Atrial FibrillationNCT06174129
Prevalence and Factors Associated With Atrial Fibrillation in Patients With Type 2 Diabetes
An observational study of Atrial Fibrillation and Type 2 Diabetes, run by Burapha University at 1 site in Thailand.
Trial summary
This case-control study was conducted at Burapha University Hospital. The 12-lead electrocardiography recordings of type 2 diabetes patients were reviewed by a cardiologist to confirm the presence of atrial fibrillation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Type 2 Diabetes
- What is being tested?
- Routine examinations
- How many people
- 427 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2022to 31 Jul 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Outpatients with type 2 diabetes who visited the medical clinic at Burapha University Hospital, Chonburi province, Thailand between June 2022 and June 2023 were enrolled in the present study.
Who may be able to join
- Outpatients with type 2 diabetes who visited the medical clinic between June 2022 and June 2023
Who cannot join
- Patients with missing information on the urinary albumin value and electrocardiograms at the latest date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Factors Associated With Atrial Fibrillation in Patients With Type 2 Diabetes: A Case-Control Study
This case-control study was conducted at Burapha University Hospital. The 12-lead electrocardiography recordings of type 2 diabetes patients were reviewed by a cardiologist to confirm the presence of atrial fibrillation. The clinical parameters, including age, sex, body-mass index, underlying medical conditions, blood pressure, heart rate, type 2 diabetes duration, laboratory values, and medications were analyzed and compared between atrial fibrillation and non-atrial fibrillation patients.
- Conditions
- Atrial Fibrillation, Type 2 Diabetes
- Being tested
- Routine examinations
- Medical subject headings
- Atrial Fibrillation, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine examinationsOther
Electrocardiography and clinical parameters examinations, including age, sex, body-mass index, underlying medical conditions, blood pressure, heart rate, type 2 diabetes duration, laboratory values, and medications
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes patients with atrial fibrillation | The 12-lead electrocardiography recordings of type 2 diabetes patients were reviewed by a cardiologist to confirm the presence of atrial fibrillation. The clinical parameters, including age, sex, body-mass index, underlying medical conditions, blood pressure, heart rate, type 2 diabetes duration, laboratory values, and medications were analyzed and compared between atrial fibrillation and non-atrial fibrillation patients. Receives: Other: Routine examinations | |
| Type 2 diabetes patients without atrial fibrillation | The 12-lead electrocardiography recordings of type 2 diabetes patients were reviewed by a cardiologist to confirm the presence of atrial fibrillation. The clinical parameters, including age, sex, body-mass index, underlying medical conditions, blood pressure, heart rate, type 2 diabetes duration, laboratory values, and medications were analyzed and compared between atrial fibrillation and non-atrial fibrillation patients. Receives: Other: Routine examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of atrial fibrillation
Prevalence of atrial fibrillation in patients with type 2 diabetes
Measured: June 2022 and June 2023
Factors associated with atrial fibrillation
Factors associated with atrial fibrillation in patients with type 2 diabetes, including age, hypertension, heart failure, thyroid disease, type 2 diabetes duration, body mass index, estimated glomerular filtration rate, glycated hemoglobin, presence of albuminuria, and use of diuretic medications
Measured: June 2022 and June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Jun 2022
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burapha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukrisd Koowattanatianchai, Burapha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174129
- Sponsor's protocol ID
- HS114/2565
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Factors Associated With Atrial Fibrillation in Patients With Type 2 Diabetes: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06174129
- Acronym / sponsor ID
- HS114/2565
- Conditions
- Atrial Fibrillation, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Burapha UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 Dec 2023 (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.
This case-control study was conducted at Burapha University Hospital. The 12-lead electrocardiography recordings of type 2 diabetes patients were reviewed by a cardiologist to confirm the presence of atrial fibrillation. The clinical parameters, including age, sex, body-mass index, underlying medical conditions, blood pressure, heart rate, type 2 diabetes duration, laboratory values, and medications were analyzed and compared between atrial fibrillation and non-atrial fibrillation patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes patients with atrial fibrillation | – | Other: Routine examinationsThe 12-lead electrocardiography recordings of type 2 diabetes patients were reviewed by a cardiologist to confirm the presence of atrial fibrillation. The clinical parameters, including age, sex, body-mass index, underlying medical conditions, blood pressure, heart rate, type 2 diabetes duration, laboratory values, and medications were analyzed and compared between atrial fibrillation and non-atrial fibrillation patients. |
| Type 2 diabetes patients without atrial fibrillation | – | Other: Routine examinationsThe 12-lead electrocardiography recordings of type 2 diabetes patients were reviewed by a cardiologist to confirm the presence of atrial fibrillation. The clinical parameters, including age, sex, body-mass index, underlying medical conditions, blood pressure, heart rate, type 2 diabetes duration, laboratory values, and medications were analyzed and compared between atrial fibrillation and non-atrial fibrillation patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatients with type 2 diabetes who visited the medical clinic at Burapha University Hospital, Chonburi province, Thailand between June 2022 and June 2023 were enrolled in the present study.
Key inclusion criteria (1 listed)
- Outpatients with type 2 diabetes who visited the medical clinic between June 2022 and June 2023
Key exclusion criteria (1 listed)
- Patients with missing information on the urinary albumin value and electrocardiograms at the latest date
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 |
|---|---|---|
| Routine examinationsElectrocardiography and clinical parameters examinations, including age, sex, body-mass index, underlying medical conditions, blood pressure, heart rate, type 2 diabetes duration, laboratory values, and medications | Other | Type 2 diabetes patients with atrial fibrillation, Type 2 diabetes patients without atrial fibrillation |
Primary outcome
Prevalence of atrial fibrillation
Time frame: June 2022 and June 2023
Prevalence of atrial fibrillation in patients with type 2 diabetes
Factors associated with atrial fibrillation
Time frame: June 2022 and June 2023
Factors associated with atrial fibrillation in patients with type 2 diabetes, including age, hypertension, heart failure, thyroid disease, type 2 diabetes duration, body mass index, estimated glomerular filtration rate, glycated hemoglobin, presence of albuminuria, and use of diuretic medications
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 18 Dec 2023.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Type 2 Diabetes, run by Burapha University at 1 site in Thailand.
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 1 inclusion and 1 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 18 Dec 2023. 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 Thailand. 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?
Prevalence of atrial fibrillation (time frame: June 2022 and June 2023). The study lists 2 primary outcomes in all. 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 18 Dec 2023.