ANZCTR search results

The purpose of this study is to understand how different foods can affect blood glucose responses when a young person sits for a long period of time and when that sitting is interrupted with light exercise breaks. We hypothesise that the glucose responses will be minimised when healthier foods are eaten and when the sitting is interrupted by light exercise breaks.

This study aims to investigate the safety and tolerability of intramuscular DVC1-0101 injections, at both high and low doses, when compared with placebo, in patients with intermittent claudication or critical limb ischaemia secondary to peripheral arterial disease. The secondary aims are to investigate the efficacy of DVC1-0101, compared with placebo, in promoting revascularisation in the target leg limb. Enrolled participants will receive a single dose (30 intramuscular injections) in the target limb. They will be required to return for regular outpatient visits over a 6 month follow up period. A final follow up phone call will be conducted at 12 months post-dose. Safety and tolerability will be measured via physical examination, clinical laboratory results and monitoring of injection site reactions. Secondary efficacy outcomes include exercise treadmill testing to obtain absolute claudication distance (ACD) and patient self-reported walking impairment data. Blood samples will be collected for pharmacodynamic measurements. The results of the study will be used to develop DVC1-0101 as a treatment for patients with claudication and critical limb ischaemia.

This is a first in human, randomized, placebo-controlled, double-blind, single dose, escalating dose and Multiple-Dose study of the safety and pharmacokinetics of RA101495 in healthy volunteers to evaluate safety of RA101495. There will be up to 5 single dose cohorts with doses of 0.05, 0.10, 0.20, 0.40 and 0.80 mg/kg. There will be up to 2 multiple dose cohorts with doses of 0.20 and 0.40 mg/kg. Study drug will be administered on Day1 for single dose cohorts and on Day1-7 for multiple dose cohorts as a single SC injection and the amount of drug given will depend on the dose of the cohort and the weight of the subject. Each cohort will be dosed a minimum of 7 days for single days cohorts and 14 days for multiple dose cohorts after the first subject in the previous cohort received the last dose. If 2 or more subjects administered RA101495 in a dose cohort experience a dose-limiting toxicity, dose administration in that cohort will stop and escalation to the next dose level will not proceed.

A recent meta-analysis of 13 randomised controlled trials involving 1910 patients has shown that the application of a bundle of care, as part of the enhanced recovery after surgery (ERAS), relative to standard surgical care, results in a significant decrease in the length of hospital stay and overall complication rates (Zhuang et al. 2013). Apart from associated benefits to the patient in terms of quicker return of normal function and less complication rates, there are significant economic implications as well. Current practice at The Northern Hospital is to provide ERAS to all surgical patients undergoing colorectal surgery. The provision of deep neuromuscular blockade, relative to standard neuromuscular blockade has been shown to improve surgical conditions in laparoscopic surgery (Blobner, et al. 2015; Madsen et al. 2015) and to decrease post-operative pain (Hua et al. 2014). To date, no trials have been conducted to determine whether the use of deep neuromuscular blockade to patients having laparoscopic colorectal surgery and being managed with the ERAS bundle of care, leads to further improvements in patient outcomes, in particular, quicker return of bowel function and reduced length of hospital stay. In addition, it is likely that deep neuromuscular blockade for the duration of surgery will minimise the possibility of trauma to surrounding tissues and reduce surgical operating time, with its associated economic implications.

This is the 2nd human trial in gerilimzumab testing the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of gerilimzumab. A single dose of 5 mg gerilimzumab or 20 mg gerilimzumab or placebo is administered at three 4-weekly intervals (D1, 28, 56). Participants are followed through to D84. This is a randomized, double-blind, placebo-controlled, multiple dose study.

Low plasma vitamin C and E have been more likely to be found in demented patients than in healthy controls. This is supported by findings from a prospective cohort study from Department of Health/Medical Research Council Nutritional Programme in which participants (n = 921; greater than or equal to 65 years) with the lowest Vitamin C status displayed the poorest cognitive function, a finding which persisted when corrected for age, illness, social class, or other dietary variables. Additionally, a recent an epidemiological prospective cohort study showed that high dietary intake of vitamin C and vitamin E may lower the risk of Alzheimer disease. Higher vitamin C blood levels have been found in association with a better memory performance among subjects older than 65 years. Studies have shown that blood vitamin C concentration falls during acute phase responses such as after surgery, trauma, sepsis, and burns. Researchers at the University of Toronto have shown that anaesthetics following surgery can cause long-term memory loss. In a recent study, blood concentration of vitamin C decreased post-operatively and the reduction was significant 7 days after coronary heart surgery. A study is yet to correlate paper and pen assessments such as the Mini mental State Examination (MMSE), Hopkins Verbal Learning test (HVLT-R) and symbol digit modalities test (SDMT) with a computer based cognitive testing such as the SUCCAB. The SUCCAB assesses accuracy and speed, which have been shown to correlate to cognitive decline through ageing. There is consensus that crystallised abilities (vocabulary and general knowledge) can remain stable until very late in life whereas fluid abilities (attention, executive function and memory) decline from middle adulthood until late age. The cognitive tests incorporated in the present study will primarily examine these fluid abilities. The MMSE assesses cognitive impairments in clinical and research settings. The HVLT-R is a reliable neuropsychological test of many aspects of verbal learning and memory, requiring subjects to recall as many items as possible from a list of common words. The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. Previous research measuring vitamin C has incorporated simple food questionnaires to predict vitamin C levels. The proposed study will measure serum vitamin C levels thoroughly through a means of ELISA testing. The proposed project aims to examine vitamin C serum concentration and cognitive performance measured by SUCCAB, and the pen and paper tests, including the MMSE, SDMT, and HVLT-R.

