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

NCT01163591 | Completed

• 1 other identifier: CRE-2008.470-T
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy

Keywords

Diabetes; Nephropathy; Screening

Outcome Measures

Primary Outcomes (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.

  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.

  9 months

Study Arms (2)

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

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes mellitus patients with and without diabetic nephropathy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Diabetes Mellitus and Endocrine Centre, Prince of Wales Hospital

Shatin, Hong Kong, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Risa Ozaki, MBChB, MRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Associate Professor

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: July 16, 2010
• Study Start: January 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

CN (1)