To Assess the Accuracy of the eZscan Study in the Screening for 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.

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetes Mellitus and Endocrine Centre, Prince of Wales Hospital

Shatin, Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jul 16, 2010
Registry last updated: Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed