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The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial
Laura MC Welschen, Sandra DM Bot, Jacqueline M Dekker, Dani?lle RM Timmermans, Trudy van der Weijden, Giel Nijpels
BMC Public Health , 2010, DOI: 10.1186/1471-2458-10-457
Abstract: The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception, attitude and intention to change lifestyle behaviour in patients with T2DM. The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory.A randomised controlled trial will be performed in the Diabetes Care System West-Friesland (DCS), a managed care system. Newly referred T2DM patients of the DCS, younger than 75 years will be eligible for the study. The intervention group will be exposed to risk communication on CVD, on top of standard managed care of the DCS. This intervention consists of a simple explanation on the causes and consequences of CVD, and possibilities for prevention. The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram. The control group will receive standard managed care. The primary outcome is appropriateness of risk perception. Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception. Differences between baseline and follow-up (2 and 12 weeks) between groups will be analysed according to the intention-to-treat principle. The study was powered on 120 patients in each group.This innovative risk communication method based on two behavioural theories might improve patient's appropriateness of risk perception and attitude concerning lifestyle change. With a better understanding of their CVD risk, patients will be able to make informed choices concerning diabetes care.The trial is registered as NTR1556 in the Dutch Trial Register.Patients with type 2 diabetes mellitus (T2DM) have an increased risk to develop severe complications including cardiovascular disease (CVD). The risk of these complications can be reduced by an adequate treatment with medication and by adopting a healthy lifestyle [1-3]. During the last few decades, patie
The DiGEM trial protocol – a randomised controlled trial to determine the effect on glycaemic control of different strategies of blood glucose self-monitoring in people with type 2 diabetes [ISRCTN47464659]
Andrew Farmer, Alisha Wade, David P French, Elizabeth Goyder, Ann Kinmonth, Andrew Neil
BMC Family Practice , 2005, DOI: 10.1186/1471-2296-6-25
Abstract: DiGEM is a three arm randomised parallel group trial set in UK general practices. A total of 450 patients with type 2 diabetes managed with lifestyle or oral glucose lowering medication are included. The trial compares effectiveness of three strategies for monitoring glycaemic control over 12 months (1) a control group with three monthly HbA1c measurements; interpreted with nurse-practitioner; (2) A self-testing of blood glucose group; interpreted with nurse- practitioner to inform adjustment of medication in addition to 1; (3) A self-monitoring of blood glucose group with personal use of results to interpret results in relation to lifestyle changes in addition to 1 and 2.The trial has an 80% power at a 5% level of significance to detect a difference in change in the primary outcome, HbA1c of 0.5% between groups, allowing for an attrition rate of 10%. Secondary outcome measures include health service costs, well-being, and the intervention effect in sub-groups defined by duration of diabetes, current management, health status at baseline and co-morbidity. A mediation analysis will explore the extent to which changes in beliefs about self-management of diabetes between experimental groups leads to changes in outcomes in accordance with the Common Sense Model of illness. The study is open and has recruited more than half the target sample. The trial is expected to report in 2007.The DiGEM intervention and trial design address weaknesses of previous research by use of a sample size with power to detect a clinically significant change in HbA1c, recruitment from a well-characterised primary care population, definition of feasible monitoring and behaviour change strategies based on psychological theory and evidence, and measures along the hypothesised causal path from cognitions to behaviours and disease and well being related outcomes. The trial will provide evidence to support, focus or discourage use of specific BGSM strategies.Diabetes is now a major public health pro
Screening asymptomatic patients with diabetes for unknown coronary artery disease: Does it reduce risk? An open-label randomized trial comparing a strategy based on exercise testing aimed at revascularization with management based on pharmacological/behavioural treatment of traditional risk factors. DADDY-D Trial (Does coronary Atherosclerosis Deserve to be Diagnosed and treated early in Diabetics?)
Fabrizio Turrini, Roberto Messora, Paolo Giovanardi, Stefano Tondi, Paolo Magnavacchi, Rita Cavani, Giandomenico Tosoni, Carlo Cappelli, Elisa Pellegrini, Stefania Romano, Augusto Baldini, Romeo Zennaro, Marco Bondi
Trials , 2009, DOI: 10.1186/1745-6215-10-119
Abstract: In the present study a cohort of diabetic patients without any symptoms and without known coronary artery disease will be screened at two diabetes outpatients services. Those with intermediate or high risk (equal or greater than 10% according to the Italian risk chart) will be asked to participate and enrolled. They will be seen and followed in order to provide the best adherence to medical therapy. Half of the patients will be randomized to undergo an exercise tolerance testing while the other group will continue to be regularly seen at diabetes outpatients services. Best medical/behavioral therapy will be offered to both groups. Those patients with a positive exercise tolerance testing will be studied by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery.The objective of the study is to evaluate the efficacy of the screening strategy aimed at revascularization. A cost-effectiveness analysis will be performed at the end of the follow up.The study will provide useful information about prevention and treatment of diabetic patients at high risk of coronary events. It will be made clearer if detection of silent coronary artery disease has to be recommended and followed by treatment. Given the simplicity of the study protocol, it will be easily transferable to the real world.(ClinicalTrials.gov): NCT00547872The association between diabetes and cardiovascular disease is well established. Prevalence of cardiac ischemic disease in the general population is between 2 and 4%, while it reaches 55% among adult diabetic patients [1].Coronary artery disease is the leading cause of death in diabetic patients accounting for more than 70% of the deaths [2,3].It is well known that patients with type 2 diabetes without prior myocardial infarction have a similar risk of death from coronary artery disease as patients without diabetes with prior myocardial infarction. Diabetes is considered to be a risk equivalent of corona
Evaluation of a pharmacist-managed diabetes medication therapy adherence clinic
Lim,Phei Ching; Lim,Kelvin;
Pharmacy Practice (Internet) , 2010, DOI: 10.4321/S1886-36552010000400008
Abstract: patient adherence to prescribed medication regimens is important in diabetes care to prevent or delay microvascular and macrovascular complications such as retinopathy, nephropathy and myocardial infarction. in penang hospital, malaysia, pharmacists collaborate with physicians in diabetes care through a pharmacist-managed diabetes medication therapy adherence clinic (dmtac) in the endocrine clinic, in operation since 2006. objective: to evaluate the effectiveness of the pharmacist-managed dmtac program in improving glycaemic control, lipid parameters and patients′ medication adherence. method: a retrospective study among patients enrolled in the dmtac program was conducted between september 2007 and december 2008. data was included from patients with a glycosylated haemoglobin (hba1c) >8% and who had completed eight visits with the pharmacists. medical records and dmtac forms that provided patients′ demographics, medication regimens, adherence and laboratory parameters as well as pharmacists′ interventions were reviewed. hba1c, fasting blood glucose (fbg), low-density lipoprotein cholesterol (ldl), triglycerides (tg) and high-density lipoprotein cholesterol (hdl) were evaluated. documented data of patients′ adherence to medication regimen [modified morisky medication adherence score (mmmas); high adherence if score >8, medium adherence if score 6 to <8 and low adherence if score <6] was also evaluated. results: a total of 43 patients (53.5% females; 46.5% malays, 44.2% chinese and 9.3% indians) were included in the analysis. a mean reduction in hba1c of 1.73% (p<0.001), mean reduction in fbg of 2.65mmol/l (p=0.01) and mean reduction in ldl cholesterol of 0.38mmol/l (p=0.007) were achieved. the difference in tg and hdl cholesterol were not significant. patients′ adherence to medication regimens improved significantly with an increase in the mean mmmas score from 7.00 to 10.84 (p<0.001) after completion of the dmtac program. conclusion: the pharmacist-managed dmtac pr
Evaluation of a pharmacist-managed diabetes medication therapy adherence clinic  [cached]
Lim PC,Lim K
Pharmacy Practice (Granada) , 2010,
Abstract: Patient adherence to prescribed medication regimens is important in diabetes care to prevent or delay microvascular and macrovascular complications such as retinopathy, nephropathy and myocardial infarction. In Penang Hospital, Malaysia, pharmacists collaborate with physicians in diabetes care through a pharmacist-managed Diabetes Medication Therapy Adherence Clinic (DMTAC) in the Endocrine Clinic, in operation since 2006. Objective: To evaluate the effectiveness of the pharmacist-managed DMTAC program in improving glycaemic control, lipid parameters and patients’ medication adherence. Method: A retrospective study among patients enrolled in the DMTAC program was conducted between September 2007 and December 2008. Data was included from patients with a glycosylated haemoglobin (HbA1c) >8% and who had completed eight visits with the pharmacists. Medical records and DMTAC forms that provided patients’ demographics, medication regimens, adherence and laboratory parameters as well as pharmacists’ interventions were reviewed. HbA1c, fasting blood glucose (FBG), low-density lipoprotein cholesterol (LDL), triglycerides (TG) and high-density lipoprotein cholesterol (HDL) were evaluated. Documented data of patients’ adherence to medication regimen [Modified Morisky Medication Adherence Score (MMMAS); high adherence if score >8, medium adherence if score 6 to <8 and low adherence if score <6] was also evaluated. Results: A total of 43 patients (53.5% females; 46.5% Malays, 44.2% Chinese and 9.3% Indians) were included in the analysis. A mean reduction in HbA1c of 1.73% (p<0.001), mean reduction in FBG of 2.65mmol/l (p=0.01) and mean reduction in LDL cholesterol of 0.38mmol/l (p=0.007) were achieved. The difference in TG and HDL cholesterol were not significant. Patients’ adherence to medication regimens improved significantly with an increase in the mean MMMAS score from 7.00 to 10.84 (p<0.001) after completion of the DMTAC program. Conclusion: The pharmacist-managed DMTAC program resulted in significant improvements in HbA1c, glucose and LDL cholesterol levels as well as medication adherence in patients with diabetes.
