Diabetic NephropathyNCT01163591
To Assess the Accuracy of the eZscan Study in the Screening for Diabetic Nephropathy
An observational study of Diabetic Nephropathy, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Diabetes mellitus (DM) is a metabolic disorder commonly encountered by the healthcare professionals. Diabetic nephropathy is one of its complications, which is becoming the most common cause of end-stage renal failure in Hong Kong. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetic Nephropathy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetes mellitus patients with and without diabetic nephropathy
Who may be able to join
- Male or female aged between 21 and 75 years (inclusive).
- Has confirmed type 2 diabetes mellitus
- With or without diabetic nephropathy based on recent complication screening
- Written informed consent given
Who cannot join
- Has amputation of arm or leg
- Uses beta blockers or drugs known to affect the sympathetic nervous system
- Has an electrical implantable device (pacemaker, defibrillator)
- Known to have sensitivity to nickel or any other standard electrodes
- Sufferers from epilepsy or seizures
- Patients on renal replacement therapy
- Patients with chronic kidney disease due to known non-diabetes causes e.g. renal stone or obstructive uropathy.
- Patients confirmed to have urinary tract infection on the day of assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
Diabetes Mellitus and Endocrine Centre, Prince of Wales Hospital
Shatin, Hong Kong
About this study
Official title: A Phase II, Open-Label, Cross-Sectional, Study to Compare eZscan, With Standard Methods of Screening for Diabetic Nephropathy, As a Tool for Detection of Type 2 Diabetic Nephropathy
Diabetes mellitus (DM) is a metabolic disorder commonly encountered by the healthcare professionals. Diabetic nephropathy is one of its complications, which is becoming the most common cause of end-stage renal failure in Hong Kong. As of March 31, 2000, a total of 1026 patients with diabetes were on renal replacement therapy and the number is steadily increasing. According to ADA guidelines, screening for diabetic nephropathy should be performed on an annual basis to assess urine albumin excretion rate. Serum creatinine should also be measured in all diabetic patients regardless of the degree of urine albumin excretion rate. Timed urinary collection can be a cumbersome procedure for patients and a simpler and fast test that maintains reasonable sensitivity is called for. A tool that is non-invasive and able to identify patients with early nephropathy changes would be valuable.
The skin has been found to have the potential to provide an important non-invasive route for diagnostic monitoring of human subjects for a wide range of applications. eZscan® technology is a patented active electrophysiological technology which uses low level DC-inducing reverse iontophoresis, together with chronoamperometry, to evaluate the behaviour of the tissues in specific locations of the body. This non invasive test is a potential tool for the screening for diabetic nephropathy.
The aim of this study is to compare eZscan with the standard methods of screening for diabetic nephropathy in patients with type 2 diabetes mellitus.
Read the detailed description
Patients with type 2 diabetes mellitus with and without diabetic nephropathy will be identified from clinical records and approached for their interest in participating in the study. Written informed consent will be obtained from patients who qualify according to the eligibility criteria and agree to join the study.
Inclusion criteria:
- Male or female aged between 21 and 75 years (inclusive).
- Has confirmed type 2 diabetes mellitus
- With or without diabetic nephropathy based on recent complication screening
- Written informed consent given
Exclusion criteria:
- Has amputation of arm or leg
- Uses beta blockers or drugs known to affect the sympathetic nervous system
- Has an electrical implantable device (pacemaker, defibrillator)
- Known to have sensitivity to nickel or any other standard electrodes
- Sufferers from epilepsy or seizures
- Patients on renal replacement therapy
- Patients with chronic kidney disease due to known non-diabetes causes e.g. renal stone or obstructive uropathy.
- Patients confirmed to have urinary tract infection on the day of assessment.
Primary endpoint:
- The optimal eZscan unit to detect the presence of diabetic nephropathy as defined by eGFR and ACR using ROC analysis, sensitivity and specificity values. Other analysis:
- A prediction algorithm using age, sex, body mass index and eZcan score will be developed to predict eGFR as continuous and categorical variables using Cox regression analysis.
- Students t test and analysis of variance will be used to compare the eZcan values between patients with and those without diabetic nephropathy with age and sex adjustment Frequency of adverse events will also be listed.
- Conditions
- Diabetic Nephropathy
- Keywords
- Diabetes, Nephropathy, Screening
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with overt diabetic nephropathy as evidenced by ACR greater than or equal to 30mg/mmol on urinalysis and eGFR greater than or equal to 15ml/min/1.73m2 and less than 60ml/min/1.73m2 | |
| Control | Patients without diabetic nephropathy as defined by the absence of albuminuria (defined by a random spot urinary ACR <2.5 mg/mmol in women or ACR<3.5 mg/mmol in men)and eGFR greater or equal to 90 ml/min/1.73m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The optimal eZscan unit to detect the presence of diabetic nephropathy as defined by eGFR and ACR using ROC analysis, sensitivity and specificity values.
