Type 2 Diabetes Mellitus (T2DM), Atrial Fibrillation (AF)
Conditions
Keywords
Catheter ablation, Glucagon-like Peptide-1 receptor agonist, Atrial fibrillation, overweight, obesity
Brief summary
Objective To compare, in patients with Type 2 Diabetes Mellitus (T2DM) and Atrial Fibrillation (AF) undergoing radiofrequency ablation (RFA), whether strict weight management and glycemic control based on Glucagon-like Peptide-1 (GLP-1) receptor agonist treatment reduces the recurrence rate of atrial arrhythmias and rehospitalization rates for cardiac diseases compared to conventional post-procedural management (antiarrhythmic drugs and anticoagulants) and general antidiabetic drugs (excluding GLP-1 receptor agonists). Study Design This trial randomly divides participants into two groups: The GLP-1 receptor agonist treatment-based strict weight management and glycemic control group. The conventional treatment group
Interventions
In addition to the routine use of Antiarrhythmic Drugs (AADs) and anticoagulants, the strict weight reduction intervention group also uses GLP-1 receptor agonists for glycemic control and weight loss according to guidelines. This group receives a structured weight loss program, regular nutritional advice in accordance with current guidelines, and physical training assistance over a 12-month period. The intervention plan aims for a total weight loss of 10 kilograms while using GLP-1 receptor agonists.
Sponsors
The Third Affiliated Hospital of Anhui Medical University
The Second People's Hospital of Anhui Province
Hefei Second People's Hospital
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age \> 18 years. Symptomatic atrial fibrillation (AF) that has been ineffective or intolerable to at least one Class I or III antiarrhythmic drug. Diagnosed with Type 2 Diabetes Mellitus. Body Mass Index (BMI) greater than 25 kg/m². Ability to understand the purpose of the trial, willingness to participate, and signing of the informed consent form.
Exclusion criteria
Permanent atrial fibrillation (failed cardioversion or episode duration \>12 months). Previous history of AF ablation treatment. History of acute coronary syndrome or percutaneous coronary intervention within 6 months prior to enrollment. History of implantation of an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT). History of stroke or transient ischemic attack within 6 months prior to enrollment. Severe organic heart disease, including moderate to severe mitral regurgitation or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc. History of left atrial appendage occlusion or planned for one-stop AF ablation and left atrial appendage occlusion. Pregnant, breastfeeding, or planning to become pregnant. Significant bleeding tendency precluding post-procedural systemic anticoagulation. Contraindications to oral hypoglycemic agents such as SGLT2 inhibitors or GLP-1 receptor agonists. Presence of left atrial thrombus identified before the procedure. Previous cardiac surgery (valve repair/replacement, coronary artery bypass grafting). Unable to perform physical exercise due to illness or disability. Significant hyperthyroidism or hypothyroidism. Drug abuse or chronic alcoholism. Comorbidity with other serious illnesses with an expected survival less than 12 months. Any condition that does not align with the best interest of the subject. Other conditions determined by the investigator as unsuitable for inclusion in this study, such as psychiatric disorders or psychological impairments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia events lasting ≥30 seconds occurring from the end of a 3-month blanking period post-procedure up to 12 months of follow-up. | at least 12 months of follow-up, beyond the initial 3-month blanking period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological distress | at least 12 months of follow-up, beyond the initial 3-month blanking period | Psychological distress was assessed using the HADS (Hospital Anxiety and Depression Scale). |
| Changes in Body Mass Index (BMI) from baseline to 12 months. | at least 12 months of follow-up, beyond the initial 3 month blanking period | Combine weight and height, and report the Body Mass Index (BMI) in units of kilograms per square meter (kg/m²). |
| Quality of life assessments. | at least 12 months of follow-up, beyond the initial 3-month blanking period | The quality of life and cardiac function of the subjects were assessed using the World Health Organization Quality of Life (WHOQOL-100) questionnaire. |
| Quality of life assessments | at least 12 months of follow-up, beyond the initial 3-month blanking period | Quality of life assessments were conducted within at least 12 months of follow-up using measures such as the AF6. |
| Functional status | at least 12 months of follow-up, beyond the initial 3 month blanking period | Functional status was assessed using the CCS-SAF (Canadian Cardiovascular Society - Self-Assessed Functioning scale). |
| quality of life | at least 12 months of follow-up, beyond the initial 3-month blanking period | The quality of life and cardiac function of the subjects were assessed using the New York Heart Association (NYHA) functional classification. |
| Complications associated with AF ablation and serious adverse events (such as rehospitalizations, cardiovascular rehospitalizations) occurring during the study period. | at least 12 months of follow-up, beyond the initial 3-month blanking period | — |
Countries
China
Outcome results
None listed