Rob C Andrews

Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial

BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus, but no large trials have compared interventions. We investigated the effects of diet and physical activity on blood pressure and glucose concentrations. METHODS We did a randomised, controlled trial in southwest England in adults aged 30-80 years in whom type 2 diabetes had been diagnosed 5-8 months previously. Participants were assigned usual care (initial dietary consultation and follow-up every 6 months; control group), an intensive diet intervention (dietary consultation every 3 months with monthly nurse support), or the latter plus a pedometer-based activity programme, in a 2:5:5 ratio. The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c)) concentration and blood pressure at 6 months. Analysis was done by intention to treat. This study is registered, number ISRCTN92162869. FINDINGS Of 593 eligible individuals, 99 were assigned usual care, 248 the diet regimen, and 246 diet plus activity. Outcome data were available for 587 (99%) and 579 (98%) participants at 6 and 12 months, respectively. At 6 months, glycaemic control had worsened in the control group (mean baseline HbA(1c) percentage 6·72, SD 1·02, and at 6 months 6·86, 1·02) but improved in the diet group (baseline-adjusted difference in percentage of HbA(1c) -0·28%, 95% CI -0·46 to -0·10; p=0·005) and diet plus activity group (-0·33%, -0·51 to -0·14; p<0·001). These differences persisted to 12 months, despite less use of diabetes drugs. Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups. Blood pressure was similar in all groups. INTERPRETATION An intensive diet intervention soon after diagnosis can improve glycaemic control. The addition of an activity intervention conferred no additional benefit. FUNDING Diabetes UK and the UK Department of Health.

What are the health benefits of physical activity in type 1 diabetes mellitus? A literature review

Physical activity improves well-being and reduces the risk of heart disease, cancer and type 2 diabetes mellitus in the general population. In individuals with established type 2 diabetes, physical activity improves glucose and lipid levels, reduces weight and improves insulin resistance. In type 1 diabetes mellitus, however, the benefits of physical activity are less clear. There is poor evidence for a beneficial effect of physical activity on glycaemic control and microvascular complications, and significant risk of harm through hypoglycaemia. Here we review the literature relating to physical activity and health in type 1 diabetes. We examine its effect on a number of outcomes, including glycaemic control, lipids, blood pressure, diabetic complications, well-being and overall mortality. We conclude that whilst there is sufficient evidence to recommend physical activity in the management of type 1 diabetes, it is still unclear as to what form, duration and intensity should be recommended and whether there is benefit for many of the outcomes examined.

Effect of the definition of type II diabetes remission in the evaluation of bariatric surgery for metabolic disorders.

The American Diabetes Association recently defined remission of type II diabetes as a return to normal measures of glucose metabolism (haemoglobin (Hb) A1c below 6 per cent, fasting glucose less than 5·6 mmol/l) at least 1 year after bariatric surgery without hypoglycaemic medication. A previously used common definition was: being off diabetes medication with normal fasting blood glucose level or HbA1c below 6 per cent. This study evaluated the proportion of patients achieving complete remission of type II diabetes following bariatric surgery according to these definitions.

Patients with Type 2 diabetes experiences of making multiple lifestyle changes: a qualitative study

OBJECTIVES To explore patients newly diagnosed with Type 2 Diabetes Mellitus (T2DM) experiences of making single (diet) or multiple (diet and physical activity) changes in order to (1) assess whether patients experienced increases in physical activity as supporting or hindering dietary changes and vice versa, and (2) whether patients found making multiple lifestyle changes counterproductive or beneficial. METHODS In-depth interviews with 30 individuals taking part in a randomised controlled trial that aimed to determine the effect of diet and physical activity on T2DM. Interviewees had been randomised to receive usual care, intensive dietary advice, or intensive dietary advice plus information on physical activity. Respondents were interviewed 6 and 9 months post-randomisation. They were asked about their experiences of making lifestyle changes. Data were analysed thematically. RESULTS Findings suggest providing diet and physical activity information together encourages patients to use physical activity in strategic ways to aid disease management and that most patients find undertaking multiple lifestyle changes helpful. CONCLUSION Increasing physical activity can act as a gateway behaviour, i.e. behaviour that produces positive effects in other behaviours. PRACTICE IMPLICATIONS Practitioners should provide diet and physical activity information together to encourage patients to use physical activity strategically to maintain dietary changes.

