ANZCTR search results

Semaglutide is a long-acting GLP-1 analogue used in the treatment of patients with type 2 diabetes (T2D) has shown to improve glycaemic control and result in meaningful weight loss. The drug has a well described safety profile including a low risk of hypoglycaemia. This short duration pilot study will evaluate the biological activity of a single dose of 4mg of oral Semaglutide in Diabetology’s Axcess formulation. Eight healthy volunteers will receive 4mg of the encapsulated semaglutide on an empty stomach with a glass of 100ml of water, on Day 0. They would also have received a placebo 2 days prior to this. Both the placebo and the semaglutide will be administered on the same day, in a fasting state. An intravenous glucose tolerance test (IVGTT) will be conducted two hours after placebo and treatment, before any food is consumed. The IVGTT will also be performed at approximately the same time on days 1, 4 and 6 post-treatment. The primary aim of the study is to determine whether, compared to a placebo, orally delivered encapsulated semaglutide is associated with a difference in plasma blood glucose levels during an intravenous glucose tolerance test (IVGTT). The secondary aims are to 1) explore changes in plasma insulin during an IVGTT, and 2) to explore the duration of action over a span of 7 days.

The relationships between disordered eating and higher weight is of critical importance for treatment of weight because 1 in 5 people with higher weight also have an eating disorder. While resources have been spent on treatment for higher weight, less attention has been paid to potential and underlying psychological factors affecting weight as well as psychological support in vulnerable times to minimise relapse. In light of this, we aim to understand and compare evidence-based psychological treatments for this population to better inform standard care policy moving forward. Participants will complete a baseline assessment and various questionnaires. They will then be randomly allocated to either a psychological intervention group (Schema Therapy) or to continued care with their GP (Treatment as Usual). Treatment will involve group therapy of 8 to 10 participants per group, for 2 hours a week, for 16 weeks, run by a clinical psychologist. Schema Therapy will be modified, following the manual set out by Simpson & Smith (2020). Primary Outcomes The primary goal of this research is to evaluate the effectiveness of STE-g for disordered eating symptom severity (measured using the EDE-Q) and weight change (measured using participants’ BMI). Secondary Outcomes The secondary goal of this research project is to evaluate the efficiency of 16 weeks of STE-g for the following: emotional regulation (measured by the DERS-18), trauma (measured by the PCL-5), schemas (measured by the YSQ-3-SF) and schema modes (measured by the SMI).

This study has been designed to assess the benefit of a stem-cell technology known as Rigenera Autologous Micrograft Therapy (AMT) in hair restoration. Patient tissue is processed to produce a concentrated stem-cell solution which will be injected in to the scalp. We are assessing if there is any improvement in FUT (Follicular Unit Transplant, aka “Strip surgery”) hair transplant surgery results when performed with Rigenera AMT during the operation. We hypothesise that using Rigenera AMT solution in FUT surgery will improve graft survival and increase hair follicle thickness and density.

Contact lens discomfort and its associated dryness are the primary reasons to discontinue using contact lenses. In addition, users with decreased tear volume are more prone to be intolerant to soft contact lenses. The lipids (oils) of the tear film are produced in the meibomian glands in the eyelids, and these lipids are delivered from the meibomian glands to the eye to form part of the tear film lipid layer. This layer promotes tear film stability and prevents drying of the ocular surface. Several of these lipids help stabilize and spread tears across the ocular surface and retard tear evaporation. The amount of lipids in tears is reduced in people with dry eyes, and dry eye is related to contact lens discomfort. Contact lens discomfort is worse when people's meibomian glands are blocked. Therefore, we hypothesize that adding lipids back to the eye during contact lens wear will help form a stable tear film and reduce dry eye sensations. We and many others have shown that delivering components from contact lenses is preferable to delivering by eyedrops as more of the component remains on the eye. The aim of this study is to investigate changes in the ocular surface (corneal and conjunctival staining, non-invasive tear break-up time, and comfort level) of experienced contact lens wearers wearing oil-loaded contact lenses. This study was designed as a single-center, double-masked, randomized study. At the baseline visit, experienced contact lens wearers who meet the inclusion criteria will be enrolled in the study. After baseline, participants will be asked to attend the clinic on three different days with two visits per day (morning and evening). The same lens will be worn in both eyes, all participants will wear all three lens types (in total, three visits), and the lenses will be randomly assigned for wear. Participants will randomly wear oil-imbibed lenses (O-L), control lenses that contain only small particles of surfactant with no oil (C-L), and normal commercially available contact lenses (M-L). The primary endpoint is the changes in the tear break-up time of contact lens wearers over the 8 hours of lens wear.

