Melanie J Davies

University Hospitals Of Leicester NHS Trust, Leicester, ENG, United Kingdom

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Publications (59)168.8 Total impact

  • Article: Evaluation of the Healthy LifeCheck programme: a vascular risk assessment service for community pharmacies in Leicester city, UK.
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    ABSTRACT: BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death globally. Vascular risk assessment is recognized as playing a key role in reducing premature CVD-related morbidity and mortality. The current study evaluated the effectiveness of a pharmacy-led risk assessment service in Leicester City, UK. METHODS: The vascular risk assessment was offered opportunistically to individuals between 40 and 70 years without any prior diagnosis of CVD on attending their community pharmacist. Individuals were risk stratified using the Framingham score and those classified as high risk were referred to their general practitioner (GP). RESULTS: Overall, 2521 individuals were recruited from 39 pharmacies consisting of 1059 (42%) males, 1696 (67%) South Asians and 199 (7.9%) individuals not registered with a GP. A total of 462 (18%) individuals were referred to primary care and 52.6% of a representative subset were subsequently recorded as having attended an appointment with their GP; diagnoses and treatments commenced were recorded. CONCLUSIONS: Cardiovascular risk assessment led by community pharmacies can successfully assess people from large, multi-ethnic UK populations and identify those at high cardiovascular risk or with undiagnosed cardiovascular disease. The service may improve rates of assessments undertaken by individuals who do not access health care through traditional routes.
    Journal of Public Health 03/2013; · 2.06 Impact Factor
  • Article: Psychometric validation of the Self-Care Inventory-Revised (SCI-R) in UK adults with type 2 diabetes using data from the AT.LANTUS follow-on study.
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    ABSTRACT: BACKGROUND: Achieving optimal outcomes in type 2 diabetes (T2DM) involves several demanding self-care behaviours, e.g. managing diet, activity, medications, monitoring glucose levels, footcare. The Self-Care Inventory-Revised (SCI-R) is valid for use in people with T2DM in the US. Our aim was to determine its suitability for use in the UK. METHODS: 353 people with T2DM participated in the AT.LANTUS Follow-on study, completing measures of diabetes self-care (SCI-R), generic and diabetes-specific well-being (W-BQ28), and diabetes treatment satisfaction (DTSQ). Statistical analyses were conducted to explore structure, reliability, and validity of the SCI-R. RESULTS: Principal components analysis indicated a 13-item scale (items loading >0.39) with satisfactory internal consistency reliability (alpha = 0.77), although neither this model nor any alternatives were confirmed in the confirmatory factor analysis. Acceptability was high (>95% completion for all but one item); ceiling effects were demonstrated for six items. As expected, convergent validity (correlations between self-care behaviours) was found for few items. Divergent validity was supported by expected low correlations between SCI-R total and well-being (rs = 0.02-0.21) and treatment satisfaction (rs = 0.29). Known-groups validity was partially supported with significant differences in SCI-R total by HbA1c (<=7.5% (58 mmol/mol): 72 +/- 11, >7.5% (58 mmol/mol): 68 +/- 14, p < 0.05) and diabetes duration (<=16 years: 67 +/- 13, >16 years: 71 +/- 12, p < 0.001) but not by presence/absence of complications or by insulin treatment algorithm. CONCLUSIONS: The SCI-R is a brief, valid and reliable measure of self-care in people with T2DM in the UK. However, ceiling effects raise concerns about its potential for responsiveness in clinical trials. Individual items may be more useful clinically than the total score.Word count: 253 (350 max).
    Health and Quality of Life Outcomes 02/2013; 11(1):24. · 2.11 Impact Factor
  • Article: Effect of physical activity measurement type on the association between walking activity and glucose regulation in a high-risk population recruited from primary care.