Participation will involve being randomly assigned to one of two routinely used pain management protocols to provide pain relief in the period immediately after total knee replacement surgery. Participants will be unaware as to which group they are in. A pain specialist doctor and nurse will assess pain control and range of movement of the knee at regular intervals following the surgery. This will assist surgeons and anaesthetists to determine the most effective regimen for future patients.

Background: Young people with type 1 diabetes (T1DM) are life-long health service users. Good control of blood glucose can reduce or slow complications, but require services that support effective self-management. When teenagers must move to adult care, transition is often problematic; up to 40% attrition and poor diabetic control result in crisis use of acute services. Evidence is limited, especially outside urban services, but effective transition provides age-appropriate care and can maintain young people in the health system. Aims: To examine whether a new Systems Navigation model of transition and care for young people with type 1 diabetes in regional/rural NSW will result in the improved outcomes seen for this model in other settings; To examine the effectiveness of service redesign processes to support implementation of this new care model. Design is a single blind cluster randomized controlled trial, randomizing the 8 service clusters of Hunter New England Health to either intervention (new Systems Navigation model) or control (current) service models with patient-level outcomes assessment. Participants are young people with T1DM transitioning from paediatric care in their first two years with HNEH adult services. Sample size calculation is based on the primary outcome of usage of planned, routine preventive services; 152 subjects will convey 80% power to detect a 50% improvement in the intervention compared to control group. Outcomes: We aim to increase follow-up of young people with T1DM moving to adult services, and their retention in contact with services. This should improve indices of diabetes control such as HbA1c levels, reduce use of acute services and costs. Patient service satisfaction should be maintained. Data will be analysed on intention to treat basis, taking account of clustering of patients; appropriate regression models will determine if there is statistically significant difference between intervention versus control group outcomes.

In this project, we will study the clinical efficacy of an 8 week graded isometric home exercise program in patients with tennis elbow, by comparing it to a wait and see approach. Exercise is commonly prescribed to reduce pain and disability from tendinopathy, however the optimal type and dose of exercise is not clear. A recent systematic review identified only two clinical trials investigating the effects of isometric exercise in people with tennis elbow, with inconsistent findings. Neither of these studies quantified the exercise load, limiting conclusions regarding dose response. We will compare the effects of an 8 week home program of isometric exercise with a wait and see approach on global recovery, pain, disability and pain free grip strength. Many patients with tennis elbow exhibit signs of central sensitisation, including widespread sensitivity to mechanical and thermal stimuli. It is not known whether exercise can improve the processes involved in central sensitisation. We will test the effects of 8 weeks of exercise on quantitative sensory tests and conditioned pain modulation. Exercise induced analgesia will be also evaluated at baseline using a submaximal (20% MVC) isometric endurance task.

Older people are more likely to lose than gain weight and weight loss is a strong predictor of poor outcomes in older people. Weight lost in older people predominantly comprises muscle and insufficient protein intake is likely to exacerbate muscle loss by limiting muscle anabolism. When severe, muscle loss leads to sarcopenia or cachexia, which are strongly associated with adverse outcomes. Protein-enriched supplements are often used to preserve and restore skeletal muscle mass in the elderly population. The rationale for using protein supplements in older people is strengthened by evidence that ageing has a minimal effect on the capacity to synthesize muscle protein acutely after protein ingestion. Accordingly if older people can ingest enough protein it is likely to have beneficial effects on muscle mass. Muscle protein deposition and anabolic effects are greater when amino acid concentrations are higher, however, there are limits to the amount of protein that can be chronically ingested, particularly by older people, due to factors such as cost, palatability and suppression of energy intake at subsequent meals. Furthermore, in young adults, the onset of satiety after ingestion of more rapidly digested and absorbed proteins is earlier, and its duration shorter than with ‘slower’ proteins. Administration of more rapidly absorbed proteins to under-nourished older people may, therefore, have the advantages of not only enhancing muscle protein synthesis, but also of minimising the duration of any potentially appetite suppressant effects. An effective way to increase muscle protein deposition, by accelerating the absorption of proteins, may be to hydrolyse them, ie digest proteins in their component amino acids. In healthy older people, for example, administration of partially hydrolysed casein resulted in earlier and higher peak amino acids (particularly essential amino acids, e.g. ~3-fold increase in peak plasma leucine concentration) than administration of the same amounts of un-hydrolysed casein (~2-fold increase). Insights into the digestion and absorption kinetics of dietary protein-derived amino acids after protein ingestion can successfully be obtained by using cow milk protein with intrinsically labelled amino acids (L-[1-13C]-phenylalanine and L-[1-13C]-leucine), which are measured in muscle biopsies after administration to calculate fractional synthetic rates of the muscle. Aim: To determine the acute effects of hydrolysis of protein on protein absorption and digestion kinetics of milk protein, administered directly into the small intestine. Hypothesis: In older subjects the plasma amino acid concentrations will peak more rapidly and the muscle protein deposition will be higher after ingestion of the completely digested protein (free amino acids) when compared with the intact intrinsically-labelled milk protein.