The effects of Hartcoach, a life style intervention provided by telephone on the reduction of coronary risk factors: a randomised trial

ABSTRACT: BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death worldwide. Secondary prevention is essential, but participation rates for cardiac rehabilitation are low. Furthermore, current programmes do not accomplish that patients with CVD change their lifestyle in a way that their individual risk factors for recurrent events decrease, therefore more effective interventions are needed. In this study, the effectiveness of the Hartcoach-programme, a telephonic secondary prevention program focussing on self management, is studied. Methods/design A multicenter, randomised parallel-group study is being conducted. Participants are 400 patients with acute myocardial infarction (STEMI, NSTEMI,) and patients with chronic or unstable angina pectoris (IAP). Patients are recruited through the participating hospitals and randomly assigned to the experimental group (Hartcoach-programme plus usual care) or the control group (usual care). The Hartcoach-programme consists of a period of six months during which the coach contacts the patient every four to six weeks by telephone. Coaches train patients to take responsibility for the achievement and maintenance of the defined target levels for their particular individual modifiable risk factors. Target levels and treatment goals are agreed by the nurse and patient together. Data collection is blinded and occurs at baseline and after 26 weeks (post-intervention). Primary outcome is change in cardiovascular risk factors (cholesterol, body mass index, waist circumference, blood pressure, physical activity and diet). Secondary outcomes include chances in glucose, HbA1c, medication adherence, selfmanagement and quality of life. DISCUSSION: This study evaluates the effects of the Hartcoach-programme on the reduction of individual risk factors of patients with CVDs. Patients who are not invited to follow a hospital based rehabilitation programme or patients who are unable to adhere to such a programme, may be reached by this home based Hartcoach-programme. If positive results are found, the implementation of the Hartcoach-programme will be extended, having implications for the management of many people with CVD. Trial registration NTR2388.     

Different strategies for screening and prevention of type 2 diabetes in adults: cost effectiveness analysis

Objective To compare four potential screening strategies, and subsequent interventions, for the prevention and treatment of type 2 diabetes: (a) screening for type 2 diabetes to enable early detection and treatment, (b) screening for type 2 diabetes and impaired glucose tolerance, intervening with lifestyle interventions in those with a diagnosis of impaired glucose tolerance to delay or prevent diabetes, (c) as for (b) but with pharmacological interventions, and (d) no screening.Design Cost effectiveness analysis based on development and evaluation of probabilistic, comprehensive economic decision analytic model, from screening to death.Setting A hypothetical population, aged 45 at time of screening, with above average risk of diabetes.Data sources Published clinical trials and epidemiological studies retrieved from electronic bibliographic databases; supplementary data obtained from the Department of Health statistics for England and Wales, the screening those at risk (STAR) study, and the Leicester division of the ADDITION study.Methods A hybrid decision tree/Markov model was developed to simulate the long term effects of each screening strategy, in terms of both clinical and cost effectiveness outcomes. The base case model assumed a 50 year time horizon with discounting of both costs and benefits at 3.5%. Sensitivity analyses were carried out to investigate assumptions of the model and to identify which model inputs had most impact on the results.Results Estimated costs for each quality adjusted life year (QALY) gained (discounted at 3.5% a year for both costs and benefits) were £14 150 (€17 560; $27 860) for screening for type 2 diabetes, £6242 for screening for diabetes and impaired glucose tolerance followed by lifestyle interventions, and £7023 for screening for diabetes and impaired glucose tolerance followed by pharmacological interventions, all compared with no screening. At a willingness-to-pay threshold of £20 000 the probability of the intervention being cost effective was 49%, 93%, and 85% for each of the active screening strategies respectively.Conclusions Screening for type 2 diabetes and impaired glucose tolerance, with appropriate intervention for those with impaired glucose tolerance, in an above average risk population aged 45, seems to be cost effective. The cost effectiveness of a policy of screening for diabetes alone, which offered no intervention to those with impaired glucose tolerance, is still uncertain.     