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    ABSTRACT: BACKGROUND: We investigate associations of self-reported and objectively assessed walking activity with measures of glucose regulation in a multi-ethnic population at high risk of type 2 diabetes. METHODS: This study reports data from a 2009-2011 screening programme for impaired glucose regulation (IGR) within a high-risk primary care population in Leicestershire, UK; 2532 participants (38% women, 8% South Asian) with a mean age of 64 ± 8 years and an average BMI of 32.1 ± 5.6 kg/m(2) were included. Walking activity was measured by self-report (International Physical Activity Questionnaire) and objectively (pedometer). Glucose regulation assessments included 2h post-challenge glucose, fasting glucose and HbA1c. RESULTS: Higher levels of self-reported walking activity and pedometer steps were associated with lower 2h post-challenge glucose after controlling for several known confounding variables, including BMI. Similarly, when categorized in tertiles, both measures were associated with a lower odds of having any form of IGR; odds ratio for lowest vs highest tertile was 0.64 (0.51-0.80) for self-report and 0.69 (0.55-0.87) for pedometer steps. There was no significant difference between self-reported and objective measures in the strength of associations with glucose regulation; associations with self-report were maintained when further adjusted for pedometer steps. Stronger associations between self-reported walking activity and glucose regulation were observed in South Asians compared with White Europeans. CONCLUSIONS: Self-reported and objectively measured walking activity were equally associated with indices of glucose regulation. Associations with self-reported walking activity were maintained when further adjusted for pedometer steps, suggesting that self-reported walking activity may measure facets of physical activity that are beyond total volume.
    International Journal of Epidemiology 02/2013; · 6.41 Impact Factor
  • Article: The impact of diet and lifestyle management strategies for obstructive sleep apnoea in adults: a systematic review and meta-analysis of randomised controlled trials.
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    ABSTRACT: PURPOSE: To systematically evaluate the impact of diet, exercise and lifestyle modification programmes on indices of obesity, Obstructive Sleep Apnoea (OSA) parameters and quality of life (QoL) in adults with OSA. METHODS: Electronic databases were searched to identify randomised controlled trials published in English with an intervention based on dietary weight loss, exercise and/or lifestyle programme in adults with OSA. Meta-analyses were conducted using random-effects models. RESULTS: Twelve studies met the inclusion criteria with nine comparing similar interventions. Diet and diet plus continuous positive airway pressure (CPAP) therapy were compared in three studies (n = 261), and intensive lifestyle programmes and routine care were compared in six studies (n = 483). Diet with CPAP therapy reduced weight by -2.64 kg (95 % Confidence Interval (CI) -3.98, -1.30, I (2) = 0 %) compared with diet alone. No differences were observed for QoL or Epworth Sleepiness Scale. A significant reduction in weight was seen in participants receiving an intensive lifestyle intervention of -5.65 kg (95 % CI -10.91, -0.40, I (2) = 95.7 %) compared with controls. Reductions were also observed for waist circumference (-5.80 cm, 95 % CI -8.64, -2.96, I(2) = 77.7 %), body mass index (BMI) (-2.33 kg/m(2), 95 % CI -3.41, -1.24, I(2) = 78.8 %) and the Apnoea Hypopnoea Index (AHI) (-4.55 events/h, 95 % CI -7.12, -1.98, I (2) = 54.4 %) but with high levels of heterogeneity. CONCLUSIONS: Intensive lifestyle management can significantly reduce obesity indices and improve AHI. Future research is required to investigate this effect due to a limited number of studies identified.
    Sleep And Breathing 01/2013; · 1.84 Impact Factor
  • Article: Severe hypoglycaemia requiring emergency medical assistance by ambulance services in the East Midlands: A retrospective study.
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    ABSTRACT: AIMS: To report the characteristics and treatment of individuals requiring emergency ambulance services for severe hypoglycaemia and estimate associated provider costs. METHODS: Retrospective analysis of routinely collected data collected by the East Midlands Ambulance Trust, UK, of episodes of severe hypoglycaemia attended by emergency ambulance services during a four-month period. Standard clinical measures, response time, on-site treatment and transportation were recorded and ambulance services costs calculated. RESULTS: 90,435 emergency calls were recorded, 523 (0.6%) for severe hypoglycaemia, equating to an incidence of to 2.76 per 100 patient years; 74% of individuals were insulin-treated, 28% of events occurred nocturnally (00:00-07:59), and 32% were transported to hospital. Higher respiratory rate was a positive predictor (p=0.03), whereas higher post treatment blood glucose (p=0.05) and insulin treatment (p<0.01) were negative predictors of transport to hospital. Median treatment costs for individuals transported and not transported to hospital were £92 and £176 respectively. CONCLUSIONS: Most cases of severe hypoglycaemia requiring assistance from emergency ambulance services are successfully treated at the scene. Individuals not responding to treatment or were non insulin-treated were more likely to be transported to hospital. Further studies are needed to evaluate the effect of prehospital ambulance care by treatment and diabetes type on subsequent outcomes.
