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3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial
Liraglutide 3·0 mg was shown to reduce bodyweight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE programme. In the 3-year assessment of the SCALE Obesity and Prediabetes trial we aimed to evaluate the proportion of individuals with prediabetes who were diagnosed with type 2 diabetes.
In this randomised, double-blind, placebo-controlled trial, adults with prediabetes and a body-mass index of at least 30 kg/m2, or at least 27 kg/m2 with comorbidities, were randomised 2:1, using a telephone or web-based system, to once-daily subcutaneous liraglutide 3·0 mg or matched placebo, as an adjunct to a reduced-calorie diet and increased physical activity. Time to diabetes onset by 160 weeks was the primary outcome, evaluated in all randomised treated individuals with at least one post-baseline assessment. The trial was conducted at 191 clinical research sites in 27 countries and is registered with ClinicalTrials.gov, number NCT01272219.
The study ran between June 1, 2011, and March 2, 2015. We randomly assigned 2254 patients to receive liraglutide (n=1505) or placebo (n=749). 1128 (50%) participants completed the study up to week 160, after withdrawal of 714 (47%) participants in the liraglutide group and 412 (55%) participants in the placebo group. By week 160, 26 (2%) of 1472 individuals in the liraglutide group versus 46 (6%) of 738 in the placebo group were diagnosed with diabetes while on treatment. The mean time from randomisation to diagnosis was 99 (SD 47) weeks for the 26 individuals in the liraglutide group versus 87 (47) weeks for the 46 individuals in the placebo group. Taking the different diagnosis frequencies between the treatment groups into account, the time to onset of diabetes over 160 weeks among all randomised individuals was 2·7 times longer with liraglutide than with placebo (95% CI 1·9 to 3·9, p<0·0001), corresponding with a hazard ratio of 0·21 (95% CI 0·13–0·34). Liraglutide induced greater weight loss than placebo at week 160 (–6·1 [SD 7·3] vs −1·9% [6·3]; estimated treatment difference −4·3%, 95% CI −4·9 to −3·7, p<0·0001). Serious adverse events were reported by 227 (15%) of 1501 randomised treated individuals in the liraglutide group versus 96 (13%) of 747 individuals in the placebo group.
In this trial, we provide results for 3 years of treatment, with the limitation that withdrawn individuals were not followed up after discontinuation. Liraglutide 3·0 mg might provide health benefits in terms of reduced risk of diabetes in individuals with obesity and prediabetes.
Novo Nordisk, Denmark.
Journal Article
Suspended bodyweight training : workout programs for total-body fitness
Offers instruction on how to use a suspeneded bodyweight trainer to build muscle and lose weight.
Book
Effect of intermittent compared to continuous energy restriction on weight loss and weight maintenance after 12 months in healthy overweight or obese adults
Background and ObjectiveIntermittent energy restriction (IER) is an alternative to continuous energy restriction (CER) for weight loss. There are few long-term trials comparing efficacy of these methods. The objective was to compare the effects of CER to two forms of IER; a week-on-week-off energy restriction and a 5:2 program, during which participants restricted their energy intake severely for 2 days and ate as usual for 5 days, on weight loss, body composition, blood lipids, and glucose.Subjects and MethodsA one-year randomized parallel trial was conducted at the University of South Australia, Adelaide, Australia. Participants were 332 overweight and obese adults, ages 18–72 years, who were randomized to 1 of 3 groups: CER (4200 kJ/day for women and 5040 kJ/day for men), week-on-week-off energy restriction (alternating between the same energy restriction as the continuous group for one week and one week of habitual diet), or 5:2 (2100 kJ/day on modified fast days each week for women and 2520 kJ/day for men, the 2 days of energy restriction could be consecutive or non-consecutive). Primary outcome was weight loss, and secondary outcomes were changes in body composition, blood lipids, and glucose.ResultsFor the 146 individuals who completed the study (124 female, 22 male, mean BMI 33 kg/m2) mean weight loss, and body fat loss at 12 months was similar in the three intervention groups, −6.6 kg for CER, −5.1 kg for the week-on, week-off and −5.0 kg for 5:2 (p = 0.2 time by diet). Discontinuation rates were not different (p = 0.4). HDL-cholesterol rose (7%) and triglycerides decreased (13%) at 12 months with no differences between groups. No changes were seen for fasting glucose or LDL-cholesterol.Discussion and ConclusionThe two forms of IER were not statistically different for weight loss, body composition, and cardiometabolic risk factors compared to CER.
