control and hypoglycaemia risk.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
A consensus meeting was held in Vienna on September 8–9, 2013, to discuss diagnostic and therapeutic challenges surrounding development of diabetes mellitus after transplantation. The International ...Expert Panel comprised 24 transplant nephrologists, surgeons, diabetologists and clinical scientists, which met with the aim to review previous guidelines in light of emerging clinical data and research. Recommendations from the consensus discussions are provided in this article. Although the meeting was kidney‐centric, reflecting the expertise present, these recommendations are likely to be relevant to other solid organ transplant recipients. Our recommendations include: terminology revision from new‐onset diabetes after transplantation to posttransplantation diabetes mellitus (PTDM), exclusion of transient posttransplant hyperglycemia from PTDM diagnosis, expansion of screening strategies (incorporating postprandial glucose and HbA1c) and opinion‐based guidance regarding pharmacological therapy in light of recent clinical evidence. Future research in the field was discussed with the aim of establishing collaborative working groups to address unresolved questions. These recommendations are opinion‐based and intended to serve as a template for planned guidelines update, based on systematic and graded literature review, on the diagnosis and management of PTDM.
This article summarizes the opinion‐based recommendations from an international consensus meeting of experts in the field of posttransplantation diabetes mellitus, with the aim to review previous guidelines in light of emerging clinical data and to guide the direction of future research.
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BFBNIB, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background Clinicians and health professionals are increasingly challenged to understand and consider the different health needs of women and men. The increase of gender awareness and the expanding ...science of gender medicine will affect more and more clinical practice. This review addresses gender‐specific aspects in metabolic disorders and related complications, which represent an increasing burden of this century and a great challenge to public health.
Design There is increasing evidence of gender‐related differences in risk factors, clinical manifestation and sequelae of obesity and diabetes and increasing knowledge that prevention, detection and therapy of illness affect men and women differently.
Results Some gender‐specific aspects, especially regarding cardiovascular disease, have been studied in more detail, but for many complications sex‐related analyses of the results of both clinical trials and basic science are still missing or disregarded. Impaired glucose and lipid metabolism as well as dysregulation of energy balance and body fat distribution have a great impact on overall health via neuroendocrine changes and inflammatory pathways and deteriorate the course of many diseases with particular harm for women. Metabolic diseases dramatically affect life of men and women from infancy up to old age and are a major challenge for women during pregnancy. Great impact is attached to the intrauterine period and the lifelong implications of fetal programming.
Conclusions Initiation of prospective studies on the impact of gender as primary outcome and investigation of gender‐related pathophysiological mechanisms of chronic diseases will help to improve patient care and to implement evidence‐based gender‐specific prevention programs and clinical recommendations in future.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK
Obesity and associated metabolic disorders have become highly prevalent diseases worldwide, and the human gut microbiota, due to its influence on host energy metabolism, has been attributed an ...important role therein. This pilot study explores host-microbiota relationships in men and women affected by various types of glucose metabolism disorder. Among 20 individuals aged 58 to 71 years with either normal glucose tolerance, prediabetes, or type 2 diabetes mellitus the gut bacterial communities were compared based on barcoded 454 sequencing of 16S rRNA genes amplified from stool samples. We found that specific microbiota groups were relatively enriched or reduced in different metabolic states. Further, positive or negative associations with clinical manifestations of metabolic disease suggest that these organisms indicate and possibly contribute to metabolic impairment or health. For instance, a higher prevalence of Erysipelotrichaceae and Lachnospiraceae was found associated with metabolic disorders, and the Holdemania and Blautia genera correlated with clinical indicators of an impaired lipid and glucose metabolism. The Bacteroidetes and groups therein, by contrast, displayed inverse relationships with metabolic disease parameters and were found relatively enriched in participants not diagnosed with metabolic syndrome or obesity. Further, the prevalence of specific Clostridia and Rikenellaceae members also pointed towards a healthier metabolic state. Links with diet as an intermediate factor included positive and negative associations of Lachnospiraceae with relative consumption rates of fat and carbohydrates, respectively, and positive associations of Turicibacteraceae with the consumption of protein. Identifying critical roles of major gut microbiota components in metabolic disorders has important translational implications regarding the prevention and treatment of metabolic diseases by means of preventing or reversing dysbiosis and by controlling exacerbating diet and life style factors particularly in sensitive population groups.
Aims
To describe the metabolic phenotypes of early gestational diabetes mellitus and their association with adverse pregnancy outcomes.
Methods
We performed a post hoc analysis using data from the ...Vitamin D And Lifestyle Intervention for gestational diabetes prevention (DALI) trial conducted across nine European countries (2012–2014). In women with a BMI ≥29 kg/m2, insulin resistance and secretion were estimated from the oral glucose tolerance test values performed before 20 weeks, using homeostatic model assessment of insulin resistance and Stumvoll first‐phase indices, respectively. Women with early gestational diabetes, defined by the International Association of Diabetes and Pregnancy Study Groups criteria, were classified into three groups: GDM‐R (above‐median insulin resistance alone), GDM‐S (below‐median insulin secretion alone), and GDM‐B (combination of both) and the few remaining women were excluded.
