- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06174129
Prevalence and Factors Associated With Atrial Fibrillation in Patients With Type 2 Diabetes
December 8, 2023 updated by: Sukrisd Koowattanatianchai, Burapha University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
427
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chonburi
-
Mueang, Chonburi, Thailand, 20131
- Burapha University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Outpatients with type 2 diabetes who visited the medical clinic between June 2022 and June 2023
Exclusion Criteria:
- Patients with missing information on the urinary albumin value and electrocardiograms at the latest date
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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
|
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of atrial fibrillation
Time Frame: June 2022 and June 2023
|
Prevalence of atrial fibrillation in patients with type 2 diabetes
|
June 2022 and June 2023
|
|
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
|
June 2022 and June 2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
December 8, 2023
First Submitted That Met QC Criteria
December 8, 2023
First Posted (Actual)
December 18, 2023
Study Record Updates
Last Update Posted (Actual)
December 18, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS114/2565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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