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

NCT05299918 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 437

Last updated 2022-04-06

No results posted yet for this study

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.

Conditions

  • Neuropathy Autonomic
  • Cardiac Autonomic Neuropathy
  • Type2Diabetes
  • Diabetic Neuropathy Peripheral
  • Diabetic Neuropathies

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-15
Primary Completion
2015-07-15
Completion
2015-07-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299918 on ClinicalTrials.gov