BMJ Open. 2026 Aug 25;16(8):e121200. doi: 10.1136/bmjopen-2026-121200.
ABSTRACT
INTRODUCTION: Diabetic cardiomyopathy (DCM) is an important contributor to heart failure and death in patients with diabetes. Current management strategies mainly focus on glycaemic control and symptomatic treatment with limited disease-specific therapeutic options available. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have demonstrated promising cardioprotective effects beyond glucose lowering; however, their efficacy and safety in DCM remain unclear. Therefore, this protocol describes the methods for a systematic review and meta-analysis to evaluate the efficacy and safety of GLP-1RAs in patients with DCM.
METHODS AND ANALYSIS: A systematic search will be conducted in PubMed (National Library of Medicine), Embase (Elsevier), the Cochrane Library (Wiley) and Web of Science (Clarivate Analytics), along with clinical trial registries and other relevant sources, up to 31 December 2026. All randomised controlled trials investigating GLP-1RAs for the treatment of DCM will be included. The primary outcomes will be cardiac function parameters, including left ventricular ejection fraction and left ventricular fractional shortening, while secondary outcomes will include metabolic indicators such as glycaemic and lipid profiles, biochemical markers such as oxidative stress-related indices and safety outcomes. Study selection and data extraction will be performed independently by two reviewers and risk of bias will be evaluated using version 2 of the Cochrane Risk of Bias tool. Statistical analyses will be performed using Stata V.16.0. Pooled effect sizes will be calculated using mean differences for continuous outcomes and risk ratios for dichotomous outcomes, with fixed-effect or random-effect models applied as appropriate. Meta-regression, subgroup and sensitivity analyses will be conducted to investigate the sources of heterogeneity. Publication bias will be assessed using funnel plots and Egger's test, and the certainty of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
ETHICS AND DISSEMINATION: Ethical approval is not required because this protocol relies exclusively on secondary analysis of previously published randomised trial data. The review findings will be disseminated through peer-reviewed journal publication.
PROSPERO REGISTRATION NUMBER: CRD420261360886.
PMID:42642087 | DOI:10.1136/bmjopen-2026-121200