Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/01/2018
Date assigned
17/01/2018
Last edited
16/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 December 2018

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, 01/25/2017, ref: TCHIRB-10512113-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

28/02/2019

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

Target number of participants: 2000

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

31/12/2018

Locations

Countries of recruitment

Taiwan

Trial participating centre

Taipei City Hospital
Division of Endocrinology & Metabolism of Zhongxiao Branch
11556
Taiwan

Sponsor information

Organisation

Taipei City Hospital

Sponsor details

Division of Endocrinology & Metabolism of Zhongxiao Branch
No.87
Tongde Road
Nangang District
Taipei City 115
Taipei
11556
Taiwan

Sponsor type

Hospital/treatment centre

Website

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

28/02/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes