Clinical trial NCT05299918: Diabetic Neuropathy Rapid Screening Test in Turkish Patients With Type 2 Diabetes: Sudoscan
Official title: Diabetic Neuropathy Rapid Screening Test in Turkish Patients With Type 2 Diabetes Sudoscan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathy Autonomic
Cardiac Autonomic Neuropathy
Type2Diabetes
Diabetic Neuropathy Peripheral
Diabetic Neuropathies
Keywords: SUDOSCAN
Cardiac Autonomic Neuropathy
Neuropathy Autonomic
Diabetic Neuropathy Peripheral
Type2Diabetes
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was selected among adult type 2 diabetes patients under control at Istanbul University Istanbul Medical Faculty Diabetes Polyclinic between July 2014 and July 2015. The 437 patients included studying were the ages of 18 and older.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Peripheral Neuropathy assesed by sudoscan
timeFrame: 15.07.2014 to15.07.2015
measure: Peripheral Neuropathy assesed by sudoscan
timeFrame: 15.07.2014 to15.07.2015
measure: Peripheral Neuropathy assesed by Monofilament
timeFrame: 15.07.2014 to15.07.2015
measure: Peripheral Neuropathy assesed by Douleur Neuropathique 4 Questions (DN4)
timeFrame: 15.07.2014 to15.07.2015
measure: Peripheral Neuropathy assesed by diapason
timeFrame: 15.07.2014 to15.07.2015
measure: Cardiac Autonomic Neuropathy assesed by electrocardiogram (ECG)
timeFrame: 15.07.2014 to15.07.2015
measure: Peripheral Neuropathy assesed by NC-Stat (Neurometrix)
timeFrame: 15.07.2014 to15.07.2015
measure: Cardiac Autonomic Neuropathy assesed by Othostatic BP change
timeFrame: 15.07.2014 to15.07.2015
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.
citation: Gin H, Baudoin R, Raffaitin CH, Rigalleau V, Gonzalez C. Non-invasive and quantitative assessment of sudomotor function for peripheral diabetic neuropathy evaluation. Diabetes Metab. 2011 Dec;37(6):527-32. doi: 10.1016/j.diabet.2011.05.003. Epub 2011 Jun 28.
citation: Mayaudon H, Miloche PO, Bauduceau B. A new simple method for assessing sudomotor function: relevance in type 2 diabetes. Diabetes Metab. 2010 Dec;36(6 Pt 1):450-4. doi: 10.1016/j.diabet.2010.05.004. Epub 2010 Aug 23.
citation: Ewing DJ, Martyn CN, Young RJ, Clarke BF. The value of cardiovascular autonomic function tests: 10 years experience in diabetes. Diabetes Care. 1985 Sep-Oct;8(5):491-8. doi: 10.2337/diacare.8.5.491.
citation: Casellini CM, Parson HK, Richardson MS, Nevoret ML, Vinik AI. Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction. Diabetes Technol Ther. 2013 Nov;15(11):948-53. doi: 10.1089/dia.2013.0129. Epub 2013 Jul 27.
citation: Yajnik CS, Kantikar VV, Pande AJ, Deslypere JP. Quick and simple evaluation of sudomotor function for screening of diabetic neuropathy. ISRN Endocrinol. 2012;2012:103714. doi: 10.5402/2012/103714. Epub 2012 Jul 9.
citation: Grandinetti A, Chow DC, Sletten DM, Oyama JK, Theriault AG, Schatz IJ, Low PA. Impaired glucose tolerance is associated with postganglionic sudomotor impairment. Clin Auton Res. 2007 Aug;17(4):231-3. doi: 10.1007/s10286-007-0426-z. Epub 2007 Aug 23.
citation: Low VA, Sandroni P, Fealey RD, Low PA. Detection of small-fiber neuropathy by sudomotor testing. Muscle Nerve. 2006 Jul;34(1):57-61. doi: 10.1002/mus.20551.
citation: Unal-Cevik I, Sarioglu-Ay S, Evcik D. A comparison of the DN4 and LANSS questionnaires in the assessment of neuropathic pain: validity and reliability of the Turkish version of DN4. J Pain. 2010 Nov;11(11):1129-35. doi: 10.1016/j.jpain.2010.02.003. Epub 2010 Apr 24.
citation: Selvarajah D, Cash T, Davies J, Sankar A, Rao G, Grieg M, Pallai S, Gandhi R, Wilkinson ID, Tesfaye S. SUDOSCAN: A Simple, Rapid, and Objective Method with Potential for Screening for Diabetic Peripheral Neuropathy. PLoS One. 2015 Oct 12;10(10):e0138224. doi: 10.1371/journal.pone.0138224. eCollection 2015.