Behavioural innovation is key to improving the health of one million Australians living with type 2 diabetes

Policy, research and clinical practice need a paradigm shift, focused on human behaviour and psychology.

Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy:a multicenter prospective 8 years follow up study

Background: Although numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention. Methods: We conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B). Results: Notably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan-Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012). Conclusions: These findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy.

The impact of bariatric surgery on estimated glomerular filtration rate in patients with type 2 diabetes:a retrospective cohort study

Background: Diabetes mellitus is the most common cause of end-stage renal disease, which is associated with increased morbidity and mortality. The impact of bariatric surgery on chronic kidney disease is unclear. Objectives: Our primary aim was to assess the impact of bariatric surgery on estimated glomerular filtration rate (eGFR) in type 2 diabetes (T2D) patients. Our secondary aim was to compare the impact of bariatric surgery versus routine care on eGFR in patients with T2D. Setting: University Hospital, United Kingdom. Methods: A retrospective cohort analysis of adults with T2D who underwent bariatric surgery at a single center between January 2005 and December 2012. Data regarding eGFR were obtained from electronic patients records. eGFR was calculated using the Modification of Diet in Renal Disease formula. Data regarding patients with T2D who did not undergo bariatric surgery ("routine care") were obtained from patients attending the diabetes clinic at the same center from 2009 to 2011. Results: One hundred sixty-three patients were included (mean age 48.5±8.8 yr; baseline body mass index 50.8±9.1 kg/m2) and were followed for 3.0±2.3 years. Bariatric surgery resulted in an improvement in eGFR (median [interquartile range] 86.0 [73.0-100.0] versus 92.0 [77.0-101.0] mL/min/1.73 m2 for baseline versus follow-up, respectively; P = .003), particularly in patients with baseline eGFR≤60 mL/min/1.73 m2 (48.0 [42.0-57.0] versus 61.0 [55.0-63.0] mL/min/1.73 m2; P = .004). After adjusting for baseline eGFR, glycated hemoglobin (HbA1C), body mass index, age, and gender, bariatric surgery was associated with higher study-end eGFR compared with routine care (B = 7.787; P< .001). Conclusion: Bariatric surgery results in significant improvements in eGFR in T2D patients, particularly those with an eGFR≤60 mL/min/1.73 m2, while routine care was associated with a decline in eGFR.

Sustained efficacy of dapagliflozin when added to metformin in type 2 diabetes inadequately controlled by metformin monotherapy

Background and aims: The selective SGLT2 inhibitor dapagliflozin (DAPA) reduces hyperglycaemia independently of insulin secretion or action by inhibiting renal glucose reabsorption. This study (MB102014) is a randomised double-blind, placebo (PBO)-controlled trial of DAPA added to metformin (MET) in T2DM (n=546) inadequately controlled with MET alone. Previously reported short-term data at week 24 showed significant mean reductions in the primary [HbA1c] and secondary [fasting plasma glucose (FPG) and weight] endpoints with DAPA compared to PBO. Here we report efficacy and safety results at week 102 of the long-term extension. Materials and methods: Patients aged 18-77 years with HbA1c 7-10% received DAPA 2.5 mg, 5 mg, 10 mg or PBO, plus open-label MET (≥1500mg/d). Exploratory endpoints at week 102 included changes from baseline in HbA1c, FPG and weight, and were analyzed by longitudinal repeated measures analysis. Results: Overall 71.2% of patients completed 102 weeks of the study; fewer on PBO (63.5%) than on DAPA 2.5 mg, 5 mg, and 10 mg (68.3%, 73.0%, 79.8%), due mainly to more patients on PBO discontinuing for lack of efficacy. At week 102, all DAPA groups showed greater mean reductions from baseline in HbA1c, FPG and weight compared to PBO (table), effects that were similar to those observed at week 24 and maintained throughout the trial. More patients at week 102 also achieved a therapeutic response of HbA1c<7% with DAPA 2.5 mg, 5 mg, and 10 mg (20.7%, 26.4%, 31.5%) than with PBO (15.4%). Adverse events (AEs), serious AEs and AEs leading to discontinuation were balanced across all groups. Signs and symptoms suggestive of genital infection (GenInf) were reported in 11.7%, 14.6%, 12.6% (DAPA 2.5 mg, 5 mg, 10 mg) and 5.1% (PBO) of patients, with 1 discontinuation due to GenInf. Signs and symptoms suggestive of urinary tract infection (UTI) were reported in 8.0%, 8.8%, 13.3% (DAPA 2.5 mg, 5 mg, 10 mg) and 8.0% (PBO), with 1 discontinuation due to UTI. No event of pyelonephritis was reported. Conclusion: In comparison to PBO, DAPA added to MET over 102 weeks demonstrated greater and sustained improvements in glycaemic control, clinically meaningful reduction in weight, and no increased risk of hypoglycaemia in patients with T2DM inadequately controlled with MET alone.

