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Assessment of the Prevalence of Small Fiber Peripheral Neuropathy Among Non-diabetic Obese Patients (NEUROBISITE)

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ClinicalTrials.gov Identifier: NCT02767583
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

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:

  • Evaluation of the prevalence of occurrence of peripheral neuropathy by Sudoscan® during follow-up after treatment of obese patients with bariatric surgery (months) M1, 3, 6, 9, 12.
  • Correlation of results obtained Sudoscan® quantitative sensory testing (QST) Thermotest® evaluating small sensory fibers Aδ, among non-operated non-diabetic obese patients and in the postoperative follow-up (months) M1, 3, 6, 9, 12.
  • Characterization of electromyographic parameters (motor and sensory conduction) in patients with a skin conductance measured by lowered Sudoscan® and / or a threshold of sensitivity to pain increased Thermotest®.
  • Correlation between the presence of a small fiber neuropathy in non-diabetic obese subjects with clinical and biological parameters collected.

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.


Condition or disease Intervention/treatment Phase
Neuropathology Device: Exams Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessment of the Prevalence of Small Fiber Peripheral Neuropathy Among Non-diabetic Obese Patients
Actual Study Start Date : March 2, 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non diabetic obese
Non diabetic obese with BMI 35-55 kg / m2 consulting for the first time at the Centre of obesity of Paris Saint Joseph Hospital Group will got a themotest and Sudoscan exams de determine their neuropathology.
Device: Exams
Patients the eligibility criteria 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.




Primary Outcome Measures :
  1. Assessment of Chlorine ion production change [ Time Frame: at inclusion then 1 month, 3 months, 6months and 12 months after surgery ]
    Patients will be a measure of impedance of the skin to products chlorine ions by the sweat glands via the Sudoscan® Device, marketed and used among diabetic patients or not for the detection of violations neuropathic (cf. references and CE certificate attached to the dossier)

  2. Assessment of Temperature changing sensitivity [ Time Frame: At inclusion then 1 month, 3 months, 6months and 12 months after surgery ]
    Patients will be measured their sensitivity to temperature changing using the Thermotest Device



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • morbidly obese patients:
  • BMI 35-55 kg / m²
  • Male or female
  • Age> 18 and <60 years
  • Consultant for the first time at the Centre of obesity of Paris Saint Joseph Hospital Group.

Exclusion Criteria:

  • Diabetes known treaty
  • Co-morbidity related to obesity: heart disease, respiratory failure
  • Other causes of peripheral neuropathy:
  • Alcohol Poisoning
  • Renal failure (clearance ≤ 60 mL / min)
  • Infection HIV, hepatitis B, C
  • Deficiencies vitamins B1, B6, B12, folate
  • Treatment with vitamin B6
  • thyroid disease antecedent
  • Previous history of autoimmune disease
  • Previous history of cancer
  • Previous history of neurotoxic treatment (chemotherapy, etc. see list provided in annex)
  • ICU hospitalization antecedent> 48 hours.
  • known history of peripheral neuropathy.

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): NCT02767583


Locations
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France
Groupe Hopitalier Paris Saint Joseph Service de neurologie
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Mathieu ZUBER, MD Groupe Hospitalier Paris Saint-Joseph (FRANCE)
Publications of Results:
Other Publications:
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02767583    
Other Study ID Numbers: Neuropathies and obesity
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Neuropathology
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases