New aid to help identify and manage patients with diabetes at increased risk of fracture

Fragility fractures are a serious yet neglected complication of both type 1 and type 2 diabetes, with increased risk of fragility fractures in people with diabetes extending across the life span.

This is a concern as, globally, the prevalence of diabetes in adults is expected to increase from almost 425 million today, to approximately 629 million by 2045. At the same time, many clinicians who treat patients with diabetes are not aware of their patients’ heightened risk of disabling and potentially life-threatening fractures.

Given this scenario, the International Osteoporosis Foundation (IOF) Bone and Diabetes Working Group has published a new expert review that summarizes key research, highlights clinical issues, and provides a helpful ‘decision-tree’ style algorithm for the identification and management of diabetic patients at increased fracture risk.

Professor Serge Ferrari, chair of the IOF Committee of Scientific Advisors and of the IOF Bone and Diabetes Working Group, stated:

“The link between diabetes and skeletal health is complex and the optimal approach to the management of bone health in patients with diabetes is not yet definitive and may change over time as findings of new clinical studies become available. This new review will inform clinicians about the current state of knowledge, and, importantly, the clear algorithm will facilitate the clinical assessment and management of fragility fracture risk in their patients according to current best practice.”

The review outlines the clinical characteristics of bone fragility in adults with diabetes, and highlights recent studies that have evaluated bone mineral density (BMD), bone microstructure and material properties, biochemical markers, and fracture prediction (FRAX). It also looks at the impact of diabetes drugs on bone, as well as the efficacy of osteoporosis treatments in these patients.

Key messages include:

  • The pathophysiology of bone fragility in diabetes is likely multifactorial.
  • FRAX and BMD T-score predict fracture risk in those with type 2 diabetes, but both require adjustment for diabetes to avoid underestimation of risk.
  • If a patient has indication for therapy based on criteria developed for non-diabetes patients, these patients should be treated with osteoporosis drugs. In the absence of established osteoporosis, these medications may be used, although with caution as the effects of these drugs in situations where bone fragility is mainly due to alterations in bone quality remain to be thoroughly evaluated.
  • Future studies should continue to evaluate the structural determinants (microstructure, material properties, etc.) of bone fragility and refine fracture prediction algorithms by including disease-specific determinants of fracture.
  • New trials will have to prospectively investigate the efficacy and safety of osteoporosis treatment in diabetics with and without low aBMD.

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Exercise shown to improve symptoms of patients with chronic kidney disease: Leicester’s Hospitals and University of Leicester lead research into CKD

Just 12 weeks of aerobic and strength-based exercise reduces symptoms and levels of fatigue in patients with chronic kidney disease, a study in Leicester has found.

The study was carried out by Leicester’s Hospitals and University of Leicester Kidney Lifestyle Team, led by Professor Alice Smith.

The researchers randomly divided 36 non-dialysis patients with chronic kidney disease into two groups. The first group completed aerobic exercises, such as walking and cycling. The second group was given strength training exercises, such as leg presses, in addition to the aerobic activities. Exercises were completed three times per week for the duration of the study. The difficulty of the exercises was increased as the patients got fitter and stronger.

Symptoms were measured using a kidney-specific symptom questionnaire developed by the team. This asks patients to rate on a scale of 0 to 5 how frequent and how much impact 11 different symptoms have on their lives.

Across both groups, the total number of symptoms was reduced by 17 per cent, with large improvements seen in fatigue, with reductions between 10 and 16 per cent. Performing aerobic exercise reduced the symptom ‘shortness of breath’ by 40 per cent, and ‘itching’ by 35 per cent.

By adding strength training exercises, participants reported an increase in ‘muscle strength and power’ by 41 per cent, as well as feeling less weak and having fewer muscle spasms and episodes of stiffness.

Dr Tom Wilkinson, from the University of Leicester’s Department of Infection, Immunity and Inflammation, said: “Patients with chronic kidney disease experience many unpleasant symptoms, including fatigue and pain. We know that — in general — exercise improves physical fitness levels and strength but until now we had little evidence that exercise also has a significant positive effect on symptoms in this patient group, as well as on their self-reported quality of life.

“We have now shown that exercise has positive benefits on patients’ reported symptoms. These include sleep problems, weakness, muscle spasms and restless legs. To maximise the health benefits, patients should undertake both aerobic and strength training exercises.”