Therapeutic education, the premise of adherence to the type 2 diabetes therapeutic regimen

Background: type 2 diabetes mellitus includes changes in lifestyle in its etiology of prevention, but the evidence is clear —even when people know what to do and what they want to do, they simply do not adopt adherence behaviors. Structured education will allow improving not only metabolic control, but also the adjustment process to a new situation of disease, as well as to develop the patient’s skills in order to make him the key manager of his illness. Objectives: To determine patients’ adherence to prescribed therapeutic regimens. Material and methods: Quantitative, cross-sectional, non-experimental, descriptive, correlational study, with a sample of 102 people with type 2 diabetes, aged between 40 and 85 years old, mostly male (51.96%). The evaluation protocol included social-demographic and clinical questionnaire, Diabetes Self-care Scale and a questionnaire on Diabetes’ knowledge. We also used HbA1c in order to directly assess adherence. Results: It appears that there is no statistically signiicant correlation between socio-demographic variables such as gender and age and adherence. Variables, such as blood glucose monitoring, speciic diet compliance and knowledge, reveal a statistically signiicant effect on adherence (P < .05). Conclusion: The evidence is clear on the urgent need to recognize the importance of measuring patient adherence to a diabetes treatment plan for the maintenance of glycaemic control. We suggest the reinforcement of educational programs in people with type 2 diabetes so as to improve adherence to self-care.

Anabolic resistance does not explain sarcopenia in patients with type 2 diabetes mellitus, compared with healthy controls, despite reduced mTOR pathway activity

Background Ageing and type 2 diabetes mellitus (T2DM) are risk factors for skeletal muscle loss. We investigated whether anabolic resistance to feeding might underlie accelerated muscle loss in older people with T2DM and whether dysregulated mTOR signalling was implicated. Subjects 8 obese men with T2DM, and 12 age-matched controls were studied (age 68±3 vs. 68±6y; BMI: 30±2 vs. 27±5 kg·m-2). Methods Body composition was measured by dual-X-ray absorptiometry. Insulin and glucose were clamped at post-absorptive concentrations (13±2 vs. 9±3 mU·l-1; 7.4±1.9 vs. 4.6±0.4 mmol·l-1; T2DM vs. controls). Fractional synthetic rates (FSR) of myofibrillar and sarcoplasmic proteins were measured as the rate of incorporation of [13C] leucine during a primed, constant infusion of [1-13C] α-ketoisocaproic acid, 3 h after 10 or 20g of essential amino acids (EAA) were orally administered. Protein expression of total and phosphorylated mTOR signalling proteins was determined by Western blot analysis. Results Despite a significantly lower appendicular lean mass index and a greater fat mass index in T2DM vs. controls, basal myofibrillar and sarcoplasmic and post-prandial myofibrillar FSR were similar. After 20g EAA, stimulation of sarcoplasmic FSR was slightly blunted in T2DM patients. Furthermore, feeding 20g EAA increased phosphorylation of mTOR, p70S6k and 4E-BP1 by 60-100% in controls with no response observed in T2DM. Conclusions There was clear dissociation between changes in mTOR signalling versus changes in protein synthesis rates. However, the intact anabolic response of myofibrillar FSR to feeding in both groups suggests anabolic resistance may not explain accelerated muscle loss in T2DM.

Determination of metabolic equivalents during low-and high-intensity resistance exercise in healthy young subjects and patients with type 2 diabetes

The purpose of this study was to quantify the metabolic equivalents (METs) of resistance exercise in obese patients with type 2 diabetes (T2DM) and healthy young subjects and to evaluate whether there were differences between sessions executed at low- versus high-intensity resistance exercise. Twenty obese patients with T2DM (62.9±6.1 years) and 22 young subjects (22.6±1.9 years) performed two training sessions: one at vigorous intensity (80% of 1-repetition maximum (1RM)) and one at moderate intensity (60% of 1RM). Both groups carried out three strength exercises with a 2-day recovery between sessions. Oxygen consumption was continuously measured 15 min before, during and after each training session. Obese T2DM patients showed lower METs values compared with young healthy participants at the baseline phase (F= 2043.86; P<0.01), during training (F=1140.59; P<0.01) and in the post-exercise phase (F=1012.71; P<0.01). No effects were detected in the group x intensity analysis of covariance. In this study, at both light-moderate and vigorous resistance exercise intensities, the METs value that best represented both sessions was 3 METs for the obese elderly T2DM patients and 5 METs for young subjects.

