Australian general practitioners' perspectives on integrating specialist diabetes care with primary care: qualitative study.

BACKGROUND: Improving the coordination and integration of health services is recognised nationally and internationally as a key strategy for improving the quality of diabetes care. The Australian Diabetes Alliance Program (DAP) is an integrated care model implemented in the Hunter New England Local Health District (HNELHD), New South Wales (NSW), in which endocrinologists and diabetes educators collaborate with primary care teams via case-conferencing, practice performance review, and education sessions. The objective of this study was to report on general practitioners' (GPs) perspectives on DAP and whether the program impacts on their skills, knowledge, and approach in delivering care to adult patients with type 2 diabetes. METHODS: Four primary care practices with high rates of monitoring haemoglobin A1c (HbA1c) levels (> 90% of patients annually) and five practices with low rates of monitoring HbA1c levels (< 80% of patients annually) from HNELHD, NSW provided the sampling frame. A total of nine GPs were interviewed. The transcripts from the interviews were reviewed and analysed to identify emergent patterns and themes. RESULTS: Overall, GPs were supportive of DAP. They considered that DAP resulted in significant changes in their knowledge, skills, and approach and improved the quality of diabetes care. Taking a more holistic approach to care, including assessing patients with diabetes for co-morbidities and risk factors that may impact on their future health was also noted. DAP was noted to increase the confidence levels of GPs, which enabled active involvement in the provision of diabetes care rather than referring patients for tertiary specialist care. However, some indicated the program could be time consuming and greater flexibility was needed. CONCLUSIONS: GPs reported DAP to benefit their knowledge, skills and approach for managing diabetes. Future research will need to investigate how to improve the intensity and flexibility of the program based on the workload of GPs to ensure long-term acceptability of the program.

The effect of zinc supplementation on glucose homeostasis: a randomised double-blind placebo-controlled trial.

AIMS: The burden and health costs of Type 2 Diabetes Mellitus continue to increase globally and prevention strategies in at-risk people need to be explored. Previous work, in both animal models and humans, supports the role of zinc in improving glucose homeostasis. We, therefore, aimed to test the effectiveness of zinc supplementation on glycaemic control in pre-diabetic adults. METHODS: We conducted a randomized, double-blind, placebo-controlled trial across 10 General Practitioner (GP) practices in NSW, Australia. The trial is known as Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD)Study. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7-6.4%, 39-46 mmol/mol) men and women (N = 98) were all assigned to a free state government telephone health coaching service (New South Wales Get Healthy Information and Coaching Service) and then randomised to either daily 30 mg zinc gluconate or placebo. Blood tests were collected at baseline, 1, 6 and 12 months for the primary outcomes (HbA1c, fasting blood glucose (FBG)); secondary outcomes included Homeostasis Model Assessment 2 (HOMA 2) parameters, lipids, body weight, height, waist circumference, blood pressure and pulse. RESULTS: The baseline-adjusted mean group difference at 6 months, expressed as treatment-placebo, (95% CI) was -0.02 (-0.14, 0.11, p = 0.78) for HbA1c and 0.17 (-0.07, 0.42; p = 0.17) for FBG, neither of which were statistically significant. There were also no significant differences between groups in any of the secondary outcomes. Zinc was well tolerated, and compliance was high (88%). CONCLUSION: We believe our results are consistent with other Western clinical trial studies and do not support the use of supplemental zinc in populations with a Western diet. There may still be a role for supplemental zinc in the developing world where diets may be zinc deficient. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268. Registered on 6 July 2018.

"They were all together discussing the best options for me": Integrating specialist diabetes care with primary care in Australia.

Over one-third of diabetes-related encounters with healthcare providers in Australia fail to meet clinical guidelines. Evidence is mounting that care provision within an integrated framework may facilitate greater adherence to clinical guidelines and improved outcomes for patients. The Diabetes Alliance Program was implemented across a large healthcare district to enhance diabetes care capacity at the primary care level through intensive case-conferencing involving the primary care team, patients and visiting specialist team, whole practice performance review and regular diabetes education for practitioners. Here, we provide an in-depth patient assessment of the case-conferencing process and impact on diabetes management. Two practices with high pre-intervention HbA1c monitoring and three practices with low HbA1c monitoring provided the sampling frame. Patients were selected according to their score on the Patient Activation MeasureTM to achieve maximum variation, with up to two patients with high scores and three with low scores, selected from each practice. Patients were sampled until data saturation was achieved and then subjected to thematic content analysis (n = 19). Patients mostly described the model of care as a positive experience, reporting a boost in confidence in diabetes self-management (particularly around nutrition). The program was also seen to be helpful in providing an opportunity to refocus when "life gets in the way". Other valued aspects of the program included the holistic approach to healthcare, reduced travel time, familiarity in environment and clinical care, top-down knowledge transfer as well as mutual learning by the patient and their primary care team. Despite this, difficulties in coping with diabetes and adherence to treatment recommendations remained for a minority of patients. Integrating specialist teams within primary care has the ability to provide efficient healthcare delivery, better patient experience and health outcomes. Investment in such approaches will be critical to navigating healthcare provision in order to meet the demands of an ageing population.

