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Take a look at a selection of our recent media coverage:

Semaglutide significantly reduces risk of type 2 diabetes in obese patients

28th September 2022

Semaglutide 2.4 mg given weekly with diet and exercise reduced the 10-year risk of type 2 diabetes in obese patients compared to placebo

Semaglutide 2.4 mg given as a weekly subcutaneous injection to patients with obesity but without type 2 diabetes in combination with diet and exercise, led to a significant reduction in their 10-year risk of developing type 2 diabetes compared to placebo according to the findings of a study by US researchers presented at the 58th European Association for the Study of Diabetes (EASD) 2022.

Obesity is a major public health challenge and several lines of evidence from both observational and clinical studies over the past 30 years have clearly demonstrated a strong link between visceral and ectopic fat and the development of a clinical syndrome characterised by atherogenic dyslipidaemia, hyper-insulinaemia/glucose intolerance, hypertension, atherosclerosis and adverse cardiac remodelling and heart failure. Although diet and exercise are recommended as a first step to reduce obesity, some evidence shows that among obese individuals who have lost weight, multiple compensatory mechanisms encouraging weight gain, can persist for at least 12 months after weight loss. Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue that is approved as an adjunct to diet and exercise in adults with insufficiently controlled type 2 diabetes mellitus. However, the STEP 1 trial showed that semaglutide at a dose of 2.4 mg weekly in combination with a lifestyle intervention could also result in sustained, clinically relevant reductions in body weight among patients with a body mass index (BMI) > 30. Moreover, in a further trial (STEP 4), researchers examined the effect of continuing vs withdrawing treatment with semaglutide on weight loss maintenance and showed that after a 20-week run-in period, maintaining treatment with semaglutide 2.4 mg once weekly, compared with switching to placebo resulted in continued weight loss over the following 48 weeks.

With clear evidence that semaglutide could lead to weight loss, whether this also reduced an individual’s risk of developing type 2 diabetes was unclear and was the objective of the study presented at the EASD meeting. Researchers used data from both STEP 1 and 4, to assess an individual’s 10-year risk of developing type 2 diabetes. The team used the cardiometabolic disease staging tool which uses three unmodifiable factors (age, sex, and race) and five modifiable factors (BMI, blood pressure, glucose level, high-density lipoprotein (HDL) cholesterol, and triglycerides) to predict an individual’s percentage risk of developing the disease over the next 10 years.

Semaglutide and 10-year diabetes risk

For the STEP 1 trial, the 10-year risk scores of developing T2D after 68 weeks of treatment decreased from 18.2% to 7.1% with semaglutide 2.4 mg, and 17.8% to 15.6% with placebo (p < 0.01). In STEP 4, most of the risk score reduction with semaglutide 2.4 mg occurred during weeks 0-20, from 20.6% to 11.4% but the risk score decreased further to 7.7% with continued semaglutide 2.4 mg during weeks 20-68 but increased to 15.4% after a switch to placebo (p < 0.01). In addition, data from STEP 4 showed that weight loss was 11% for weeks 0 – 20 and a further 9% with continued semaglutide 2.4 mg vs a 6%
regain with switch to placebo for weeks 20 – 68.

The authors concluded that treatment with semaglutide 2.4 mg reduces the 10-year risk of T2D by
~60% adding that sustained treatment was required to maintain this benefit but suggested that semaglutide 2.4 mg could help prevent type 2 diabetes in people with obesity.

Citation
Garvey TW et al. Semaglutide 2.4 mg reduces the 10-year type 2 diabetes risk in people with overweight or obesity Abstract 562. EASD 2022

Early time-restricted eating effective for weight loss in obese patients

11th August 2022

Early time-restricted eating combined with a reduced energy intake is more effective for weight loss than a 12 hour or longer eating pattern

Early time-restricted eating (eTRE) in combination with a reduction of energy intake is more effective for weight loss in comparison to a similar reduced intake of energy but where feeding occurs over a period of 12 hours or more according to the findings of a randomised trial by US researchers.

