Evaluating the relationship between the radial pulse wave and the progression of kidney disease in type 2 diabetic patients
| ISRCTN | ISRCTN14306167 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14306167 |
| Secondary identifying numbers | TCHIRB-10512113-E |
- Submission date
- 08/01/2018
- Registration date
- 17/01/2018
- Last edited
- 13/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes mellitus (when the body cannot control the sugar levels in the blood) is a strong risk factor for kidney disease and heart disease. These diseases can cause death in diabetic patients. Early predictors of these two diseases can lead to early diagnosis and medical treatment to prevent adverse renal disease and cardiovascular events. Thus, the first aim of this observational study is to find the potential risk markers for kidney disease. The additional purpose is to assess the risk of cardiovascular events and evaluate the relationship between kidney disease and cardiovascular events.
Who can participate?
Adults aged 30 and older with type 2 diabetes.
What does the study involve?
Participants are provided with information sheets and obtain written informed consent. Information on lifestyle questionnaires and medical history (including renal and cardiovascular events and procedures) are updated in each follow-up visit. Participants are then invited to a clinic room for radial pressure wave measurement and ankle-brachial index measurement.
What are the possible benefits and risks of participating?
Doctors take the ABI-index and radial pulse spectrum as risk variables based on the study and previous research. The patients may benefit from early detection of kidney disease or cardiovascular risk in the future. The radial pulse measuring device and ankle-brachial measuring device are both non-invasive.
Where is the study run from?
Taipei City Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
December 2016 to February 2020
Who is funding the study?
Taipei City Hospital (Taiwan)
Who is the main contact?
1. Dr Kuo-Meng Liao (Public)
2. Dr Chi-Wei Chang (Scientific)
Contact information
Public
Taipei City Hospital
Division of Endocrinology & Metabolism of Zhongxiao Branch
No.87, Tongde Road
Nangang District
Taipei City 115
Taipei
11556
Taiwan
Scientific
Graduate Institute of Biomedical Electronics and Bioinformatics
National Taiwan University
Room 410
Barry Lam Hall
No.1, Sec.4
Roosevelt Road
Taipei
10617
Taiwan
Study information
| Study design | This is an non-invasive and observational study that focus on radial pulse spectrum in type 2 diabetic patients with and without nephropathy within 2 years. Both cross-sectional and longitudinal method included. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A study on progression diabetic nephropathy by harmonic analysis of pressure pulse waveform |
| Study objectives | Diabetic nephropathy will affect the renal vascular bed and reflect on the radial pulse spectrum. Therefore, harmonics of radial pulse could be an risk marker for the progress of diabetic nephropathy. |
| Ethics approval(s) | Institutional Review Board of Taipei City Hospital, 25/01/2017, ref: TCHIRB-10512113-E. Extension granted 29/01/2019, ref: TCHIRB-10704114-E. |
| Health condition(s) or problem(s) studied | Risk factors in diabetes care |
| Intervention | All subjects underwent radial pressure wave measurement. Spectrum analysis of radial pressure wave was calculated and transformed into Fourier series coefficients Cn and Pn. The enrolled group is investigated between February 2017 to December 2018. Both oral and written information about the study is given to the subjects. Informed consent is obtained from subjects after receiving approval from the institutional review board of Taipei City Hospital. The enrolled patients receive radial pulse wave measurement and ABI measurement twice a year and two-year follow-up until the end of the study or quit the project. The study consists of two clinical tests: 1. The cross-sectional part measures the radial, ankle, and brachial blood pressure wave when a person first joined this study. The radial pulse spectrum and the ankle-brachial index is derived from these two measurements. These two measurements are both noninvasive. The interactions among the kidney disease, the cardiovascular events, and the risk factors (including the radial pulse spectrum and ankle-brachial index) are evaluated. The medical records of subjects including the blood test, urine examination, medication history, and lifestyle questionnaires to investigate the risk confounder such as age, gender, body mass index, blood pressure, low-density cholesterol, high-density cholesterol, and smoke history are analysed. 2. The longitudinal part: This part takes the risk evaluation of cross-sectional cohort study as the baseline. We continue to measure the radial pulse spectrum and ankle-brachial index and record the new onset of kidney disease and cardiovascular events at 2-year intervals. In both parts of the cross-sectional and longitudinal part, it builds up the clinical risk variables for type 2 diabetic patients with kidney disease and cardiovascular events. Those clinical variables are safe enough to facilitate in routine clinical practice and also are cost-effective to repeat within months. Thus, periodic screening for those risk factors may help the doctors to evaluate the conditions of patients with type 2 diabetes. |
| Intervention type | Other |
| Primary outcome measure | 1. Radial blood pressure wave is assessed using a miniature pressure transducer (TD01C, Taiwan) at time of enrollment 2. Ankle-brachial index is assessed using vascular screening system (VaSera VS-1500N, Japan) at time of enrollment 3. Albumin-to-creatinine ratio level is assessed using urine test at time of enrollment 4. Estimated glomerular filtration rate level is assessed using blood test at time of enrollment 5. Events of composite renal end point: 5.1. Doubling of the serum creatinine level is assessed using blood test 5.2. End-stage renal disease is assessed from the medical record 5.3. Death is assessed from the medical history |
| Secondary outcome measures | Cardiovascular events and its risk factors, from the medical record at time of enrollment. |
| Overall study start date | 01/12/2016 |
| Completion date | 28/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2500 |
| Total final enrolment | 1911 |
| Key inclusion criteria | 1. Type 2 diabetic patients 2. Aged 30 to 95 years |
| Key exclusion criteria | Severe diseases or acute symptoms are excluded if the pressure wave measurement could not be performed. |
| Date of first enrolment | 08/02/2017 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
11556
Taiwan
Sponsor information
Hospital/treatment centre
Division of Endocrinology & Metabolism of Zhongxiao Branch
No.87, Tongde Road
Nangang District
Taipei City 115
Taipei
11556
Taiwan
"ROR" |
https://ror.org/02gzfb532 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 28/02/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to publish the cross-sectional results in a high-impact peer-reviewed journal at 31/02/2018 and to publish the whole longitudinal results from 31/12/2018 to 31/02/2019. |
| IPD sharing plan | All the data such as medical history and the results of pulse wave measurement and ABI-index were recorded in the database system of the Division of Endocrinology & Metabolism of Zhongxiao Branch of Taipei City Hospital and will be governed by Dr. Liao within the study duration. Part of the clinical data is available through official request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Association with macrovascular and microvascular events | 01/10/2019 | 07/09/2020 | Yes | No |
| Abstract results | Association with cerebrovascular disease and dementia | 05/12/2019 | 09/11/2022 | No | No |
| Other publications | Association with silent coronary artery disease and adverse cardiac events | 23/10/2018 | 09/11/2022 | Yes | No |
| Other publications | Association with adverse cardiac events | 01/06/2019 | 29/12/2022 | Yes | No |
| Other publications | Association with diabetic retinopathy | 01/10/2022 | 29/12/2022 | Yes | No |
| Other publications | Association with major adverse cardiovascular and microvascular events | 01/11/2019 | 29/12/2022 | Yes | No |
| Other publications | Association with silent myocardial ischemia | 11/09/2018 | 29/12/2022 | Yes | No |
| Protocol file | in Chinese version 4.0 |
24/01/2019 | 29/12/2022 | No | No |
| Results article | 11/09/2018 | 13/02/2024 | Yes | No | |
| Results article | 01/02/2019 | 13/02/2024 | Yes | No |
Additional files
- ISRCTN14306167_Protocol_V4.0_24Jan2019.pdf
- in Chinese
Editorial Notes
13/02/2024: Publication references added.
29/12/2022: The following changes have been made:
1. Publication references added.
2. Protocol file uploaded.
3. The final enrolment number was changed from 2324 to 1911.
09/11/2022: Abstract and publication reference added.
07/09/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
07/03/2019: The following changes were made to the trial record:
1. The ethical approval for trial extension was added.
2. The overall end date was changed from 28/02/2020 to 28/02/2022
3. The recruitment end date was changed from 31/12/2019 to 31/12/2021
4. The intention to publish date was changed from 28/02/2020 to 28/02/2022
5. The target number of participants was changed from 2000 to 2500
08/01/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2018 to 31/12/2019.
2. The overall trial end date was changed from 28/02/2019 to 28/02/2020.
3. The intention to publish date was changed from 28/02/2019 to 28/02/2020.