    Primary care diabetes. 01/2013;
  • Article: The development and validation of the Portuguese risk score for detecting type 2 diabetes and impaired fasting glucose.
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    ABSTRACT: AIMS: To develop and validate a non-invasive score for detecting undiagnosed impaired fasting glucose (IFG) and type 2 diabetes (T2DM) in a Portuguese population. METHODS: We used data from 3,374 individuals aged 18-94 years from a Portuguese cross-sectional study. We developed a logistic regression model for predicting IFG/T2DM (diagnosed using fasting glucose). We externally validated the score using data from two cohorts of the EPI-Porto study, cross-sectional (n=2,131) and data from the 5 year follow-up (n=1,304). RESULTS: The final model included age, sex, BMI and hypertension with an area under the ROC curve of 70.1 (95%CI 68.4, 71.7). Using a cut-point which classifies 50% of the EPI-Porto cross-sectional data as high-risk gave sensitivity 73.2% (95%CI 68.5%, 77.6%), specificity 55.5% (53.1%, 57.8%), positive predictive value (PPV) 27.0% (24.3%, 29.8%) and negative predictive value (NPV) 90.2% (88.3%, 92.0%) for IFG/T2DM. Using the same cut-point on the prospective data classified 45% as high-risk; sensitivity 69.1% (63.4%, 74.4%), specificity 63.3% (60.0%, 66.5%), PPV 38.0% (33.9%, 42.4%), and NPV 86.2% (83.3%, 88.8%). CONCLUSION: The Portuguese risk score can be used to identify those at high risk of both prevalent undiagnosed and incident IFG/T2DM.
    Primary care diabetes. 01/2013;
  • Article: Joint prevalence of diabetes, impaired glucose regulation, cardiovascular disease risk and chronic kidney disease in South asians and white europeans.
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    ABSTRACT: Multiple vascular risk factors may confer very high risk, but the degree of commonality between risk factors is unclear, particularly among ethnic minorities. Furthermore, it is unknown what impact this commonality will have on the UK-based NHS Health Check Programme; a vascular disease prevention programme that screens individuals aged 40-74 years. We estimated the joint prevalence of diabetes, impaired glucose regulation (IGR), high cardiovascular disease (CVD) risk and chronic kidney disease (CKD) among White Europeans and South Asians who would be eligible for the Programme. Cross-sectional data were analysed for 3707 participants (23.6% South Asian) in a screening study set in Leicestershire, UK. Diabetes and IGR were screen-detected. CKD may have been diagnosed previously. IGR was defined as impaired fasting glucose and/or impaired glucose tolerance, and high CVD risk as 10 year risk greater than 20%. Among males, South Asians had higher prevalence than White Europeans of diabetes (9.0% vs. 3.9%, respectively, p<0.001), IGR (12.5% vs. 9.2%, p = 0.06), and high CVD risk (39.1% vs. 33.1%, p = 0.03), but lower prevalence of CKD (1.5% vs. 4.6%, p<0.01). Among females, South Asians had higher prevalence than White Europeans of diabetes (7.4% vs. 3.3%, p<0.001), but lower prevalence of CKD (3.7% vs. 13.0%, p <0.001) and CVD risk (2.4% vs. 4.6%, p = 0.03), and a non-significant difference in IGR prevalence. At least one risk factor was diagnosed in 34% of participants, and all of them in 0.4%, suggesting that 723,589-734,589 more individuals each year will require monitoring following implementation of the Health Check Programme. The collective prevalence of risk factors for vascular disease in this population was high, but there was little overlap between the risk factors, and prevalence differed by ethnicity. This has implications for service delivery and resources, and should be considered when planning screening and intervention programmes.
    PLoS ONE 01/2013; 8(1):e55580. · 4.09 Impact Factor
  • Article: Comparison of efficacy between incretin-based therapies for type 2 diabetes mellitus.
    Kaustubh Nisal, Ram Kela, Kamlesh Khunti, Melanie J Davies
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    ABSTRACT: Type 2 diabetes mellitus is widely prevalent and is often coexistent with obesity. Many of the available treatment options have side effects such as weight gain which often affect patient's willingness to continue the treatment. Effective weight loss, lack of significant hypoglycaemia, and favourable cardiometabolic profile make Incretin based therapies an attractive treatment option for type 2 diabetes. Incretin based therapies are available as either incretin mimetics (also called GLP-1 agonists) or incretin enhancers (DPP-4 inhibitors). Although agents in both these classes of incretin based therapy are effective through a common GLP-1 pathway, there are many differences amongst them including the route of administration, frequency of administration, effects on body weight, extent of glycaemic improvement. There are several trials evaluating these individual incretin based agents either as monotherapy or in combination with other anti-diabetic agents, however very few have looked into direct comparison amongst the agents in these two classes. This review is aimed to look at important mechanistic differences between incretin mimetics and enhancers through direct comparison trials and impact of these differences on biochemical, metabolic and patient satisfaction parameters.
    BMC Medicine 11/2012; 10(1):152. · 6.03 Impact Factor
  • Article: The Association Between Body Mass Index and Heath Related Quality of Life: Influence of Ethnicity on this Relationship.
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    ABSTRACT: AIMS: The association between obesity and a poorer health related quality of life (HRQL) has previously been explored. The influence of ethnicity on this relationship has less frequently been considered. We aimed to explore the relationship between body mass index (BMI) and HRQL in a mixed population of White European and South Asian ethnicity. METHODS: Cross-sectional data were analysed (n = 4989, 16% South Asian) from a population based diabetes screening study. BMI categories were based on ethnic specific cut-points. HRQL was categorised low (<0.848) or high (≥0.848) according to the median EQ5D score. Logistic regression was used to examine the relationship between BMI and HRQL. Interaction analysis was conducted to determine the effect of ethnicity. RESULTS: Overweight (OR = 1.22, 95% CI: 1.10 - 1.41, p<0.001) and obese people (OR = 1.81, 95% CI: 1.56 - 2.10, p<0.001) had increased odds of having a low HRQL compared to normal weight people. After adjusting for potential confounders, age, gender, ethnicity, deprivation score, fruit and vegetable intake, physical activity, cardiovascular disease, chronic kidney disease and smoking, this association was strengthened further. However, for obese people, South Asian ethnicity significantly reduced the risk of having a low HRQL when compared to White Europeans (adjusted OR = 0.58, 95% CI: 0.34 - 0.97). CONCLUSIONS: Our findings provide further evidence of an association between increasing BMI and low HRQL but suggest that South Asian ethnicity modifies this relationship. These results could have important health implications and are a basis for further research.
    Diabetes Obesity and Metabolism 11/2012; · 3.38 Impact Factor
  • Article: Diabetes and cardiovascular events in women with polycystic ovary syndrome; a 20 years retrospective cohort study.
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    ABSTRACT: OBJECTIVE: Women with polycystic ovary syndrome (PCOS) are potentially at increased risk of cardiovascular (CV) diseases due to well-established risk factors, including insulin resistance, obesity and type 2 diabetes mellitus (T2DM). However data showing excess CV events in this population are still lacking. We investigated the incidence and prevalence of CV events in a cohort of women with PCOS. DESIGN: Retrospective cohort study (total follow-up > 12,000 person-years). SETTING: Leicester, Leicestershire and Rutland (Total Female population of 434,859), UK. PARTICIPANTS: 2301 women with PCOS (mean age = 29.6 years) attending a speciality clinic in Leicestershire, UK. MAIN OUTCOMES MEASURES: T2DM, myocardial infarction (MI), angina, heart failure (HF), stroke, and cardiovascular (CV) related death. RESULTS: Incidence of T2DM, MI, angina, HF, stroke and CV death was respectively 3.6, 0.8, 1.0, 0.3, 0.0, and 0.4 per 1000 person-years. At the end of follow-up, the prevalence of MI in the age groups 45-54, 55-64, and >65 years were 1.9%, 6.0% and 27.3% and of angina were 2.6%, 6.0%, and 27.3%, respectively. Age group-specific odds ratios for the prevalence of MI and angina compared to the local female population ranged between 2.6 (95% CI: 1.0, 6.3) and 12.9 (CI: 3.4, 48.6) with the highest ratio being for MI in the group >65 years old. Age, history of hypertension and smoking had significant correlations with CV outcomes in the PCOS patients. CONCLUSION: We have shown a high incidence and age group-specific prevalence of T2DM, MI and angina in the women with PCOS, with over a quarter having had MI or angina in those >65 years. These findings should be considered in the treatment strategies and long term planning for women with PCOS. © 2012 Blackwell Publishing Ltd.