Caloric restriction whilst maintaining adequate nutritional intake, can extend both lifespan and delay the onset of age-related disorders in monkeys, indicating that this approach would be of value to human health. Moreover, in a randomised trial in humans, a 6-month period of calorie restriction (roughly 12% over 2 years) concluded that 2 biomarkers of longevity (fasting insulin level and body temperature) are decreased by prolonged calorie restriction in humans. An alternative strategy to calorie restriction is intermittent fasting (IF) and has become popular in recent years as a means of weight loss although the benefits of IF compared to calorie restriction are still uncertain. Evidence from a 50-week randomised trial, suggested that there was no appreciable difference in outcomes between IF and continuous calorie restriction. But what if individuals practiced a form of IF and simultaneously reduced their calorie intake? Might this approach be easier to implement and increase weight loss among obese individuals? This was the objective of the current study in which researchers examined the value of ‘early time-restricted eating’ (between 7 am and 3 pm) in combination with a reduced energy diet. This approach was compared to one in which there was a similar reduced energy intake but where food intake was spread over a 12-hour or longer period. Participants were equally randomised to either eTRE or the control group and which the researchers said was designed to mimic typical US median meal timing habits. In both groups, participants reduced their energy intake by 500 kcal/day below their measured resting energy expenditure, measured by indirect calorimetry. In addition, all participants received counselling from a registered dietitian and were asked to exercise for 75 to 150 minutes per week.

The co-primary outcomes were weight and fat loss, whereas secondary outcomes were fasting cardiometabolic risk factors e.g., blood pressure, fasting glucose, insulin levels.

Early time-restricted eating and weight loss

A total of 90 participants with a mean age of 43 years (80% female) and mean body mass index (BMI) or 39.6, were recruited and equally randomised to eTRE or control arms.

The eTRE group lost a mean of 6.3 kg compared to a mean of 4 kg for the control group and this mean difference of 2.3 kg was statistically significant (p = 0.002). In contrast, there was no significant difference in fat loss (mean difference = -1.4, p = 0.09). Furthermore, there were no differences in trunk or visceral fat or waist circumferences. While eTRE did not significantly reduce systolic blood pressure, the difference in mean diastolic pressure was significant (mean difference = – 4 mmHg, p = 0.04).

The authors concluded that eTRE was more effective as a weight loss strategy in conjunction with energy restriction compared to eating over a 12-hour window.

Citation
Jamshed H et al. Effectiveness of Early Time-Restricted Eating for Weight Loss, Fat Loss, and Cardiometabolic Health in Adults With Obesity: A Randomized Clinical Trial JAMA Intern Med 2022

Vaccination protects overweight and obese against severe COVID-19 and death

12th July 2022

Overweight and obese patients protection against severe disease and death when infected with COVID-19 is similar to those of a healthy weight

Both overweight and obese patients who have been vaccinated against COVID-19 have a similar degree of protection against severe disease and death as those of a healthy weight according to a large, population-based cohort study by researchers from the UK and Spain.

Since the start of the COVID-19 pandemic, considerable evidence has emerged indicating how obesity is a risk factor for more severe disease. For example, in a 2020 systematic review of 24 retrospective cohort studies, the odds ratio for intensive care unit admission for obese patients was 1.21 and higher still, for invasive mechanical ventilation (OR = 2.05). With the widespread introduction of COVID-19 vaccines, it is necessary to understand how overweight and obese patients respond to vaccination. This is especially important in light of evidence showing that despite generating a robust serological response, vaccinated obese adults are twice as likely to develop influenza and influenza-like illness compared with healthy weight adults. Furthermore, another study found that CD4(+) and CD8(+) T cells from overweight and obese individuals expressed lower levels of CD69, CD28, CD40 ligand, and interleukin-12 receptor, compared with healthy weight and which may contribute to the increased morbidity and mortality from H1N1 influenza A virus.

