How common are diabetes and prediabetes in people with atrial fibrillation?

ISRCTN	ISRCTN18614953
DOI	https://doi.org/10.1186/ISRCTN18614953
Secondary identifying numbers	2017/1878-31/2

Submission date: 27/08/2023
Registration date: 30/08/2023
Last edited: 13/11/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Type 2 diabetes is a big health problem. Around half of the people who have diabetes don't even know they have it. Finding diabetes early and treating it can really help stop bad things from happening because of the disease.

In the past, scientists found out that many people who had heart attacks also had diabetes or a condition that's like a warning sign for diabetes. Almost two-thirds of people with heart attacks had either new type 2 diabetes or this warning sign, which is called impaired glucose tolerance. But we're not sure if this is the same for people with a heart condition called atrial fibrillation.

So, we're doing this study to figure out how common it is for people with atrial fibrillation to have diabetes or this warning sign for diabetes that we talked about. If we find out that a lot of them do have these glucose problems, it could change how we take care of these patients. Maybe we'll start checking everyone with atrial fibrillation for glucose problems, like we do for people with heart attacks.

Also, we want to see if finding these glucose problems later affects how well a treatment called electrical cardioversion works for people with atrial fibrillation. We're also checking if it makes it more likely for atrial fibrillation to come back or for other heart problems to happen.

Who can participate?
Patients with atrial fibrillation undergoing electrical cardioversion at the Cardiology Department, Danderyd University Hospital who are under 80 years old and have no previous known diabetes.

What does the study involve?
The participants in this study will have an additional appointment at the Cardiology Department following the electrical cardioversion procedure. During this visit, their medical history will be documented and screening for glucose abnormalities will be conducted. The screening involves obtaining a blood sample to assess levels of glycated haemoglobin A1c (HbA1c) and performing an oral glucose tolerance test (OGTT). For the OGTT, a morning blood sample is taken after an overnight fast, followed by another blood sample 2 hours after consuming a sugary drink. Additionally, blood samples will be collected to analyse various risk markers for cardiovascular disease. Moreover, an echocardiogram will be performed to assess the cardiac function. This comprehensive visit is expected to last approximately 2.5 to 3 hours.

What are the possible benefits and risks of participating?
There are no specific risks involved in participating in this study. A potential benefit is that the results of the blood tests can lead to an earlier initiation of treatment for previously undiagnosed glucose abnormalities.

Where is the study run from?
Cardiology Department, Danderyd University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
October 2017 to October 2028.

Who is funding the study?
Region Stockholm and Stiftelsen Hjärtat (Sweden)

Who is the main contact?
Dr. Pia Lundman, pia.lundman@ki.se

Contact information

Dr Pia Lundman
Principal Investigator

Department of Clinical Sciences
Karolinska Institutet Danderyd Hospital and Department of Cardiology
Danderyd University Hospital
Stockholm
18288
Sweden

Phone	+46 739736454
Email	pia.lundman@ki.se

Dr Stelios Karayiannides
Scientific

Department of Clinical Sciences
Danderyd Hospital
Stockholm
18288
Sweden

ORCID ID	0000-0002-7826-1302
Phone	+46 812367168
Email	stelios.karayiannides@ki.se