One 80 year old female participant on the trial said: “I found that the exercise routine was brilliant, my muscles were really strong afterwards and I felt really, really good; really, really well. I felt great, actually.”

Along with improvements in physical fitness and reductions in symptoms, exercise also has other favourable benefits for patients with chronic kidney disease. These include improvements in blood pressure, cholesterol, and diabetic control.

Patients on the study were supervised in the gym at Leicester Diabetes Centre. It is advised that patients and members of the public should speak to their doctor if they are interested in getting started in exercise.

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Can radar replace stethoscopes? Procedure for touch-free monitoring of heart sounds

In conjunction with researchers at Brandenburg University of Technology (BTU) in Cottbus and the Department of Palliative Medicine at Universitätsklinikum Erlangen, electronic engineers at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) have developed a procedure for reliably detecting and diagnosing heart sounds using radar. In future, mobile radar devices could replace conventional stethoscopes and permanent touch-free monitoring of patients’ vital functions could be possible using stationary radar devices.

Along with a white coat, a stethoscope is the hallmark of doctors everywhere. Stethoscopes are used to diagnose the noises produced by the heart and lungs. Used in the conventional way, vibrations from the surface of the body are transmitted to a membrane in the chest-piece and then to the user’s eardrum where they are perceived as sounds. Acoustic stethoscopes are comparatively inexpensive and have been used reliably for several decades, but they have one drawback. The diagnosis of heart murmurs, such as the assessment of heart valve function, is carried out subjectively and is directly dependent on the experience of the doctor conducting the examination.

Radar can measure heart sounds

In a joint project funded by the Federal Ministry of Education and Research, FAU researchers at the Institute of Electronics Engineering (LTE) have now developed a procedure that could eventually replace conventional phonocardiology. Using a six-port continuous wave radar system, they measured the vibrations on the skin caused by the heartbeat. ‘In principle, we’re using a similar method to detecting speed in road traffic,’ explains Christoph Will, a doctoral candidate at LTE. ‘During this process, a radar wave is aimed at the surface of an object and reflected. If the object moves, the phase of the reflecting wave changes. This is used to calculate the strength and frequency of the movement — of the chest in our case.’ In contrast to radar systems for traffic monitoring, the biomedical radar system can detect changes in movement that measure a few micrometres, which is an important prerequisite to diagnosing even the smallest anomalies such as insufficiency, stenoses or heart valves that do not close properly.

As reliable as established measuring methods

Initial tests were very successful. The test patients were examined in various states of activity such as while resting and after sports and their heart sounds were detected. A direct comparison between the radar system and conventional standard instruments with a digital stethoscope and an electrocardiograph (ECG) showed a very high correlation. ‘While diagnosing S1, which is the first heart sound, for example, we achieved a correlation of 92 percent with the ECG,’ says Kilin Shi, who is also a doctoral candidate at LTE. ‘The correlation was 83 percent in a direct comparison of the signal shapes with the digital stethoscope. That’s absolutely reliable.’ The researchers say that the slight deviations are caused by the fact that measurements using the radar system and the reference systems cannot be carried out simultaneously on exactly the same place on the body. In addition, the radar system measures a surface area and not a single spot like the stethoscope, which is also a reason for the varying measurement values.

Touch-free and objective

The FAU researchers are optimistic that mobile radar systems could replace conventional stethoscopes in diagnosing heart function in the near future. A significant advantage offered by radar is the fact that the values are recorded digitally and are thus not subjective allowing human error to be increasingly ruled out during the diagnosis of anomalies or diseases. Using biomedical radar systems for automated prophylactic examinations for example in doctors’ waiting rooms, at work, or at home, is also feasible.

The researchers are already working on another project for monitoring the vital functions of patients who are seriously ill using stationary radar systems around the clock and without disruptive cables. ‘Touch-free and therefore stress-free measurement of vital parameters such as heart sounds has the potential to revolutionise clinical care and research, for example, in palliative medicine,’ explains Prof. Dr. Christoph Ostgathe, Head of Palliative Medicine at Universitätsklinikum Erlangen at FAU and co-author of the study. ‘For example, we could inform relatives of terminally ill patients more quickly at the beginning of the dying phase, as the radar system immediately detects any changes in patients’ health. It would also be possible to detect any painful symptoms in patients who cannot communicate’.

