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Physical activity, inactivity and sleep during the Diabetes Remission Clinical Trial (DiRECT).
Cassidy, S, Trenell, M, Stefanetti, RJ, Charman, SJ, Barnes, AC, Brosnahan, N, McCombie, L, Thom, G, Peters, C, Zhyzhneuskaya, S, et al
Diabetic medicine : a journal of the British Diabetic Association. 2023;40(3):e15010
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Increasing physical activity is difficult for many individuals living with obesity and diabetes. Sustained, moderate activity is likely to be valuable for weight loss maintenance. The aim of this study was to explore whether randomisation to weight loss plus maintenance in the DiRECT trial was associated with physical activity, inactivity or sleep. DiRECT was a 2-year, open-label, cluster-randomised controlled trial conducted at 49 primary care (PC) practices. PC practices were randomised (1:1) to either an evidence-based weight management programme (Counterweight Plus; intervention) or best-practice care in accordance with guidelines (control). Results showed that: - repeated low-intensity advice to increase physical activity in the DiRECT intervention group did not produce change. - those people who had long-term weight loss success with the low-energy diet had positive changes in physical activity and inactivity. - wakefulness after sleep onset decreased in the intervention group. - weight loss ≥10% was associated with both increased physical activity and sleep quality. Authors conclude that it is important to optimise long-term weight loss maintenance by developing interventions encompassing restrained food intake, together with effective but affordable physical activity/inactivity strategies.
Abstract
AIMS: As sustained weight loss is vital for achieving remission of type 2 diabetes, we explored whether randomisation to weight loss plus maintenance in the DiRECT trial was associated with physical activity, inactivity or sleep. METHODS Participants were randomised to either a dietary weight management programme or best-practice care. The weight management group were encouraged to increase daily physical activity to their sustainable maximum. Objective measurement was achieved using a wrist-worn GENEActiv accelerometer for 7 days at baseline, 12 and 24 months in both groups. RESULTS Despite average weight loss of 10 kg at 12 months in the intervention (n = 66) group, there were no differences in total physical activity or inactivity compared with the control (n = 104) at any time point. However, in our exploratory analysis, those who lost more than 10% of their baseline body weight performed on average 11 mins/day more light activity than the <10% group at 24 months (p = 0.033) and had significantly lower bouts of Inactivity30min (interaction, p = 0.005) across 12 and 24 months. At 24 months, the ≥10% group had higher daily acceleration (38.5 ± 12.1 vs. 33.2 ± 11.1 mg, p = 0.020), and higher accelerations in the most active 5-hour period (59.4 ± 21.8 vs. 50.6 ± 18.3 mg, p = 0.023). Wakefulness after sleep onset decreased in the intervention group compared with the control group and also in the ≥10% weight loss group at 12 and 24 months. CONCLUSIONS Randomisation to a successful intensive weight loss intervention, including regular physical activity encouragement, was not associated with increased physical activity although sleep parameters improved. Physical activity was greater, and night-time waking reduced in those who maintained >10% weight loss at 12 and 24 months. TRIAL REGISTRATION ISRCTN03267836.
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Dietary Glycemic Index and Load and the Risk of Type 2 Diabetes: Assessment of Causal Relations.
Livesey, G, Taylor, R, Livesey, HF, Buyken, AE, Jenkins, DJA, Augustin, LSA, Sievenpiper, JL, Barclay, AW, Liu, S, Wolever, TMS, et al
Nutrients. 2019;11(6)
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It is generally accepted that certain diet and lifestyle choices contribute to a person’s risk of developing type 2 diabetes (T2D). In this meta-analysis, researchers set out to review previous studies and assess whether there is any evidence that the amount and type of carbohydrate (measured by Glycaemic Index (GI) and Glycaemic Load (GL)) in a person’s diet has a direct influence on their risk of developing T2D. The authors concluded with a high level of confidence that eating high GI and GL foods can lead to a higher risk of developing T2D. They suggest that nutrition advice that favours low GI and GL foods could produce significant cost savings for public healthcare.
Abstract
While dietary factors are important modifiable risk factors for type 2 diabetes (T2D), the causal role of carbohydrate quality in nutrition remains controversial. Dietary glycemic index (GI) and glycemic load (GL) have been examined in relation to the risk of T2D in multiple prospective cohort studies. Previous meta-analyses indicate significant relations but consideration of causality has been minimal. Here, the results of our recent meta-analyses of prospective cohort studies of 4 to 26-y follow-up are interpreted in the context of the nine Bradford-Hill criteria for causality, that is: (1) Strength of Association, (2) Consistency, (3) Specificity, (4) Temporality, (5) Biological Gradient, (6) Plausibility, (7) Experimental evidence, (8) Analogy, and (9) Coherence. These criteria necessitated referral to a body of literature wider than prospective cohort studies alone, especially in criteria 6 to 9. In this analysis, all nine of the Hill's criteria were met for GI and GL indicating that we can be confident of a role for GI and GL as causal factors contributing to incident T2D. In addition, neither dietary fiber nor cereal fiber nor wholegrain were found to be reliable or effective surrogate measures of GI or GL. Finally, our cost-benefit analysis suggests food and nutrition advice favors lower GI or GL and would produce significant potential cost savings in national healthcare budgets. The high confidence in causal associations for incident T2D is sufficient to consider inclusion of GI and GL in food and nutrient-based recommendations.
