DECODING Study (Dermal Electrochemical Conductance in Diabetic Neuropathy)

NCT03495089 | Completed

• 1 other identifier: P14/147
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 3

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.

Conditions

Neuropathy, Diabetic; Diabetes Mellitus, Type 2

Keywords

Screening; Sudomotor reflex; DEC; Primary Care

Outcome Measures

Primary Outcomes (1)

• Presence of diabetic neuropathy diagnosed by EMG

  Presence of diabetic neuropathy diagnosed by electromyography

  Day 1

Secondary Outcomes (2)

• Neuropathy Disability Score

  Day 1

• Utah Early Neuropathy Scale

  Day 1

Study Arms (3)

patients with type 2 DM

EXPERIMENTAL

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); Diagnostic Test: Monofilament testing

prediabetes

EXPERIMENTAL

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); Diagnostic Test: Monofilament testing

control group

EXPERIMENTAL

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); Diagnostic Test: Monofilament testing

Interventions

dermal electrochemical conductance (DEC) DIAGNOSTIC_TEST

The patient will undergo DEC quantification using the Sudoscan® device.(Sudoscan®, Impeto Medical, France)

control group; patients with type 2 DM; prediabetes

Monofilament testing DIAGNOSTIC_TEST

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

control group; patients with type 2 DM; prediabetes

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Hospital Mutua de Terrassa: collaborator
• Hospital Universitari Sant Joan de Reus: collaborator

Study Sites (3)

Hospital Universitari Mútua Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Mútua Terrassa Primary Care

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, 43204, Spain

Location

Related Publications (24)

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MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus, Type 2; Hamartoma Syndrome, Multiple

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bernardo Costa, MD

  Jordi Gol Primary Care Research Institute, Catalan Health Institute, Primary Health Care Division, Reus-Barcelona, Catalonia, Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 11, 2018
• Study Start: May 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 27, 2019

Record last verified: 2018-04

Locations

ES (3)