ANZCTR search results

Clinical experience and reports from families of children with type 1 diabetes has long suggested that meals high in protein and/or fat cause an increase in blood glucose levels after eating. Increased blood glucose levels, including after consumption of food, is well-known to add to long term health complications in type 1 diabetes. Current type 1 diabetes management guidelines recommend adjusting insulin doses for food based on the amount of carbohydrate to be eaten at each meal. However, there has been an increase in evidence, including that from a lanmark study by our study group, to suggest that other nutrients such as fat and protein should be considered when calculating pre meal insulin. High levels of protein and/or fat in a meal cause a larger than expected rise in blood glucose levels after eating and these high blood glucose levels persist, suggesting the need for extra insulin. This research project will compare the insulin required to maintain blood glucose levels within target range when consuming two meals, one high in protein and fat and the other low in protein and fat, both with the same carbohydrate content. This will be determined by looking at the difference in intra venous insulin requirements after both meals. IV insulin will be given to participants to maintain blood glucose levels at a constant level whilst they are eating the meal and in the 5 hours following. Thirteen participants will consume both test meals, one week apart. The different insulin amounts needed to maintain blood glucose levels after each test meal will provide accurate calculation of the expected increase in insulin requirements on consumption of a high protein/high fat meal. This study will provide important information in the management of type 1 diabetes in both adults and children. This information will be used immediately in our day to day management of patients and will guide the development of clinical guidelines to minimize the rise in blood glucose levels after eating.

This study will answer the research question of whether receiving contextually and culturally appropriate parenting support early in the settlement period can improve adjustment in migrant and former-refuge families, and by extension, facilitate positive sociocultural adaptation. The aims of the project are to: (a) Determine whether parental participation in a Triple P intervention within the first five years of settlement is effective at improving migrant and former-refugee family outcomes, and (b) Evaluate the efficacy of the program for improving sociocultural adjustment and reducing acculturative stress in migrant parents. The rigorous methodology being utilised in the current study will provide a strong indication as to the generalizability of the results to migrant and former-refugee families in other geographic regions. Should the intervention prove to be effective, it has the potential to fill an important research and service gap, providing an innovative, cost-effective, and evidence-based means to strengthen family relationships and promote positive adjustment in migrant children and their parents.

There is evidence of anomalies in redox biology in schizophrenia; (i) the presence of oxidative stress (where the levels of antioxidants are decreased or the levels of free radicals are increased to a point that is damaging to the function of the cell, increasing inflammation) particularly implicating the glutathione system ; (ii) changes in oxidative status with treatment; and (iii) evidence that other glutathione and redox active agents have therapeutic value. Garcinia mangostana Linn, known colloquially as mangosteen, is a tropical evergreen fruit tree originating from Indonesia. Its rind or pericarp contains an exudate containing a large number of bioactive compounds called xanthones that have robust effects on the glutathione system and many other pathways germane to schizophrenia. Motivated by the results of the first pilot randomised, double blind placebo trial of adjunctive Garcinia mangostana Linn for the treatment of schizophrenia we speculate that this research may uncover a new class of agents for the treatment of the disorder, and uncover novel pathophysiological pathways. The trial involves 150 participants aged 18 years or older with a DSM-V diagnosis of schizophrenia or schizoaffective disorder. Participants referred to the trial will have an initial face–to-face screening interview. All randomised participants will receive two 500mg mangosteen pericarp capsules once a day to a total dose of 1000mg daily or placebo, in addition to treatment as usual, for 24 weeks. Assessment will occur at regular 4 weekly intervals throughout the 24 weeks and 1 month after completion of the study. The primary outcome will be the change in schiaophrenia symptom severity using the PANSS total scale at the end of the 24-week treatment phase. The secondary outcomes will include changes in depressive symptoms, quality of life, functioning and life satisfaction which will be measured using the PANSS subscales, Q-LES-Q scale, GAF, LIFE-RIFT, PGI and Cogstate. Blood biomarkers will also be analysed. Blood samples will be obtained at baseline and week 24. Blood will be analysed for relevant markers based on preclinical evidence including markers of antioxidant defence, oxidative stress and markers of inflammation. The research will have immediate and direct translational benefits. The safety and tolerability of Garcinia mangostana Linn, its affordability and accessibility and that the general public are accepting of plant-derived compounds, raise its attraction as a potential therapeutic agent.

Primary aim: The aim of this project is to pilot a culturally adapted physiotherapy assessment and treatment approach for use with three CALD communities living in Australia and contrast it with ‘usual’ evidence based physiotherapy care. This project will seek to identify aspects of trial design that may need to be modified in a larger RCT. This includes establishing community acceptance and satisfaction with the novel treatment approaches and determining community willingness to participate in randomised research. It will also generate outcome data that will be used for sample size estimates and predicting the magnitude of treatment effects for a future clinical trial. Hypothesis It is hypothesised that the culturally adapted approaches will be well accepted by participants and significantly more effective at improving function, burden of suffering and patient adherence, when compared to usual care. Proposed research design Pilot Randomised Controlled Trial. Two group pre-test, post-test design. Methods: Potential participants will be identified from physiotherapy wait-lists and assessed to ascertain eligibility for trial inclusion. Those who meet the inclusion criteria and consent to participate will be randomly assigned to either the culturally adapted physiotherapy treatment or evidence based usual physiotherapy care. The culturally adapted physiotherapy treatment approach will be a combination of group physiotherapy education and exercise, and individual treatment. Participants allocated to this treatment arm will attend a group session for two hours a week, for six weeks and up to four individual sessions over three months with a qualified physiotherapist. The control group is evidence based usual care and will include treatment by a qualified physiotherapist who has not been trained in cultural adaptation methods. Participants randomised to this treatment arm will attend up to ten physiotherapy sessions that incorporate evidenced based physiotherapy management, over three months. Data that will help determine the feasibility of future trials will be collected including recruitment rates, drop-out rates, adherence and patient satisfaction will be collected at three months. Physical performance outcomes (six minute walk distance and the number of sit to stand’s performed in 1 minute) and pain related questionnaires (Brief Pain Inventory, Pictorial Representation of Illness and Self-Measure, Depression Anxiety and Stress Scale) will collected at pre and post treatment to inform treatment efficacy.