Despite the concern that overweight and obese patients may not produce a satisfactory immune response to vaccination, there are limited data on the association between body mass index (BMI) and COVID-19 vaccine effectiveness and the risk of severe COVID-19 outcomes after vaccination. Using the QResearch database, in the present study, researchers used an anonymised patient data set derived from over 1,700 general practices in England and collated demographic and clinical data. They linked this information with the NHS Digital database of positive COVID-19 tests, hospital episode statistics and death certificates. Included patients were adults and who had a BMI measurement recorded in their medical records and which were then categorised as underweight (BMI < 18.5), healthy weight (BMI 18.5 – 24.9), overweight (BMI 25 – 29.9) and obese (BMI > 30). They examined vaccine effectiveness across the different weight categories and set the main outcomes of interest as hospitalisation and death.

Overweight and obese patients and severe COVID-19 outcomes

A total of 9,171,524 individuals with a mean age of 52 years (47% male) were included in the analysis. During the period of study there were 566,461 positive tests for COVID-19, 32,808 COVID-19-related hospital admissions and 14,389 COVID-related deaths. Across the whole cohort, 19.2% were unvaccinated, 3.1% had at least one dose, 52.6% two doses and 25% three doses. Uptake of two or three vaccine doses was more than 80% among those deemed overweight or obese.

At least 14 days after the second vaccine dose, the likelihood (based on the odds ratio, OR) of a COVID-19-related hospitalisation (compared to those who were unvaccinated) was lowest for those who were either overweight (OR = 0.32, 95% CI 0.30 – 0.34) or obese (OR = 0.32, 95% CI 0.30 – 0.34) which was similar to those with a healthy weight (OR = 0.34). Among those who were underweight, there was a slightly higher risk of hospitalisation (OR = 0.51, 95% CI 0.41 – 0.63). However, the odds of hospitalisation after a third vaccine dose were significantly less and similar for each of the different BMI categories.

In relation to mortality, there was a similar pattern 14 days after the second dose, e.g., underweight individuals (OR = 0.60), healthy weight (OR = 0.30) with overweight and obese individuals having the same odds ratio (OR = 0.26). Mortality was also significantly lower after the third dose though there was more uncertainty given the lower number of cases.

The authors concluded that both overweight and obese patients appear to be equally well protected against severe COVID-19 outcomes as those of a healthy weight although vaccine effectiveness appeared to be less in those classed as underweight.

Citation
Piernas C et al. Associations of BMI with COVID-19 vaccine uptake, vaccine effectiveness, and risk of severe COVID-19 outcomes after vaccination in England: a population-based cohort study Lancet Diabetes Endocrinol 2022

Study suggests adult asthmatics at higher risk of developing obesity

9th May 2022

Among adult asthmatics who have longstanding disease and using oral corticosteroids, there appears to be an increased risk of developing obesity

Adult asthmatics and, in particular individuals who have had the disease for a long period of time and use oral corticosteroids, have been found to have a small, but significantly increased risk of developing obesity compared with those without the disease. This was the main finding of a study by researchers from the Division of Pulmonary Medicine, Department of Medicine, Faculty of Medicine & Dentistry, University of Alberta, Canada.

Data for 2016 shows that more than 1.9 billion adults were overweight and, of these, over 650 million were obese. It has also been found that while obese people report more incident asthma, it is not clear whether this represents reactivation of previously diagnosed asthma or the onset of new cases. Nevertheless, data for children are much clearer with one study finding that among asthmatics, there is a 51% increased risk of developing obesity during childhood and adolescence compared to children without asthma.

