ANZCTR search results

The Vigilance with Vital Signs Study aims to establish a system for early identification of high-risk patients through the continuous electronic monitoring of vital signs (respiratory rate, heart rate, blood pressure, skin temperature, ECG and oxygen saturation) to trigger a response and prevent adverse events in general wards. Our hypothesis is that a continuous monitoring system including clinical training, the mobile device and pre-defined alarm thresholds can reduce adverse events,deaths and unplanned admissions to intensive care by detecting earlier deterioration and prompting earlier intervention by ward staff.

Ageing is associated with a physiological reduction of appetite and energy intake, which has been called the “anorexia of ageing”. Dietary supplementation with liquid protein preparations is now used frequently to increase energy and protein intake in older adults in both institutionalized and community-dwelling populations. Although the latter would appear a logical approach, evidence for success of increased energy intake in older individuals is limited. It is well established that the ingestion of nutrients induce a number of changes in gastrointestinal (GI) function, which are associated with the modulation of appetite and energy intake. These changes include the slowing of gastric emptying, which sustains gastric distension and is associated with proximal gastric relaxation. Urgent investigation is warranted to determine the optimal load of protein that can be incorporated into their diet to assist in sparing muscle mass without reducing their appetite. The study aims to characterise in healthy older individuals, absolute and in comparison to young individuals, the effect of different oral protein-rich loads on energy intake, appetite, antral area, gastric emptying, plasma concentrations of amino acids, hormones (i.e. CCK, PYY, ghrelin, GLP-1, GIP, glucagon and insulin) and glucose, and studies the relationship between the suppression of appetite and energy intake by protein with ‘intragastric’ mechanisms.

The hypotheses were that the provision of culturally accessible cardiac and pulmonary rehabilitation would increase participation and improve health outcomes for Aborigines with established disease, and would reduce risk factors such as obesity and physical inactivity for people with risk factors.

The aim of the research is to determine the effect of pork consumption on serum irisin levels in people with type 2 diabetes. Study participants will be adults (aged 18 to 60 yrs) with type 2 diabetes from the Hunter Region, NSW. Participants will be asked to consume diets containing pork meat for a period of 4 weeks. Blood samples will be collected at baseline and 4 weeks and analysed for irisin, blood glucose and insulin levels. Data will be assessed for a possible role of pork meat consumption on glucose homeostasis.

Altered mood is a common problem after stroke and can impact on stroke survivors’ recovery. Despite this it is often poorly identified by health professionals. Accessing psychology services after stroke is an enormous issue with only 12% of acute services having access to clinical psychology and 29% having protocols for referral to psychology. This pilot, implementation study aims to improve the identification of suspected altered mood in patients with stroke admitted to Hunter New England Health (HNEH) hub services. It will trial standardised processes and tools, supported by training for clinicians. Identification processes will commence early in the acute setting and continue during the stroke survivor's inpatient stay in HNEH hub facilities. Results from identifying suspected altered mood will be included in the patient discharge summary. This controlled, pre and post-implementation cohort design study will include comparisons to historical audit data and control sites.

The aim of this study is to determine if we can prevent the development of uterine cancer in women who need to take tamoxifen therapy. We will investigate whether metformin, commonly used to treat diabetes, blocks cell pathways by which tamoxifen (and oestrogen) stimulates growth of the lining of the uterus. This study will enable us to determine if there is a potential role for metformin a) to prevent changes to the uterine lining in women treated with tamoxifen b) possibly prevent cancer of the uterus This study also offers a unique opportunity for us to determine whether all women with breast cancer should have ultrasound of their uterus before starting tamoxifen and after one year of therapy. Reasons for the study: Over 75% of women diagnosed with breast cancer in Australia have hormone sensitive cancer. Of these, at least 1/3 will be treated with a drug called tamoxifen, which blocks oestrogen action. A recent large study has shown that 10 years of tamoxifen therapy is more effective than 5 years in prolonging survival. However, a downside of tamoxifen therapy is a 75% increase in the risk of uterine (endometrial) cancer. Presently there is no treatment to prevent endometrial cancer in women treated with tamoxifen, or for that matter for women in general. Endometrial cancer, the most common gynaecologic cancer, affects approximately 1 in 73 Australian women by the age of 75 years and 1 in 52 by the age of 85 years. We do know that: tamoxifen is associated with a 7 fold increase in endometrial cancer over 5 years most women who develop an endometrial abnormality on tamoxifen do so in the first year of treatment 1 in 5 women have an endometrial abnormality before starting tamoxifen (this increases the risk for tamoxifen-induced changes) We will recruit women with hormone receptor positive breast cancer who are postmenopausal, less than 75 years old not diabetic.

Obesity has reached epidemic proportions globally and is associated with serious co-morbidities, including type 2 diabetes. Once adipose tissue has been accumulated, and food intake is limited by low calorie diets, counter-regulatory mechanisms induce an increase in appetite and a decrease in energy expenditure, which makes weight loss very difficult to maintain. To combat the global burden of obesity and its co-morbidities, a major challenge lies in the development of effective therapies that increase fullness and satiety, and result in good blood glucose control, while lacking adverse effects that are often associated with current therapies. There is increasing evidence that nutrient stimuli in the gastrointestinal tract play a central role in the control of energy intake and blood glucose. Proteins, and their building blocks, amino acids, are of interest, since high-protein diets are very effective for weight loss, particularly loss of fat, rather than muscle mass, and for improving postprandial glycaemic control, in obese individuals with and without type 2 diabetes. There is some evidence that a number of amino acids (including those to be studied) may also have effects on energy intake, blood glucose and gut function in humans. Thus, they are of special interest in terms of potential therapeutic approaches for obesity and type 2 diabetes. This study will investigate the dose-related effects of intragastric administration of specific L-amino acids on gastric emptying, gut hormone release, glycaemic control, appetite perceptions and energy intake in healthy, normal weight and overweight or obese type 2 diabetic patients.

Update Prior clinical case studies of patients with type 2 diabetes mellitus on sulphonylurea monotherapy, who have taken a purified natural plant oligosaccharide supplementation (approved for human consumption as part of their diet) have shown significant improvements in their glycaemic control. Current findings suggest a synergy between sulphonylurea anti-diabetes drugs and the active oligosaccharide. OzStar Therapeutics has formulated and wishes to test OZ101, a GMP manufactured proprietary tablet, as an add-on therapy to patients treated with sulphonylurea-only or metformin and sulphonylurea combination therapy. Patients must have been on sulphonylurea for at least 6 months prior to recruitment, with any duration of metformin intake, exhibit uncontrolled blood glucose levels, been diagnosed with diabetes for between 1-10 years. The clinical trial has been designed to be a proof-of-concept and signal finding study on the efficacy of two different doses of OZ101 on glycaemic control in patients with T2DM.

This study aimed to investigate the preliminary effectiveness and feasibility of a patient led goal setting approach in chronic low back pain.

Malnutrition is common in hospitalized patients and is associated with adverse health outcomes including prolonged length of stay, increased risk of pressure sores and increased re-admission rates and proves costly for the hospitals. Diagnosis of malnutrition is often missed due to a number of factors including lack of awareness among clinicians and low priority given other medical conditions. The main purpose of this study is to find out whether nutrition supplementation started early in hospital and extending for three months after discharge has any beneficial effects on health outcomes of patients and whether this intervention is a cost-effective strategy.