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Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial.
Lean, ME, Leslie, WS, Barnes, AC, Brosnahan, N, Thom, G, McCombie, L, Peters, C, Zhyzhneuskaya, S, Al-Mrabeh, A, Hollingsworth, KG, et al
Lancet (London, England). 2018;391(10120):541-551
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Most individuals with type 2 diabetes are obese with accumulation of fat around the liver and pancreas. Many studies have demonstrated that dietary induced weight loss can improve type 2 diabetes, however none have assessed whether dietary weight loss can sustain type 2 diabetes remission. This 12-month randomised trial of 306 individuals with type 2 diabetes aimed to determine whether weight management led by doctors would achieve long-term remission of type 2 diabetes. The results showed that weight loss of 15kg or more resulted in significantly higher rates of type 2 diabetes remission after 12 months, with 48% of the weight loss group achieving remission compared to 4% of the individuals who were not assigned a weight loss regimen. It was concluded that nearly half of the participants who were on a dietary weight loss programme achieved type 2 diabetes remission and were able to stop their medications. This study could be used by healthcare professionals to understand that type 2 diabetes remission is a possibility with a supervised dietary weight loss programme.
Abstract
BACKGROUND Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes. METHODS We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20-65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27-45 kg/m2, and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825-853 kcal/day formula diet for 3-5 months), stepped food reintroduction (2-8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA1c) of less than 6·5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. These outcomes were analysed hierarchically. This trial is registered with the ISRCTN registry, number 03267836. FINDINGS Between July 25, 2014, and Aug 5, 2017, we recruited 306 individuals from 49 intervention (n=23) and control (n=26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, we recorded weight loss of 15 kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0·0001). Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19·7, 95% CI 7·8-49·8; p<0·0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, six (7%) of 89 participants who maintained 0-5 kg weight loss, 19 (34%) of 56 participants with 5-10 kg loss, 16 (57%) of 28 participants with 10-15 kg loss, and 31 (86%) of 36 participants who lost 15 kg or more. Mean bodyweight fell by 10·0 kg (SD 8·0) in the intervention group and 1·0 kg (3·7) in the control group (adjusted difference -8·8 kg, 95% CI -10·3 to -7·3; p<0·0001). Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7·2 points (SD 21·3) in the intervention group, and decreased by 2·9 points (15·5) in the control group (adjusted difference 6·4 points, 95% CI 2·5-10·3; p=0·0012). Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, were deemed potentially related to the intervention. No serious adverse events led to withdrawal from the study. INTERPRETATION Our findings show that, at 12 months, almost half of participants achieved remission to a non-diabetic state and off antidiabetic drugs. Remission of type 2 diabetes is a practical target for primary care. FUNDING Diabetes UK.
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Acceptability of a very-low-energy diet in Type 2 diabetes: patient experiences and behaviour regulation.
Rehackova, L, Araújo-Soares, V, Adamson, AJ, Steven, S, Taylor, R, Sniehotta, FF
Diabetic medicine : a journal of the British Diabetic Association. 2017;34(11):1554-1567
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Patients with type 2 diabetes can return to normal blood glucose levels through substantial weight loss. While many studies have addressed this, very few have assessed the effects of adherence to a very-low-energy diet (VLED) on patients’ quality of life. The aim of this study was to evaluate the experiences of adhering to VLED for patients in remission for type 2 diabetes. Fifteen participants were interviewed before and after the 8-week VLED intervention and narratives were analysed. This study identified common barriers, facilitators and strategies used by the participants. Overall, participants found adherence easier than anticipated, and found barriers to be offset by suggested behaviour-regulation strategies. Based on this study, the authors conclude dietary treatment for reversal of type 2 diabetes is acceptable and feasible in motivated patients, and suggest further controlled research be done to confirm the validity and applicability of these findings.
Abstract
AIMS: To evaluate the acceptability of an 8-week very-low-energy diet for remission of Type 2 diabetes, and to identify barriers and facilitators of adherence and behaviour-regulation strategies used by participants in the Counterbalance study. METHODS Eighteen of 30 participants in the Counterbalance study (ISRCTN88634530) took part in semi-structured interviews. Of these, 15 participants were interviewed before and after the 8-week very-low-energy diet intervention. Thematic analysis was used to analyse the narratives. RESULTS The prospect of diabetes remission, considerable weight loss, and long-term health improvement provided participants with substantial initial motivation. This motivation was sustained through the experience of rapid weight loss, improvements in blood glucose levels, social support and increased physical and psychological well-being. Overall, adherence to the very-low-energy diet for 8 weeks was perceived as much easier than anticipated, but required personal effort. Participants addressed challenges by removing food from the environment, planning, avoidance of tempting situations or places, and self-distraction. Weight loss and improvements in blood glucose levels lead to a sense of achievement and improvements in physical and psychological wellbeing. CONCLUSIONS Dietary treatment for reversal of Type 2 diabetes is acceptable and feasible in motivated participants, and the process is perceived as highly gratifying. Research outside of controlled trial settings is needed to gauge the generalisability of these findings.
