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

NCT02767583 | Completed

• 1 other identifier: Neuropathies and obesity
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathology

Keywords

Neuropathology

Outcome Measures

Primary Outcomes (2)

• Assessment of Chlorine ion production change

  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)

  at inclusion then 1 month, 3 months, 6months and 12 months after surgery

• Assessment of Temperature changing sensitivity

  Patients will be measured their sensitivity to temperature changing using the Thermotest Device

  At inclusion then 1 month, 3 months, 6months and 12 months after surgery

Study Arms (1)

Non diabetic obese

EXPERIMENTAL

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

Interventions

Exams DEVICE

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.

Non diabetic obese

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hopitalier Paris Saint Joseph Service de neurologie

Paris, Île-de-France Region, 75014, France

Location

Related Publications (8)

• Smith AG, Lessard M, Reyna S, Doudova M, Singleton JR. The diagnostic utility of Sudoscan for distal symmetric peripheral neuropathy. J Diabetes Complications. 2014 Jul-Aug;28(4):511-6. doi: 10.1016/j.jdiacomp.2014.02.013. Epub 2014 Mar 6.

  PMID: 24661818 BACKGROUND

• Kopelman PG. Obesity as a medical problem. Nature. 2000 Apr 6;404(6778):635-43. doi: 10.1038/35007508.

  PMID: 10766250 RESULT

• Herman RM, Brower JB, Stoddard DG, Casano AR, Targovnik JH, Herman JH, Tearse P. Prevalence of somatic small fiber neuropathy in obesity. Int J Obes (Lond). 2007 Feb;31(2):226-35. doi: 10.1038/sj.ijo.0803418. Epub 2006 Jun 13.

  PMID: 16770330 RESULT

• Philippi N, Vinzio S, Collongues N, Vix M, Boehm N, Tranchant C, Echaniz-Laguna A. [Peripheral neuropathies after bariatric surgery]. Rev Neurol (Paris). 2011 Aug-Sep;167(8-9):607-14. doi: 10.1016/j.neurol.2011.01.011. Epub 2011 Apr 22. French.

  PMID: 21514611 RESULT

• Thaisetthawatkul P, Collazo-Clavell ML, Sarr MG, Norell JE, Dyck PJ. A controlled study of peripheral neuropathy after bariatric surgery. Neurology. 2004 Oct 26;63(8):1462-70. doi: 10.1212/01.wnl.0000142038.43946.06.

  PMID: 15505166 RESULT

• Sumner CJ, Sheth S, Griffin JW, Cornblath DR, Polydefkis M. The spectrum of neuropathy in diabetes and impaired glucose tolerance. Neurology. 2003 Jan 14;60(1):108-11. doi: 10.1212/wnl.60.1.108.

  PMID: 12525727 RESULT

• Devigili G, Tugnoli V, Penza P, Camozzi F, Lombardi R, Melli G, Broglio L, Granieri E, Lauria G. The diagnostic criteria for small fibre neuropathy: from symptoms to neuropathology. Brain. 2008 Jul;131(Pt 7):1912-25. doi: 10.1093/brain/awn093. Epub 2008 Jun 4.

  PMID: 18524793 RESULT

• 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.

  PMID: 23889506 RESULT

Study Officials

• Mathieu ZUBER, MD

  Groupe Hospitalier Paris Saint-Joseph (FRANCE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 10, 2016
• Study Start: March 2, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

FR (1)