Measured: 9 months
Secondary outcomes (1)
A prediction algorithm using age, sex, body mass index and eZcan score will be developed to predict eGFR as continuous and categorical variables using Cox regression analysis.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Risa Ozaki, Chinese University of Hong Kong
- Investigators
- Risa Ozaki, MBChB, MRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163591
- Sponsor's protocol ID
- CRE-2008.470-T
- Status last verified
- Oct 2015
- First submitted
- 24 Nov 2009
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Cross-Sectional, Study to Compare eZscan, With Standard Methods of Screening for Diabetic Nephropathy, As a Tool for Detection of Type 2 Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01163591
- Acronym / sponsor ID
- CRE-2008.470-T
- Conditions
- Diabetic Nephropathy
- Keywords
- Diabetes, Nephropathy, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes mellitus (DM) is a metabolic disorder commonly encountered by the healthcare professionals. Diabetic nephropathy is one of its complications, which is becoming the most common cause of end-stage renal failure in Hong Kong. As of March 31, 2000, a total of 1026 patients with diabetes were on renal replacement therapy and the number is steadily increasing. According to ADA guidelines, screening for diabetic nephropathy should be performed on an annual basis to assess urine albumin excretion rate. Serum creatinine should also be measured in all diabetic patients regardless of the degree of urine albumin excretion rate. Timed urinary collection can be a cumbersome procedure for patients and a simpler and fast test that maintains reasonable sensitivity is called for. A tool that is non-invasive and able to identify patients with early nephropathy changes would be valuable.
The skin has been found to have the potential to provide an important non-invasive route for diagnostic monitoring of human subjects for a wide range of applications. eZscan® technology is a patented active electrophysiological technology which uses low level DC-inducing reverse iontophoresis, together with chronoamperometry, to evaluate the behaviour of the tissues in specific locations of the body. This non invasive test is a potential tool for the screening for diabetic nephropathy.
The aim of this study is to compare eZscan with the standard methods of screening for diabetic nephropathy in patients with type 2 diabetes mellitus.
Detailed description
Patients with type 2 diabetes mellitus with and without diabetic nephropathy will be identified from clinical records and approached for their interest in participating in the study. Written informed consent will be obtained from patients who qualify according to the eligibility criteria and agree to join the study.
Inclusion criteria:
- Male or female aged between 21 and 75 years (inclusive).
- Has confirmed type 2 diabetes mellitus
- With or without diabetic nephropathy based on recent complication screening
- Written informed consent given
Exclusion criteria:
- Has amputation of arm or leg
- Uses beta blockers or drugs known to affect the sympathetic nervous system
- Has an electrical implantable device (pacemaker, defibrillator)
- Known to have sensitivity to nickel or any other standard electrodes
- Sufferers from epilepsy or seizures
- Patients on renal replacement therapy
- Patients with chronic kidney disease due to known non-diabetes causes e.g. renal stone or obstructive uropathy.
- Patients confirmed to have urinary tract infection on the day of assessment.
Primary endpoint:
- The optimal eZscan unit to detect the presence of diabetic nephropathy as defined by eGFR and ACR using ROC analysis, sensitivity and specificity values. Other analysis:
- A prediction algorithm using age, sex, body mass index and eZcan score will be developed to predict eGFR as continuous and categorical variables using Cox regression analysis.
- Students t test and analysis of variance will be used to compare the eZcan values between patients with and those without diabetic nephropathy with age and sex adjustment Frequency of adverse events will also be listed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Patients with overt diabetic nephropathy as evidenced by ACR greater than or equal to 30mg/mmol on urinalysis and eGFR greater than or equal to 15ml/min/1.73m2 and less than 60ml/min/1.73m2 |
| Control | – | –Patients without diabetic nephropathy as defined by the absence of albuminuria (defined by a random spot urinary ACR <2.5 mg/mmol in women or ACR<3.5 mg/mmol in men)and eGFR greater or equal to 90 ml/min/1.73m2 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes mellitus patients with and without diabetic nephropathy
Key inclusion criteria (4 listed)
- Male or female aged between 21 and 75 years (inclusive).
- Has confirmed type 2 diabetes mellitus
- With or without diabetic nephropathy based on recent complication screening
- Written informed consent given
Key exclusion criteria (8 listed)
- Has amputation of arm or leg
- Uses beta blockers or drugs known to affect the sympathetic nervous system
- Has an electrical implantable device (pacemaker, defibrillator)
- Known to have sensitivity to nickel or any other standard electrodes
- Sufferers from epilepsy or seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The optimal eZscan unit to detect the presence of diabetic nephropathy as defined by eGFR and ACR using ROC analysis, sensitivity and specificity values.
Time frame: 9 months
1 secondary outcome
A prediction algorithm using age, sex, body mass index and eZcan score will be developed to predict eGFR as continuous and categorical variables using Cox regression analysis.
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Risa Ozaki, MBChB, MRCP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathy, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The optimal eZscan unit to detect the presence of diabetic nephropathy as defined by eGFR and ACR using ROC analysis, sensitivity and specificity values. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.