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Tracking post-infectious fatigue in clinic using routine Lab tests.
Harvey, JM, Broderick, G, Bowie, A, Barnes, ZM, Katz, BZ, O'Gorman, MRG, Vernon, SD, Fletcher, MA, Klimas, NG, Taylor, R
BMC pediatrics. 2016;16:54
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Chronic fatigue syndrome (CFS) is a complex disease with many different symptoms and there are no definitive tests for diagnosis. This cohort study of 301 adolescents, who had suffered a viral infection, aimed to analyse several commonly used biological markers to determine who may experience CFS symptoms. The results showed variations in several biomarkers, however, decreases in hormones related to the stress response were highly predictive of CFS. Sex hormones and the proportion of immune cells were also markedly disrupted. It was concluded that assessing stress hormones, sex hormones and the proportion of immune cells could be used to diagnose CFS following a viral infection. This study could be used by healthcare professionals to understand that several commonly tested biomarkers could be potentially used to diagnose post-viral CFS.
Abstract
BACKGROUND While biomarkers for chronic fatigue syndrome (CFS) are beginning to emerge they typically require a highly specialized clinical laboratory. We hypothesized that subsets of commonly measured laboratory markers used in combination could support the diagnosis of post-infectious CFS (PI-CFS) in adolescents following infectious mononucleosis (IM) and help determine who might develop persistence of symptoms. METHODS Routine clinical laboratory markers were collected prospectively in 301 mono-spot positive adolescents, 4 % of whom developed CFS (n = 13). At 6, 12, and 24 months post-diagnosis with IM, 59 standard tests were performed including metabolic profiling, liver enzyme panel, hormone profiles, complete blood count (CBC), differential white blood count (WBC), salivary cortisol, and urinalysis. Classification models separating PI-CFS from controls were constructed at each time point using stepwise subset selection. RESULTS Lower ACTH levels at 6 months post-IM diagnosis were highly predictive of CFS (AUC p = 0.02). ACTH levels in CFS overlapped with healthy controls at 12 months, but again showed a trend towards a deficiency at 24 months. Conversely, estradiol levels depart significantly from normal at 12 months only to recover at 24 months (AUC p = 0.02). Finally, relative neutrophil count showed a significant departure from normal at 24 months in CFS (AUC p = 0.01). Expression of these markers evolved differently over time between groups. CONCLUSIONS Preliminary results suggest that serial assessment of stress and sex hormones as well as the relative proportion of innate immune cells measured using standard clinical laboratory tests may support the diagnosis of PI-CFS in adolescents with IM.
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Glycemic response and health--a systematic review and meta-analysis: relations between dietary glycemic properties and health outcomes.
Livesey, G, Taylor, R, Hulshof, T, Howlett, J
The American journal of clinical nutrition. 2008;87(1):258S-268S
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All carbohydrates are ranked based on their glycaemic impact, or the response they provoke in blood glucose after consumption. It has been proposed that diets with a low impact on blood glucose are associated with a reduction in disease risk, however the specific dietary factors and degree of influence of this association remains unclear. The aim of this meta-analysis was to assess which glycaemic impact factors are important for affecting the maintenance of health and management of disease. Data from 45 relevant publications were included to investigate various health risk markers of overweight and obesity, diabetes mellitus and coronary heart disease. This review found that diets with a reduced glycaemic impact and higher unavailable carbohydrate are associated with favourable changes for all examined health risk markers. The authors conclude that these interventions led to improved glycaemic control, therefore provide a compelling diet for managing chronic disease.
Abstract
BACKGROUND Reduction of dietary glycemic response has been proposed as a means of reducing the risk of diabetes and coronary heart disease. The impact of glycemic response on markers of health remains to be elucidated. OBJECTIVE We assessed the evidence relating the glycemic impact of foods to measures relevant for health maintenance and management of disease. DESIGN This was a systematic review and synthesis of interventional evidence from literature reported on glycemic index and markers of health through the use of meta-analyses and meta-regression models. RESULTS Data from 45 relevant publications were found to January 2005. Lower glycemic index (GI) diets reduced both fasting blood glucose and glycated proteins independently of variance in available and unavailable carbohydrate intakes. Elevated unavailable carbohydrate added to improvements in both blood glucose and glycated protein control. These effects were greater in persons with poor fasting blood glucose control. No effects were seen on fasting insulin<100 pmol/L; above this, study numbers were few but consistent with prevention of hyperinsulinemia in some but not all overweight persons. Insulin sensitivity according to a variety of measurement methods was improved by lower GI, higher unavailable carbohydrate interventions in persons with type 2 diabetes, in overweight and obese persons, and in all studies combined. Fasting triacylglycerol in addition to body weight reduction related more to glycemic load than to GI. Glycemic load reduction by >17 g glucose equivalents/d was associated with reduced body weight. CONCLUSIONS Consumption of reduced glycemic response diets are followed by favorable changes in the health markers examined. The case for the use of such diets looks compelling. Unavailable carbohydrate intake is equally important.