Plain English Summary
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)
Trial website
Contact information
Type
Public
Primary contact
Dr Kuo-Meng Liao
ORCID ID
Contact details
Taipei City Hospital
Division of Endocrinology & Metabolism of Zhongxiao Branch
No.87
Tongde Road
Nangang District
Taipei City 115
Taipei
11556
Taiwan
Type
Scientific
Additional contact
Dr Chi-Wei Chang
ORCID ID
Contact details
Graduate Institute of Biomedical Electronics and Bioinformatics
National Taiwan University
Room 410
Barry Lam Hall
No.1
Sec.4
Roosevelt Road
Taipei
10617
Taiwan
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TCHIRB-10512113-E
Study information
Scientific title
A study on progression diabetic nephropathy by harmonic analysis of pressure pulse waveform
Acronym
Study hypothesis
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
Institutional Review Board of Taipei City Hospital, 25/01/2017, ref: TCHIRB-10512113-E. Extension granted 29/01/2019, ref: TCHIRB-10704114-E.
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
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/12/2016
Overall trial end date
28/02/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Type 2 diabetic patients
2. Aged 30 to 95 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2500
Total final enrolment
2324
Participant exclusion criteria
Severe diseases or acute symptoms are excluded if the pressure wave measurement could not be performed.
Recruitment start date
08/02/2017
Recruitment end date
31/12/2021
Locations
Countries of recruitment
Taiwan
Trial participating centre
Taipei City Hospital
Division of Endocrinology & Metabolism of Zhongxiao Branch
11556
Taiwan
Funders
Funder type
University/education
Funder name
Taipei City Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement:
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.
Intention to publish date
28/02/2022
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 risk assessment in https://pubmed.ncbi.nlm.nih.gov/31591828/ (added 07/09/2020)