This research project is being conducted to look at how safe and well tolerated a new drug called DUR-928 is when given as an intravenous infusion to healthy volunteers. The study will look at the study drug’s safety and tolerability when given as a single dose at 2 different dose levels. The pharmacokinetics of DUR-928 will also be studied; this is done by measuring the amount of DUR-928 in the blood at different times throughout the dosing periods, allowing us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream).

Macular oedema (swelling of the central retina) is the commonest cause of visual loss in people with diabetes. Monthly injections of Anti VEGF are superior to conventional laser treatment when there is moderate visual loss from central macular oedema. However, monthly injections are less practical in central Australia and laser may be more effective than injections in many common clinical scenarios. Our pilot audit showed that results from laser in central Australia were equivalent to some of the original published cohorts of laser treatment. This study planned to audit results of laser treatment for diabetic maculopathy in central Australia over a longer period, and identify scenarios where laser remains an effective and affordable option in the treatment of diabetic maculopathy

This study aims to explore the effects of rhythmic music as an external cue for walking in people with Progressive Supranuclear Palsy (PSP) and Alzheimer's disease (AD). Music cued exercise has been shown to be effective in improving walking in people with Parkinson's disease and stroke. People with other degenerative neurological disorders may also benefit from this approach. Twenty people (10 PSP / 10 AD) will undergo measures of walking using a pressure sensitive carpet at Latrobe University before and after an intervention which will consist of 8 home visit sessions of systematically progressed exercises synchronised to rhythmic music conducted by experienced physiotherapists.

Atrial fibrillation (AF) is the most common heart arrhythmia, affecting 1 in 4 adults worldwide, and at least 240,000 Australians. Prevalence rises with age from approximately 1% of the whole population to 5% in those over 65 years. People with AF are up to seven times more likely to have a stroke than the general population. Almost one in every three strokes is AF-related, and AF-related strokes are likely to be more severe, with a whole of life cost of each stroke estimated at $103,566. However, strokes in AF can be effectively prevented using oral anticoagulants. Unfortunately in Australia oral anticoagulant prescription is only about 60% even in those patients with known AF who are therefore at high risk for stroke. This gap has been difficult to close despite having therapeutic management guidelines. Many people in the general population are unaware that they have AF, with first diagnosis being made when they are admitted to hospital with a stroke or transient ischaemic attack. The diagnosis of unknown AF can be easily made using a 30 second ECG rhythm strip obtained with a TGA approved smartphone ECG (iECG). Using this device, unknown AF can be identified and treated, thus reducing the number of strokes due to AF. We have previously shown that community screening for AF to prevent stroke is likely to be cost-effective, but the magnitude of the benefit in terms of numbers of strokes prevented, is determined by the proportion of the population screened. This study therefore explores screening for AF in primary care, by performing iECG screening during annual influenza vaccination currently administered to over 70% of patients aged 65 or over in general practice. Screening will also take place during annual chronic care assessments such as Diabetes Cycle of Care and Health Assessment for People Aged 75 and Older. This opportunistic method of screening, through its reach, could approximate systematic population screening for AF. Screening will be performed in 10 practices across NSW to gauge and efficacy and cost effectiveness of community-based AF screening. In addition to the handheld iECG device, this study will also implement the electronic decision support software called HealthTracker-CVD. A special AF module has been designed as part of this software to automatically calculate the stroke risk score for patients with AF, and provide individualised advice on evidence-based management of AF. An automated tool such as this available to both general practitioners and practice nurses is ideal to facilitate closing the gap in oral anticoagulant prescription for stroke prevention in patients with diagnosed AF.

The aim of this study is to determine if intervention for speech problems in preschool-aged children is effective when delivered by parents and a speech pathologist. Specifically, this study will determine if “multiple oppositions” intervention, an approach established as effective when delivered intensively by a speech pathologist, is still effective when modified and delivered by parents in conjunction with a speech pathologist, with children who have a speech sound disorder.

Arm/hand dysfunction after stroke is a common (85% of stroke survivors), disabling and persistent problem which contributes to poor well-being and quality of life and is rated as a top ten research priority in stroke by both survivors and their carers. Neuroplasticity is the term used to describe the ability of our brain to change, make new connections and re-wire itself in response to internal and external demands and stimuli. Evidence suggests that aerobic exercise can facilitate neuroplasticity by increasing the number of and connections between brain cells, increasing the release of various neurotransmitters (chemical messengers in the brain) and nerve growth factors, and stimulating the formation of new blood vessels necessary for neuronal growth. Due to the positive effects of aerobic exercise on neuroplasticity, it has been suggested that it could be utilised to improve the efficacy of rehabilitation programs by ‘priming’ the brain prior to the delivery of therapy. Our study explores the feasibility of using Aerobic Exercise and Consecutive Task-specific Training (AExaCTT) to investigate whether the addition of aerobic exercise enhances the efficacy of task-specific training to improve arm/hand motor function after stroke.