Fasting Plasma Glucose as Initial Screening for Diabetes and Prediabetes in Irish Adults: The Diabetes Mellitus and Vascular Health Initiative (DMVhi)

Objective

Type 2 diabetes has a long pre clinical asymptomatic phase. Early detection may delay or arrest disease progression. The Diabetes Mellitus and Vascular health initiative (DMVhi) was initiated as a prospective longitudinal cohort study on the prevalence of undiagnosed Type 2 diabetes and prediabetes, diabetes risk and cardiovascular risk in a cohort of Irish adults aged 45-75 years.

Research Design and Methods

Members of the largest Irish private health insurance provider aged 45 to 75 years were invited to participate in the study. Exclusion criteria: already diagnosed with diabetes or taking oral hypoglycaemic agents. Participants completed a detailed medical questionnaire, had weight, height, waist and hip circumference and blood pressure measured. Fasting blood samples were taken for fasting plasma glucose (FPG). Those with FPG in the impaired fasting glucose (IFG) range had a 75gm oral glucose tolerance test performed.

Results

122,531 subjects were invited to participate. 29,144 (24%) completed the study. The prevalence of undiagnosed diabetes was 1.8%, of impaired fasting glucose (IFG) was 7.1% and of impaired glucose tolerance (IGT) was 2.9%. Dysglycaemia increased among those aged 45-54, 55-64 and 65-75 years in both males (10.6%, 18.5%, 21.7% respectively) and females (4.3%, 8.6%, 10.9% respectively). Undiagnosed T2D, IFG and IGT were all associated with gender, age, blood pressure, BMI, abdominal obesity, family history of diabetes and triglyceride levels. Using FPG as initial screening may underestimate the prevalence of T2D in the study population.

Conclusions

This study is the largest screening study for diabetes and prediabetes in the Irish population. Follow up of this cohort will provide data on progression to diabetes and on cardiovascular outcomes.     

Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care: protocol of the ProAct 65+ trial

Background

Earlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in Type 2 Diabetes Mellitus (T2DM). Latent phase identification through screening requires structured, appropriately targeted population-based approaches. Providers responsible for implementing screening policy await evidence of clinical and cost effectiveness from randomised intervention trials in screen-detected T2DM cases. UK South Asians are at particularly high risk of abnormal glucose tolerance and T2DM. To be effective national screening programmes must achieve good coverage across the population by identifying barriers to the detection of disease and adapting to the delivery of earlier care. Here we describe the rationale and methods of a systematic community screening programme and randomised controlled trial of cardiovascular risk management within a UK multiethnic setting (ADDITION-Leicester).

Design

A single-blind cluster randomised, parallel group trial among people with screen-detected T2DM comparing a protocol driven intensive multi-factorial treatment with conventional care.

Methods

ADDITION-Leicester consists of community-based screening and intervention phases within 20 general practices coordinated from a single academic research centre. Screening adopts a universal diagnostic approach via repeated 75g-Oral Glucose Tolerance Tests within an eligible non-diabetic population of 66,320 individuals aged 40-75 years (25-75 years South Asian). Volunteers also provide detailed medical and family histories; complete health questionnaires, undergo anthropometric measures, lipid profiling and a proteinuria assessment. Primary outcome is reduction in modelled Coronary Heart Disease (UKPDS CHD) risk at five years. Seven thousand (30% of South Asian ethnic origin) volunteers over three years will be recruited to identify a screen-detected T2DM cohort (n = 285) powered to detected a 6% relative difference (80% power, alpha 0.05) between treatment groups at one year. Randomisation will occur at practice-level with newly diagnosed T2DM cases receiving either conventional (according to current national guidelines) or intensive (algorithmic target-driven multi-factorial cardiovascular risk intervention) treatments.

Discussion

ADDITION-Leicester is the largest multiethnic (targeting >30% South Asian recruitment) community T2DM and vascular risk screening programme in the UK. By assessing feasibility and efficacy of T2DM screening, it will inform national disease prevention policy and contribute significantly to our understanding of the health care needs of UK South Asians.