Development and evaluation of a computer-based, self-management tool for people recently diagnosed with type 2 diabetes

Aim. The purpose of this study was to develop and evaluate a computer-based, dietary, and physical activity self-management program for people recently diagnosed with type 2 diabetes. Methods. The computer-based program was developed in conjunction with the target group and evaluated in a 12-week randomised controlled trial (RCT). Participants were randomised to the intervention (computer-program) or control group (usual care). Primary outcomes were diabetes knowledge and goal setting (ADKnowl questionnaire, Diabetes Obstacles Questionnaire (DOQ)) measured at baseline and week 12. User feedback on the program was obtained via a questionnaire and focus groups. Results. Seventy participants completed the 12-week RCT (32 intervention, 38 control, mean age 59 (SD) years). After completion there was a significant between-group difference in the "knowledge and beliefs scale" of the DOQ. Two-thirds of the intervention group rated the program as either good or very good, 92% would recommend the program to others, and 96% agreed that the information within the program was clear and easy to understand. Conclusions. The computer-program resulted in a small but statistically significant improvement in diet-related knowledge and user satisfaction was high. With some further development, this computer-based educational tool may be a useful adjunct to diabetes self-management. This trial is registered with clinicaltrials.gov NCT number NCT00877851.

Methodological comparisons of heart rate variability analysis in patients with type 2 diabetes and angiotensin converting enzyme polymorphism

Angiotensin converting enzyme (ACE) polymorphism has been shown to be important in hypertension progression and also in diabetes complications, especially associated with heart disease. Heart rate variability (HRV) is an established measure for classification of autonomic function regulating heart rate, based on the interbeat interval time series derived from a raw ECG recording. Results of this paper show that the length (number of interbeat intervals) and preprocessing of the tachogram affect the HRV analysis outcome. The comparison was based on tachogram lengths of 250, 300, 350, and 400 RR-intervals and five preprocessing approaches. An automated adaptive preprocessing method for the heart rate biosignal and tachogram length of 400 interbeat intervals provided the best classification. HRV results differed for the Type 2 Diabetes Mellitus (T2DM) group between the I/I genotype and the I/D and D/D genotypes, whereas for controls there was no significant difference in HRV between genotypes. Selecting an appropriate length of recording and automated preprocessing has confirmed that there is an effect of ACE polymorphism including the I/I genotype and that I/I should not be combined with I/D genotype in determining the extent of autonomic modulation of the heart rate.

Age of onset of obesity and risk of type 2 diabetes

OBJECTIVE: To compare a simple measure - age of onset of obesity - to an obese-years construct (a product of duration and magnitude of obesity) as risk factors for type 2 diabetes.

METHOD: Participants from the Framingham Heart Study who were not obese and did not have diabetes at baseline were included (n=4,320). The Akaike Information Criterion (AIC) was computed to compare four Cox proportional hazards models with incident diabetes as the outcome and: (i) obese-years; (ii) age of onset of obesity; (iii) body mass index (BMI); and (iv) age of onset of obesity plus magnitude of BMI combined, as exposures.

RESULTS: AIC indicated that the model with obese-years provided a more effective explanation of incidence of type 2 diabetes compared to the remaining three models. Models including age of onset of obesity plus BMI were not appreciably different from the model with BMI alone, except in those aged ≥60.

CONCLUSIONS: While obese-years was the optimal obesity construct to explain risk of type 2 diabetes, age of onset may be a useful, practical addition to current BMI in the elderly.

IMPLICATIONS: Where computation of obese-years is not possible or impractical, age of onset of obesity combined with BMI may provide a useful alternative.

