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Background / rational:
Obesity is associated with significant comorbidities including type 2 diabetes (insulin resistance), heart disease, stroke, hypertension, sleep apnea syndrome, dyslipidemia, cancer, hepatobiliary diseases, orthopedic complications and psychosocial impact 1 .
Peripheral neuropathy is a known complication in the type I and II diabetes and glucose intolerance and metabolic syndrome in 2. Outside of diabetes (type I and II) that are associated with cardiovascular risk high vascular, presence of metabolic syndrome constitutes in itself a well demonstrated vascular risk factor. Its definition requires the presence of three elements from the following 5: abdominal obesity (high waist circumference), high blood pressure, high fasting blood sugar, high triglycerides and / low HDL-cholesterol 3.
This peripheral neuropathy predominantly affects sensory fibers of small poorly myelinated diameter (Aδ fibers and C) and autonomous sensory fibers and is called small fiber neuropathy 4. The cardinal sign of NAION is the presence of neuropathic pain but abnormalities in physical examination are often absent and conventional electromyography is faulted to make the diagnosis. These small fibers are also constituent of the autonomic nervous system and causes damage autonomic dysfunction that can manifest the cardiovascular system (hypotension, cardiac conduction disorders), digestive, sweat, sphincter. neuropathy of the diagnosis of small fibers is suggested clinically by the presence of neuropathic pain often contrasting with a normal clinical examination. The confirmation is based on electrophysiology with various techniques and quantification of intra-epidermal nerve fibers.
Main objective / secondary:
Primary objective :
To determine the prevalence of a small fiber peripheral neuropathy in nondiabetic obese patients, by measuring skin conductance ion Chlorine (Sudoscan®) evaluating small fibers C autonomic
Secondary objectives:
Methodology Design: prospective, single-center Study duration: 24 months (estimate: 3-5 patients included / week of 15 patients collected in central obesity / week) including 12 months of inclusion.
Number of topics to include: 100 over a period of one year to adjust to the rhythm of the inclusions.
As mentioned, patients will be a measure of impedance of the skin to products chlorine ions by the sweat glands via the Sudoscan®, marketed and used among diabetic patients or not for the detection of violations neuropathic (cf. references and CE certificate attached to the dossier).
The Thermotest® is also marketed and used in diabetic and non-diabetic patients (see references and CE certificate attached to the dossier).
Our center has gained experience of these techniques for the detection of peripheral neuropathy in several patient populations (diabetes and cancer in particular); manipulators (doctors and technicians) are trained in these techniques.
Full description
Main objective / secondary:
Primary objective :
To determine the prevalence of a small fiber peripheral neuropathy in nondiabetic obese patients, by measuring skin conductance ion Chlorine (Sudoscan®) evaluating small fibers C autonomic
Secondary objectives:
Inclusion / non-inclusion:
Inclusion criteria:
morbidly obese patients:
Exclusion criteria:
Diabetes known treaty
Co-morbidity related to obesity: heart disease, respiratory failure
Other causes of peripheral neuropathy:
Development of the study:
If patients the eligibility criteria, it will be proposed at the first consultation in central obesity, participate in a clinical study to assess the prevalence of subclinical damage peripheral nerves by simple and painless rapid measurement of skin conductance on the palm of the feet with the Sudoscan® device during the consultation and a Thermotest®, as well as monitoring during the various follow-up consultation after any bariatric surgery or not. This monitoring will be done by the same neurophysiological tests.
Methodology Design: prospective, single-center Study duration: 24 months (estimate: 3-5 patients included / week of 15 patients collected in central obesity / week) including 12 months of inclusion.
Number of topics to include: 100 over a period of one year to adjust to the rhythm of the inclusions.
As mentioned, patients will be a measure of impedance of the skin to products chlorine ions by the sweat glands via the Sudoscan®, marketed and used among diabetic patients or not for the detection of violations neuropathic (cf. references and CE certificate attached to the dossier).
The Thermotest® is also marketed and used in diabetic and non-diabetic patients (see references and CE certificate attached to the dossier).
Our center has gained experience of these techniques for the detection of peripheral neuropathy in several patient populations (diabetes and cancer in particular); manipulators (doctors and technicians) are trained in these techniques.
Data collection for each patient:
Clinical data:
electrophysiological data
o skin conductance (μSiemens) measured by the Sudoscan®
Plants Average feet (right, left)
Sensitive Conduction:
• sural nerve left and right (lateral malleolus collection, antidromic calf stimulation), radial nerve left and right (wrist collection, antidromic stimulation forearm)
Motor Conduction:
Sciatic nerve popliteal internal right and left (short collection flexor hallucis longus, ankle stimulation)
tibial nerve left and right anterior (short collection extensor hallucis longus, ankle stimulation under neck of the fibula, above-neck of the fibula)
EMG needle:
Muscles studied: tibialis anterior right, wide left inner, right brachioradialis.
Rest Activities: yes / no
Activation Pattern:
Biological data:
Data processing :
For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data.
Statistical analysis :
The patient will be considered to have a small fiber neuropathy, symptomatic or not, when the skin conductance of chloride ions will be below the threshold for 60μSiemens soles. The prevalence shall be calculated from that definition.
Stratified by age will be made during the statistical analysis.
A test will be performed to analyze the statistical relationship between:
Skin conductance AND
Ethics / Regulatory:
The patient will be informed orally of the objective of the study, a leaflet it will also be provided (attached); its information and not be drawn opposition in his file.
All tests are part of the normal patient care. The ethics of the CPP Ile de France approved this study on march 15th 2015. The manager research center will be the hospital group Paris Saint-Joseph (GHPSJ).
partnerships
Impeto the company, the manufacturer will provide Sudoscan® (loan agreement) the machine for the duration of the study.
GHPSJ ensure the neurologist time, diabetologist, biologist and ARC necessary and will provide the Thermotest® machine for the duration of the study.
Conflicts of interest :
No conflict of interest.
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16 participants in 1 patient group
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