ANZCTR search results

The incidence of type 2 diabetes mellitus (T2DM) is growing rapidly, in part because of the aging population, sedentary lifestyle and diet habits. In 2010, an estimated 257 million people worldwide had T2DM, representing an important global public health issue. Non-healthy diet is commonly accompanied by consumption of sugar-sweetened beverages (SSB), reported to provide little (if any) other nutrition or health benefit. The last 2010 National Nutrition Survey in Australia found that 58% of young adults drink an average of 2.1 cans per day (800mL), which is the first everyday source of sugar. In this context, several studies reported in children and adults high correlation between SSB consumption and risk to develop T2DM due to its effects on weight gain and glucose metabolism. These drinks represent 70 to 120g of sugar per litre and lead to acute transient hyperglycaemia (high level of glucose in blood), reported as a precursor of insulin-resistance but also responsible of endothelial dysfunction in the whole arterial tree. The endothelium is the thin layer of cells that lines the interior surface of heart and blood vessels and helps to control blood pressure through vasodilation and vasoconstriction, the widening and constricting of the blood vessels respectively. However, very few studies have investigated the underlying mechanisms involved in endothelial dysfunction in response to SSB -induced acute hyperglycemia. Briefly, endothelial dysfunction in this context has been demonstrated as an impairment of the capacity of blood vessels vasodilation, probably associated with a reduction in nitric oxide (NO) synthesis or biodisponibility. Previous results from our team has reported for the first time in cutaneous microcirculation the implication of oxidative stress and lower activity of endothelial nitric oxide synthase (eNOS, which is responsible of NO synthesis) in endothelial dysfunction after an acute hyperglycemia in healthy rats. On the top that, our works and other demonstrated that patients with T2M or patients in pre-diabetic state (obese or metabolic syndrome) have chronic NO related endothelial dysfunction even without environmental stress. Thus, the first objective of the present study is to explore the effect of SSB consumption on endothelial function in large as well as in small vessels in healthy and T2M subjects, with a focus on underlying mechanisms of the NO pathway. To improve cardiovascular dysfunction in several diseases, physical exercise is a well-known non pharmacological strategy. The higher antioxidant status in cardiovascular and muscular tissues are likely to account for the positive effects of this strategy for disease prevention or rehabilitation. Physical Exercise exercise training is also reported to improve the NO pathway with higher eNOS expression. Thus, the second objective of the present work will be to investigate the potential preventive effects of physical activity on endothelial dysfunction following acute hyperglycemia in healthy and T2DM participants.

The purpose of this study is to understand how well oxymorphone in combination with tocopheryl phosphate mix (TPM), is absorbed through the skin and into the bloodstream, with the use of two patches.

This study is evaluating the tolerability, safety and pharmacokinetics of Oral Monepantel (MPL) in patients with advanced solid tumours that do not respond to standard treatments. Who is it for? You may be eligible to joint this study if you have progressing and unresectable tumours, and have a life expectancy of greater than three months. All standard treatments need to have been exhausted or are contraindicated. Study details Following enrolment in the study, participants will receive an oral liquid dose of MPL once daily for 28 days. The first three participants enrolled in the study will receive 5mg /kg of body weight in each dose. If there are no toxicities or safety events observed in the first three participants, another three participants will be enrolled and receive 25 mg/kg of body weight in each dose. An additional three participants will be enrolled at 62.5 mg/kg body weight per dose if no toxicities/safety events are observed at 25 mg /kg body weight. If dose-limiting toxicities are observed at any dose level, an additional three participants will be enrolled at the same dose level, before the next dose level is initiated. This study design aims to determine whether there is a safe maximum dose that can be provided to patients with this condition. The results of the study will contribute towards the development of MPL as an anticancer treatment.

The primary aim of the study is to investigate the impact of telmisartan treatment on brown fat in humans. The hypothesis is that telmisartan recruits brown fat in humans, thereby improving glucose metabolism.

More people require kidney transplants which are in short supply. It is imperative that people who have kidney transplants take their medicines as prescribed. Poor adherence to prescribed medicines can cause a 60% increased risk of kidney transplant failure. Rejection requires costly hospitalisations, laboratory tests and anti-rejection therapies with associated poor outcomes. This project will develop and test an intervention to help adults requiring a kidney transplant to take their medicines as prescribed. Better medicine adherence results in improved graft life, general well-being, and reduced health care expenditure. Our industry partners share this vision of improved health for people requiring kidney transplantation.

This 3-year RCT will involve the development, implementation and evaluation of an intervention to increase the duration of breastfeeding amongst participating families in metropolitan Perth WA. The study will require the development and testing of additional intervention elements to enhance those already developed during the FIFI trial. This will be followed by the implementation of a RCT involving a sample of 1200 parents (1200 fathers and 1200 mothers) recruited from hospitals in the Perth metropolitan area. The interventions will consist of a control group intervention (the usual antenatal education offered by that hospital), two medium interventions groups and one high level intervention group. Beneficial outcomes may include increased duration of breastfeeding, delaying the use of infant formula and solid foods, a better start to life for the infants and less potential disease later in life. The study will also explore the cost effectivness of each of the three interventions.

This trial aims to study the pharmacokinetics, effectiveness and safety of 12 pellets of 75mg testosterone (900mg total) implanted under the skin in males who have hypogonadism. Testosterone replacement therapy may help to restore male secondary characteristics, sexual behaviour, energy, mood and muscle development. This trial will enrol 24 male participants between the ages of 18-70 who have blood testosterone levels below 300ng/dL. All participants will undergo a screening visit 21 days prior to check for eligibility. Eligible participants will undergo an implantation procedure where 12 testosterone pellets will be implanted under the skin. Blood samples will be collected at various timepoints throughout the trial for pharmacokinetic analysis and safety parameters. Participants will also complete a series of questionnaires throughout the trial. Participants will be followed up for 113 days.

There is currently no evidence indicating that it is possible to prevent falls in community dwelling older people with dementia despite this group having a disproportionately higher rate of falls and fractures and poorer outcomes post event. However, there is evidence that a dementia specific approach to care, in which interventions are based on the individuals’ preserved abilities and in which the caregiver is provided with the skills to work effectively with the person with dementia, can be effective in improving daily function for the person with dementia and sense of competence for the carer. The purpose is to investigate whether a home-based exercise program and home hazard reduction program can: 1) reduce the risk of falls in older people with cognitive impairment or dementia, and 2) improve the quality of life of the person with cognitive impairment or dementia and their carer(s).

The purpose of this study is to evaluate whether the proposed algorithm-based approach to the global management (triage, screening, diagnosis and treatment) of Functional Gastrointestinal Disorders is feasible, acceptable, safe and effective.

This project aims to evaluate the effectiveness of a brain stimulation technique referred to as transcranial magnetic stimulation (TMS) in treating obsessive compulsive disorder (OCD). Thirty OCD patients will allocated to either the control or experimental condition and receive TMS once daily for three weeks (Monday to Friday). Patients will then be followed up at two times points; after one week and four weeks post-treatment. The treatment protocol will consist of identifying and stimulating three brain regions which have been shown to be involved in OCD. Each region will be stimulated for 10 minutes using TMS parameters developed within well-established safety guidelines. We will measure the primary and secondary symptoms that patients experience and also measure their ability to perform computerised and pen and paper tasks. It is hypothesised that patients who undergo active treatment will experience a reduction in their OCD symptoms when compared to patients in the control condition.