Dietary supplementation with docosahexaenoic acid rich fish oil increases circulating levels of testosterone in overweight and obese men.

Pre-clinical evidence suggests that omega-3 (n-3) polyunsaturated fatty acids (PUFAs), in particular, docosahexaenoic acid (DHA) have been shown to affect testosterone synthesis in males. This study is a secondary analysis of a randomized controlled trial which determined the effect of a DHA-enriched fish oil supplement on insulin resistance. The aim of the current study was to determine whether testosterone levels change in response to a DHA-enriched fish oil intervention. Overweight and obese men and women without diabetes were recruited to the study. Participants were stratified by sex and randomly allocated to intervention (860 mg DHA + 120 g EPA/day; FO) or an isocaloric control (corn oil; CO) for 12 weeks. A fasted blood sample was collected pre- and post-intervention. Fatty acid composition of erythrocyte membranes was measured using gas chromatography. Total testosterone and metabolic parameters were measured by an accredited commercial pathology laboratory. Sixty-one participants (CO/FO: n = 29/32) were included in the current analysis (male: n = 22, 36.07%).  DHA-enriched fish oil supplementation increased total testosterone levels in males after adjusting for baseline levels, age and BMI. There was no treatment effect in females. Changes in testosterone levels in males were positively associated with changes to omega-3 PUFAs EPA and DHA and inversely correlated with omega-6 PUFA, arachidonic acid and dihomo-gamma-linolenic acid content in erythrocyte membranes, and was associated with beneficial changes to fasting insulin and HOMA-IR across the course of the study. DHA-enriched fish oil supplementation increases testosterone levels in overweight and obese men. Further research is warranted to substantiate these findings with a larger sample size and a longer follow-up period.

Association between plasma phospholipid omega-3 polyunsaturated fatty acids and type 2 diabetes is sex dependent: The Hunter Community Study.

BACKGROUND & AIMS: Chronic inflammation drives the development of insulin resistance and type 2 diabetes. Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) eicosapentaenoic acid (EPA, c20:5n-3) and docosahexaenoic acid (DHA, c22:6n-3) may protect against type 2 diabetes development. The aim of this current study is to determine whether LCn-3PUFA status is associated with type 2 diabetes in the Hunter Community Study. METHODS: Men and women aged 55-85 years were randomly selected from the electoral roll and invited to participate. Participants were included in the current study if they had plasma phospholipid fatty acid composition data available and diabetes status could be determined. LCn-3PUFA status was determined by fatty acid composition of plasma phospholipids (EPA + DHA, %,w/w). Diabetes was determined according to World Health Organisation criteria. Insulin was measured in n = 251 participants and HOMA-IR calculated. RESULTS: In total, n = 2092 (diabetes: n = 249) participants were included. After adjusting for confounders of diabetes, LCn-3PUFA status was inversely associated with diabetes in overweight/obese females (OR [95%CI]: 0.90 [0.80, 1.00], p = 0.045) but not males (p-interactionsex = 0.041). Overweight/obese females with diabetes had significantly lower levels of DHA than those without diabetes (mean difference [95%CI]: -0.53 [-0.87, -0.20], p = 0.002), with no difference in EPA. LCn-3PUFA was inversely associated with HOMA-IR (r = -0.175, p = 0.005). CONCLUSIONS: This study provides further evidence of a sex-dependent association between LCn-3PUFA and type 2 diabetes. Causal pathways between LCn-3PUFA and type 2 diabetes merits delineation.

Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD Study) - study protocol for a randomised placebo-controlled trial in Australia.

