NCT06174129

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
427

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

December 8, 2023

Last Update Submit

December 8, 2023

Conditions

Atrial FibrillationType 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Prevalence of atrial fibrillation

    Prevalence of atrial fibrillation in patients with type 2 diabetes

    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

    June 2022 and June 2023

Study Arms (2)

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.

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.

Other: Routine examinations

Interventions

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

Type 2 diabetes patients with atrial fibrillationType 2 diabetes patients without atrial fibrillation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Outpatients with type 2 diabetes who visited the medical clinic between June 2022 and June 2023

You may not qualify if:

  • Patients with missing information on the urinary albumin value and electrocardiograms at the latest date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burapha University Hospital

Mueang, Changwat Chon Buri, 20131, Thailand

Location

MeSH Terms

Conditions

Atrial FibrillationDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr.

Study Record Dates

First Submitted

December 8, 2023

First Posted

December 18, 2023

Study Start

June 1, 2022

Primary Completion

June 30, 2023

Study Completion

July 31, 2023

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers.

Locations

TH(1)