Correlation between postprandial very-low-density lipoprotein and atrial remodeling

ISRCTN ISRCTN69295295
DOI https://doi.org/10.1186/ISRCTN69295295
Submission date
08/06/2020
Registration date
09/06/2020
Last edited
24/09/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Hsiang-Chun Lee
Scientific

100 Tzyou 1sr Rd
Kaohsiung
807
Taiwan

ORCiD logoORCID ID 0000-0002-5877-9059
Phone +886 (0)7 3121101 ext. 2293
Email hclee@kmu.edu.tw

Study information

Study designObservational longitudinal study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a particular information sheet
Scientific titleThe alliance of lipoproteins-lipids with early atrial myopathy and atrial fibrillation
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedPrevention of atrial fibrillation in patients with metabolic syndrome
InterventionParticipants 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 typeBehavioural
Primary outcome measureAtrial size measured using ultrasonography at baseline, 6, 18, 24, and 36 months
Secondary outcome measuresLipid profiles measured using Ultra Performance Liquid Chromatography (UPLC) at baseline, 6, 18, 24, and 36 months
Overall study start date01/01/2018
Completion date31/12/2021

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants80 healthy volunteers and 80 metabolic syndrome patients
Total final enrolment167
Key inclusion criteria1. Age 20 to 80 years
2. Healthy volunteers or patients diagnosed with metabolic syndrome
Key exclusion criteriaSerious infection
Date of first enrolment23/01/2018
Date of final enrolment05/10/2018

Locations

Countries of recruitment

  • Taiwan

Study participating centre

Kaohsiung Medical University Hospital
100 Tzyou 1st Road
Kaohsiung
807
Taiwan

Sponsor information

Kaohsiung Medical University Chung-Ho Memorial Hospital
Hospital/treatment centre

100 Tzyou 1st Rd
Kaohsiung City
807
Taiwan

Phone +886 (0)7 3121101
Email hclee@kmu.edu.tw
Website http://www.kmuh.org.tw/
ROR logo "ROR" https://ror.org/02xmkec90

Funders

Funder type

Government

National Health Research Institutes, Taiwan

No information available

Results and Publications

Intention to publish date06/12/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-review journal.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 03/07/2020 No No
Results article results 22/09/2020 24/09/2020 Yes No

Additional files

ISRCTN69295295_PROTOCOL.pdf
Uploaded 03/07/2020

Editorial Notes

24/09/2020: Publication reference added.
03/07/2020: Uploaded protocol (not peer reviewed)
09/06/2020: Trial's existence confirmed by Kaohsiung Medical University Hospital.