ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31247 results sorted by trial registration date.
  • The effect of a Chinese diabetes education workshop named ‘Not Scared of Sugar’ among Cantonese-speaking Australians with type 2 diabetes

    This intervention study will test the effectiveness and explore appropriateness of a Chinese multi-session culturally-tailored diabetes group education program which is designed to carefully match with the Chinese people’s preferred learning style and include Chinese-specific strategies to motivate and sustain healthy behaviour change. The research will involve recruiting 50 Chinese Cantonese-speaking people with type 2 diabetes into this study. Participants will attend a 6-session group education program delivered in Cantonese by a dietitian, physiotherapist, podiatrist and diabetes nurse. The program will then be evaluated on its effectiveness and appropriateness via pre- and post-program anthropometric and biochemical measurements, questionnaires and qualitative participant-observation. This research is expected to provide new practice ideas to enhance diabetes education, especially for the culturally and linguistically diverse populations.

  • The psychosocial impact of haematopoietic stem cell donation on adult related donors

  • ‘SIFT’ that social information! Feasibility of a novel social cognition treatment for people with acquired brain injury

    Understanding emotions, understanding that other people think or feel things differently to ourselves, and thinking and feeling from another’s perspective are all skills associated with social cognition. There are many reasons why some people find it more difficult to do these things, and having a brain injury is one of them: the regions in the brain that can be damaged through injury often affect the areas we know are important for social cognition. What is less well understood is whether it is possible to treat social cognitive deficits after such an injury. This is because very little research has been done trialling these kinds of treatments for people with a brain injury, and there have been no trials that have ‘comprehensively’ targeted the interrelating process of social cognition. The aim of this study, therefore, is to trial a novel social cognition treatment (SIFT IT), a therapy that has been developed considering the needs of those living with a brain injury, yet still informed by treatments developed in other clinical populations. SIFT IT: The Social Thinking Therapy has been designed as a group program that will run for 14 weekly sessions, each 90-120 minutes. It combines principles of cognitive behavioural therapy (CBT) with cognitive remediation to help participants understand the breadth of processes involved in social cognition and then to apply them to their everyday lives. As SIFT IT is a new psychotherapeutic group intervention, the focus of this study is on whether it is possible to treat social cognitive deficits in this way in this population: i.e. to examine the intervention’s feasibility. Feasibility will be examined by looking at the demand for the therapy, how well the therapy can be implemented, the acceptability of the treatment, and whether it looks like the therapy is helping people improve their social cognitive skills. The study will run as a randomised controlled trial. Participants with a brain injury who have scored lower than expected on at least one social cognition assessment measure will be randomly allocated to the SIFT IT therapy group or to a waitlist control. Testing will take place after initial recruitment to gather baseline performance, then again after the SIFT IT therapy group has finished, then again after a further three months. The participants in the waitlist control will be offered to take part in the therapy group after the second round of testing. All participants will be asked to take part in a semi-structured interview after they have taken part in the therapy group to find out more detailed information about how they found the program. Data gathered from the trial will be analysed in a mixed methods approach. Some data will provide descriptive information about the participants and feasibility outcomes. Some data will allow for examination of changes in outcomes pre- to post-intervention. Other data will be analysed for common themes from feedback to examine therapy acceptability.

  • Does maternal omega-­3 fatty acid supplementation reduce body fat mass at 7 years of age?

    Docosahexaenoic acid (DHA) is an n­3 long chain polyunsaturated fatty acid (LCPUFA) which is important for optimum health of the mother and growth and development of the fetus. During the prenatal period, the time before birth, the only source of LCPUFAs for the fetus is from the mother via transfer across the placenta. The last trimester of gestation is the major period of n­3 LCPUFA accumulation in fetal tissues, including fetal fat tissue. The n­3 LCPUFAs inhibit fat cell formation and lipid accumulation in adults and this has led to the suggestion that prenatal exposure to an increased supply of n­3 LCPUFA could reduce the subsequent accumulation of fat tissue in childhood, and hence the risk of obesity and diabetes later in life. However, results of the studies which have attempted to study this question to date have been inconclusive. The DOMInO trial (DHA to Optimise Mother Infant Outcome) was designed to evaluate the effects of supplementing women with 800mg DHA/day during the second half of pregnancy on maternal and infant outcomes. The growth andinsulin resistance follow­up of children in this study was undertaken when they were 3 and 5 years old and aimed to determine whether increasing the amount of n­3 LCPUFA in the diet during pregnancy could reduce the risk of obesity and diabetes in the children. In the present study, we are proposing to extend this follow­up of the DOMInO children to 7 years of age. This is important, since major changes in body composition (the balance of muscle and fat) occur in the first few years after children start school. Capturing the growth and body composition of the DOMInO children at 7 years of age will therefore provide a more complete picture of changes in body composition over this critical period of growth and will enable us to determine the effects of maternal n­3 LCPUFA supplementation on the body fat mass at school age. The body fat mass of children at school age is also a stronger predictor of their body fat mass and metabolic health later in development than fat mass at earlier ages. The primary outcome of the current study is to assess if omega 3 LCPUFA supplementation during pregnancy is associated with a reduced body fat mass later in childhood. This will be achieved by measuring body composition and body mass index (BMI) z-scores in children (n=252) of mother's who were enrolled in the DOMInO trial at 7 years of age. The findings from this study will provide valuable information as to whether maternal n­3 LCPUFA supplementation in pregnancy has the potential to reduce body fat mass in children at school age, and therefore reduce their future risk of obesity.