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Men take care of their spouses just as well as women (new research suggests)

Men respond to their spouse’s illness just as much as women do and as a result are better caregivers in later life than previous research suggests, according to a new Oxford University collaboration.

The study, published in Journals of Gerontology, Series B, is good news for our increasingly stretched adult care services, which have become more reliant on patients’ family and spouses for support. Conducted with peers from the University of Pennsylvania, the research sits in contrast to previous studies on spousal caregiving, which found that female caregivers tend to be more responsive. However, the new results reveal that men are just as responsive to a partner’s illness, as women.

Using data from the German Socio-Economic Panel Study, the research carried out by Dr Langner of Oxford University and Professor Frank Furstenberg of the University of Pennsylvania, focused on 538 couples in Germany with an average age of 69, where one of them had developed the need for spousal care, between 2001-2015, and looked at how caregivers adjusted their hours in response to the new care need: whether directly responding to their physical needs or performing errands and housework.

The findings show that men increased their care hours as much as women did, resulting in similar levels of care once their partner became ill. These similarities were particularly pronounced when a spouse was deemed severely ill, when there was little to no difference in the level of care given.

Perhaps surprisingly, when their spouse is severely ill, men also increase the time they spend on housework and errands, more than women. However, at lower levels of spousal care need — when a spouse is only slightly unwell, women still spend more time doing housework and errands than men — because they already did more housework and errands prior to the disease onset.

There were also significant differences in levels of care given, for couples where the spouse was only unofficially seen to be ‘in need of care’. However, these differences disappeared in homes where no other household help was provided, when regardless of gender, male or female, spouses stepped up to care for each other.

Dr Laura Langner, Research Fellow at Nuffield College, Oxford and ESRC Future Research Leader, said: ‘Our results suggest that gender differences in spousal caregiving in old age are not as pronounced as previously thought. Past studies had numerous limitations, which we could overcome with our data.

‘We found that, unlike many previous studies on caregiving in later life — male caregivers were just as responsive towards their partner’s onset of illness as female caregivers. This stands in sharp contrast the division of caregiving (i.e. childcare) and housework in mid-life. There could be a number of reasons for this, but a key factor may be that in later life many people retire and no longer have the responsibility of work, so are able to focus on other priorities — that their spouse may have been doing already’.

Discussing the potential future implications of the research for patients and services, she adds: ‘People are living longer, meaning that we have an increasingly dependent aging population and we face an elderly care cost problem. Reforms are likely to continue reducing more expensive institutionalised care, and increase cheaper home care. With the gender gap in life expectancy closing, and children becoming less available to care for their parents, it is likely that many more men will be called upon to care for their partners. But, our findings at least suggest that women won’t have to worry that their partners are not up to the job of caring for them, should they need to.’

The team intend to build on the findings by applying the research approach to other countries and assessing how the results compare.

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Over-the-counter drugs, dietary supplements and their effect on lab test results: Patients’ reluctance to disclose OTC drug use can lead to inaccurate test results

Over-the-counter (OTC) drugs and dietary supplements are widely used and popular, with US households spending an average of almost USD 350 annually on OTC products. In 2006 an average of EUR 67.50 was spent per person on OTC products in Germany.

The use of various OTC drugs and dietary supplements is highly prevalent in Europe and patients are often not willing to disclose this information to laboratory staff and the ordering physician as a survey published in Clinical Chemistry and Laboratory Medicine, published by De Gruyter in association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), shows.

The study reports on the results of a survey of patients in 18 European countries which shows that those taking OTC products and dietary supplements are not aware of the potential effects on laboratory test results they may have. In addition, patients do not believe that they need to disclose this use to medical and/or laboratory staff.

The study shows that dietary supplements and OTC drugs are more frequently used by middle-aged patients — especially women — with the most common being multivitamins, multiminerals, cranberry and aspirin. All of these compounds, if consumed shortly before blood sampling, may cause changes in lab test results, thus leading to interpretation difficulties and possibly incorrect diagnoses.

Although more data is needed about the frequency of the consumption of various dietary products, vitamins or OTC drugs, the authors believe that a multifaceted approach is necessary to draw attention to the issue using educational interventions which target both healthcare professionals and patients.