Trial registration

Clinicaltrial.gov (NCT00318032).     

Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial

Background

Cardiovascular disease (including coronary heart disease and stroke) is a major cause of death and disability in the United Kingdom, and is to a large extent preventable, by lifestyle modification and drug therapy. The recent standardisation of electronic codes for cardiovascular risk variables through the United Kingdom's new General Practice contract provides an opportunity for the application of risk algorithms to identify high risk individuals. This randomised controlled trial will test the benefits of an automated system of alert messages and practice searches to identify those at highest risk of cardiovascular disease in primary care databases.

Design

Patients over 50 years old in practice databases will be randomised to the intervention group that will receive the alert messages and searches, and a control group who will continue to receive usual care. In addition to those at high estimated risk, potentially high risk patients will be identified who have insufficient data to allow a risk estimate to be made. Further groups identified will be those with possible undiagnosed diabetes, based either on elevated past recorded blood glucose measurements, or an absence of recent blood glucose measurement in those with established cardiovascular disease.

Outcome measures

The intervention will be applied for two years, and outcome data will be collected for a further year. The primary outcome measure will be the annual rate of cardiovascular events in the intervention and control arms of the study. Secondary measures include the proportion of patients at high estimated cardiovascular risk, the proportion of patients with missing data for a risk estimate, and the proportion with undefined diabetes status at the end of the trial.     

Comparison of active treatments for impaired glucose regulation: a Salford Royal Foundation Trust and Hitachi collaboration (CATFISH): study protocol for a randomized controlled trial

BackgroundDiabetes is highly prevalent and contributes to significant morbidity and mortality worldwide. Behaviour change interventions that target health and lifestyle factors associated with the onset of diabetes can delay progression to diabetes, but many approaches rely on intensive one-to-one contact by specialists. Health coaching is an approach based on motivational interviewing that can potentially deliver behaviour change interventions by non-specialists at a larger scale. This trial protocol describes a randomized controlled trial (CATFISH) that tests whether a web-enhanced telephone health coaching intervention (IGR3) is more acceptable and efficient than a telephone-only health coaching intervention (IGR2) for people with prediabetes (impaired glucose regulation).MethodsCATFISH is a two-parallel group, single-centre individually randomized controlled trial. Eligible participants are patients aged ≥18 years with impaired glucose regulation (HbA1c concentration between 42 and 47 mmol/mol), have access to a telephone and home internet and have been referred to an existing telephone health coaching service at Salford Royal NHS Foundation Trust, Salford, UK. Participants who give written informed consent will be randomized remotely (via a clinical trials unit) to either the existing pathway (IGR2) or the new web-enhanced pathway (IGR3) for 9 months. The primary outcome measure is patient acceptability at 9 months, determined using the Client Satisfaction Questionnaire. Secondary outcome measures at 9 months are: cost of delivery of IGR2 and IGR3, mental health, quality of life, patient activation, self-management, weight (kg), HbA1c concentration, and body mass index. All outcome measures will be analyzed on an intention-to-treat basis. A qualitative process evaluation will explore the experiences of participants and providers with a focus on understanding usability of interventions, mechanisms of behaviour change, and impact of context on delivery and user acceptability. Qualitative data will be analyzed using Framework.DiscussionThe CATFISH trial will provide a pragmatic assessment of whether a web-based information technology platform can enhance acceptability of a telephone health coaching intervention for people with prediabetes. The data will prove critical in understanding the role of web applications to improve engagement with evidence-based approaches to preventing diabetes.

Trial registration

ISRCTN16534814. Registered on 7 February 2016.

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-016-1519-6) contains supplementary material, which is available to authorized users.     

Randomised controlled trial evaluating cardiovascular screening and intervention in general practice: principal results of British family heart study. Family Heart Study Group.

