Condition category
Circulatory System
Date applied
08/06/2020
Date assigned
09/06/2020
Last edited
03/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

http://www.kmuh.org.tw/

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

Publication citations

Additional files

Editorial Notes

03/07/2020: Uploaded protocol (not peer reviewed) 09/06/2020: Trial's existence confirmed by Kaohsiung Medical University Hospital.