    Clinical Endocrinology 10/2012; · 3.17 Impact Factor
  • Article: Treatment evaluation of liraglutide in type 2 diabetes.
    Ram Kela, Melanie J Davies
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    ABSTRACT: Liraglutide is a Glucagon like Peptide-1 (GLP-1) receptor agonist, which stimulates GLP-1 receptors and consequently leads to various cardio-metabolic and glycemic improvements in individuals with Type 2 Diabetes Mellitus (T2DM). It is administered once daily as a subcutaneous injection and has been extensively studied in randomized placebo and active comparator studies demonstrating favorable effects on glycemic control and weight reduction. This short review summarizes the role and practical use of this agent in the context of efficacy and safety information obtained during clinical trials.
    Expert opinion on biological therapy 08/2012; 12(11):1551-6. · 3.22 Impact Factor
  • Article: Association of Sitting Time and Physical Activity With CKD: A Cross-sectional Study in Family Practices.
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    ABSTRACT: Chronic kidney disease (CKD) represents a significant and growing health care burden globally. Lifestyle factors, such as physical activity and sitting-related sedentary behavior, have been hypothesized to be directly associated with CKD; however, epidemiologic research is limited. Cross-sectional analysis. A population-level diabetes screening program conducted across 20 family practices in Leicester, United Kingdom, August 2004 to December 2007. Self-reported sitting time and physical activity, obtained using the International Physical Activity Questionnaire. CKD, defined using NKF-KDOQI (National Kidney Foundation's Kidney Disease Outcomes Quality Initiative) criteria. 6,379 (52% women) individuals were included. Lower levels of sitting time were associated with lower risk of CKD after controlling for physical activity, body mass index, and other potential confounding variables (OR, 0.74 [95% CI, 0.62-0.92] for lowest vs highest tertile). Interaction analysis showed that women trended toward a significantly higher risk of CKD with higher levels of sitting time compared with men. Participating in levels of physical activity that were at least consistent with the minimum recommendations for health was associated with lower risk of CKD. A significant interaction with sex was observed, with men showing a lower risk of CKD with high levels of physical activity compared with women. Cross-sectional design, self-reported lifestyle data, CKD defined at a single time, and estimated glomerular filtration rate and microalbuminuria were the only measures used to define CKD. This study suggests that higher levels of physical activity and lower levels of sitting time are associated with a lower prevalence of CKD independently of each other and other risk factors. However, results may vary by sex, with sitting time being the more important factor in women and physical activity the more important factor in men. These results have important implications for future research.
    American Journal of Kidney Diseases 06/2012; 60(4):583-90. · 5.43 Impact Factor
  • Article: Independent effect of ethnicity on glycemia in South Asians and white Europeans.
