AzTrials
AzTrials

Neuropathy AutonomicNCT05299918

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

An observational study of Neuropathy Autonomic and Cardiac Autonomic Neuropathy, run by Istanbul University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
437 participants
Where
No sites listed yet
Study dates
15 Jul 2014to 15 Jul 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • <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.

About this study

Official title: 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.

Read more

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.

Keywords
SUDOSCAN, Cardiac Autonomic Neuropathy, Neuropathy Autonomic, Diabetic Neuropathy Peripheral, Type2Diabetes
Medical subject headings
Diabetic Neuropathies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peripheral Neuropathy assesed by sudoscan

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

    Measured: 15.07.2014 to15.07.2015

  2. Peripheral Neuropathy assesed by sudoscan

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

    Measured: 15.07.2014 to15.07.2015

  3. Peripheral Neuropathy assesed by Monofilament

    Neuropathy assesed by Monofilament Light touch with 10 g monofilament

    Measured: 15.07.2014 to15.07.2015

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

    Measured: 15.07.2014 to15.07.2015

  5. Peripheral Neuropathy assesed by diapason

    Neuropathy assessed by diapason Light touch with 128 Hz diapason

    Measured: 15.07.2014 to15.07.2015

  6. 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.

    Measured: 15.07.2014 to15.07.2015

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

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

    Measured: 15.07.2014 to15.07.2015

  8. 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.

    Measured: 15.07.2014 to15.07.2015

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2022
  2. Study start15 Jul 2014
  3. Primary completion15 Jul 2015
  4. Study completion15 Jul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05299918
Sponsor's protocol ID
2014/495
Status last verified
Mar 2022
First submitted
20 Mar 2022
Last updated
6 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 20876709

  • 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.

    PubMed 21715211

  • 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.

    PubMed 20739207

  • 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.

    PubMed 4053936

  • 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.

    PubMed 23889506

  • 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.

    PubMed 22830040

  • 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.

    PubMed 17717720

  • 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.

    PubMed 16718689

  • 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.

    PubMed 20418179

  • 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.

    PubMed 26457582

Questions about this trial

What is this clinical trial studying?

An observational study of Neuropathy Autonomic and Cardiac Autonomic Neuropathy, run by Istanbul University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peripheral Neuropathy assesed by sudoscan (time frame: 15.07.2014 to15.07.2015). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05299918, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.

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