  • Effects of A1 versus A2 milk on cardiometabolic risk in overweight and obese Australians

    Obesity significantly increases the risk of developing metabolic syndrome (MS), which is associated with increased cardiovascular morbidity/mortality. Presently, there is fierce debate surrounding the effects of the A1 beta-casein protein variant (A1) in bovine milk compared to the progenitor A2 variant (A2) with respect to their relative impact on MS risk factors. Most milk and milk products available commercially in Australia contain the A1 protein from dairy cows which carry the A1 gene. The A1 variant in Australian dairy cattle is the result of a mutation from the A2 gene in European herds ~5,000 years ago. Alternatively, milk produced by cows specially selected and then bred to produce only the original A2 beta-casein type is also available in Australia, but it is a specialty milk brand. Ample evidence now suggests that A1 milk beta-casein can affect features of MS and so has important public health implications. Given the Australian Dietary Guidelines recommend 2.5-4 dairy serves/day, the effect of milk variety on MS warrants investigation. A1 and A2 protein have differences in bioactivity on digestion, due to the release of the 7-amino acid opioid peptide beta-casomorphin-7 (BCM-7), from the digestion of A1 but not A2. In vitro and animal studies have demonstrated that BCM-7 oxidises low density lipoprotein (LDL)-cholesterol and increases levels of the inflammatory marker myeloperoxidase, both of which are implicated in the development of heart disease. A1 beta-casein and BCM-7 also stimulate inflammatory markers and so may contribute to the overall inflammatory milieu in MS. We have also shown in our recent randomised cross-over study that A1 milk stimulates differences in gastrointestinal inflammatory responses compared to A2 milk. The aim of the current proposed project is to investigate the difference between A1 and A2 beta-casein protein containing milk on cardiovascular and metabolic risk factors in overweight/obese individuals. Simple and affordable nutrition interventions that can positively affect modifiable risk factors for heart disease and T2D in Australian adults are needed. If the predicted differences between A1 and A2 beta-casein containing milk on cardiometabolic risk outcomes are found, it will have important ramification for public health and the prevention of chronic illness like cardiovascular disease. Dairy farmers would be advised to choose A2 semen for their dairy breeding programs to change to the A2 milk type for Australian consumers. We hypothesise that A1, but not A2 beta-casein containing milk, will correspond to shifts in cardiometabolic risk factors mediated via BCM-7 in blood. In contrast, we propose that A2 beta-casein containing milk will have a neutral, rather than beneficial, effect on metabolic syndrome factors. Thus, the hypothesis implies that A2 will do no harm, while the mutated A1 variant may increase the risk of chronic disease at a population health level.

  • Endoscopic ablation of dysplastic Barrett’s oesophagus

    The primary purpose of this pilot trial is to evaluate the efficacy and safety of Hybrid-APC ablation for the treatment of Barrett's oesophagus. Who is it for? You may be eligible to participate in this trial if you are aged 18-85 years and have been diagnosed with Barrett's oesophagus with low grade dysplasia, high grade dysplasia or T1a adenocarcinoma. Study details All participants enrolled in this trial will receive the Hybrid-APC ablation procedure which involves an gastroscopy with use of so called Hybrid-APC ablation. This means that a saline solution (NaCl 0.9%) will be injected into the submucosal lining of the affected area and thereafter the affected tissue will be coagulated using APC. Participants will then be followed up every three months during 5 years of follow-up to assess disease progression and whether any additional procedures are required. It is hoped that the findings from this pilot trial will provide preliminary information regarding the safety and efficacy of ablation for Barrett's oesophagus, which may be used to inform larger clinical trials in the future.

  • Effect of Alirocumab on Lipoprotein(a) (Lp(a)) Metabolism in Subjects with Moderate to High Risk of Heart Disease

    Primary Objective: To describe and determine the mechanism by which a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alters the kinetics of Lp(a) and its protein components, as well as the concentrations and kinetics of apoB-100 containing lipoproteins in statin-treated patients with inherited high plasma Lp(a) who are at moderate-to-high risk of cardiovascular disease (CVD). Hypothesis: Inhibition of PCSK9 increases apoB-100 catabolism and decreases hepatic secretion of apoB-100, and hence, the pool of apoB-100 available for binding to apo(a), resulting in a decrease in the production and plasma concentrations of Lp(a). Study Design: A 12-week (treatment period) single-arm, open-label, pre- and post-designed pilot study of the effect of Alirocumab (two-weekly subcutaneously injected dose of 150 mg) on plasma Lp(a) concentration and metabolism in 21 patients with inherited high plasma Lp(a). The CVD risk (low or moderate-to-high) of participants will be determined based on the Australian National Vascular Disease Prevention Alliance (NVDPA) Guidelines for management of absolute cardiovascular disease risk. Participant Numbers: N=21 participants to complete the study

  • PRT MEDIC: Progressive Resistance Training for MEtabolic Syndrome and Depression Integrated Care

    Individuals with depression and metabolic syndrome are 6.6 times more likely to develop type 2 diabetes within 5 years compared to individuals without either condition. Thus, early, robust and targeted interventions are warranted to alleviate symptoms of depression and improve the metabolic health of these at-risk individuals. The primary aims of this project are to determine the effects of progressive resistance training on insulin resistance (measured using the Homeostatic Model of Assessment-2) and depressive symptoms [assessor-rated Hamilton Depression Rating Scale (HDRS), Patient Health Questionnaire (PHQ-9) and Center for Epidemiologic Studies Depression Scale (CES-D) in adults with co-existing metabolic syndrome and major depressive disorder. Participants will be randomized to receive either progressive resistance training (PRT), 3 days per week for 12 weeks in addition to usual care from their GP, or referred to their GP for usual care. Participants randomised to the control intervention will be referred to their GP for management of their depression and metabolic syndrome. Blinded assessments will occur pre, and post intervention. This will be the first trial of PRT for individuals with co-existing major depressive disorder, metabolic syndrome and impaired glucose tolerance, and only the 5th trial of PRT in clinical depression. Primary Hypotheses 1. 12 weeks of PRT will significantly reduce insulin resistance, measured via Homeostatic Model of Assessment-2 (HOMA2-IR) compared to controls referred for General Practitioner (GP) care. 2. 12 weeks of PRT will significantly improve therapist-rated depressive symptoms [Hamilton Depression Rating Scale (HDRS)] as well as self-rated symptoms [Patient Health Questionnaire (PHQ-9)] and Center for Epidemiologic Studies Depression Scale (CES-D) compared to controls referred for GP care. Secondary Hypotheses 1. 12 weeks of PRT will significantly reduce glucose and insulin area under the curve during an oral glucose tolerance test (OGTT) compared to controls referred for GP care. 2. 12 weeks of PRT will significantly reduce glycated haemoglobin (HbA1c) compared to controls referred for GP care. 3. 12 weeks of PRT will significantly increase lean body mass (LBM) and decrease central adiposity compared to controls referred for GP care. 4. 12 weeks of PRT sill significantly improve central haemodynamics compared to controls referred for GP care. 4. Reductions in depressive symptoms will be associated with reductions in HOMA2-IR. 5. Improvements in body composition (increases in lean tissue and reductions in central adiposity), and reductions in systemic inflammation and serum cortisol will be independently associated with improvements in metabolic profile and depressive symptoms.

  • Can sleep and cognition in healthy adult males be improved using an acoustic device?

    The deepest and most recuperative part of sleep, SWS, begins to decline from mid-adulthood. These reductions include both duration and the depth of SWS. This impairment may be linked to changes in cognitive performance. Therefore, we hypothesize that enhancing SWS via acoustic stimuli leads to improvements in cognitive performance.

  • Randomised controlled trial of continuous wound infusion of local anaesthetic agent (Bupivacaine) for pain relief in new born babies undergoing major abdominal surgery

    The aim of the study was to compare the postoperative analgesia of continuous infusion of Bupivacaine via wound catheters in newborn babies undergoing major abdominal surgery for congenital or acquired gastrointestinal conditions.

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