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The MenoStim Trial: Study Protocol for a Randomised, Sham-Controlled, Double-Blinded, Pilot Clinical Trial Exploring the Neurophysiological, Cognitive, Mood and Biochemical Effects Associated with Non-Invasive Brain Stimulation During the Menopause Transi

Por: Metri · N.-J. · Cavaleri · R. · Alhassani · G. · Ee · C. · Lim · C. K. · Francis · H. M. · Hochstrasser · D. · Bou Merhy · R. M. · Steiner-Lim · G. Z.
Introduction

Intermittent theta-burst stimulation (iTBS) is a non-invasive brain stimulation technique that has been shown to improve cognition and mood when applied to certain brain structures and regions. Despite research demonstrating that iTBS may have clinical utility in treating cognitive and mood changes, no study has yet been conducted to explore the potential to modulate the neurophysiological changes that can underpin cognitive and mood changes during the menopause transition. Cognitive and psychological symptoms are commonly reported by females experiencing the menopause transition, and it is thought that these symptoms arise due to various neurophysiological, metabolic and endocrinological changes. Despite being common, there is a lack of treatments available for managing these symptoms and a scarcity of data regarding the mechanisms by which they occur.

Methods and analysis

The aim of this 5-week randomised, sham-controlled, double-blinded pilot clinical trial (n=72) is to assess the underlying mechanisms of action of iTBS in females in the late menopause transition and the relationship with cognition and mood. Data will be analysed using StataTM. Normality checks will guide the choice between parametric and non-parametric tests. Generalised linear models will assess within-subject and between-subject effects across timepoints, with additional regression analyses exploring associations between biomarkers, cognition and mood. Effect sizes, CIs and relevant test statistics will be reported, with significance set at p

Ethics and dissemination

The study protocol has been reviewed and ethically approved by the Western Sydney University Human Research Ethics Committee (H16200; 8 November 2024). All participants will provide written informed consent prior to enrolment. Results from this trial will be disseminated via peer-reviewed publications and conference presentations, with findings shared in accordance with open science and data transparency principles.

ANZCTR registration number

ACTRN12625000030471, Australian New Zealand Clinical Trials Registry

Euglycaemic diabetic ketoacidosis and its risk factors in patients undergoing coronary artery bypass grafting surgery: a single-centre nested case-control study in China

Por: Hu · R. · Lu · C. · Liu · Y. · Yang · M. · Xing · H. · Dai · K. · Li · J. · Zheng · H. · Chen · X. · Tang · N.-J.
Objectives

This study examines the incidence and risk factors of euglycaemic diabetic ketoacidosis (euDKA) in patients undergoing coronary artery bypass grafting (CABG) and evaluates their postoperative outcomes over a 6-month follow-up period.

Design

This study is a single-centre, nested case-control study, conducted in Tianjin, China.

Setting

An international cardiovascular hospital.

Participants

A total of 1524 patients, with a mean age of 64 (9) years, who underwent isolated elective CABG surgery were reviewed.

Primary and secondary outcome measures

Data were extracted from electronic medical records. EuDKA cases were identified by reviewing laboratory examination results until discharge, including arterial blood gas analysis and urine samples. Logistic regression analysis was used in a case-control design to identify potential risk factors of sodium-glucose cotransporter 2 inhibitor (SGLT2i)-associated euDKA. Post-discharge follow-up was conducted through regular outpatient visits.

Results

15 patients with euDKA, all with type 2 diabetes, were identified post-surgery, 13 of whom were SGLT2i users. The cumulative incidence of euDKA within 7 days after surgery was 1% in the cohort, increasing to 7.6% among those who discontinued SGLT2i 1–6 days (n=171) before surgery. A case-control study added seven additional confirmed euDKA patients to the case group, resulting in 20 cases and 95 controls. Univariate regression analysis revealed that the risk of euDKA was 7.304 times higher (95% CI 2.517 to 21.197; p–1 (OR: 6.882, 95% CI 1.822 to 25.997; p=0.004) were associated with a higher risk of euDKA. Compared with controls, euDKA patients experienced a higher rate of type 5 myocardial infarction (6/20 (30%) vs 9/95 (9.5%); p=0.035) and recurrent ketosis post-discharge (3/19 (15.8%) vs 0/87 (0%); p=0.005).

Conclusions

This cohort study highlights a notable incidence of euDKA following CABG, particularly among patients using SGLT2i. Close monitoring in the ICU is recommended for patients with intraoperative abnormal blood glucose and pH levels to prevent euDKA.

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