Correlation between postprandial very-low-density lipoprotein and atrial remodeling
| ISRCTN | ISRCTN69295295 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69295295 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| Funder | National Health Research Institutes, Taiwan |
- 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
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
Scientific
100 Tzyou 1sr Rd
Kaohsiung
807
Taiwan
 ORCID ID |
0000-0002-5877-9059 |
|---|---|
| Phone | +886 (0)7 3121101 ext. 2293 |
| hclee@kmu.edu.tw |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational longitudinal study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | The alliance of lipoproteins-lipids with early atrial myopathy and atrial fibrillation |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Atrial size measured using ultrasonography at baseline, 6, 18, 24, and 36 months |
| Key secondary outcome measure(s) |
Lipid profiles measured using Ultra Performance Liquid Chromatography (UPLC) at baseline, 6, 18, 24, and 36 months |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 160 |
| Total final enrolment | 167 |
| Key inclusion criteria | 1. Age 20 to 80 years 2. Healthy volunteers or patients diagnosed with metabolic syndrome |
| Key exclusion criteria | Serious infection |
| Date of first enrolment | 23/01/2018 |
| Date of final enrolment | 05/10/2018 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Kaohsiung
807
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The 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? |
|---|---|---|---|---|---|
| Results article | results | 22/09/2020 | 24/09/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 03/07/2020 | No | 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.