Study information

Study design	Single-center observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format please use contact details to request a participant information sheet.
Scientific title	Early Detection of Glucose Abnormalities in Atrial Fibrillation
Study acronym	EDGA-AF
Study objectives	To study the prevalence of previously undiagnosed diabetes and prediabetes in individuals with atrial fibrillation undergoing electrical cardioversion and investigate the prognostic importance of these glucose abnormalities in this group of patients.
Ethics approval(s)	Approved 25/10/2017, Regional Ethical Review Board in Stockholm (Tomtebodavägen 18A, plan 3, Solna, Stockholm, 17165, Sweden; +46 8-52487000; kansli@stockholm.epn.se), ref: 2017/1878-31/2
Health condition(s) or problem(s) studied	Prevalence and prognostic importance of previously undiagnosed glucose abnormalities in patients with atrial fibrillation.
Intervention	Study participants (individuals with atrial fibrillation undergoing electrical cardioversion) will be screened for previously undiagnosed glucose abnormalities with a glycated haemoglobin A1c (HbA1c) and a standardised 75-g oral glucose tolerance test (OGTT). Depending on the result of the screening, the study participants will be divided in 3 groups (normal glucose metabolism, prediabetes, diabetes) and followed prospectively for recurrence of atrial fibrillation and for the incidence of death or hospitalization for other cardiovascular disease, such as myocardial infarction, stroke, heart failure. Baseline differences in the echocardiographic and electrocardiographic findings and differences in biochemical variables, such as troponin, pro-BNP, and markers of inflammation and fibrosis, between patients with normal and abnormal glucose metabolism will also be analyzed and described.
Intervention type	Other
Primary outcome measure	Prevalence of previously undiagnosed diabetes and prediabetes measured at baseline using the recorded values of plasma glucose (fasting or 2-hour value after the Oral Glucose Tolerance Test) or HbA1c according to the criteria set forth by the World Health Organisation (WHO) and American Diabetes Association (ADA).
Secondary outcome measures	1. Recurrence of atrial fibrillation after successful electrical conversion after three months and twelve months, respectively measured using patient records 2. Recurrence of atrial fibrillation or hospitalisation for other cardiovascular disease, such as myocardial infarction, stroke, heart failure and occurrence of death over 3 years measured using patient records 3. Echocardiographic and electrocardiographic findings at inclusion measured by performing a standardised adult transthoracic echocardiography examination and by registering a standard 12-lead electrocardiogram (ECG) 4. Biochemical variables, such as troponin, pro-BNP, and markers of inflammation and fibrosis at inclusion measured by analysis of plasma venous samples in an accredited laboratory
Overall study start date	25/10/2017
Completion date	01/10/2028

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	300
Key inclusion criteria	Individuals with atrial fibrillation undergoing electrical cardioversion
Key exclusion criteria	1. Diabetes mellitus type 1 2. Stage 4 or 5 CKD (GFR<30 ml/min, dialysis). 3. Malignant tumor under treatment (or metastatic cancer) with life expectancy <12 months. 4. Thyrotoxicosis 5. Acute infection and/or chronic inflammatory disease (with highly elevated inflammatory markers and/or ongoing steroid therapy). 6. Advanced COPD (e.g. treatment with steroids). 7. Conditions that complicate participation in the study as assessed by the treating physician or the study investigators.
Date of first enrolment	18/10/2018
Date of final enrolment	13/06/2024

Locations

Countries of recruitment

Sweden

Study participating centre

Cardiovascular laboratory, KFC

Danderyd University Hospital
Entrévägen 2
Stockholm
18288
Sweden

Sponsor information

Stockholm County Council
Government

Box 30215
Stockholm
104 25
Sweden

Phone	+46 8-123 100 00
Email	kontakt@regionstockholm.se
Website	http://www.sll.se/om-landstinget/Information-in-English1/
"ROR"	https://ror.org/02zrae794

Karolinska Institutet
University/education

Department of Clinical Sciences
Danderyd Hospital
Stockholm
18288
Sweden

Phone	+46 8-524 800 00
Email	tomas.jernberg@ki.se
Website	https://ki.se/kids
"ROR"	https://ror.org/056d84691

Funders

Funder type

Government

Stockholms Läns Landsting
Government organisation / Local government

Alternative name(s): Stockholm County Council
Location: Sweden

Stiftelsen Hjärtat

No information available

Results and Publications

Intention to publish date	01/10/2029
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from the principal investigator of the study. pia.lundman@ki.se

Editorial Notes

13/11/2024: The recruitment end date was changed from 01/10/2025 to 13/06/2024.
30/08/2023: Trial's existence confirmed by Regional Ethical Review Board in Stockholm.