Type 2 Diabetes Mellitus (T2DM)NCT06660134
Strict Weight Management Based on GLP-1 RA for Ablation Outcomes in Overweight or Obese Patients with T2DM and AF
A study testing Glucagon-like peptide-1 receptor agonists (GLP 1 RA) in people with Type 2 Diabetes Mellitus (T2DM) and Atrial Fibrillation (AF), run by Shanghai Chest Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Atrial Fibrillation (AF)
- What is being tested?
- Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Strict Weight Management and Glycemic Control Based on Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Treatment VS. Conventional Antidiabetic Drugs for Ablation Outcomes in Overweight or Obese Patients with Type 2 Diabetes and Atrial Fibrillation
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
Read more
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
- Being tested
- Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
- Keywords
- Catheter ablation, Glucagon-like Peptide-1 receptor agonist, Atrial fibrillation, overweight, obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Atrial Fibrillation, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-like peptide-1 receptor agonists (GLP 1 RA)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Strict Weight Reduction Intervention Group | Experimental | 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. Receives: Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA) |
| Standard Care Group | Active comparator | Receives standard glycemic control treatment for diabetes and follows the recommended anticoagulant and antiarrhythmic drug regimens post ablation. Receives: Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Secondary outcomes (8)
Changes in Body Mass Index (BMI) from baseline to 12 months.
Combine weight and height, and report the Body Mass Index (BMI) in units of kilograms per square meter (kg/m²).
Measured: at least 12 months of follow-up, beyond the initial 3 month blanking period
Quality of life assessments.
The quality of life and cardiac function of the subjects were assessed using the World Health Organization Quality of Life (WHOQOL-100) questionnaire.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Complications associated with AF ablation and serious adverse events (such as rehospitalizations, cardiovascular rehospitalizations) occurring during the study period.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Quality of life assessments
Quality of life assessments were conducted within at least 12 months of follow-up using measures such as the AF6.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Quality of life assessments
Quality of life assessments were conducted using the AFEQT (Atrial Fibrillation Effect on Quality of Life) questionnaire.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Psychological distress
Psychological distress was assessed using the HADS (Hospital Anxiety and Depression Scale).
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Functional status
Functional status was assessed using the CCS-SAF (Canadian Cardiovascular Society - Self-Assessed Functioning scale).
Measured: at least 12 months of follow-up, beyond the initial 3 month blanking period
quality of life
The quality of life and cardiac function of the subjects were assessed using the New York Heart Association (NYHA) functional classification.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Aug 2021
- Primary completion31 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated Hospital of Anhui Medical University, The Second People's Hospital of Anhui Province, Hefei Second People's Hospital
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
- Investigators
- Xu Liu, Dr, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660134
- Sponsor's protocol ID
- SWGLP-AF
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strict Weight Management and Glycemic Control Based on Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Treatment VS. Conventional Antidiabetic Drugs for Ablation Outcomes in Overweight or Obese Patients with Type 2 Diabetes and Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06660134
- Acronym / sponsor ID
- SWGLP-AF
- Keywords
- Catheter ablation, Glucagon-like Peptide-1 receptor agonist, Atrial fibrillation, overweight, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- The Third Affiliated Hospital of Anhui Medical University, The Second People's Hospital of Anhui Province, Hefei Second People's Hospital
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strict Weight Reduction Intervention Group | Experimental | Drug: 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 | Active comparator | Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)Receives standard glycemic control treatment for diabetes and follows the recommended anticoagulant and antiarrhythmic drug regimens post ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Standard Care Group, Strict Weight Reduction Intervention Group |
Primary outcome
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.
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
8 secondary outcomes
Changes in Body Mass Index (BMI) from baseline to 12 months.
Time frame: at least 12 months of follow-up, beyond the initial 3 month blanking period
Quality of life assessments.
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Complications associated with AF ablation and serious adverse events (such as rehospitalizations, cardiovascular rehospitalizations) occurring during the study period.
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Quality of life assessments
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Quality of life assessments
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Psychological distress
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Functional status
Time frame: at least 12 months of follow-up, beyond the initial 3 month blanking period
quality of life
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Liu, Dr principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucagon-like peptide-1 receptor agonists (GLP 1 RA) in people with Type 2 Diabetes Mellitus (T2DM) and Atrial Fibrillation (AF), run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.