Journal Article
GDF15 mediates the effects of metformin on body weight and energy balance
Metformin, the world’s most prescribed anti-diabetic drug, is also effective in preventing type 2 diabetes in people at high risk
1
,
2
. More than 60% of this effect is attributable to the ability of metformin to lower body weight in a sustained manner
3
. The molecular mechanisms by which metformin lowers body weight are unknown. Here we show—in two independent randomized controlled clinical trials—that metformin increases circulating levels of the peptide hormone growth/differentiation factor 15 (GDF15), which has been shown to reduce food intake and lower body weight through a brain-stem-restricted receptor. In wild-type mice, oral metformin increased circulating GDF15, with
GDF15
expression increasing predominantly in the distal intestine and the kidney. Metformin prevented weight gain in response to a high-fat diet in wild-type mice but not in mice lacking GDF15 or its receptor GDNF family receptor α-like (GFRAL). In obese mice on a high-fat diet, the effects of metformin to reduce body weight were reversed by a GFRAL-antagonist antibody. Metformin had effects on both energy intake and energy expenditure that were dependent on GDF15, but retained its ability to lower circulating glucose levels in the absence of GDF15 activity. In summary, metformin elevates circulating levels of GDF15, which is necessary to obtain its beneficial effects on energy balance and body weight, major contributors to its action as a chemopreventive agent.
In mouse studies, metformin treatment results in increased secretion of growth/differentiation factor 15 (GDF15), which prevents weight gain in response to high-fat diet, and GDF15-independent lowering of circulating blood glucose.
Journal Article
Weight change across adulthood in relation to all cause and cause specific mortality: prospective cohort study
AbstractObjectiveTo investigate the association between weight changes across adulthood and mortality.DesignProspective cohort study.SettingUS National Health and Nutrition Examination Survey (NHANES) 1988-94 and 1999-2014.Participants36 051 people aged 40 years or over with measured body weight and height at baseline and recalled weight at young adulthood (25 years old) and middle adulthood (10 years before baseline).Main outcome measuresAll cause and cause specific mortality from baseline until 31 December 2015.ResultsDuring a mean follow-up of 12.3 years, 10 500 deaths occurred. Compared with participants who remained at normal weight, those moving from the non-obese to obese category between young and middle adulthood had a 22% (hazard ratio 1.22, 95% confidence interval 1.11 to 1.33) and 49% (1.49, 1.21 to 1.83) higher risk of all cause mortality and heart disease mortality, respectively. Changing from obese to non-obese body mass index over this period was not significantly associated with mortality risk. An obese to non-obese weight change pattern from middle to late adulthood was associated with increased risk of all cause mortality (1.30, 1.16 to 1.45) and heart disease mortality (1.48, 1.14 to 1.92), whereas moving from the non-obese to obese category over this period was not significantly associated with mortality risk. Maintaining obesity across adulthood was consistently associated with increased risk of all cause mortality; the hazard ratio was 1.72 (1.52 to 1.95) from young to middle adulthood, 1.61 (1.41 to 1.84) from young to late adulthood, and 1.20 (1.09 to 1.32) from middle to late adulthood. Maximum overweight had a very modest or null association with mortality across adulthood. No significant associations were found between various weight change patterns and cancer mortality.ConclusionsStable obesity across adulthood, weight gain from young to middle adulthood, and weight loss from middle to late adulthood were associated with increased risks of mortality. The findings imply that maintaining normal weight across adulthood, especially preventing weight gain in early adulthood, is important for preventing premature deaths in later life.
Journal Article
The effect of GLP-1 receptor agonist use on negative evaluations of women with higher and lower body weight
Background
GLP-1 receptor agonists (GLP-1 RAs) have dramatically altered obesity treatment. Media reports suggest that GLP-1 RAs users often report feeling judged for taking a “shortcut” to lose weight, which may be related to negative stereotypes toward people with larger bodies. Media reports also describe negative attitudes about lean people who take GLP-1 RAs to enhance their appearance. The present research used a 2 × 2 experimental design to test the effects of GLP-1 RA use and body size on attitudes and egocentric impressions.
Subjects/Methods
A sample of 357 U.S. adults (
M
age
= 37.8, SD = 13) were randomly assigned to read about a woman, who either was lean or had obesity, and who lost 15% of her body weight either with diet/exercise or a GLP-1 RA. Participants answered questions measuring endorsement of negative weight-related stereotypes and egocentric attitudes toward the woman, as well as beliefs that she took a shortcut to lose weight and beliefs that biogenetic factors caused her baseline weight.
Results
Negative evaluations and egocentric impressions were stronger toward a woman who lost weight with a GLP-1 RA compared to diet/exercise. Losing weight with a GLP-1 RA led to stronger negative evaluations through higher weight loss shortcut beliefs irrespective of body size. Losing weight with a GLP-1 RA also led to higher egocentric impressions through higher shortcut beliefs, and this effect was stronger for a lean woman. Finally, losing weight with a GLP-1 RA led to more negative evaluations through stronger endorsement of biogenetic causal beliefs for a lean woman only.
Conclusions
This timely study provides evidence that people with larger and smaller bodies alike are at-risk for being judged for using GLP-1 RAs due to beliefs that these medications are a shortcut. Findings also demonstrate novel reactions related to egotism when weight loss is achieved with pharmacological interventions.
Pre-registration and data
osf.io/xme4w.
Journal Article