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DECODING Study (Dermal Electrochemical Conductance in Diabetic Neuropathy) (DECODING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495089
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Hospital Mutua de Terrassa
Hospital Universitari Sant Joan de Reus
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief Summary:
Diabetes mellitus is the leading cause of polyneuropathy in the Western world. Diabetic neuropathy is a frequent complication of diabetes and may have great clinical transcendence due to pain and possible ulceration of the lower extremities. It is also a relevant cause of morbidity and mortality in patients with diabetes. Although the cause of polyneuropathy in patients with diabetes is only partially known, it has been associated with chronic hyperglycaemia suggesting the possible aetiopathogenic implication of advanced glycosylation end-products. The strategy of choice in the medical management of diabetic neuropathy is early detection since glycaemic control and the use of certain drugs may prevent or slow the development of this disease. Diabetic neuropathy most often presents with a dysfunction of unmyelinated C-fibers, manifested as an alteration of the sweat reflex of the eccrine glands. This dysfunction can now be demonstrated using a newly developed technology which measures dermal electrochemical conductivity. This noninvasive test is easy and cost-effective. The aim of the present study is to evaluate the feasibility and effectiveness of dermal electrochemical conductance measurement (quantitative expression of the sudomotor reflex) as a screening test for the diagnosis of diabetic neuropathy in patients in primary care.

Condition or disease Intervention/treatment Phase
Neuropathy, Diabetic Diabetes Mellitus, Type 2 Diagnostic Test: dermal electrochemical conductance (DEC) Diagnostic Test: Monofilament testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: consecutively there will be included patients with type 2 DM over 40 years of age, with or without symptoms of neuropathy, attended in Primary Care. We will also include the following two groups of patients matched by age and gender: one including patients with prediabetes (intermediate alterations of glucose metabolism defined as impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) determined by OGTT after 2-hour 75 g oral glucose administration and another including patients without glucose alterations (normal glucose tolerance) (control group)
Masking: Single (Investigator)
Masking Description: A neurologist will be blinded to previous test results and will perform neurographyc test including sensory conduction study of the median, ulnar and sural nerves, and motor conduction study of the deep peroneal nerve.
Primary Purpose: Screening
Official Title: Feasibility and Effectiveness of Electrochemical Dermal Conductance Measurement for the Screening of Diabetic Neuropathy in Primary Care.
Actual Study Start Date : May 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patients with type 2 DM

Patients with type 2 DM over 40 years of age, with or without symptoms of neuropathy, attended in Primary Care.

Intervention(s) to be administered:After verifying the inclusion criteria and receiving written informed consent to participate, during the first visit to the Primary Care centres the medical history of the patient will be obtained and a physical examination will be performed using the Monofilament testing -MFT and the Neuropathy Disability Score-NDS and Utah Early Neuropathy Scale-UENS questionnaires will be given to screen for polyneuropathy-PN. The patient will also undergo dermal electrochemical conductance- DEC quantification using the Sudoscan® device.

Diagnostic Test: dermal electrochemical conductance (DEC)
The patient will undergo DEC quantification using the Sudoscan® device.(Sudoscan®, Impeto Medical, France)

Diagnostic Test: Monofilament testing
Monofilament testing by Semmes-Weinstein 5:07 MFT (10 g),

Experimental: prediabetes

Patients with intermediate alterations of glucose metabolism defined as impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) determined by OGTT after 2-hour 75 g oral glucose administration.

Intervention(s) to be administered:After verifying the inclusion criteria and receiving written informed consent to participate, during the first visit to the Primary Care centres the medical history of the patient will be obtained and a physical examination will be performed using the Monofilament testing -MFT and the Neuropathy Disability Score-NDS and Utah Early Neuropathy Scale-UENS questionnaires will be given to screen for polyneuropathy-PN. The patient will also undergo dermal electrochemical conductance-DEC quantification using the Sudoscan® device.

Diagnostic Test: dermal electrochemical conductance (DEC)
The patient will undergo DEC quantification using the Sudoscan® device.(Sudoscan®, Impeto Medical, France)

Diagnostic Test: Monofilament testing
Monofilament testing by Semmes-Weinstein 5:07 MFT (10 g),

Experimental: control group
Patients without glucose alterations (normal glucose tolerance). Intervention(s) to be administered:After verifying the inclusion criteria and receiving written informed consent to participate, during the first visit to the Primary Care centres the medical history of the patient will be obtained and a physical examination will be performed using the Monofilament testing -MFT and the Neuropathy Disability Score-NDS and Utah Early Neuropathy Scale-UENS questionnaires will be given to screen for polyneuropathy-PN. The patient will also undergo dermal electrochemical conductance-DEC quantification using the Sudoscan® device.
Diagnostic Test: dermal electrochemical conductance (DEC)
The patient will undergo DEC quantification using the Sudoscan® device.(Sudoscan®, Impeto Medical, France)

Diagnostic Test: Monofilament testing
Monofilament testing by Semmes-Weinstein 5:07 MFT (10 g),




Primary Outcome Measures :
  1. Presence of diabetic neuropathy diagnosed by EMG [ Time Frame: Day 1 ]
    Presence of diabetic neuropathy diagnosed by electromyography


Secondary Outcome Measures :
  1. Neuropathy Disability Score [ Time Frame: Day 1 ]
    Presence of diabetic neuropathy diagnosed by Neuropathy Disability Score (NDS). - A NDS score greater than or equal to 6 points will be considered as the presence of diabetic neuropathy.

  2. Utah Early Neuropathy Scale [ Time Frame: Day 1 ]
    Presence of diabetic neuropathy diagnosed by Utah Early Neuropathy Scale (UENS). A UENS score greater than or equal to 10 points will be considered as the presence of diabetic neuropathy.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with type 2 DM
  • patients with pre-diabetes
  • patients without glucose alterations

Three main diagnostic categories (normal, pre-diabetes and diabetes) were defined using the WHO criteria based on 2-h postload glucose [<7.8 (140 mg/dL), 7.8-11.0 mmol/L (140-200 mg/dL) and / or fasting plasma glucose (6.1-6.9 mmol/L; 110-126 mg/dL) and >11.1 mmol/L (>200 mg/dL), respectively.

Exclusion Criteria:

  • Type 1 DM
  • upper or lower limb amputation (except phalanges),
  • diagnosis of neuropathy not related to diabetes
  • neuropathy by entrapment
  • use of psychoactive substances
  • chronic alcoholism
  • malnutrition
  • treatment with beta-blockers
  • presence of terminal disease or life expectancy less than 3 years

Pregnancy will be ruled out in women (negative pregnancy test) and a possible history of gestational diabetes will also be taken into account.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495089


Locations
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Spain
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona, Spain, 08221
Mútua Terrassa Primary Care
Terrassa, Barcelona, Spain, 08221
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain, 43204
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Hospital Mutua de Terrassa
Hospital Universitari Sant Joan de Reus
Investigators
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Study Chair: Bernardo Costa, MD Jordi Gol Primary Care Research Institute, Catalan Health Institute, Primary Health Care Division, Reus-Barcelona, Catalonia, Spain
  Study Documents (Full-Text)

Documents provided by Jordi Gol i Gurina Foundation:
Publications:
Samper Bernal D, Monerris Tabasco MM, Homs Riera M, Soler Pedrola M. Etiología y manejo de la neuropatía diabética dolorosa. Rev Soc Esp Dolor. 2010;17(6):286-96. [article in Spanish].
Vidal MA, Martínez-Fernández E, Martínez-Vázquez de Castro J, Torres LM. Neuropatía diabética. Eficacia de la amitriptilina y de la gabapentina. Rev Soc Esp Dolor. 2004;11:490-504 [article in Spanish].
Pirart J. Diabetes mellitus and its degenerative complications: a prospective study of 4,400 patients observed between 1947 and 1973. Diabetes Care. 1978;1(3):168-88.
Gómez MA GM. Estudio de la conduccion nerviosa en pacientes con diabetes mellitus tipo 2. Rev Peru Endocrinol Metab. 1998;IV:23-33. [article in Spanish].
Puig ML, Aguirre DR, Rodríguez MC, Alonso ED. Neuropatía periférica de los miembros inferiores en diabéticos tipo 2 de diagnóstico reciente. Av Endocrinol 2006;22(2):149. [article in Spanish].
Calle Pascual AL, Runkle Vega I, Díaz Pérez JA, Durán Hervada A, Romero Pérez L. Técnicas de exploración. Av Diabetol. 2006;22(1):42-9. [article in Spanish].

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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03495089    
Other Study ID Numbers: P14/147
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordi Gol i Gurina Foundation:
Screening; Sudomotor reflex; DEC; Primary Care
Additional relevant MeSH terms:
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Diabetic Neuropathies
Diabetes Mellitus, Type 2
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes Complications