BACKGROUND: Diabetes is increasing in incidence, morbidity and treatment costs globally, hence prevention strategies need to be explored. Animal studies and some human data have shown that zinc can improve glycaemic control, but the impact of this effect in a pre-diabetic population remains uncertain. This study is designed to investigate whether zinc gluconate and lifestyle coaching can improve glucose handling and ultimately reduce diabetes incidence in an at-risk pre-diabetic population in Australia. METHODS/DESIGN: The study will be a randomised, placebo-controlled, double-blind clinical trial. The study will be conducted at the Hunter New England Local Health District New South Wales (NSW), Australia. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7-6.4) male and female participants (n = 410) aged 40-70 years will be recruited through the Diabetes Alliance Network, a collaboration of diabetes specialists and general practitioner practices. All participants will be given routine care to encourage healthy lifestyle changes using a telephone coaching service (Get Healthy Information and Coaching Service, NSW Health) and then randomised to receive a supplement, either zinc gluconate (equivalent to 30 mg of elemental zinc) or placebo of identical appearance for 12 months. The identity of the supplements will be blinded to both research personnel and the participants. Participants will be asked to complete medical, lifestyle and dietary surveys and will have baseline and final visits at their general practitioner practice. Primary outcomes will be HbA1c and insulin sensitivity collected at baseline and at 1, 6 and 12 months; secondary outcomes will include fasting blood glucose, fasting cholesterol, blood pressure and body mass index. The primary efficacy endpoint will be judged at 6 months. DISCUSSION: This study will generate new evidence about the potential for health coaching, with or without zinc supplementation, to improve glucose handling and ultimately to reduce progression from pre-diabetes to diabetes. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268 . Registered on 6 July 2018.

Curcumin and/or omega-3 polyunsaturated fatty acids supplementation reduces insulin resistance and blood lipids in individuals with high risk of type 2 diabetes: a randomised controlled trial.

BACKGROUND: Lowering insulin resistance and dyslipidaemia may not only enhance glycaemic control but also preserve the ß-cell function, reducing the overall risk of developing type 2 diabetes (T2D). The current study was aimed to evaluate the effects of curcumin and/or long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) supplementation on glycaemic control and blood lipid levels in individuals at high risk of developing T2D. METHODS: This was a 2 × 2 factorial, randomised, double-blinded, placebo-controlled study. Participants were allocated to either double placebo (PL) or curcumin plus placebo matching for LCn-3PUFA (CC), or LCn-3PUFA plus placebo matching for curcumin (FO), or curcumin plus LCn-3PUFA (CC-FO) for twelve weeks. Primary outcome of the trial was glycaemic indices (HbA1C, fasting glucose and insulin). Insulin resistance and sensitivity is measured using homeostatic model assessment model. RESULTS: A total of sixty-four participants (PL, n = 16; CC, n = 15; FO, n = 17, CC-FO, n = 16) were included in the final analysis. Post-intervention, HbA1c and fasting glucose remained unchanged across all the groups. Insulin sensitivity was significantly improved in the CC supplemented group (32.7 ± 10.3%) compared to PL (P = 0.009). FO and CC-FO tended to improve insulin sensitivity by 14.6 ± 8.5% and 8.8 ± 7.7% respectively, but the difference did not reach significance. Triglyceride levels were further increased in the PL (26.9 ± 7.4%), however, CC and CC-FO supplementation reduced the triglycerides, FO resulted in the greatest reduction in triglycerides (- 16.4 ± 4.5%, P < 0.001). CONCLUSION: Reduction in insulin resistance and triglycerides by curcumin and LCn-3PUFA appears to be attractive strategies for lowering the risk of developing T2D. However, this study failed to demonstrate complimentary benefits of curcumin and LCn-3PUFA on glycaemic control. TRAIL REGISTRATION: ACTRN12615000559516 .

Curcumin alleviates postprandial glycaemic response in healthy subjects: A cross-over, randomized controlled study.

In the current study, we aimed to evaluate the effects of a single dose of curcumin and/or fish oil on postprandial glycaemic parameters in healthy individuals. This was a randomised, placebo-controlled and crossover study. Sixteen (n = 16) volunteers were randomised to receive placebo, curcumin (180 mg) tablets, fish oil (1.2 g long chain omega-3 polyunsaturated fatty acids) capsules and curcumin + fish oil prior to a standard meal on 4 test days separated by a week. Blood glucose, serum insulin and triglycerides were measured at intervals between 0-120 min. Difference between the treatments was measured using two-way repeated measures analysis of variance and pair-wise comparisons using Wilcoxon signed-rank or paired t-test as appropriate. Postprandial glucose concentrations were significantly lower in the curcumin (60.6%, P = 0.0007) and curcumin + fishoil group (51%, P = 0.002) groups at 60 min from baseline. Compared with placebo, area under the curve (AUC) for change in blood glucose concentration was reduced by curcumin (36%, P = 0.003) and curcumin + fishoil (30%, 0.004), but not fish oil alone (p = 0.105). Both curcumin (P = 0.01) and curcumin + fishoil (P = 0.03) treatments significantly lowered postprandial insulin (AUC) by 26% in comparison with placebo. Curcumin, but not fish oil, reduces postprandial glycaemic response and insulin demand for glucose control.

