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
hclee@kmu.edu.tw
Trial website
Contact information
Type
Scientific
Primary contact
Prof Hsiang-Chun Lee
ORCID ID
http://orcid.org/0000-0002-5877-9059
Contact details
100 Tzyou 1sr Rd
Kaohsiung
807
Taiwan
+886 (0)7 3121101 ext. 2293
hclee@kmu.edu.tw
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
The alliance of lipoproteins-lipids with early atrial myopathy and atrial fibrillation
Acronym
Study hypothesis
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).
Ethics approval
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; irb@kmuh.org.tw), ref: KMUHIRB-E(I)-20170256
Study design
Observational longitudinal study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a particular information sheet
Condition
Prevention of atrial fibrillation in patients with metabolic syndrome
Intervention
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.
Intervention type
Behavioural
Phase
Drug names
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
01/01/2018
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 20 to 80 years
2. Healthy volunteers or patients diagnosed with metabolic syndrome
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
80 healthy volunteers and 80 metabolic syndrome patients
Total final enrolment
167
Participant exclusion criteria
Serious infection
Recruitment start date
23/01/2018
Recruitment end date
05/10/2018
Locations
Countries of recruitment
Taiwan
Trial participating centre
Kaohsiung Medical University Hospital
100 Tzyou 1st Road
Kaohsiung
807
Taiwan
Sponsor information
Organisation
Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor details
100 Tzyou 1st Rd
Kaohsiung City
807
Taiwan
+886 (0)7 3121101
hclee@kmu.edu.tw
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Health Research Institutes, Taiwan
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
06/12/2020
Participant level data
Other
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32962696/ (added 24/09/2020)
Publication citations
Additional files
- ISRCTN69295295_PROTOCOL.pdf Uploaded 03/07/2020