DiAlert: a lifestyle education programme aimed at people with a positive family history of type 2 diabetes and overweight, study protocol of a randomised controlled trial
Wieke H Heideman, Vera Nierkens, Karien Stronks, Barend JC Middelkoop, Jos WR Twisk, Arnoud P Verhoeff, Maartje de Wit, Frank J Snoek
BMC Public Health , 2011, DOI: 10.1186/1471-2458-11-751
Abstract: In this RCT, 268 (134 Dutch and 134 Turkish) overweight 1st degree relatives of patients with T2DM will be allocated to either the intervention or control group (leaflet). The intervention DiAlert aims to promote intrinsic motivation to change lifestyle, and sustain achieved behaviour changes during follow-up. Primary outcome is weight loss. Secondary outcomes include biological, behavioural and psychological indices, along with process indicators. Measurements will take place at baseline and after 3 and 9 months. Changes in outcomes are tested between intervention and control group at 3 months; effects over time are tested within and between both ethnic groups at 3 and 9 months.The DiAlert intervention is expected to be more effective than the control condition in achieving significant weight loss at 3 months, in both Dutch and Turkish Dutch participants.Netherlands National Trial Register (NTR): NTR2036The prevalence of people with type 2 diabetes (T2DM) in the general population is reaching epidemic proportions in many countries, with the total number of people with T2DM projected to rise to 366 million in 2030 worldwide [1]. It is therefore imperative that strategies to prevent the disease are implemented, this might include targeting high-risk populations to increase effectiveness. The increased prevalence is associated with lifestyle dependent risk factors, including being overweight, physical inactivity and unhealthy diet. In addition, the chance of developing T2DM is two to fourfold greater for people with a positive family history (FH) compared to those without, depending on the number of and the distance to the affected family members [2-4]. Since members of families share the same variations of genes, environment and behaviour patterns, family history information could possibly be used for screening and as a vehicle to motivate people at risk for T2DM to change behaviour [5,6]. However, targeting people with a positive family history of T2DM to promote li
Latent Autoimmune Diabetes Mellitus in Adults (LADA) and it’s characteristics in a subset of Nigerians initially managed for type 2 diabetes  [cached]
Adeleye Olufunmilayo O,Ogbera Anthonia O,Fasanmade Olufemi,Ogunleye Olayinka O
International Archives of Medicine , 2012, DOI: 10.1186/1755-7682-5-23
Abstract: Introduction Latent autoimmune diabetes in adults (LADA) is an entity characterized by the presence of GAD autoantibodies. LADA is largely understudied and underreported amongst Nigerians with Diabetes Mellitus (DM). We undertook to document the Prevalence, clinical and biochemical characteristics of LADA in a subset of Nigerians who hitherto had been treated for type 2 DM. Methods This is a cross-sectional study conducted on 235 patients being managed for type 2 DM. The diagnosis of LADA was made in the presence of Glutamic Acid Decarboxylase autoantibody (GADA) positivity in the study subjects. Thereafter persons with LADA were compared with those without LADA. Clinical parameters such as demographic data, history of diabetes mellitus (DM) and its complications were obtained, biochemical parameters including Fasting blood glucose (FBG), C-peptide, glycated haemoglobin (HbA1c) and lipid parameters were compared in both groups of Study subject. Test statistics used were Student t- test and χ 2. SPSS was used for data analysis. Results Thirty three out of 235 of the Study subjects were GADA positive, giving a prevalence of 14%. The mean age (SD) of the subjects with LADA is 53.24(7.22) with an age range of 30–63 years. Majority (48%) of LADA subjects were in the 50–59 age category. There was no significant difference in the proportion of males and females with LADA (p = 0.3). 37% of patients with LADA were on insulin for glycaemic control. Three (3) LADA subjects had history/clinical evidence of autoimmune thyroid disease. 66% of LADA were in the overweight/obese category. LADA subjects had significant poor long term glycaemic control compared with anti-GAD negative subjects (p = 0.026). About half of LADA subjects were insulinopaenic. LADA subjects had lower levels of total cholesterol than GADA-ve subjects (p = 0.03). A higher proportion of LADA had evidence of microvascular complications of DM compared with antiGAD negative individuals. Conclusion The diagnosis of LADA should be entertained in overweight/obese persons from the fourth decade of life presenting with DM. Pharmacotherapy with insulin is a potential means of managing hyperglycaemia in this group of patients especially since a significant proportion are insulinopaenic. The Prevalence of LADA in our patients is comparable to what obtains in Ghanaian and Caucasian populations.