Assessment of Health-Related Quality of Life using the EQ-5D-3L in Individuals with Type 2 Diabetes Mellitus

The daily experience with type 2 diabetes mellitus (T2DM) has significant adverse effects on health-related quality of life (HRQoL). HRQoL assessment is essential for measuring the impact of the disease on the patient and selecting individualized strategies. Generic measures for assessing HRQoL are very useful because, unlike specific measurement instruments, they allow for the comparison with other instruments. The EQ-5D-3L is a generic measure and it describes HRQoL in five dimensions; mobility, self-care, usual activities, pain/discomfort and anxiety/depression, with three levels each. In Portugal, studies using the EQ-5D-3L as a generic measure to assess HRQoL in diabetic patients are scarce. Objective: To assess HRQoL in individuals with T2DM using the Portuguese version of the EQ-5D-3L. Methodology: An accidental sample of patients with T2DM (n=437) was selected at Family Health Units and healthcare centers in Coimbra, Portugal, between January 2013 and January 2014. The EQ-5D-3L was applied in interviews. The EQ-5D-3L score was calculated based on the answers to the five dimensions and the value system for the Portuguese population. Results: In this sample, 100% of the participants answered the EQ-5D-3L. The HRQoL score was 0.6772 in the EQ-5D-3L and 64.85 in the EQ-VAS. The most frequent answers to the five dimensions were no problems or some problems. The mean score of the EQ-5D-3L was significantly associated with age, male gender, high level of education, having an occupation, practicing physical activity, being single and having been diagnosed with T2DM for less time. The Cronbach alpha's value was 0.674, confirming an acceptable internal consistency. Conclusion: HRQoL levels in individuals with T2DM are lower than the national average and vary depending on sociodemographic and clinical characteristics. The EQ-5D-3L is a reliable instrument that can be used to assess the quality of life of diabetic patients and contribute to assess the patients' overall health status, adding data from the subjective dimension of self-care management.

Envelhecimento e Diabetes Mellitus Tipo 2: estudo dos efeitos do exercício físico no comportamento postural e capacidade funcional de pacientes com Diabetes Mellitus Tipo 2

A Diabetes Mellitus é uma patologia fortemente associada ao processo de envelhecimento, afectando cada vez mais pessoas em todo o mundo. Uma das maiores complicações observadas nesta população prende-se com a diminuição do controlo postural e da capacidade funcional relacionada com a locomoção. O exercício físico tem sido apontado como uma das formas de prevenção e tratamento deste problema, no entanto existe ainda uma lacuna no conhecimento sobre o modo mais indicado de exercício. O presente pretende avaliar os efeitos de um programa de exercício físico aeróbio sobre o controlo postural e a capacidade funcional de pacientes portadores de Diabetes Mellitus Tipo 2. A amostra do estudo foi composta por 30 sujeitos de ambos os sexos, distribuídos por um grupo experimental (n=16) a quem foi aplicado o programa de exercício físico, e por um grupo de controlo (n=14), o qual não usufruiu de qualquer programa de exercício físico. O programa teve a duração de 12 semanas de treino, e uma frequência de 3 vezes por semana. Os participantes mantiveram-se em movimento constante durante as sessões tendo os exercícios realizados possuído uma forte componente dinâmica. Foi avaliado o controlo postural através de uma plataforma de forças e a capacidade funcional através de um conjunto de cinco testes funcionais. Os resultados obtidos revelam não terem existido diferenças estatisticamente significativas (p>0,05) na interacção entre grupos e momentos de avaliação nas variáveis analisadas, com excepção para a performance no Timed Get Up & Go Test, a qual melhorou significativamente (p<0,05) no grupo experimental. Estes dados sugerem que a especificidade tanto estática como dinâmica dos exercícios e a intensidade a que são realizados são factores fundamentais a ter em consideração no planeamento de programas de exercício físico, com vista à melhoria quer do controlo postural quer da capacidade funcional em portadores de Diabetes Mellius Tipo 2. ABSTRACT: Diabetes Mellitus is a disease associated with aging, affecting a growing number of people all over the world. One of the major concerns in this population relates to the decline of postural control and functional capacity. Exercise has been suggested as one way of preventing and treating this problem, however little is known about the most appropriate mode of exercise. This study evaluates the effect of an aerobic exercise program on postural control and functional capacity of patients with Type 2 Diabetes Mellitus. The sample consisted of 30 subjects, over an experimental group (n = 16) applied to an exercise program, and a control group (n = 14), that received no treatment. The program lasted 12 weeks, three times a week. Participants remained in constant motion during the sessions and the exercises performed had a strong dynamic component. Postural control was assessed using a force platform and functional capacity through a set of five functional tests. The results show that there were no statistically significant differences (p>O, O5) in group/moment interaction in the variables analyzed, except for the Timed Get Up & Go Test, which improved significantly (p <0,05) in the experimental group. These data suggest that both static and dynamic specificity and intensity of exercises are key factors in exercises programs planning, targeted to improve both postural control and functional capacity in patients with Type 2 Diabetes Mellius.