Ignite Creation Date:
2024-05-06 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05299918
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2022-03-20
Brief Title:
Diabetic Neuropathy Rapid Screening Test in Turkish Patients With Type 2 Diabetes Sudoscan
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
Diabetic Neuropathy Rapid Screening Test in Turkish Patients With Type 2 Diabetes Sudoscan
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Neuropathy is a frequently observed complication occurring in 60-70 of diabetic patients throughout their lives In addition neuropathy is a severe disease that progresses insidiously its diagnosis can be delayed due to the absence of clinical findings affects the quality of life and increases mortality and morbidity Up to 50 of patients with diabetic peripheral neuropathy DPN may be asymptomatic Typically DPN progresses in the form of chronic symmetrical and progressive sensorimotor polyneuropathy The five-year mortality rate of individuals with diabetes with autonomic neuropathy is three times higher than those without The diagnosis of clinical neuropathy is usually made by the symptoms the vibration sensation with the diapason and the tactile sensation tests Although diapason and monofilament tests are easy they are qualitative tests that the patient must be careful and coordinate with Biothesiometry or Semmes-Weinstein monofilament tests cannot examine autonomous involvement Cardiovascular autonomic neuropathy tests based on heart rate variability HRV on the other hand can be affected by factors such as age body position cigarette-coffee consumption blood pressure exercise heart rate and respiratory rate An easy and fast diagnostic method may be more helpful in diagnosing peripheral and autonomic neuropathy
Distal small-fiber polyneuropathy can be detected by measuring sweat function using Sudoscan a rapid non-invasive and quantitative method This measurement method is based on the electrochemical reaction between sweat chlorides and stainless steel electrodes that come into contact with the palms of the hands and soles of the feet Results are provided as a Diabetic Autonomic Neuropathy DAN score based on conductances micro siemens μS and conductivity values for the hands and feet right and left sides SUDOSCAN can detect distal small-fiber polyneuropathy with 75 sensitivity SUDOSCAN can be considered a robust method for detecting sudomotor dysfunction and is used for clinical and research purposes
In the American Diabetes Association ADA consensus statement sudomotor functions are mentioned in the early diagnosis of autonomic neuropathy in people with diabetes
This study aimed to evaluate the effectiveness of this method in clinical applications by comparing sudomotor test results with other conventional measurement methods in the evaluation of diabetic peripheral and cardiac neuropathy
Distal small-fiber polyneuropathy can be detected by measuring sweat function using Sudoscan a rapid non-invasive and quantitative method This measurement method is based on the electrochemical reaction between sweat chlorides and stainless steel electrodes that come into contact with the palms of the hands and soles of the feet Results are provided as a Diabetic Autonomic Neuropathy DAN score based on conductances micro siemens μS and conductivity values for the hands and feet right and left sides SUDOSCAN can detect distal small-fiber polyneuropathy with 75 sensitivity SUDOSCAN can be considered a robust method for detecting sudomotor dysfunction and is used for clinical and research purposes
In the American Diabetes Association ADA consensus statement sudomotor functions are mentioned in the early diagnosis of autonomic neuropathy in people with diabetes
This study aimed to evaluate the effectiveness of this method in clinical applications by comparing sudomotor test results with other conventional measurement methods in the evaluation of diabetic peripheral and cardiac neuropathy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None