Strict Weight Management Based on GLP-1 RA for Ablation Outcomes in Overweight or Obese Patients with T2DM and AF
NCT ID: NCT06660134
Last Updated: 2024-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
174 participants
INTERVENTIONAL
2021-08-01
2024-01-10
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Strict Weight Reduction Intervention Group
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.
Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
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.
Standard Care Group
Receives standard glycemic control treatment for diabetes and follows the recommended anticoagulant and antiarrhythmic drug regimens post ablation.
Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
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.
Interventions
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Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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The Third Affiliated Hospital of Anhui Medical University
UNKNOWN
The Second People's Hospital of Anhui Province
OTHER
Hefei Second People's Hospital
UNKNOWN
Shanghai Chest Hospital
OTHER
Responsible Party
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Xu Liu
Dr
Principal Investigators
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Xu Liu, Dr
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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Shanghai Chest Hospital
Shanghai, , China
Countries
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Other Identifiers
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SWGLP-AF
Identifier Type: -
Identifier Source: org_study_id
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