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    ABSTRACT: HbA(1c) levels are higher in most ethnic groups compared with white Europeans (WEs) independent of glycemic control. This comparison has not been performed between South Asians (SAs) and WEs. We analyzed the independent effect of ethnicity on HbA(1c) and fasting and 2-h plasma glucose (FPG and 2 hrPG, respectively) between these groups. Analysis of the ADDITION-Leicester study, in which 4,688 WEs and 1,352 SAs underwent oral glucose tolerance testing, HbA(1c), and other risk factor measurements. Significant associations with HbA(1c) included ethnicity, FPG, 2 hrPG, and homeostasis model assessment of β-cell function (P < 0.001); age and sex (P < 0.01); and fasting insulin and potassium (P < 0.05). After adjusting for these and other risk factors, SAs demonstrated higher HbA(1c) (6.22 and 6.02%, mean difference 0.20%, 0.10-0.30, P < 0.001), FPG (5.15 and 5.30 mmol/L, mean difference 0.15 mmol/L, 0.09-0.21, P < 0.001), and 2 hrPG (5.82 and 6.57 mmol/L, mean difference 0.75 mmol/L, 0.59-0.92, P < 0.001) compared with WEs, respectively. HbA(1c), FPG, and 2 hrPG levels were higher in SAs independent of factors affecting glycemic control.
    Diabetes care 06/2012; 35(8):1746-8. · 8.09 Impact Factor
  • Article: Conduit vessel stiffness in British south Asians of Indian descent relates to 25-hydroxyvitamin D status.
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    ABSTRACT: South Asians migrating to Northern latitudes are more susceptible to premature cardiovascular disease (CVD) than expected for given levels of blood pressure. Vitamin D deficiency is common in this group and may play an important role mediating vascular wall senescence in response to central pressure effects. A cross-sectional association study. South Asian and White European participants were randomly recruited from a population-based diabetes-screening programme. Carotid-femoral pulse wave velocity (cfPWV), biochemistry (25-hydroxyvitamin D, fasting glucose), anthropometrics, resting blood pressure and a physical activity measure (International Physical Activity Questionnaire) were measured under controlled conditions. One hundred and thirty-two and 125 age-matched South Asians and White Europeans not taking vitamin D supplementation with a risk factor for diabetes but no overt CVD. Age (mean south Asian: 55.7 vs. White European: 56.0 years), mean arterial pressure (MAP) and calculated CVD risk were similar in both groups. Unadjusted (cf)PWV (m/s) was higher (9.32 vs. 8.68 P = 0.001) and 25-hydroxyvitamin D (nmol/l) lower in (21.29 vs. 52.5 P < 0.001) south Asians. 25-Hydroxyvitamin D independently associated with cfPWV in multivariate modelling adjusted for age, MAP, sex, glucose, heart rate, vasoactive medication and south Asian ethnicity (R = 0.73, P = 0.004). 25-Hydroxyvitamin D but not physical activity was negatively correlated with cfPWV independent of south Asian ethnicity. Aortic stiffness is increased in British Indo-Asians without vascular disease despite conventional risk profiles, which are comparable to age-matched white Europeans. This effect may be mediated by a greater pressure-dependent increase in stiffness in individuals with vitamin D insufficiency.
    Journal of hypertension 06/2012; 30(8):1588-96. · 4.02 Impact Factor
  • Article: Walking away from type 2 diabetes: trial protocol of a cluster randomised controlled trial evaluating a structured education programme in those at high risk of developing type 2 diabetes.
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    ABSTRACT: The prevention of type 2 diabetes is a recognised health care priority globally. Within the United Kingdom, there is a lack of research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. This study aims to establish the behavioural and clinical effectiveness of a structured educational programme designed to target perceptions and knowledge of diabetes risk and promote a healthily lifestyle, particularly increased walking activity, in a multi-ethnic population at a high risk of developing type 2 diabetes. Cluster randomised controlled trial undertaken at the level of primary care practices. Follow-up will be conducted at 12, 24 and 36 months. The primary outcome is change in objectively measured ambulatory activity. Secondary outcomes include progression to type 2 diabetes, biochemical variables (including fasting glucose, 2-h glucose, HbA1c and lipids), anthropometric variables, quality of life and depression. 10 primary care practices will be recruited to the study (5 intervention, 5 control). Within each practice, individuals at high risk of impaired glucose regulation will be identified using an automated version of the Leicester Risk Assessment tool. Individuals scoring within the 90th percentile in each practice will be invited to take part in the study. Practices will be assigned to either the control group (advice leaflet) or the intervention group, in which participants will be invited to attend a 3 hour structured educational programme designed to promote physical activity and a healthy lifestyle. Participants in the intervention practices will also be invited to attend annual group-based maintenance workshops and will receive telephone contact halfway between annual sessions. The study will run from 2010-2014. This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme run within routine primary care in the United Kingdom. ClinicalTrials.Gov identifier: NCT00941954.
