Diabetic Neuropathy Rapid Screening Test in Turkish Patients With Type 2 Diabetes: Sudoscan

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT05299918

Collaborator

(none)

437

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuropathy Autonomic Cardiac Autonomic Neuropathy Type2Diabetes Diabetic Neuropathy Peripheral Diabetic Neuropathies

Study Design

Study Type:

Observational

Actual Enrollment :

437 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Diabetic Neuropathy Rapid Screening Test in Turkish Patients With Type 2 Diabetes Sudoscan

Actual Study Start Date :

Jul 15, 2014

Actual Primary Completion Date :

Jul 15, 2015

Actual Study Completion Date :

Jul 15, 2015

Outcome Measures

Primary Outcome Measures

Peripheral Neuropathy assesed by sudoscan [15.07.2014 to15.07.2015]
Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in feet
Peripheral Neuropathy assesed by sudoscan [15.07.2014 to15.07.2015]
Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in hands
Peripheral Neuropathy assesed by Monofilament [15.07.2014 to15.07.2015]
Neuropathy assesed by Monofilament Light touch with 10 g monofilament
Peripheral Neuropathy assesed by Douleur Neuropathique 4 Questions (DN4) [15.07.2014 to15.07.2015]
Peripheral Neuropathy assesed by diapason [15.07.2014 to15.07.2015]
Neuropathy assessed by diapason Light touch with 128 Hz diapason
Cardiac Autonomic Neuropathy assesed by electrocardiogram (ECG) [15.07.2014 to15.07.2015]
The expiration/inspiration (E/I) ratio was calculated by dividing the mean of the longest RR interval during expiration by the mean of the shortest RR interval during inspiration while the patient was lying quietly and breathing deeply with an electrocardiogram recording the heart rate change. This ratio is considered ≥ 1.21 normal, between 1.11-1.20 borderline, and ≤ 1.1 abnormal.
Peripheral Neuropathy assesed by NC-Stat (Neurometrix) [15.07.2014 to15.07.2015]
In the evaluation of Neurometric Measurement; normal limits are >4 microvolts and >40 second meters
Cardiac Autonomic Neuropathy assesed by Othostatic BP change [15.07.2014 to15.07.2015]
The blood pressure is measured using a standard sphygmomanometer while the subject is lying down again after standing up. The difference in systolic blood pressure is taken to measure postural blood pressure change. The measured blood pressure difference is considered normal if ≤10 mmHg, borderline between 11-29 mmHg, and abnormal if ≥30 mmHg.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The ability to give informed consent
Male or female persons >18 years of age with a diagnosis of type 2 DM (WHO criteria)

Exclusion Criteria:

<18 years of age
Participants with type 1 diabetes
Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study at the discretion of the investigator
Pregnant or breastfeeding participants
Participants with atrial fibrillation, atrial flutter, or pacemakers will not be subjected to cardiac autonomic neuropathy measurements.
Participants with toe or foot amputations or foot ulcer
vitamin B12 deficiency and other causes of peripheral neuropathy.