Does exercise improve glycaemic control in type 1 diabetes? A systematic review and meta-analysis.

Objective Whilst regular exercise is advocated for people with type 1 diabetes, the benefits of this therapy are poorly delineated. Our objective was to review the evidence for a glycaemic benefit of exercise in type 1 diabetes. Research Design and Methods Electronic database searches were carried out in MEDLINE, Embase, Cochrane’s Controlled Trials Register and SPORTDiscus. In addition, we searched for as yet unpublished but completed trials. Glycaemic benefit was defined as an improvement in glycosylated haemoglobin (HbA1c). Both randomised and non-randomised controlled trials were included. Results Thirteen studies were identified in the systematic review. Meta-analysis of twelve of these (including 452 patients) demonstrated an HbA1c reduction but this was not statistically significant (standardised mean difference (SMD) −0.25; 95% CI, −0.59 to 0.09). Conclusions This meta-analysis does not reveal evidence for a glycaemic benefit of exercise as measured by HbA1c. Reasons for this finding could include increased calorie intake, insulin dose reductions around the time of exercise or lack of power. We also suggest that HbA1c may not be a sensitive indicator of glycaemic control, and that improvement in glycaemic variability may not be reflected in this measure. Exercise does however have other proven benefits in type 1 diabetes, and remains an important part of its management.

Patient-reported outcomes in bariatric surgery: a systematic review of standards of reporting

Bariatric surgery is increasingly being used to treat severe obesity, but little is known about its impact on patient‐reported outcomes (PROs). For PRO data to influence practice, well‐designed and reported studies are required. A systematic review identified prospective bariatric surgery studies that used validated PRO measures. Risk of bias in randomized controlled trials (RCTs) was assessed, and papers were examined for reporting of (i) who completed PRO measures; (ii) missing PRO data and (iii) clinical interpretation of PRO data. Studies meeting all criteria were classified as robust. Eighty‐six studies were identified. Of the eight RCTs, risk of bias was high in one and unclear in seven. Sixty‐eight different PRO measures were identified, with the Short Form (SF)‐36 questionnaire most commonly used. Forty‐one (48%) studies explicitly stated measures were completed by patients, 63 (73%) documented missing PRO data and 50 (58%) interpreted PRO data clinically. Twenty‐six (30%) met all criteria. Although many bariatric surgery studies assess PROs, study design and reporting is often poor, limiting data interpretation and synthesis. Well‐designed studies that include agreed PRO measures are needed with reporting to include integration with clinical outcomes to inform practice.

Obstructive sleep apnoea in patients with type 2 diabetes: aetiology and implications for clinical care

Recent attention has been drawn to the close association between obstructive sleep apnoea (OSA) and type 2 diabetes mellitus (T2DM). Debate has included much discussion about cause and effect with mechanisms proposed whereby one condition might cause the other. However, both clearly share a common phenotype, namely, obesity that overlaps considerably with the other components of the metabolic syndrome, hypertension and hyperlipidaemia. It would therefore appear likely that all are manifestations of the same basic pathological processes. Possible interacting aetiological mechanisms are reviewed along with treatment options. A recent report by the International Diabetes Federation has made recommendations to raise awareness of possible OSA in patients with T2DM and also for screening for hypertension, hyperlipidaemia and T2DM in patients with known OSA. The clinical implications are discussed.

Attitudes and Barriers to Exercise in Adults with Type 1 Diabetes (T1DM) and How Best to Address Them: A Qualitative Study

Background Regular physical activity has recognised health benefits for people with T1DM. However a significant proportion of them do not undertake the recommended levels of activity. Whilst questionnaire-based studies have examined barriers to exercise in people with T1DM, a formal qualitative analysis of these barriers has not been undertaken. Our aims were to explore attitudes, barriers and facilitators to exercise in patients with T1DM. Methodology A purposeful sample of long standing T1DM patients were invited to participate in this qualitative study. Twenty-six adults were interviewed using a semi-structured interview schedule to determine their level of exercise and barriers to initiation and maintenance of an exercise programme. Principal findings Six main barriers to exercise were identified: lack of time and work related factors; access to facilities; lack of motivation; embarrassment and body image; weather; and diabetes specific barriers (low levels of knowledge about managing diabetes and its complications around exercise). Four motivators to exercise were identified: physical benefits from exercise; improvements in body image; enjoyment and the social interaction of exercising at gym or in groups. Three facilitators to exercise were identified: free or reduced admission to gyms and pools, help with time management, and advice and encouragement around managing diabetes for exercise. Significance Many of the barriers to exercise in people with T1DM are shared with the non-diabetic population. The primary difference is the requirement for education about the effect of exercise on diabetes control and its complications. There was a preference for support to be given on a one to one basis rather than in a group environment. This suggests that with the addition of the above educational requirements, one to one techniques that have been successful in increasing activity in patients with other chronic disease and the general public should be successful in increasing activity in patients with T1DM.