Results
Compared with women in the normal glucose tolerance group (n = 651), women in the GDM‐R group (n = 143) had higher fasting and post‐load glucose values and insulin levels, with a greater risk of having large‐for‐gestational age babies adjusted odds ratio 3.30 (95% CI 1.50–7.50) and caesarean section adjusted odds ratio 2.30 (95% CI 1.20–4.40). Women in the GDM‐S (n = 37) and GDM‐B (n = 56) groups had comparable pregnancy outcomes with those in the normal glucose tolerance group.
Conclusions
In overweight and obese women with early gestational diabetes, higher degree of insulin resistance alone was more likely to be associated with adverse pregnancy outcomes than lower insulin secretion alone or a combination of both.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
Aim
There is firm evidence of a relation between type 2 diabetes (T2DM) and increased risks of cancer at various sites, but it is still unclear how different antihyperglycaemic therapies modify ...site‐specific cancer risks. The aim of this study was to provide a complete characterization of all possible associations between individual T2DM therapies, statin use and site‐specific cancers in the Austrian population.
Methods
Medical claims data of 1 847 051 patients with hospital stays during 2006–2007 were used to estimate age‐ and sex‐dependent co‐occurrences of site‐specific cancer diagnoses and treatment with specific glucose‐lowering drugs and statins.
Results
Patients treated with insulin or insulin secretagogues showed up to ninefold increased risks for cancers of the colon males only (m), liver (m), pancreas, lung (m) and brain (m), as well as a strongly decreased risk for prostate cancer (m). In patients taking statins, the risks were generally decreased, with a greater risk reduction in patients not receiving antihyperglycaemic therapies. The strongest effects were observed for use of insulin and pancreatic cancer m: OR 4.5, 95% CI: 3.1–6.6; females (f): OR 4.2, 95% CI: 2.5–7.1, sulfonylureas (m: OR 2.8, 95% CI: 1.7–4.6; f: OR 3.0, 95% CI: 2.1–4.2) or glitazones and skin cancer (f: OR 0.54, 95% CI: 0.36–0.80), as well as metformin and cancer of the prostate (m: OR 0.82, 95% CI: 0.75–0.91) and corpus uteri (f: OR 1.7, 95% CI: 1.4–2.0) and non‐Hodgkin's lymphoma (f: OR 0.76, 95% CI: 0.64–0.91).
Conclusions
The use of statins offsets insulin‐related cancer risks in patients with diabetes independently of sex and age. Overall, our data support the hyperglycaemia–cancer hypothesis. A reduction in endogenous or exogenous hyperinsulinaemia may be beneficial for cancer prevention. Therefore, insulin‐sparing and insulin‐sensitizing drugs should be the preferred treatment choices.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
•Funding decisions can benefit from multi-attribute utility theory.•Value Focused Thinking can reinforce the strategic alignment of funding programs.•We suggest that agency personnel should be in the ...role of decision-makers.•We suggest that attributes of value functions should be based on factual information.•Factual assessments provided by reviewers serve as data for program evaluation.
Research funding programs are a policy instrument utilized by governments to influence the innovation process. They are usually elaborated, launched and managed by research funding agencies. In order to select the most adequate research projects, agencies often rely on the peer review process.
This paper introduces a methodology to support funding decisions based on the peer review process. The methodology involves the use of a multicriteria decision model to support the assessment, evaluation, prioritization and selection of applications, under a multi-step decision-making process, which fits into a strategic management cycle within the agency. The Multiattribute Value Theory, being considered under a Value Focused Thinking approach, provides a basis for the construction of the multicriteria decision model. The good practices in peer review and also a logical framework for program management are considered by the methodology.
A pilot study, presented in the paper, involved a retrospective implementation of a peer review process in the context of a program launched by the Ministry for Science, Technology, Innovations and Communications and the National Council of Technological and Scientific Development, in Brazil. The methodology allowed a clear distinction of roles. The agency staff in the role of decision-makers was responsible for making value judgments on behalf of the agency. The experts, in the role of committee members and ad hoc reviewers, contributed with their expertise by providing objective assessments. Such assessments served as a basis for evaluating the applications, characterizing the possible portfolios, and can be considered as data in future program evaluation studies.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objective
We aimed to explore: (i) the association of sedentary time (ST) and physical activity (PA) during pregnancy with the placental expression of genes related to glucose and lipid metabolism in ...pregnant women who are obese; (ii) maternal metabolic factors mediating changes in these placental transcripts; and (iii) cord blood markers related to the mRNAs mediating neonatal adiposity.
Design
Multicentre randomised controlled trial.
Setting
Hospitals in nine European countries.
Population
A cohort of 112 pregnant women with placental tissue.