Since the relationship between asthma and obesity in adults remains unclear, in the present study, the researchers sought to investigate the occurrence of obesity due to asthma among participants in the European Community Respiratory Health Survey (ECRHS) over 2 periods of 10 years, which were labelled ECRHS-II and ECRHS-III. ECRHS-I began in 1990 and recruited over 18,000 participants and had two follow-up periods at approximately 10-year intervals. The researchers excluded those with a diagnosis of obesity at baseline and then classified individuals as either having ‘no asthma’ or ‘current asthma’. Additional data on the duration of asthma, treatments used and the presence or absence of atopy (based on serum levels of IgE to common allergens) was also collected.

Adult asthmatics and the risk of obesity

The research team included 7576 participants with a baseline mean age of 34 years (51.5% female) in ECRHS I-II and 4976 participants (mean age 42, 51.3% female) in ECRHS-II-III.

The risk of developing obesity was higher among asthmatics compared to those without the condition (relative risk, RR = 1.22, 95% CI 1.07 – 1.38). Furthermore, this risk was also higher among those without atopy (RR = 1.47), for individuals who had asthma for longer than 20 years (RR = 1.32, 95% CI 1.10 – 1.59) and for those using oral corticosteroids (RR = 1.99, 95% CI 1.26 – 3.15). In subgroup analysis, smokers also had a higher risk of becoming obese compared to non-smokers (RR = 1.46).

The authors concluded that adult asthmatics were at a greater risk of developing obesity in later life, especially those with longstanding disease, who were using oral corticosteroids and had non-atopic asthma.

Citation
Moitra S et al. Long-term effect of asthma on the development of obesity among adults: an international cohort study, ECRHS Thorax 2022

Tirzepatide use leads to over 20% weight loss in obese patients

Study data showing how tirzepatide reduced body weight in obese or overweight patients by more than a fifth after 72 weeks has been released

In a press release from the manufacturer, Lilly, headline results from a trial have shown that use of the anti-diabetic agent tirzepatide 15 mg for 72 weeks in a Phase III randomised trial, led to a 22.5% reduction in weight among those classed as either overweight and obese patients.

Tirzepatide is described as a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that is in development for the treatment of type 2 diabetes. Early data from studies in mice suggested that chronic administration of the drug, could reduce both food intake and body weight and how it was suitable for administration on a weekly basis. Moreover, studies in humans have shown the drug to be an effective treatment for patients with type 2 diabetes. For example, in randomised, double-blind phase 3 trial in patients with type 2 diabetes, tirzepatide was found to produce significantly better efficacy with regard to glucose control and weight loss than the comparator, dulaglutide. In addition, in an open-label, 40-week trial, in 1879 patients with type 2 diabetes, tirzepatide was found to be non-inferior and superior to semaglutide with respect to the mean change in the glycated haemoglobin level from baseline to 40 weeks.

Tirzepatide and weight loss

Although the evidence points to tirzepatide being an effective treatment for type 2 diabetes, for the current press release, the manufacturer focused on the results from the SURMOUNT-1 trial in which the drug was administered to overweight or obese patients without type 2 diabetes, with a mean baseline body weight of 105 kg.

The SURMOUNT-1 trial randomised 2,539 participants in a 1:1:1:1 ratio to different doses of tirzepatide (5mg, 10mg or 15mg) or placebo and the treatment was given as an adjunct to a reduced-calorie diet combined with increased physical activity. All of the participants receiving tirzepatide were started at a dose of tirzepatide 2.5mg once-weekly and then increased in a step-wise approach at four-week intervals to their final randomised maintenance doses. The co-primary endpoints of the study were to show that tirzepatide 10mg and/or 15 mg were superior to placebo in the percentage reduction in body weight compared with baseline and the percentage of participants who achieved a ≥5% body weight reduction at 72 weeks, again compared with placebo.

At the end of the trial, among those taking tirzepatide, average weight reductions were 16.0% (5mg), 21.4% (10mg) and 22.5% (15mg), compared with 2.4% in the placebo arm. Furthermore, the proportion of participants achieving a body weight reduction of ≥5% were 85% (5mg), 89% (10mg), 91% (15mg), and 35% (placebo).

