Strict Weight Management Based on GLP-1 RA for Ablation Outcomes in Overweight or Obese Patients with T2DM and AF

Shanghai Jiao Tong University

Status: Completed

Conditions: Type 2 Diabetes Mellitus (T2DM); Atrial Fibrillation (AF)

Treatments: Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06660134

SWGLP-AF

Details and patient eligibility

About

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

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Strict Weight Reduction Intervention Group

Experimental group

Description:

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.

Treatment:

Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)

Standard Care Group

Active Comparator group

Description:

Receives standard glycemic control treatment for diabetes and follows the recommended anticoagulant and antiarrhythmic drug regimens post ablation.

Treatment:

Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)