    BMC Family Practice 05/2012; 13:46. · 1.80 Impact Factor
  • Article: Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation.
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    ABSTRACT: The prevention of type 2 diabetes is a globally recognised health care priority, but there is a lack of rigorous research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. The aim of the study is to establish whether a pragmatic structured education programme targeting lifestyle and behaviour change in conjunction with motivational maintenance via the telephone can reduce the incidence of type 2 diabetes in people with impaired glucose regulation (a composite of impaired glucose tolerance and/or impaired fasting glucose) identified through a validated risk score screening programme in primary care. Cluster randomised controlled trial undertaken at the level of primary care practices. Follow-up will be conducted at 12, 24 and 36 months. The primary outcome is the incidence of type 2 diabetes. Secondary outcomes include changes in HbA1c, blood glucose levels, cardiovascular risk, the presence of the Metabolic Syndrome and the cost-effectiveness of the intervention. The study consists of screening and intervention phases within 44 general practices coordinated from a single academic research centre. Those at high risk of impaired glucose regulation or type 2 diabetes are identified using a risk score and invited for screening using a 75 g-oral glucose tolerance test. Those with screen detected impaired glucose regulation will be invited to take part in the trial. Practices will be randomised to standard care or the intensive arm. Participants from intensive arm practices will receive a structured education programme with motivational maintenance via the telephone and annual refresher sessions. The study will run from 2009-2014. This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme conducted within routine primary care in the United Kingdom. Clinicaltrials.gov NCT00677937.
    Cardiovascular Diabetology 05/2012; 11:56. · 3.35 Impact Factor
  • Article: A comparison of cost per case detected of screening strategies for Type 2 diabetes and impaired glucose regulation: Modelling study.
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    ABSTRACT: To determine a cost per case detected for different screening strategies for both Type 2 diabetes alone and in combination with impaired glucose regulation. Bayesian framework modelling study using data from the ADDITION-Leicester screening study in UK multi-ethnic primary care setting. There were 5794 people aged 40-75 years (77.4% white European; 22.6% south Asian) without previously known diabetes. We compared 212 screening strategies including blood tests, a computer practice data score and a risk score, as part of a multi-stage process that all used an oral glucose tolerance test as the diagnostic test. Simulation models were created using sensitivity estimates for the expected cost per case. The estimated costs per case identified for the 18 most sensitive strategies varied from £457 to £1639 (€526-1886, for £1=€1.15) for diabetes and £148-913 (€170-1050) for both diabetes and impaired glucose regulation. The lowest costing diabetes strategies ranged from £457 to £523 (€526-601) involving a two-stage screening strategy, a non-invasive risk stratifying tool followed by a blood test, producing sensitivities ranging from 67.1 to 82.4%. Screening a population using a non-invasive risk stratification tool followed by a screening blood test is the most cost-effective method of screening for diabetes and abnormal glucose tolerance.
    Diabetes research and clinical practice 05/2012; 97(3):505-13. · 2.16 Impact Factor
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    Article: Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol.
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    ABSTRACT: The benefit of self-monitoring of blood glucose (SMBG) in people with type 2 diabetes on diet or oral agents other than sulphonylureas remains uncertain. Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results. A recent systematic review concluded that SMBG was not cost-effective. However, what was unclear was whether a cheaper method of self-monitoring (such as urine glucose monitoring) could produce comparable benefit and patient acceptability for less cost. The DESMOND SMBG trial is comparing two monitoring strategies (blood glucose monitoring and urine testing) over 18 months when incorporated into a comprehensive self-management structured education programme. It is a multi-site cluster randomised controlled trial, conducted across 8 sites (7 primary care trusts) in England, UK involving individuals with newly diagnosed Type 2 diabetes.The trial has 80% power to demonstrate equivalence in mean HbA1c (the primary end-point) at 18 months of within ± 0.5% assuming 20% drop out and 20% non-consent. Secondary end-points include blood pressure, lipids, body weight and psychosocial measures as well as a qualitative sub-study.Practices were randomised to one of two arms: participants attend a DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose. The programme is delivered by accredited educators who received specific training about equipoise. Biomedical data are collected and psychosocial scales completed at baseline, and 6, 12, and 18 months post programme. Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring. The DESMOND SMBG trial is designed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes. Strengths include a setting in primary care, a cluster design, a health economic analysis, a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub-study. ISRCTN: ISRCTN95696668.