The press release also demonstrates how tirzepatide was well tolerated with the most commonly reported adverse events being gastrointestinal-related and generally mild to moderate in severity, usually occurring during the dose escalation period. Adverse effects included nausea, diarrhoea, vomiting and constipation which were more frequently experienced compared to placebo. In fact, the overall treatment discontinuation rates due to adverse events were 14.3% (5mg), 16.4% (10mg), 15.1% (15mg) and 26.4% (placebo).

The company is also currently undertaking further trials in overweight patients with type 2 diabetes.

Sleep extension decreases energy expenditure and might help in weight loss programmes

10th February 2022

Sleep extension by as little as an extra hour reduces energy intake and could be incorporated into weight loss or obesity prevention programmes

Sleep extension by as little as one hour per night leads a reduction in energy intake and could form part of a weight loss or obesity prevention programme. This is according to a study by researchers from the Department of Medicine, The University of Chicago, US.

Obesity is a major public health concern, with one US study finding that in 2017–2018, the age adjusted prevalence of obesity in adults was 42.4%, and that there were no significant differences between the sexes. The increase in levels of obesity have been driven over the past three decades by a substantial increase in total energy intake and some evidence suggests that short sleep duration significantly increased the risk of obesity. The authors of this analysis added that compared to a 7 hour sleep duration per day, the risk of obesity increases by 9% for each hour decrease in sleep duration. Additionally, another review concluded that short sleep duration appears independently associated with weight gain and sleep restriction results in a significant increase in subjective hunger and in particular, restricting sleep to a duration of ≤5.5 hours/day increases daily energy intake.

However, many of the above studies were undertaken in dedicated sleep laboratories and it is therefore unclear to what extent the findings are generalisable to a real-life setting. For the present study, the US team sought to determine whether a sleep extension intervention in overweight, adults aged 21 to 40 years of age, who habitually achieved less than 6.5 hours sleep per night, could positively impact on energy balance and body weight. These individuals were initially screened for two weeks to determine their sleeping habits and then randomised to either a two-week sleep extension group, which involved an individualised sleep hygiene counselling session, designed to extent their sleep time to 8.5 hours/night, or two-week continued habitual sleep (the control group).

Individuals sleep-wake patterns were continuously monitored at home using a wrist actigraph over a 4-week period. Total energy expenditure was measured with doubly labelled water and every two weeks the change in energy stores was estimated from daily measurements of home weights and changes in body composition. The primary outcome was the change in energy intake from baseline.

Sleep extension and changes in energy intake

A total of 80 individuals with a mean age of 29.8 years (51.3% male) were randomised to the sleep extension or control groups. Among those assigned to the sleep extension arm, energy expenditure decreased significantly compared to the control group (-270.4 kcal/day, 95% CI -393.4 to -147.4, p < 0.001). Furthermore, there was a significantly different increase of energy intake from baseline in the control group (114.9 kcal/day).

Among those in the sleep extension group, the duration of sleep increased by approximately 1.2 hours/night (95% CI 1 to 1.4 hours, p < 0.01). When comparing both groups, for each 1-hour increase in sleep duration, there was an associated decrease in energy intake of approximately 162 kcal/day. Interestingly, the sleep extension group experienced a mean decrease in weight of -0.87 kg (95% CI -1.29 to -0.35, p = 0.001) compared to a weight increase in the controlled group of 0.39 kg.

The authors concluded that sleep extension reduced energy intake and suggested that improving and maintaining healthy sleep duration in the longer term could form part of an obesity prevention or weight loss program.

Citation
Tasali E et al. Effect of Sleep Extension on Objectively Assessed Energy Intake Among Adults With Overweight in Real-life Settings: A Randomized Clinical Trial JAMA Intern Med 2020

Sustained weight loss reduces risk of adverse cardiometabolic outcomes

3rd November 2021

Sustained weight loss over 6 years delays the onset of the adverse cardiometabolic outcomes type 2 diabetes, hypertension and hyperlipidaemia.

