ANZCTR search results

Low-calorie sweeteners (LCS) have been widely used in food and beverages in recent decades. However, a recent World Health Organisation (WHO) report highlighted that people who consume LCS regularly have an increased risk of developing type 2 diabetes (T2D). Acesulfame potassium (Ace-K) is a widely used low-calorie sweetener that is absorbed from the gut and excreted in the urine. We want to find out whether Ace-K consumption, as compared with water and a poorly absorbed LCS, sucralose, reduces the amount of glucose excreted in the urine in people with T2D, which would promote higher blood glucose levels.

This Post-Market Clinical Follow (PMCF) study will evaluate clinical performance and safety outcomes of primary total hip arthroplasty surgeries using MobiliT™ cup and Paragon™ stem over a ten-year period. Participants will be selected for recruitment into the study from the general population of patients requiring a dual mobility total hip arthroplasty surgery and considered suitable to be implanted with MobiliT™ cup and Paragon™ and Taperfit stem (Corin Ltd). After the surgery, participants will be required to return for follow up visits and radiographic controls at specific timepoints and complete questionnaires for a period of 10 years. This PMCF prospective study is being initiated to collect performance and functional results of dual mobility procedures performed in primary THA surgery using the MobiliT™ cup and the ECiMa (highly crosslinked UHMWPE with Vitamin E) insert that received the CE mark at the end of 2020 and was recently approved by the TGA in 2022 for dual mobility procedures in primary THA surgery.

Sleep Intervention for Adults Presenting with Insomnia (SLEAPI) is a novel ACT-I/behavioural therapy (BT) intervention originally developed to increase behavioural and psychological flexibility around sleep in autistic adults (Lawson et al., 2022). Behavioural methods aimed at reducing sleep difficulties and improving sleep involve sleep hygiene, self-monitoring, relaxation, and sleep restriction. This trial aims to investigate whether SLEAPI delivered in an individual format for non-autistic adults promotes significant improvements on insomnia symptomology severity. This study will investigate the efficacy of the SLEAPI intervention on improving (1) quality of life; (2) acceptance of sleep issues; (3) individual sleep components; (4) perceived sleep quality; and reducing (5) anxiety and depression and (6) pre-sleep arousal among non-autistic adults. A non-concurrent multiple baseline design will be used to track the effects of the intervention. The use of a multiple baseline design allows participants in the longer baseline phases to act as controls/comparators for those in the intervention phase. In this design all participants will receive the same intervention.

The primary purpose of this study is to find out how much difficulty people living with HIV (PLHIV) who live in a regional area have with everyday tasks, hobbies, sports, jobs, memory, emotion, or participating in social events. These difficulties are known as ‘Disability’ and ‘Frailty’, and we will measure them using three questionnaires. Also, because one of the disability questionnaires is relatively new, we want to compare it with the established disability questionnaire we are using, to test how suitable it is to use for PLHIV in regional Australia. The study will recruit 54 volunteers (over 18 years) living with HIV. Disability due to HIV leads to a reduced quality of life, so knowing what difficulties exist will tell us what changes are needed in health and community services to improve their quality of life. Without better understanding of disability and frailty, best services and funding to improve health, function, inclusion in society, and quality of life cannot be provided. This cross-sectional study with a nested reliability and validity study will use quantitative methods of 3 self reported written questionnaires measuring disability and frailty in PLHIV. Recruitment will be conducted at the Sexual Health Service study site. Initially, participants will be recruited through leaflets and posters advertising the study available on notice boards and in reception areas at the study site.

Presenting to a surgical outpatient clinic can be a stressful experience for patients. Disparity in education levels, perceived power imbalances and other factors can result in the patient feeling unsatisfied or confused at the completion of the consultation. We propose a randomised controlled study; whereby, the participant is placed into either the intervention group and will receive a pre-designed patient prompting document, or they are placed in the control group. The outpatient consultation will be audio-video recorded. Within 7 days of the consultation the participant will be contacted by telephone to discuss their experience. The purpose is to analyse the utility of a patient prompting document in improving patient understanding, increased patient empowerment and facilitating successful outpatient consultations.

This is a prospective cohort study to observe the efficacy of LBB pacing, a newer pacing modality to the current gold standard of BiVentricular Pacing (BVP). All patients with heart failure and an indication for pacing/CRT will be selected and categorized into two cohorts. Intervention under study cohort - patients who will undergo LBB pacing CRT Comparator cohort - patients who will undergo biventricular pacing CRT It is a multicentre cohort study and those undergoing CRT at two centres - the Canberra hospital and the National capital private hospital will be enrolled. CRT is cornerstone of heart failure management apart from optimal medical treatment. BVP is current gold standard of delivering CRT but LBB pacing is a new modality which recruits conduction system and physiologically depolarises LV and could be more efficacious in improving LVEF, QRS duration and symptoms.. However, literature regarding this is scarce. We aim to compare these two cohorts in terms of primary outcomes including effect on LVEF and QRSd on follow up and secondary outcome including LV end diastolic and end systolic volumes and effect on NYHA class and QoL. The outcome data will help us understanding whether LBB pacing is more efficacious and will support conduction of prospective Randomized Control Trial.

This project will carry out a controlled randomised crossover trial, enrolling up to 20 healthy volunteers from ages 18-70 years over the next 3 years. The intervention involves a 3-day water-only fasting, with or without a single bout of glycogen depleting exercise on cycle ergometer. We and others have shown that prolonged fasting, turns on autophagy and proteostatic pathways via up-regulation of several “longevity genes”. However, we do not yet understand the timing and the dose-response of these beneficial cell and metabolic signalling adaptations in humans. The proposed study will determine the effects of a 3-day fast on activation of autophagy and associated stress-resistance pathways, and test the hypothesis that a single bout of exercise enhances this effect. This study is part of an ongoing research effort at the University of Sydney multidisciplinary hub ‘Charles Perkins Centre’ and Sydney Local Health District on healthy ageing and prevention of cardiometabolic diseases.

The technical advantages of the robotic surgical platform have been embraced by surgeons but scientific quantification of the advantages when compared to conventional laparoscopic platform is scarce. Accurate measurement of such mechanical advantages in specific surgical procedures such as obesity surgery will be beneficial to assist surgeons in selecting the best surgical platform or tools to perform complex bariatric procedures with the aim of achieving the best surgical outcomes. This project will analyse and compare surgical recordings of surgeons constructing gastro-jejunal anastomosis in gastric bypass surgery using the robotic surgical platform and conventional laparoscopic platform. The video analysis will be correlated against the difficulty of the procedure measured using the National Aeronautics and Space Administration Task Load Index (NASA TLX), a short survey regarding the performance of the gastrointestinal anastomosis and clinical outcome parameters. The project will be open to all bariatric surgeons in Australia with the aim of recruiting 50 patients in each group. A total of at least 42 patients in each group will provide the adequate volume to power the study to detect a difference in surgical proficiency between the platforms.

Studies have shown that individuals may search for suicide-related terms on the internet prior to an attempt. Thus, we investigated engagement with an advertisement campaign designed to reach individuals contemplating suicide. We utilised Google AdWords’ targeting features and investigated whether individuals show higher engagement with landing pages tailored to specific age groups compared to a general all-ages landing page. We hypothesise that we will see more engagement with the landing page in the tailored condition as it should relate more closely to the individual.

Mental health problems are very common in Aboriginal and Torres Strait Islander people. Aboriginal and Torres Strait Islander people’s physical and mental health continues to be negatively impacted by intergenerational trauma, socio-political policies, and socio-economic disadvantage. Mental health treatment must be cognisant of cultural understandings of communication (verbal and non-verbal) and experiences, in addition to the social determinants of health including poverty, housing insecurity, racism, discrimination, and under- and un-employment. This study will implement and evaluate the Indigenous Model of Mental Health Care (IMMHC) that has been developed following consultation with the community through our previous research. The IMMHC will combine trans-diagnostic cognitive-behaviour therapy (CBT) delivered by clinical psychologists with traditional healing delivered by traditional Aboriginal healers for a unique approach to treating mental illness in Aboriginal and Torres Strait Islander people. A mixed method, cross-sectional design will be employed, combining quantitative data collected to determine the impact of the IMMHC on depression, anxiety, substance use, and quality of life with qualitative data collected to determine the acceptability and features of value of the IMMHC. Approximately 30 people will be recruited to be recipients of the IMMHC, in addition to the Aboriginal traditional healers and the clinical psychologist who will participate in the qualitative component. Appropriate statistical tests will be applied to make sense of the quantitative data, and thematic narrative analysis will be used to analyse the qualitative data. The qualitative component of this study will assist with providing in-depth understanding of the quantitative results. Results will be disseminated through conference presentations, peer-reviewed journal articles, presentations to local mental health services, and a lay summary for the research participants.