OBJECTIVE--To measure the change in cardiovascular risk factors achievable in families over one year by a cardiovascular screening and lifestyle intervention in general practice. DESIGN--Randomised controlled trial in 26 general practices in 13 towns in Britain. SUBJECTS--12,472 men aged 40-59 and their partners (7460 men and 5012 women) identified by household. INTERVENTION--Nurse led programme using a family centred approach with follow up according to degree of risk. MAIN OUTCOME MEASURES--After one year the pairs of practices were compared for differences in (a) total coronary (Dundee) risk score and (b) cigarette smoking, weight, blood pressure, and random blood cholesterol and glucose concentrations. RESULTS--In men the overall reduction in coronary risk score was 16% (95% confidence interval 11% to 21%) in the intervention practices at one year. This was partitioned between systolic pressure (7%), smoking (5%), and cholesterol concentration (4%). The reduction for women was similar. For both sexes reported cigarette smoking at one year was lower by about 4%, systolic pressure by 7 mm Hg, diastolic pressure by 3 mm Hg, weight by 1 kg, and cholesterol concentration by 0.1 mmol/l, but there was no shift in glucose concentration. Weight, blood pressure, and cholesterol concentration showed the greatest difference at the top of the distribution. If maintained long term the differences in risk factors achieved would mean only a 12% reduction in risk of coronary events. CONCLUSIONS--As most general practices are not using such an intensive programme the changes in coronary risk factors achieved by the voluntary health promotion package for primary care are likely to be even smaller. The government''s screening policy cannot be justified by these results.     

The Diabetes Epidemic in China: An Integrated Review of National Surveys

Objective: To review trends in the prevalence and incidence of diabetes mellitus (DM) and related risk factors in China.Methods: We searched the literature using PubMed, China Knowledge Resource Integrated Database, and China Wanfang Digital Database for large epidemiologic studies and national surveys.Results: During the past 30 years (1980–2010), 7 national diabetes mellitus surveys were conducted in China mainland, indicating that the prevalence of DM has increased 17-fold, from 0.67 to 11.6% of the population. The prevalence of impaired glucose regulation (IGR, including impaired fasting glucose and impaired glucose tolerance) also increased, from 2.09 in 1994 to 27.2% in 2010. There was no national representative study of the incidence of diabetes to date; the reported incidence of type 2 diabetes during past 25 years in several cohort studies varied (2.7 to 15.8 per 1,000 person-years). Potential risk factors which could have contributed to the increasing prevalence and incidence of DM and IGR in the Chinese population include social and economic development, urbanization, dietary pattern, and Westernized lifestyle. Further, genetic studies have suggested that unique inheritable risk factors in the Chinese population may increase the risk for DM when compared to Caucasians.Conclusion: DM and IGR have become epidemic in China. Public health strategies should focus on modifying lifestyle and dietary factors, particularly among those with a susceptible genetic background.Abbreviations:BMI = body mass indexDM = diabetes mellitusFBG = fasting blood glucoseGWAS = genome-wide association studyIGR = impaired glucose regulationIGT = impaired glucose toleranceOGTT = oral glucose tolerance testT2D = type 2 diabetesWC = waist circumferenceWHR = waist-hip ratio     

A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. METHODS: This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control).Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice.orControl group: Standard GP care, with referral to secondary care as required, but no access to ICCD.Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (<=7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients. DISCUSSION: Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.Trial registration[ClinicalTrials.gov: Identifier NCT00945204].     

Prevention of type 2 diabetes

Changes in the human environment and in human behavior and lifestyle, in conjunction with genetic susceptibility, have resulted in a dramatic increase in the incidence and prevalence of diabetes in the world. The rapid escalation of the number of people with type 2 diabetes (T2DM) and diabetes-related cardiovascular disease demands urgent action on prevention. The Finnish Diabetes Prevention Study and The Diabetes Prevention Program showed that the prevention (or delaying) of T2DM is feasible and effective. Both of these trials led to a reduction of 58% in the conversion to diabetes in subjects with impaired glucose tolerance. Compared to lifestyle changes, drug treatment in the prevention of diabetes in people at high risk for T2DM has been less beneficial. Metformin (31%) or acarbose (25%) treatment obtained only about a half of the reduction in the conversion to diabetes compared to lifestyle changes. These drugs require monitoring, and have significant side-effects. Also the effect of orlistat (37%) did not reach the effect of lifestyle modification. Results of the Troglitazone in Prevention of Diabetes study are suggestive for the prevention, but the trial was too small, and included only one ethnic group (Hispanic) and one gender (women). On the basis of the evidence available, we do not have a definite proof that T2DM is prevented in any of these trials. However, we can safely conclude that the current evidence strongly favors the notion that lifestyle changes are the primary means to tackle the epidemic of T2DM.     

Gestational diabetes: a non-entity?

Screening for gestational diabetes is commonly recommended despite the absence of a common definition of gestational diabetes. Furthermore, there is no consensus about management or treatment. Those who recommend screening do so largely on the basis of fetal morbidity, which seems to be predominantly "macrosomia"--another term without an agreed definition. The implications of macrosomia in terms of actual morbidity are also not clear. R J Jarrett reviews the history of the subject and concludes that gestational diabetes is simply impaired glucose tolerance temporally associated with pregnancy. Its main importance is as a predictor of subsequent non-insulin dependent diabetes, but it fails the major tests for a condition suitable for a screening programme.     

An Outpatient-Based Clinical Program for Type 2 Diabetes Prevention

ObjectiveTo review first-year results of a clinic-based type 2 diabetes prevention program.MethodsFrom January through December 2007, patients with a diagnosis of prediabetes participated in the Diet-Exercise-Activity-Lifestyle program for instruction in lifestyle changes. Physical therapy assessments were retospectively reviewed to search for symptoms or findings of physical impairments. Changes in weight and 2-hour glucose tolerance test results were assessed at 6 months. Patient satisfaction with the program was evaluated.ResultsNinety-two patients qualified for the program. Mean baseline fasting glucose concentration was 108 mg/dL, and 2-hour glucose concentration was 134 mg/dL. Mean age was 62 years, and 66% were women. Review of physical therapy assessments demonstrated gait/balance disturbances in 47% of patients, peripheral neuropathy in 43%, and musculoskeletal problems in 63%. Among 47 patients who had 6-month follow-up visits, 72% lost weight. Fasting glucose levels improved in 58% in persons with impaired fasting glucose, and 2-hour glucose values decreased in patients who had impaired glucose tolerance. Seventy-eight percent graded the program as either “very good” or “excellent.”ConclusionsPrograms geared toward type 2 diabetes prevention can be feasibly implemented on an outpatient basis. Preliminary data suggest that improvements in weight and glucose values can be achieved. As the prevalence of prediabetes increases, health care systems must gain further experience with effective outpatient diabetes prevention strategies. (Endocr Pract 2010;16:21-29)     

The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial

ABSTRACT: BACKGROUND: The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established.The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention programme of 6 months duration aimed at maximum reduction of cardiovascular risk factors in patients with cardiovascular disease (CVD) compared with usual care. METHODS: A single centre, two arm, parallel group randomised controlled trial was performed. Patients with stable established CVD and at least one lifestyle-related risk factor were recruited from the vascular and cardiology outpatient departments of the university hospital. Blocked randomisation was used to allocate patients to the intervention (n = 71) or control group (n = 75) using an on-site computer system combined with allocations in computer-generated tables of random numbers kept in a locked computer file. The intervention group received the comprehensive lifestyle intervention offered in a specialised outpatient clinic in addition to usual care. The control group continued to receive usual care. Outcome measures were the lifestyle-related cardiovascular risk factors: smoking, physical activity, physical fitness, diet, blood pressure, plasma total/HDL/LDL cholesterol concentrations, BMI, waist circumference, and changes in medication. RESULTS: The intervention led to increased physical activity/fitness levels and an improved cardiovascular risk factor profile (reduced BMI and waist circumference). In this setting, cardiovascular risk management for blood pressure and lipid levels by prophylactic treatment for CVD in usual care was already close to optimal as reflected in baseline levels. There was no significant improvement in any other risk factor. CONCLUSIONS: Even in CVD patients receiving good clinical care and using cardioprotective drug treatment, a comprehensive lifestyle intervention had a beneficial effect on some cardiovascular risk factors. In the present era of cardiovascular therapy and with the increasing numbers of overweight and physically inactive patients, this study confirms the importance of risk factor control through lifestyle modification as a supplement to more intensified drug treatment in patients with CVD.Trial registrationISRCTN69776211 at http://www.controlled-trials.com.     