A sustained weight loss over several years, not only delays but reduces the overall incidence of adverse cardiometabolic outcomes including type 2 diabetes, hypertension and hyperlipidaemia. This was the conclusion of a retrospective analysis of nearly 50,0000 patients by researchers from Geisinger Health, Pennsylvania, US. According to the world Health Organisation (WHO), worldwide levels of obesity have tripled since 1975 and in 2016, more than 1.9 billion adults, 18 years and older, were overweight and of these over 650 million were obese. However, obesity is not limited to adults and WHO data also suggests that in 2020, 39 million children under the age of 5 were overweight or obese. In a 2017 article, the World Obesity Federation issued a position statement, arguing that obesity should be perceived as a chronic relapsing disease process in which an abundance of food, coupled with low levels of physical activity, various environmental factors and genetic susceptibilities, all interact to create a positive energy balance. Increased weight and obesity are linked to a higher incidence of cardiovascular diseases, musculoskeletal disorders and some cancers. Nevertheless, even a 5% sustained weight loss improves metabolic function in multiple organs although longer term maintenance of weight loss is challenging, with one meta-analysis of 29 weight loss studies concluding that “weight-loss maintenance 4 or 5 y after a structured weight-loss program averages 3.0 kg or 23% of initial weight loss.”

However, what remains unclear is the impact of sustained weight loss on the development of cardiometabolic diseases and for the present study, researchers turned to in data held the Geisinger Health System, which represents one of the largest healthcare organisations in the US. The team looked at adult patients for whom there were 3 or more electronic health record entries for weight measurements within a 2-year period. Individuals were then categorised as obesity maintainers (OM), i.e., those with a history of obesity and who maintained their weight within 3% of their baseline levels; weight loss rebounders (WLRs) who had lost > 5% body weight but had regained > 20% of their 1-year loss and finally weight loss maintainers (WLMs), who again loss > 5% of their body weight but maintained > 80% of their 1-year weight loss. The outcomes of interest were the development of type 2 diabetes, hypertension and hyperlipidaemia, all of which were extracted from the electronic health records. In their analysis, researchers adjusted for several factors such as age, gender and various co-morbidities.

Findings

The sample contained 49,327 individuals with a mean age of 50.4 years (60.2% female) with the majority classed as OM (the reference group) and the whole sample were followed-up for a mean period of 6.6 years. After 5 years, 11.1% of the OM, 9.1% of the WLR and 6.5% of the WLM had developed type 2 diabetes and those in the sustained weight loss group (WLM) had a 33% lower risk of developing incident type 2 diabetes (adjusted hazard ratio, aHR = 0.68, 95% CI 0.62 – 0.74, p < 0.0001). Similarly, the WLM had a reduced risk of developing hypertension (aHR = 0.72) and hyperlipidaemia (aHR = 0.86).

Based on these findings, the authors concluded that sustained weight loss was associated with a delayed onset of cardiometabolic diseases and that these associations are enhanced in those with the greatest weight loss.

Citation

Bailey-Davis L et al. Impact of Sustained Weight Loss on Cardiometabolic Outcomes. Am J Cardiol 2021

Intermittent very-low calorie diet achieves remission in nearly a third of type 2 diabetics

14th September 2021

An intermittent very-low calorie diet either two or four days per week achieved similar levels of remission in patients with type 2 diabetes.

Type 2 diabetes is characterised by a progressive loss of beta-cell function in the pancreas and recent data have shown that intermittent very-low calorie diets (IVLCD) can result in a marked metabolic improvement in as little as seven days. However, maintenance of a IVLCD can be difficult over time and one study found that after 12 months of intensive weight management, less than half (46%) of patients were in diabetic remission. Among obese patients, the use of intermittent very-low calorie diets (500 – 600 kcal/d) for three days each week, was found to be an effective weight loss strategy. Moreover, a similar strategy, using a IVLCD for two days per week has been successfully used in patients with type 2 diabetes.