    BMC Family Practice 03/2012; 13:18. · 1.80 Impact Factor
  • Article: Nonpharmacological interventions for the prevention of type 2 diabetes mellitus.
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    ABSTRACT: During the past decade, improved understanding of the pathophysiological mechanisms of diabetes development has resulted in advances in therapeutic concepts, but has also supported the potential for diabetes prevention through nonpharmacological means. At the beginning of the century, we experienced a shift in paradigm, as landmark studies have shown that diabetes mellitus is preventable with lifestyle intervention; moderate changes in diet and physical activity produce a substantial and sustained reduction in the incidence of type 2 diabetes mellitus (T2DM) for individuals with impaired glucose tolerance. This evidence must now be translated into clinical and public-health practice, but translational studies have varied in their ability to replicate the results of clinical trials. This variation reflects a number of challenging barriers for diabetes prevention in real-world clinical practice, which makes it necessary to focus on identifying efficient intervention methods and delivery mechanisms. Research is now focusing on these mechanisms, as well as on developing efficient screening and risk-identification strategies and realistic scenarios for public-health policy to implement diabetes prevention programs. In this Review, we will discuss these mechanisms and will consider the implications of diabetes prevention for public-health strategy and policy.
    Nature Reviews Endocrinology 01/2012; 8(6):363-73. · 9.97 Impact Factor
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    Article: Association of sedentary behaviour with metabolic syndrome: a meta-analysis.
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    ABSTRACT: In recent years there has been a growing interest in the relationship between sedentary behaviour (sitting) and health outcomes. Only recently have there been studies assessing the association between time spent in sedentary behaviour and the metabolic syndrome. The aim of this study is to quantify the association between sedentary behaviour and the metabolic syndrome in adults using meta-analysis. Medline, Embase and the Cochrane Library were searched using medical subject headings and key words related to sedentary behaviours and the metabolic syndrome. Reference lists of relevant articles and personal databases were hand searched. Inclusion criteria were: (1) cross sectional or prospective design; (2) include adults ≥ 18 years of age; (3) self-reported or objectively measured sedentary time; and (4) an outcome measure of metabolic syndrome. Odds Ratio (OR) and 95% confidence intervals for metabolic syndrome comparing the highest level of sedentary behaviour to the lowest were extracted for each study. Data were pooled using random effects models to take into account heterogeneity between studies. Ten cross-sectional studies (n = 21393 participants), one high, four moderate and five poor quality, were identified. Greater time spent sedentary increased the odds of metabolic syndrome by 73% (OR 1.73, 95% CI 1.55-1.94, p<0.0001). There were no differences for subgroups of sex, sedentary behaviour measure, metabolic syndrome definition, study quality or country income. There was no evidence of statistical heterogeneity (I(2) = 0.0%, p = 0.61) or publication bias (Eggers test t = 1.05, p = 0.32). People who spend higher amounts of time in sedentary behaviours have greater odds of having metabolic syndrome. Reducing sedentary behaviours is potentially important for the prevention of metabolic syndrome.
    PLoS ONE 01/2012; 7(4):e34916. · 4.09 Impact Factor

Institutions

  • 2002–2013
    • University Hospitals Of Leicester NHS Trust
      • Department of Cardiovascular Sciences
      Leicester, ENG, United Kingdom
  • 2012
    • Universitätsklinikum Dresden
      Dresden, Saxony, Germany
    • Doncaster and Bassetlaw Hospitals NHS Foundation Trust
      Doncaster, ENG, United Kingdom
  • 2007–2012
    • University of Leicester
      • • Department of Cardiovascular Sciences
      • • Department of Health Sciences
      Leicester, ENG, United Kingdom
  • 2010
    • Nottinghamshire Healthcare NHS Trust
      Nottingham, ENG, United Kingdom