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NCT Number: NCT05299918

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

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.

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Key information

Conditions

Neuropathy Autonomic Cardiac Autonomic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathy Peripheral Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Type2diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Peripheral Neuropathy assesed by sudoscan

    Time frame: 15.07.2014 to15.07.2015

    Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in feet

  2. Peripheral Neuropathy assesed by sudoscan

    Time frame: 15.07.2014 to15.07.2015

    Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in hands

  3. Peripheral Neuropathy assesed by Monofilament

    Time frame: 15.07.2014 to15.07.2015

    Neuropathy assesed by Monofilament Light touch with 10 g monofilament

  4. Peripheral Neuropathy assesed by Douleur Neuropathique 4 Questions (DN4)

    Time frame: 15.07.2014 to15.07.2015

  5. Peripheral Neuropathy assesed by diapason

    Time frame: 15.07.2014 to15.07.2015

    Neuropathy assessed by diapason Light touch with 128 Hz diapason

  6. Cardiac Autonomic Neuropathy assesed by electrocardiogram (ECG)

    Time frame: 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.

  7. Peripheral Neuropathy assesed by NC-Stat (Neurometrix)

    Time frame: 15.07.2014 to15.07.2015

    In the evaluation of Neurometric Measurement; normal limits are >4 microvolts and >40 second meters

  8. Cardiac Autonomic Neuropathy assesed by Othostatic BP change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 29, 2022
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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