Nevertheless, the optimal IVLCD for those with type 2 diabetes remains to be determined and this led a team from the Division of Endocrinology and Metabolism, Chulalongkorn University, Thailand, to compare different protocols of IVLCD among those with type 2 diabetes. The team undertook a randomised controlled trial that compared the impact of a two-day/week and a four-day/week IVLCD versus a control group, on glycaemic control and diabetes remission in a group of obese type 2 patients. Included patients were between 30 and 60 years of age and with type 2 diabetes diagnosed within the last 10 years. Enrolled patients had a body mass index (BMI) > 23 and a HbA1c level between 6.5 and 10%. Individuals were then randomised to either the two, or four-days/week IVLCD arm or a control group (in which they received a normal diet of 1500 – 2000 kcal/day). The IVLCD groups had an intake of 600 kcal/day on either two or four days each week. Patients were assessed every two weeks for the duration of the study (20 weeks). The primary outcome of interest was a change in glycaemic control (glucose and HbA1c) and rate of diabetes remission, defined as a HbA1c of < 6.5% in the absence of pharmacological therapy at the end of the study.

Findings
A total of 40 participants with a mean age range of 49.6 years (73% female) and a mean BMI of 30.1 were included in the final analysis. The mean duration of diabetes was 4.9 years and the baseline HbA1c was 7.4% with 90.6% of participants prescribed metformin. There were significant reductions compared to baseline in HbA1c levels in both IVLCD groups with 64% of those in the 4-day/week and 29% in the 2-day/week achieving levels < 6.5%. Furthermore, diabetes remission was achieved in 29% of patients in both the 2-day and 4-day groups. In addition, complete withdrawal of all diabetic medication occurred in 64% of the 2 day/week group and 86% of those in the 4 day/week group. The mean reduction in BMI in the 4 day/week group was 3.6 and 2.1 kg in the 2 day/week group although this difference between the two groups was not-significant.

The authors concluded that given the similar level of diabetes remission in both groups, either would be beneficial to obese type 2 diabetic patients.

Citation
UmPhonsathien M et al. Effects of intermittent very-low calorie diet on glycemic control and cardiovascular risk factors in obese patients with type 2 diabetes mellitus: A randomised controlled trial. J Diabetes Investig 2021

Higher BMI linked to increased risk of second cancer in breast cancer patients

25th May 2021

Breast cancer survivors have a greater risk of developing a subsequent cancer but whether this is affected by obesity is unclear.

Cancer of the breast is the most common form of cancer in women although with an early diagnosis, the 5-year survival prognosis ranges from 86 to 99%. Nevertheless, women who survive breast cancer have a 17% increased risk for a second cancer compared to the general population. One factor known to be associated with cancer is obesity with one US study estimating that 40% of all cancer diagnoses occurred in people who were either overweight or obese. However, while much attention has been paid to the effect of obesity on the development of an initial cancer, far less is known about how obesity impacts on the development of a second cancer. As a result, a team from Kaiser Permanente, Denver, US, sought to examine the association between body mass index (BMI) and a second cancer among women who survived invasive breast cancer. Data were extracted from an electronic database and a surveillance tumour registry which provided information on the incidence and type of secondary cancers that occurred. Height and weight measurements within two years prior through one year after the date of the initial breast cancer diagnosis were used to calculate the BMI. All women included had surgery as part of their initial breast cancer and had no evidence of a second cancer one year later. The study outcomes included all second cancers, cancers for which there was a known association with obesity (e.g., oesophageal adenocarcinoma), and ER-positive second breast cancers.

