Women who develop gestational diabetes mellitus (GDM) have a 60% lifetime risk of developing type 2 diabetes mellitus (T2D), which is already elevated within the first decade following childbirth. Despite the impact of lifestyle interventions to reduce long-term T2D risk in women with previous GDM, successful implementation of lifestyle interventions remains a barrier. Metformin is recommended for adults at increased risk of developing T2D; however, there is limited evidence of tolerability in the early postpartum period. Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are effective at improving glycaemic status and body weight. However, GLP-1 RA have not been evaluated in the postpartum population. Finally, physical activity monitors may support behaviour changes related to physical activity to reduce long-term risk of T2D but are yet to be studied following GDM.
This will be a multicentre, randomised, open-label interventional pilot study. Using a 2x2 factorial design, we will examine the feasibility and acceptability of a pharmacotherapy intervention and a physical activity intervention in women with previous GDM at increased risk of developing T2D. Participants will be recruited from tertiary referral hospitals in Australia and will be randomised to receive either metformin alone or in combination with a GLP-1 RA and subsequently randomised to either a physical activity intervention involving activity monitor use, or usual care for 6 months, followed by a 6-month follow-up period. Primary feasibility outcomes include the acceptability and safety of the metformin and GLP-1 RA as measured through pill and injection counts, acceptability questionnaire and adverse events.
This trial is registered with the Australian and New Zealand Clinical Trials Registry (Registration Number: ACTRN12624001253594). This trial has received ethics approval from the South Eastern Sydney Local Health District Human Research Ethics Committee (Approval Number: 2024/ETH00042, protocol version v1.1, 28/02/2025).
Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.
To assess the validity of the International Classification of Diseases, 10th Revision (ICD-10) healthcare database diagnosis codes for lithium toxicity at hospital admission in Ontario, Canada.
Population-based retrospective validation study.
A total of 152 hospitals linked to a provincial laboratory database in Ontario, Canada, from 2007 to 2023.
Patients 50 years of age or older taking lithium with hospital-based serum lithium laboratory measurements during admission to the hospital (n=2804).
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) comparing an ICD-10 diagnostic coding algorithm for lithium toxicity to a serum lithium concentration of 1.5 mmol/L or more. The codes used in the algorithm were T568, T435, Y495, X41 and X49. Serum lithium values and changes in the concentration of serum lithium from baseline levels in patients with and without a diagnosis code for lithium toxicity (code-positive and code-negative, respectively).
The sensitivity of the ICD-10 coding algorithm for identifying a serum lithium level≥1.5 mmol/L was 84% (95% CI 81% to 87%). The specificity and the NPV were over 88%, and the PPV was 63% (95% CI 60% to 66%). The median (IQR) serum lithium measurement in code-positive patients was 1.7 (1.2 to 2.2) mmol/L, and it was 0.6 (0.4 to 0.9) mmol/L in code-negative patients. The median (IQR) increase in serum lithium concentration compared with the most recent prehospital baseline values was 0.7 (0.2 to 1.3) mmol/L in code-positive patients and 0.0 (–0.2 to 0.2) mmol/L in code-negative patients.
In Ontario, the sensitivity of the ICD-10 coding algorithms was moderate for identifying a serum lithium level≥1.5 mmol/L at hospital admission. The presence or absence of the ICD-10 codes for lithium toxicity at hospital admission successfully differentiated two groups of patients with distinct serum lithium measurements.
This study aims to determine the incidence and impact of ocular injuries among the different combat sports disciplines of boxing, mixed martial arts (MMA), kickboxing and Muay Thai in Texas, USA.
A case–control study was conducted to analyse retrospective postmatch physical reports from combat sports matches that took place in the state of Texas from January 2019 to January 2022. Ocular injuries and other match characteristics such as sport type and match outcome were identified by postmatch physical reports. Postmatch physical reports were collected from the Texas Department of Licensing and Regulation database. Statistical analysis was used to stratify injuries and compare the impact of injuries on match outcome.
Combat sports fighters in Texas, USA.
3070 participants were included in the study. Participants were fighters who participated in combat sports matches in Texas, USA, between January 2019 and January 2022.
The original plan was to measure the incidence of ocular injuries across different combat sports including boxing, MMA, kickboxing and Muay Thai. However, due to a limited sample size of kickboxing and Muay Thai matches, the ocular injury incidence was only measured for boxing and MMA. The association between ocular injury and match outcome was assessed using 2 statistical analysis.
The respective incidence rates of ocular injuries in boxing and MMA were 9.7 and 12.2 injuries per 100 matches. The association between ocular injury and match outcome (win, lose or draw) was statistically significant in boxing but not statistically significant in MMA matches.
Our findings revealed that ocular injuries are significantly associated to losing a boxing match (p=0.011), but not associated to match outcome in MMA (p=0.232). Additionally, MMA matches report a larger variety of ocular injuries compared with boxing matches.
Patients receiving haemodialysis are at very high risk of fragility fracture, yet there are no proven treatments for fracture prevention. We will advance a pilot study on the feasibility of a large, pragmatic, randomised controlled trial (RCT) of denosumab for fragility fracture prevention in haemodialysis.
PRevEnting FracturEs in REnal Disease-1 is a pragmatic, open-label, pilot study of an RCT of a denosumab care pathway embedded in routine care haemodialysis centres.
We will recruit at least 60 participants at high risk of fracture from at least 6 haemodialysis centres in Ontario, Canada. They must be aged 40 years or older, have access to provincial drug coverage, have appropriate baseline calcium and parathyroid hormone levels and be deemed suitable for denosumab by their kidney care provider. Participants will be randomised 1:1 to denosumab (with supports to mitigate hypocalcaemia) versus usual care using block randomisation by a central statistician (computer-generated sequence). Primary outcomes include recruitment feasibility and adherence. Secondary outcomes include safety (hypocalcaemia) and participant satisfaction with our protocol and processes. Study investigators and data analysts will be blind to treatment allocation.
We will present results descriptively. The trial was approved by Clinical Trials Ontario and local research ethics boards across study sites.
Primary and secondary outcomes will be published on trial completion.
This pilot will inform the feasibility of conducting a large-scale, efficiently run, pragmatic RCT to test whether a denosumab care pathway safely reduces the risk of fragility fracture in patients receiving haemodialysis. Results have the potential to transform fracture care in real-world patients with kidney and metabolic bone disease.