Curcumin and long-chain Omega-3 polyunsaturated fatty acids for Prevention of type 2 Diabetes (COP-D): study protocol for a randomised controlled trial.

BACKGROUND: Lifestyle interventions, including increase in physical activity and dietary counselling, have shown the ability to prevent type 2 diabetes (T2D) in high-risk state individuals, but the prevalence is still skyrocketing in Australia, in line with global prevalence. Currently, no medicines are approved by the Therapeutic Goods Administration in Australia for the management of prediabetes. Therefore, there is a need of developing a safer, biologically efficacious and cost-effective alternative for delaying the transition of individual health state from prediabetes into T2D. In the current trial we propose to evaluate the effects of curcumin and/or long-chain omega-3 polyunsaturated fatty acids on improving glycosylated haemoglobin as a primary outcome, along with secondary outcomes of glycaemic indices, lipid profile and inflammatory parameters. METHODS/DESIGN: Eighty individuals diagnosed with prediabetes, aged between 30 and 70 years, will be randomly assigned to double placebo, curcumin alone, fish oil alone or double active groups according to a computer-generated randomisation sequence for 12 weeks. At baseline and post-intervention visits participants will be asked to provide blood samples and undergo body composition measurements. A blood sample is used for estimating glycaemic profiles, lipid profiles and inflammatory parameters (C-reactive protein, whole blood cell count, adiponectin, leptin, interleukin-6). The interim visit includes review on compliance with supplements based on capsule log and capsule count, adverse events and anthropometric measurements. In addition to these procedures, participants provide self-reported questionnaires on dietary intake (using a 3-day food record), a physical activity questionnaire and medical history. DISCUSSION: This trial aims to determine whether curcumin and/or long-chain omega-3 polyunsaturated fatty acids affect surrogate markers of glycaemic control which is relevant to delaying T2D. To date 38 participants completed the trial. No changes have been made to the clinical protocol post recruitment. If successful, this trial will provide considerable evidence for performing a larger trial to investigate whether this combination can be administered for preventing or delaying the onset of T2D in high-risk individuals. TRIAL REGISTRATION: ACTRN12615000559516 , registered on 29 May 2015).

Do ω-3 PUFAs affect insulin resistance in a sex-specific manner? A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Evidence has suggested that omega-3 (n-3) polyunsaturated fatty acids (PUFAs) improve obesity-induced insulin resistance (IR); however, results from human intervention trials have been equivocal. Recently it has been reported that n-3 PUFA status is inversely associated with type 2 diabetes in women but not in men, suggesting a sex-dependent effect. OBJECTIVE: We aimed to determine whether n-3 PUFA interventions affect IR in a sex-dependent manner. DESIGN: Five databases were searched (Medline, EMBASE, CINAHL, Scopus, and Pre-Medline) for randomized controlled trials. Searches were limited to the English language and to studies with adults aged >18 y. When possible, studies were pooled for a meta-analysis. The principle summary measure was the standardized mean difference (SMD) between groups. RESULTS: Thirty-one eligible trials were identified with a total of 1848 participants [men: 45.1%; weighted mean ± SD age: 52.5 ± 8.2 y; weighted body mass index (in kg/m2): 28.8 ± 3.0]. Seven studies were conducted in women, 4 studies were conducted in men, and the remaining studies pooled men and women together. Twenty-six trials were pooled for the meta-analysis (men: n = 2; women: n = 6). With all studies (n = 26) pooled, there was no effect of n-3 PUFA on IR at the group level (SMD: 0.089; 95% CI: -0.105, 0.283; P = 0.367). In trials of ≥6 wk, a significant improvement in IR was seen in women (SMD: -0.266; 95% CI: -0.524, -0.007; P = 0.045) but not in men (SMD: 0.619; 95% CI: -0.583, 1.820; P = 0.313). CONCLUSIONS: With this analysis, we provide preliminary evidence of a sex-dependent response of IR to an n-3 PUFA intervention. Additional studies are needed to confirm sex-dependent associations and to elucidate the potential mechanisms that are involved. This trial was registered at www.crd.york.ac.uk/PROSPERO/ as CRD42015017940.