Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01163591
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2009-11-24
Brief Title:
To Assess the Accuracy of the eZscan Study in the Screening for Diabetic Nephropathy
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None