Expression of ABC Efflux Transporters in Placenta from Women with Insulin-Managed Diabetes  [PDF]
Gregory J. Anger, Alex M. Cressman, Micheline Piquette-Miller
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0035027
Abstract: Drug efflux transporters in the placenta can significantly influence the materno-fetal transfer of a diverse array of drugs and other xenobiotics. To determine if clinically important drug efflux transporter expression is altered in pregnancies complicated by gestational diabetes mellitus (GDM-I) or type 1 diabetes mellitus (T1DM-I), we compared the expression of multidrug resistance protein 1 (MDR1), multidrug resistance-associated protein 2 (MRP2) and the breast cancer resistance protein (BCRP) via western blotting and quantitative real-time polymerase chain reaction in samples obtained from insulin-managed diabetic pregnancies to healthy term-matched controls. At the level of mRNA, we found significantly increased expression of MDR1 in the GDM-I group compared to both the T1DM-I (p<0.01) and control groups (p<0.05). Significant changes in the placental protein expression of MDR1, MRP2, and BCRP were not detected (p>0.05). Interestingly, there was a significant, positive correlation observed between plasma hemoglobin A1c levels (a retrospective marker of glycemic control) and both BCRP protein expression (r = 0.45, p<0.05) and BCRP mRNA expression (r = 0.58, p<0.01) in the insulin-managed DM groups. Collectively, the data suggest that the expression of placental efflux transporters is not altered in pregnancies complicated by diabetes when hyperglycemia is managed; however, given the relationship between BCRP expression and plasma hemoglobin A1c levels it is plausible that their expression could change in poorly managed diabetes.
The impact of behavioural screening on intervention outcomes in a randomised, controlled multiple behaviour intervention trial
Lauren A Waters, Elisabeth A Winkler, Marina M Reeves, Brianna S Fjeldsoe, Elizabeth G Eakin
International Journal of Behavioral Nutrition and Physical Activity , 2011, DOI: 10.1186/1479-5868-8-24
Abstract: Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention), characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups.Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also unexpected and detrimental. Physical activity screening (alone or in combination with diet) resulted in improved intervention effects for physical activity, while fruit and vegetable screening had no impact on intervention effects for these outcomes. All three types of screening impacted detrimentally on intervention effects for behaviours not being targeted by screening.Behavioural screening may have desirable and undesirable consequences in the context of multiple behaviour intervention trials, and thus its potential merits and pitfalls should be carefully considered.Participating in regular moderate intensity physical activity and consuming a healthy diet are fundamental to the prevention and management of many prevale
Difficulties in Recruitment for a Randomised Controlled Trial of Lifestyle Intervention for Type 2 Diabetes: Implications for Diabetes Management  [PDF]
George A. Jelinek, Emily Hadgkiss, Craig Hassed, Bernard Crimmins, Peter Schattner, Danny Liew, Rick Kausman, Warrick J. Inder, Siegfried Gutbrod, Tracey J. Weiland
Open Journal of Endocrine and Metabolic Diseases (OJEMD) , 2012, DOI: 10.4236/ojemd.2012.24008
Abstract: Objective: To report our experience of attempting a randomised controlled trial of an intensive lifestyle intervention for early type 2 diabetes delivered in a residential setting. Methods: We established a trial requiring 84 participants (46 standard care and 38 intervention) to detect a 1% difference in HbA1c between intervention and control groups at 12 months, allowing for attrition. Ethics approval was obtained from Monash University. Results: The study was abandoned after five months of consistent promotion due to recruitment failure (four subjects recruited). Conclusion: It appears to be difficult for patients with diabetes to commit to a live-in period of education regarding lifestyle modification as a means of treating the illness. We recommend better education of patients and their doctors about the potential health benefits of lifestyle change to manage type 2 diabetes, and further research into novel methods of delivering lifestyle advice which are both effective and sustainable.
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