The study involves a pilot group of up to 60 young individuals (aged 16-24) with depression, assessing the impact of PGx testing on prescribing antidepressants and collecting longitudinal data to evaluate genetic testing's utility. Insights from this study are crucial for shaping the pilot and will inform a larger clinical trial focused on the role of genetic information in optimising treatment for young people with depression. The project aims to collect empirical data to evaluate PGx testing feasibility in youth psychiatric primary care practices and support the development of sound, evidence-based treatment recommendations, using genetic insights into individual metabolic enzyme profiles.

Sleep, circadian rhythms, and mental health are reciprocally interlinked. Disruption to the quality, continuity, and timing of sleep can precipitate or exacerbate psychiatric symptoms in susceptible individuals, while treatments that target sleep—circadian disturbances can alleviate psychopathology. Elite athletes are - due to their line of work - especially vulnerable to both mental health issues, and poor sleep. Sleep regularity (in timing and duration) has been suggested in previous literature as a potential candidate for an intervention target due to their i) potentially modifiable nature (as reflected in sleep hygiene recommendations for consistent bed and wake times), ii) correlation with other sleep metrics and iii) relationship with mortality risk, cardiovascular and mental health and iv) a more feasible target to continue in the longer term. Circadian strategies have also been utilized in clinical populations to target mental disorders and mood but there is no research specifically investigating the effects in athletes. There are currently no intervention studies targeting circadian alignment and sleep regularity for mental health in athletes. The majority of research has been cross-sectional and only using subjective measures meaning there is a huge lack of evidence for causational pathways. The aim of this study is to develop and pilot a novel sleep regularity and circadian alignment intervention in athletes. This intervention will target sleep regularity and be informed by individual circadian biology, participant preference and current literature guidelines.

This study aims to evaluate and identify the core components and implementation effectiveness of a novel, rapid, ambulatory subacute service for consumers living with one or more chronic diseases (diabetes, chronic respiratory disease, and/or chronic cardiovascular disease) - the Preventative Integrated Care Service. This research project will be looking at how the service operates, what contributes to successes and challenges in delivering the Preventative Integrated Care Service, what’s needed to successfully roll similar services out to other locations, and how the service can be adapted to overcome challenges to deliver high quality care to its patients.

Hyponatraemia is common in hospitalised patients. Our Australian data demonstrate that hyponatraemia leads to adverse outcomes and delays hospital discharge. In Australia, fluid restriction is the mainstay of treatment for hypotonic hyponatraemia in hospital inpatients, but it is often ineffective because it does not treat the underlying pathophysiology of hyponatraemia. Tolvaptan, a vasopressin V2-receptor antagonist, and urea are common second-line therapies for hyponatraemia, but it is not known which is more effective.

AT-01 is a novel peptide radiotracer which binds to a constant region of the insoluble amyloid protein; the agent which results in end-organ damage in AL amyloidosis. It is able to demonstrate on molecular imaging scans the presence of amyloid within all vital organs of the body, namely the heart, kidneys, liver and spleen. No other imaging modality has been able to capture this in a single scan. By accurately detecting amyloid in organs of the body and assessing for response to therapy, AT-01 PET/CT scans have the potential to revolutionise the way AL amyloidosis is diagnosed, monitored, and help to guide treatment decisions in the future.

The proposed study will aim to address existing gaps in literature by conducting a feasibility study of a group schema therapy intervention for comorbid anxiety and mood disorders in adults. This will involve conducting an empirical investigation of a manualised group schema therapy intervention to understand feasibility and assess effectiveness of the group. The manualised group intervention will be based on the group protocol established by Farrell, Reiss & Shaw (2014) and further adopted by Younan, Farrell, & May (2017). The group treatment will be conducted in an outpatient clinic by involving two co-therapists and ten patients per treatment group. Participants will complete quantitative measures of symptoms at pre, mid and post-test intervals to investigate preliminary feasibility of the program and qualitative analyses will be conducted to analyse patient experiences.