Prevention of type 2 diabetes--lessons we have learnt for implementation.

The challenge today is to implement successful diabetes prevention programs in general health care. Even if not all questions for the prevention of diabetes are answered, we have today overwhelming evidence that diabetes can be prevented or delayed in high risk population through lifestyle modification or pharmacological interventions. This information has to be translated now into well-defined strategies for screening and treating high risk population in daily practice. It is necessary then to develop and implement prevention programs into clinical practice considering scientific aspects and practical requirements during implementation. While translating the scientific evidence into population based intervention strategies more and more questions arise, mostly related to economic and structural requirements during implementation. At the end, giving the right answers to these questions will decide about the success of implemented prevention strategies. Here, we will try to answer some of the questions which arose during the implementation of a prevention management concept into clinical practice. We focus on the development of a structured prevention management program which will enable implementation of diabetes prevention into clinical practice.     

Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial

BackgroundLifestyle modification is widely recommended to kidney allograft recipients post transplantation due to the cardiometabolic risks associated with immunosuppression including new-onset diabetes, weight gain and cardiovascular events. However, we have no actual evidence that undertaking lifestyle modification protects from any adverse outcomes post transplantation. The aim of this study is to compare whether a more proactive versus passive interventional approach to modify lifestyle is associated with superior outcomes post kidney transplantation.Methods/designWe designed this prospective, single-centre, open-label, randomised controlled study to compare the efficacy of active versus passive lifestyle intervention for kidney allograft recipients early post transplantation. A total of 130 eligible patients, who are stable, nondiabetic and between 3 and 24 months post kidney transplantation, will be recruited. Randomisation is being undertaken by random block permutations into passive (n = 65, leaflet guidance only) versus active lifestyle modification (n = 65, supervised intervention) over a 6-month period. Supervised intervention is being facilitated by two dietitians during the 6-month intervention period to provide continuous lifestyle intervention guidance, support and encouragement. Both dietitians are accredited with behavioural intervention skills and will utilise motivational aids to support study recruits randomised to active intervention. The primary outcome is change in abnormal glucose metabolism parameters after 6 months of comparing active versus passive lifestyle intervention. Secondary outcomes include changes in a wide array of cardiometabolic parameters, kidney allograft function and patient-reported outcome measures. Long-term tracking of patients via data linkage to electronic patient records and national registries will facilitate long-term comparison of outcomes after active versus passive lifestyle intervention beyond the 6-month intervention period.DiscussionThis is the first randomised controlled study to investigate the benefits of active versus passive lifestyle intervention in kidney allograft recipients for the prevention of abnormal cardiometabolic outcomes. In addition, this is the first example of utilising behaviour therapy intervention post kidney transplantation to achieve clinically beneficial outcomes, which has potential implications on many spheres of post-transplant care.

Trial registration

This study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: {"type":"clinical-trial","attrs":{"text":"NCT02233491","term_id":"NCT02233491"}}NCT02233491).     

Effects of coffee consumption on glucose tolerance, serum glucose and insulin levels--a cross-sectional analysis.