Methods
Both ST and moderate‐to‐vigorous PA (MVPA) levels were measured objectively using accelerometry at three time periods during pregnancy.
Main outcome measures
Placental mRNAs (FATP2, FATP3, FABP4, GLUT1 and PPAR‐γ) were measured with NanoString technology. Maternal and fetal metabolic markers and neonatal adiposity were assessed.
Results
Longer periods of ST, especially in early to middle pregnancy, was associated with lower placental FATP2 and FATP3 expression (P < 0.05), whereas MVPA at baseline was inversely associated with GLUT1 mRNA (P = 0.02). Although placental FATP2 and FATP3 expression were regulated by the insulin–glucose axis (P < 0.05), no maternal metabolic marker mediated the association of ST/MVPA with placental mRNAs (P > 0.05). Additionally, placental FATP2 expression was inversely associated with cord blood triglycerides and free fatty acids (FFAs; P < 0.01). No cord blood marker mediated neonatal adiposity except for cord blood leptin, which mediated the effects of PPAR‐γ on neonatal sum of skinfolds (P < 0.05).
Conclusions
In early to middle pregnancy, ST is associated with the expression of placental genes linked to lipid transport. PA is hardly related to transporter mRNAs. Strategies aimed at reducing sedentary behaviour during pregnancy could modulate placental gene expression, which may help to prevent unfavourable fetal and maternal pregnancy outcomes.
Tweetable
Reducing sedentary behaviour in pregnancy might modulate placental expression of genes related to lipid metabolism in women who are obese.
Tweetable
Reducing sedentary behaviour in pregnancy might modulate placental expression of genes related to lipid metabolism in women who are obese.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
Long‐lasting Pc5 ultralow frequency (ULF) waves spanning the dayside and extending from L ∼ 5.5 into the polar cap region were observed by conjugate ground magnetometers. Observations from MMS ...satellites in the magnetosphere and magnetometers on the ground confirmed that the ULF waves on closed field lines were due to fundamental toroidal standing Alfvén waves. Monochromatic waves at lower latitudes tended to maximize their power away from noon in both the morning and afternoon sectors, while more broadband waves at higher latitudes tended to have a wave power maximum near noon. The wave power distribution and MMS satellite observations during the magnetopause crossing indicate surface waves on a Kelvin‐Helmholtz (KH) unstable magnetopause coupled with standing Alfvén waves. The more turbulent ion foreshock during an extended period of radial interplanetary magnetic field (IMF) likely plays an important role in providing seed perturbations for the growth of the KH waves. These results indicate that the Pc5 waves observed on closed field lines and on the open field lines of the polar cap were from the same source.
Plain Language Summary
The Earth's magnetic field lines can oscillate at ultralow frequencies (ULF: 1 mHz to 5 Hz). These natural oscillations of closed magnetic field lines, analogous to vibrations on a stretched string, are also called geomagnetic pulsations or ULF waves. ULF waves play a key role in the transfer of energy from terrestrial space to Earth's upper atmosphere. In this study, we report a long‐lasting large spatial scale ULF wave event observed by ground observatories from both hemispheres. Together with satellite measurements in space, we are able to confirm that these waves were driven by upstream turbulent structures due to the interaction between matter and electromagnetic fields emitted from the Sun and the Earth's outer atmosphere and magnetic field.
Key Points
Pc5 ULF waves were observed across the whole dayside from L ∼ 5.5 into the polar cap region, in contrast to typical conditions
Coordinated space and ground observations indicate that the waves on closed field lines were due to fundamental standing Alfvén waves
The ion foreshock during radial IMF conditions provides seed perturbations for the growth of KH waves which generate the dayside ULF waves
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
The objective was to identify candidate patient reported outcomes with potential to inform individual patient care and service development for inclusion in a digital outcome set to be collected in ...routine care, as part of an international project to enhance care outcomes for people with diabetes.
PubMed, COSMIN and COMET databases were searched. Published studies were included if they recommended patient reported outcomes that were clinically useful and/or important to people with diabetes. To aid selection decisions, recommended outcomes were considered in terms of the evidence endorsing them and their importance to people with diabetes.
Twenty-seven studies recommending 53 diabetes specific outcomes, and patient reported outcome measures, were included. The outcomes reflected the experience of living with diabetes (e.g. psychological well-being, symptom experience, health beliefs and stigma) and behaviours (e.g. self-management). Diabetes distress and self-management behaviours were most endorsed by the evidence.
The review provides a comprehensive list of candidate outcomes endorsed by international evidence and informed by existing outcome sets, and suggestions for measures.
The review offers evidence to guide clinical application. Integrated measurement of these outcomes in care settings holds enormous potential to improve provision of care and outcomes in diabetes.
•A broad range of patient reported outcomes is recommended for routine diabetes care.•Diabetes distress and self-management behaviours are most endorsed by evidence.•This review provides evidence to direct decisions about which outcomes to collect.•Validated tools are suggested for measuring each of the recommended outcomes.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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