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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neuropathy Autonomic, Cardiac Autonomic Neuropathy, Type2Diabetes, Diabetic Neuropathy Peripheral, Diabetic Neuropathies

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Neuropathy assesed by sudoscan | Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in feet | 15.07.2014 to15.07.2015 | 
| Peripheral Neuropathy assesed by sudoscan | Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in hands | 15.07.2014 to15.07.2015 | 
| Peripheral Neuropathy assesed by Monofilament | Neuropathy assesed by Monofilament Light touch with 10 g monofilament | 15.07.2014 to15.07.2015 | 
| Peripheral Neuropathy assesed by Douleur Neuropathique 4 Questions (DN4) |  | 15.07.2014 to15.07.2015 | 
| Peripheral Neuropathy assesed by diapason | Neuropathy assessed by diapason Light touch with 128 Hz diapason | 15.07.2014 to15.07.2015 | 
| Cardiac Autonomic Neuropathy assesed by electrocardiogram (ECG) | 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. | 15.07.2014 to15.07.2015 | 
| Peripheral Neuropathy assesed by NC-Stat (Neurometrix) | In the evaluation of Neurometric Measurement; normal limits are >4 microvolts and >40 second meters | 15.07.2014 to15.07.2015 | 
| Cardiac Autonomic Neuropathy assesed by Othostatic BP change | 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. | 15.07.2014 to15.07.2015 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUDOSCAN, Cardiac Autonomic Neuropathy, Neuropathy Autonomic, Diabetic Neuropathy Peripheral, Type2Diabetes