To Assess the Accuracy of the eZscan Study in the Screening for Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01163591
First received: November 24, 2009
Last updated: July 15, 2010
Last verified: November 2009

November 24, 2009
July 15, 2010
January 2009
October 2009   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT01163591 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
To Assess the Accuracy of the eZscan Study in the Screening for Diabetic Nephropathy
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.

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:

  1. Male or female aged between 21 and 75 years (inclusive).
  2. Has confirmed type 2 diabetes mellitus
  3. With or without diabetic nephropathy based on recent complication screening
  4. Written informed consent given

Exclusion criteria:

  1. Has amputation of arm or leg
  2. Uses beta blockers or drugs known to affect the sympathetic nervous system
  3. Has an electrical implantable device (pacemaker, defibrillator)
  4. Known to have sensitivity to nickel or any other standard electrodes
  5. Sufferers from epilepsy or seizures
  6. Patients on renal replacement therapy
  7. Patients with chronic kidney disease due to known non-diabetes causes e.g. renal stone or obstructive uropathy.
  8. Patients confirmed to have urinary tract infection on the day of assessment.

Primary endpoint:

  1. 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:

  2. 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.
  3. 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.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Type 2 diabetes mellitus patients with and without diabetic nephropathy

Diabetic Nephropathy
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female aged between 21 and 75 years (inclusive).
  2. Has confirmed type 2 diabetes mellitus
  3. With or without diabetic nephropathy based on recent complication screening
  4. Written informed consent given

Exclusion Criteria:

  1. Has amputation of arm or leg
  2. Uses beta blockers or drugs known to affect the sympathetic nervous system
  3. Has an electrical implantable device (pacemaker, defibrillator)
  4. Known to have sensitivity to nickel or any other standard electrodes
  5. Sufferers from epilepsy or seizures
  6. Patients on renal replacement therapy
  7. Patients with chronic kidney disease due to known non-diabetes causes e.g. renal stone or obstructive uropathy.
  8. Patients confirmed to have urinary tract infection on the day of assessment.
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01163591
CRE-2008.470-T
No
Dr Risa Ozaki, Chinese Universitiy of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Risa Ozaki, MBChB, MRCP Chinese University of Hong Kong
Chinese University of Hong Kong
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP