The increasing prevalence of overweight and obesity among individuals with type 1 diabetes (T1D) complicates glycaemic management and escalates insulin resistance, necessitating innovative therapeutic strategies. Tirzepatide, a dual agonist for glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors, shows promise in managing weight and glycaemic control in type 2 diabetes but is unexplored in the context of T1D. This double-blind, placebo-controlled randomised trial will evaluate the efficacy of tirzepatide in adults with T1D and overweight/obesity over 32 weeks.

60 participants (aged 18–70 years) with a body mass index ≥27 kg/m² and HbA1c≤10% will be randomised 1:1 to receive either tirzepatide or a placebo, alongside standard insulin therapy. The primary outcome is the change in body weight (%). Secondary measures include change in HbA1c (%), proportion of body weight lost (>5%, >10%, >15% and >20%), changes in insulin dosage, time in range by continuous glucose monitoring (CGM) criteria and severity of comorbidities. Compliance, adverse events and medication interactions will be closely monitored, with adjustments made for tolerability. Patient-reported outcomes and experiences will be measured to capture the benefits of glycaemic management, weight management and quality of life. To compare the means of body weight reduction (%) between the tirzepatide and control groups, an independent samples t-test will be employed under the assumption that data are normally distributed. Secondary outcome measures will be analysed by Student’s t-test. All data will be reported as group means with confidence intervals, with default statistical significance assumed at p

Ethical approval has been obtained from the Northern Sydney Local Health District’s Human Research Ethics Committee (approval ID #2024/ETH00180).

NCT06180616.

Respiratory viral infections (RVIs) are a significant cause of morbidity and hospital admission worldwide. However, the management of most viral infection-associated diseases remains primarily supportive. The recent COVID-19 pandemic has underscored the urgent need for a deeper understanding of RVIs to improve patient outcomes and develop effective treatment strategies. The Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission-Longitudinal Study is an observational study which addresses this need by investigating the heterogeneity of RVIs in hospitalised adults, aiming to identify clinical and biological predictors of adverse outcomes. This study aims to bridge critical knowledge gaps in the clinical course and the economic impact of RVIs by characterising the phenotypic diversity of these infections and their recovery patterns following hospital admission and thus assisting with the optimal design of future interventional studies.

This prospective longitudinal observational study (V.6, 20 September 2023) will be conducted across multiple UK secondary care sites from August 2022 onwards, with an aim to enrol 1000 participants testing positive for RVI. Adults admitted with respiratory symptoms who test positive for RVIs via the BioFire® FilmArray® System or other validated diagnostic PCR tests will be enrolled. The data collected include patient demographics, clinical history, comorbidities and symptoms experienced prior to, during and after hospitalisation with follow-up after discharge at weeks 1, 2, 4, 8, 12 and 26. In addition, biological samples are collected at multiple time points during the hospital stay. The primary endpoints are to study the impact of different RVIs and identify predictors of disease progression and length of stay. Secondary endpoints include time to recovery and healthcare cost. Exploratory endpoints focus on biomarker profiles associated with virus type and clinical outcomes.

The study protocol received ethical approval from the relevant committees (English Ethics Reference Number: 22/WM/0119; Scottish Ethics Reference Number: 22-SS-0101, 20/09/2023). For patients who lack the capacity to consent, the study complies with the Mental Capacity Act 2005, using a consultee process where a family member, carer or an independent clinician may provide assent on behalf of the patient. Data from all the study centres will be analysed together and disseminated through peer-reviewed journals, conference presentations and workshops. The study group will ensure that participants and their families are informed of the study findings promptly and in an accessible format.

ISRCTN49183956.

Physical activity has important benefits for the prevention and management of chronic diseases and healthy ageing. Health professionals have valuable opportunities to promote physical activity to a large group of people across the lifespan. Promotion of Physical Activity by Health Professionals is a hybrid type 1 effectiveness-implementation cluster randomised trial designed to evaluate the impact of physical activity promotion by health professionals (n=30 clusters) on physical activity participation in their patients (n=720). To inform the future implementation of this programme, we will be conducting a within-trial and modelled economic evaluation.

We will conduct a cost-effectiveness and cost-utility analysis from the perspective of the healthcare, aged care and disability funder. The time horizon will be 6 months for the within-trial analysis and 2 years for the modelled analysis. Data on intervention costs will be collected using trial records. Data on healthcare utilisation will be collected using data linkage. Incremental cost-effectiveness ratios (ICERs) will be reported for physical activity and quality-adjusted life years outcomes. Bootstrapping will be used to explore uncertainty around the ICERs and estimate 95% CIs. Results will be presented on a cost-effectiveness plane. The probability that the intervention would be cost-effective at varying willingness-to-pay thresholds will be presented using a cost-effectiveness acceptability curve.

Ethics approval was obtained through Sydney Local Health District (RPAH zone) Ethics Review Committee (X23-0197). The findings of this study will be disseminated through peer-reviewed journal articles and conference presentations.

Australian New Zealand Clinical Trials Registry: ACTRN12623000920695.