OBJECTIVE: Coffee has several metabolic effects that could reduce the risk of type 2 diabetes. Our objective was to examine the effects of coffee consumption on glucose tolerance, glucose and insulin levels. RESEARCH DESIGN AND METHODS: A subsample of subjects aged 45 to 64 years in 1987 and in 1992 from the population-based FINRISK study (12,287 individuals) was invited to receive the standard oral glucose tolerance test at baseline. Plasma samples were taken after an overnight fast, and a two-hour oral glucose tolerance test was administered. Fasting and two-hour plasma glucose and insulin were measured in 2434 subjects with data on coffee use and potential confounders. RESULTS: After adjustment for potential confounding factors (age, body mass index, systolic blood pressure, occupational, commuting and leisure time physical activity, alcohol and tea drinking, smoking), coffee consumption was significantly and inversely associated with fasting glucose, two-hour plasma glucose, and fasting insulin in both men and women. Coffee consumption was significantly and inversely associated with impaired fasting glucose, impaired glucose regulation, and hyperinsulinemia among both men and women and with isolated impaired glucose tolerance among women. CONCLUSIONS: In this cross-sectional analysis, coffee showed positive effects on several glycemia markers.     

Appropriate,timely, and rational treatment of type 2 diabetes mellitus: Meeting the challenges of primary care

Diabetes now affects >24 million people in the United States. As the prevalence of diabetes continues to increase, long-term complications of diabetes have emerged as major health care issues. Although much focus has been placed on diabetes, it is important to note that prediabetes, the intermediate state of type 2 diabetes mellitus (DM), is not benign. The progression to type 2 DM for patients with impaired glucose tolerance (IGT) is 6% to 10% per year; for persons with both impaired fasting glucose and IGT, the cumulative incidence of diabetes in 6 years may be as high as 60%. Given the significant clinical and financial impact of both conditions, it is vital that clinicians initiate treatment of diabetes and prediabetes early and aggressively. Despite advances in diabetes treatment, many health care providers do not initiate or intensify therapy appropriately during patient visits, which contributes to poor diabetes control. Although management of blood pressure and lipid levels can be complex, glycemic control is often problematic for patients and their clinicians. Thus, clinicians must learn to use the various pharmacologic and nonpharmacologic strategies effectively to achieve glucose targets in their patients with type 2 DM. Patients with prediabetes should be managed with a combination of lifestyle intervention and appropriately timed pharmacotherapy. Pancreatic β-cell preservation should be a primary metabolic target.     

The possibility of prevention of type 2 diabetes

INTRODUCTION: The aim of this study was to examine usefulness of oral glucose tolerance test (OGTT) in clinical evaluation of different glucose metabolism disturbances in subjects with at least one risk factor of type 2 diabetes. We compared the effectiveness of non-pharmacological and pharmacological prevention and treatment regiments on metabolic control in these individuals. MATERIAL AND METHODS: The study involved 130 patients, with the following characteristics: age between 18 to 76 years, mean body mass index (BMI) - 31.82 +/- 7.24 kg/m(2), and presence of at least one of the risk factor of type 2 diabetes. Glucose metabolism disturbances were diagnosed according to World Health Organization (WHO) criteria. Non-pharmacological regiments were applied for 3 months for patients with impaired glucose tolerance (IGT) and type 2 diabetes. Patients, whose still met criteria for type 2 diabetes during OGTT after non-pharmacological treatment were scheduled for pharmacological interventions. These patients were assigned at random to two groups, that were treated with either metformin or acarbose. The measurements of total cholesterol (TC), HDL-cholesterol , LDL-cholesterol, trigliceryde (TG), glucose, HbA(1c) and/or OGGT were performed during each visit. We also assessed risk factors for type 2 diabetes in these subjects. RESULTS: The prevalence of abnormal glucose tolerance in subjects with at least one of the risk factor of diabetes type 2 was near 40%. OGTT in these subjects increased the possibility of diagnosis diabetes type 2 and IGT. Hypertension (81%), hypercholesterolemia (71.4%), hypertriglicerydemia (71.4%) and obesity (66.7%) were the most frequent risk factors observed. There were no differences in biochemical measurements between these groups of patients. CONCLUSIONS: Individuals with at least one risk factor of type 2 diabetes should have screening test to diagnose glucose intolerance. Both non-pharmacological and pharmacological intervention was effective in normalization of glucose OGTT in patients with diabetes type 2 and IGT in newly diagnosed with disease patients.