Plain English Summary
Background and study aims
Metabolic syndrome is the medical term for a combination of diabetes, high blood pressure and obesity. This study aims to determine the role of molecules called lipoproteins in atrial myopathy (heart disease) in metabolic syndrome, and to identify the toxic lipoprotein as a new target for the prevention of atrial fibrillation (irregular heart rate).
Who can participate?
Healthy volunteers and patients with metabolic syndrome
What does the study involve?
Participants will be randomly allocated into two groups. Both groups have their ordinary medications continued, while participants in the intervention group will receive team-guided lifestyle modification guided by a specific health care team, including weight control, tailored physical activity, screening and treatment for sleep apnea, smoking cessation and alcohol abstinence. All participants will be followed up for 12 months to collect data including demographics, body mass index, blood pressure, echocardiography, electrocardiography (heart examinations), and blood sample collection.
What are the possible benefits and risks of participating?
The participants may benefit from receiving their heart examination results. There is a risk of bruising from the blood sample, but mostly mild and self-limited.
Where is the study run from?
Kaohsiung Medical University Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
January 2018 to December 2021
Who is funding the study?
National Health Research Institutes (Taiwan)
Who is the main contact?
Prof. Hsiang-Chun Lee
The alliance of lipoproteins-lipids with early atrial myopathy and atrial fibrillation
The negative-charged very-low-density lipoprotein (VLDL)-induced structural and electrical remodelling is an important pathogenesis of early atrial myopathy for atrial fibrillation (AF) vulnerability in metabolic syndrome (MetS).
Approved 12/06/2017, Institutional Review Board-I, Kaohsiung Medical University Hospital (100 Tzyou 1st Rd, Kaohsiung, Taiwan; +886 (0)7 31211-1 ext. 6646; firstname.lastname@example.org), ref: KMUHIRB-E(I)-20170256
Observational longitudinal study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use contact details to request a particular information sheet
Prevention of atrial fibrillation in patients with metabolic syndrome
Participants will be randomized into two groups. Both groups have their ordinary medications continued, while participants in the intervention group will be intervened with a life modification guided by a specific health care team. The team-guided lifestyle modification includes weight control, tailored physical activity, screening and treatment for sleep apnea, smoking cessation and alcohol abstinence. All participants will be followed up for 12 months.
Primary outcome measure
Atrial size measured using ultrasonography at baseline, 6, 18, 24, and 36 months
Secondary outcome measures
Lipid profiles measured using Ultra Performance Liquid Chromatography (UPLC) at baseline, 6, 18, 24, and 36 months
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Age 20 to 80 years
2. Healthy volunteers or patients diagnosed with metabolic syndrome
Target number of participants
80 healthy volunteers and 80 metabolic syndrome patients
Total final enrolment
Participant exclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Kaohsiung Medical University Hospital
100 Tzyou 1st Road
National Health Research Institutes, Taiwan
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-review journal.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Basic results (scientific)
- ISRCTN69295295_PROTOCOL.pdf Uploaded 03/07/2020