Endothelium-derived hyperpolarizing factor and potassium use different mechanisms to induce relaxation of human subcutaneous resistance arteries

This investigation examined the hypothesis that release of K+ accounts for EDHF activity by comparing relaxant responses produced by ACh and KCl in human subcutaneous resistance arteries. Resistance arteries (internal diameter 244±12 μm, n=48) from human subcutaneous fat biopsies were suspended in a wire myograph. Cumulative concentration‐response curves were obtained for ACh (10−9 – 3×10−5 M) and KCl (2.5 – 25 mM) following contraction with noradrenaline (NA; 0.1 – 3 μM). ACh (Emax 99.07±9.61%; −LogIC50 7.03±0.22; n=9) and KCl (Emax 74.14±5.61%; −LogIC50 2.12±0.07; n=10)‐induced relaxations were attenuated (P<0.0001) by removal of the endothelium (Emax 8.21±5.39% and 11.56±8.49%, respectively; n=6 – 7). Indomethacin (10 μM) did not alter ACh‐induced relaxation whereas L‐NOARG (100 μM) reduced this response (Emax 61.7±3.4%, P<0.0001; n=6). The combination of ChTx (50 nM) and apamin (30 nM) attenuated the L‐NOARG‐insensitive component of ACh‐induced relaxation (Emax: 15.2±10.5%, P<0.002, n=6) although these arteries retained the ability to relax in response to 100 μM SIN‐1 (Emax 127.6±13.0%, n=3). Exposure to BaCl2 (30 μM) and Ouabain (1 mM) did not attenuate the L‐NOARG resistant component of ACh‐mediated relaxation (Emax, 76.09±8.92, P=0.16; n=5). KCl‐mediated relaxation was unaffected by L‐NOARG+indomethacin (Emax; 68.1±5.6%, P=0.33; n=5) or the combination of L‐NOARG/indomethacin/ChTx/apamin (Emax; 86.61±14.02%, P=0.35; n=6). In contrast, the combination of L‐NOARG, indomethacin, ouabain and BaCl2 abolished this response (Emax, 5.67±2.59%, P<0.0001, n=6). The characteristics of KCl‐mediated relaxation differed from those of the nitric oxide/prostaglandin‐independent component of the response to ACh, and were endothelium‐dependent, indicating that K+ does not act as an EDHF in human subcutaneous resistance arteries.

Outcome reporting in bariatric surgery: An in-depth analysis to inform the development of a core outcome set, the BARIACT Study

Outcome reporting in bariatric surgery needs a core outcome set (COS), an agreed minimum set of outcomes reported in all studies of a particular condition. The aim of this study was to summarize outcome reporting in bariatric surgery to inform the development of a COS. Outcomes reported in randomized controlled trials (RCTs) and large non‐randomized studies identified by a systematic review were listed verbatim and categorized into domains, scrutinizing the frequency of outcome reporting and uniformity of definitions. Ninety studies (39 RCTs) identified 1,088 separate outcomes, grouped into nine domains with most (n = 920, 85%) reported only once. The largest outcome domain was ‘surgical complications’, and overall, 42% of outcomes corresponded to a theme of ‘adverse events’. Only a quarter of outcomes were defined, and where provided definitions, which were often contradictory. Percentage of excess weight loss was the main study outcome in 49 studies, but nearly 40% of weight loss outcomes were heterogeneous, thus not comparable. Outcomes of diverse bariatric operations focus largely on adverse events. Reporting is inconsistent and ill‐defined, limiting interpretation and comparison of published studies. Thus, we propose and are developing a COS for the surgical treatment of severe and complex obesity.