“We hope that our survey helps to raise awareness about this need to educate patients about the potential effect of OTC drugs and dietary supplements on lab test results, and we would encourage clinicians and lab staff to engage more with their patients and ask them direct questions about the use of various self-prescribed products,” said Professor Ana-Maria Simundic of the Sveti Duh Clinical Hospital in Zagreb, Croatia, and the corresponding author of the article.

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Discovery could lead to better treatment for leukemia

Previous research has revealed that patients with acute myeloid leukemia who also have a particular mutation in a gene called NPM1 have a higher rate of remission with chemotherapy. About one-third of leukemia patients possess this favorable mutation, but until now, how it helps improve outcomes has remained unknown.

Scientists from the University of Illinois at Chicago report on how this mutation helps improve sensitivity to chemotherapy in patients in the journal JCI Insight.

The protein coded for by the NPM1 gene affects the location and activity of another protein called FOXM1. FOXM1 activates other cancer-promoting genes and has been found to be elevated in cancer cells. The presence of FOXM1, especially at high levels, is a strong predictor of worse treatment outcomes and decreased survival in patients with cancer. When the NPM1 gene is mutated, FOXM1 can’t activate additional oncogenes, so patients with this mutation tend to respond better to chemotherapy. A drug that targets and incapacitates FOXM1 in patients without the beneficial NPM1 mutation may help improve the efficacy of chemotherapy.

Acute myeloid leukemia (AML) is a cancer of the bone marrow. In AML, stem cells that would normally differentiate into blood cells instead multiply unchecked and fail to develop into mature blood cells. Patients with AML have a high risk of death from uncontrolled infection, fatigue easily and get organ damage because they lack adequate numbers of oxygen-carrying red blood cells. They are also at high risk for dangerous bleeding because of low numbers of cells that help with blood clotting. It has been known that patients with a mutation in the NPM1 gene have a better response to standard chemotherapy, with up to 80 percent of patients being cured compared to just 40 percent for patients without the mutation.

In previous studies, researchers at UIC led by Andrei Gartel, associate professor of molecular genetics, discovered that one of the roles of the NPM protein is to stabilize FOXM1 and keep it in the nucleus where it can activate other cancer-promoting genes.

Gartel and his colleagues determined that when the NPM1 gene is mutated, FOXM1 migrates out of the nucleus and into the cell’s cytoplasm, where it can’t interact with DNA. This may explain why patients with this NPM1 mutation have a much better response to chemotherapy and are less likely to relapse.

In their current study, Gartel and his colleagues further explored the relationship between NPM1 and FOXM1 in patients with AML.

The researchers analyzed bone marrow cells taken via biopsies from 77 patients with AML and found that the presence of FOXM1 in the cells’ nuclei was a strong predictor of poor treatment outcome for individual patients.

“When we then looked in the patients’ medical records, we saw that those with FOXM1 present in the nucleus of their cancer cells had worse treatment outcomes, higher rates of chemotherapy resistance and lower survival rates compared to patients without FOXM1 present in the nucleus,” said Dr. Irum Khan, assistant professor of clinical medicine in the UIC College of Medicine and first author on the paper.

In mice engineered to overproduce FOXM1 that were caused to develop leukemia, following treatment with cytarabine, a drug commonly used to treat AML, the mice had more residual disease compared to control mice with AML and normal levels of FOXM1.

“Our finding suggests that overexpression of FOXM1 directly induces chemoresistance, which matches what we saw in our analysis of patients’ FOXM1 levels and their treatment outcomes,” said Khan.

Next, the researchers demonstrated that they could produce a therapeutic response in patient AML cells grown in the lab using a novel oral drug called ixazomib, which is approved to treat another form of cancer called multiple myeloma. In the current paper, Gartel and his colleagues show that ixazomib works in part by suppressing FOXM1.

When the patient cancer cells were treated with ixazomib plus standard chemotherapy drugs used to treat AML (cytarabine and anthracyclines) the cells showed a higher death rate compared with standard chemotherapy alone. “Ixazomib produced a synergized chemotherapeutic response when added to standard chemotherapy,” Gartel said. “We believe this is caused by ixazomib inhibiting the activity of FOXM1.”

“There is a real unmet need for new ways to get around the resistance to chemotherapy that patients who don’t have this beneficial mutation often face,” said Khan. “Drugs that suppress FOXM1 in combination with the standard treatment, such as ixazomib, should result in better outcomes, but clinical trials will ultimately be needed to prove this theory.”

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