Findings
A total of 6481 women were included in the analysis with a mean age of 60.2 years, of whom 33.4% were classed as overweight or obese (33.8%) at the time of their initial breast cancer diagnosis. During a median follow-up of 88 months, 822 (12.7%) women developed a second cancer, of which 508 (61.8%) were obesity-related and 333 (40.5%) were breast cancer, the majority of which (69.4%) were ER-positive. The authors calculated that every 5 unit increase in BMI was associated with a 7% increased risk of developing any second cancer (relative risk, RR = 1.07, 95% CL 1.01–1.14), a 13% increased for an obesity-related cancer and by 15% for a second ER-positive breast cancer.

The authors calculated that the risk of a second cancer was increased by 5% for every 5 unit increase in BMI. They concluded that these data had important public health implications given the prevalence of obesity and underscored the need for effective preventative strategies.

Citation
Feigelson HS et al. Body Mass Index and Risk of Second Cancer Among Women with Breast Cancer. J Natl Cancer Inst 2021

Bimagrumab leads to significant fat loss in obese, type 2 diabetic patients

18th January 2021

Evidence from a study in healthy volunteers showing that a single, intravenous dose of bimagrumab reduced body fat, prompted researchers to examine the value of this approach in obese, type 2 diabetic patients.

The monoclonal antibody bimagrumab binds to and blocks the activity of the activin type II receptor (ActRII), promoting skeletal muscle hypertrophy and reducing body fat mass. Given this potential action, researchers from Pennington Biomedical Research Centre, Louisiana State University, in the US, hypothesised that the drug might represent a beneficial approach to the management of obese, type 2 diabetic patients. They recruited type 2 diabetes aged between 18 and 75 years with a glycated haemoglobin (HbA1C) of 6.5 to 10%, a body mass index (BMI) of 28 to 40 and a weight of between 65 and 140kg. All patients were prescribed either metformin (as mono-therapy), dipeptidyl peptidase 4 (DPP4) inhibitors, (again as mono-therapy) or a combination of both drugs, although a small number were not prescribed any diabetic medicines. These treatments were permitted because of their weight neutral effect. Eligible participants were randomised 1:1 to either Bimagrumab (10mg/kg to a maximum of 1200mg in 5% dextrose) or placebo (5% dextrose) via 30-minute intravenous infusion every 4 weeks for a total of 48 weeks and both clinicians and patients were blinded to allocation. The primary endpoint was a change from baseline to week 48 in total fat mass (FM) which was measured by dual energy X-ray absorptiometry. Secondary endpoints included change in diabetic status (HbA1C), body weight, BMI and both HOMA2 and the Matsuda index which are measures of insulin sensitivity.

Findings
A total of 75 patients were randomised to either bimagrumab (37) or placebo (38). The mean age of those assigned to bimagrumab was 60.7 years (62.2% female). At week 48, total FM decreased by a mean of 7.49 kg in the bimagrumab group vs 0.18 kg in the placebo group (p < 0.01). Similarly, there were significant reductions in BMI (2.19 vs 0.28, p < 0.001), body weight (5.90 kg vs 0.79 (p < 0.01) and HbA1C levels (0.76 vs 0.04, p < 0.05). Interestingly, the bimagrumab group also saw a significant increase in lean muscle mass compared to the placebo group (1.70 kg vs 0.4 kg, p < 0.001). However, there were no significant changes to either measure of insulin sensitivity or in use of anti-diabetic medication. Commenting on their findings, the authors noted that treatment with bimagrumab led to a small increase in lean muscle mass which is a beneficial effect given that muscle loss is typically observed when type 2 diabetes adopt a low-calorie diet.

They concluded that inhibition of ActRII may provide a novel pathway for the management of excess body fat and metabolic disturbances as seen in type 2 diabetics.

Citation
Heymsfield SB et al. Effect of Bimagrumab vs placebo on body fat mass among adults with type 2 diabetes and obesity. A phase 2 randomised clinical trial. JAMA Netw Open 2021