Chronic Cough and Small Fiber Neuropathy

NCT03787511 | Terminated

• 2 other identifiers: RC31/18/04232018-A03340-55
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic patients with and without chronic cough will be included in this study. After giving their informed consent, the patients will perform a spirometry, chest X-ray at the inclusion visit. Cough will be assessed using the cough visual analog scale (VAS) and the Leicester Cough Questionnaire (LCQ). Within 60 days, the patient will perform neurophysiological tests. The neurophysiological assessment will be concluded with a skin biopsy to evaluate small fiber neuropathy. The aim of the study is to compare the proportion of small fiber neuropathy between diabetic patients with chronic cough and those without chronic cough.

Conditions

Chronic Cough; Type 2 Diabetes

Keywords

cough; diabetes; small fiber neuropathy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with small fiber neuropathy

  The primary endpoint is the proportion of patients with small fiber neuropathy between diabetic patients with chronic cough and those without chronic cough (defined by at least 2 abnormal neurophysiological tests).

  6 month after inclusion visit

Secondary Outcomes (7)

• proportion of patients with abnormal results of the thermotest

  6 month after inclusion visit

• proportion of patients with pathological results of the sudori-motor response

  6 month after inclusion visit

• the proportion of patients with abnormal results of cardiovascular tests

  6 month after inclusion visit

• proportion of patients with abnormal results of laser evoked potentials

  6 month after inclusion visit

• proportion of patients with abnormal findings of cutaneous biopsy

  6 month after inclusion visit

Study Arms (2)

Diabetic patients with chronic cough

OTHER

Diabetic patients with chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.

Other: Cough assessment; Other: Neurological tests and cardiovascular tests; Other: Skin biopsy

Diabetic patients without chronic cough

OTHER

Diabetic patients without chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.

Other: Cough assessment; Other: Neurological tests and cardiovascular tests; Other: Skin biopsy

Interventions

Cough assessment OTHER

Cough assessment with cough visual analog scale (VAS), and Leicester Cough Questionnaire (LCQ) for Diabetic patients with chronic cough and Diabetic patients without chronic cough

Diabetic patients with chronic cough; Diabetic patients without chronic cough

Neurological tests and cardiovascular tests OTHER

Neurological tests : electromyography, thermotest, QSAR + cardiovascular test for Diabetic patients with chronic cough and Diabetic patients without chronic cough

Diabetic patients with chronic cough; Diabetic patients without chronic cough

Skin biopsy OTHER

Skin biopsy to evaluate small fiber neuropathy for Diabetic patients with chronic cough and Diabetic patients without chronic cough

Diabetic patients with chronic cough; Diabetic patients without chronic cough

Eligibility Criteria

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

You may qualify if:

• In diabetic patients with chronic cough:
• Chronic cough defined by cough for more than 8 weeks.
• Normal chest X-ray
• history of type 2 diabetes
• Age of diabetes onset\> 40 years
• Affiliated or beneficiary person of social security
• Free, informed and written consent
• In diabetic patients without chronic cough
• History of type 2 diabetes
• Age of discovery of diabetes\> 40 years
• Affiliated or beneficiary person of social security
• Free, informed and written consent

You may not qualify if:

• Presence of physical signs of peripheral neuropathy
• Active smoking or smoking cessation within the last 12 months
• Pregnant or lactating woman
• History of non-type 2 diabetes (type I, secondary diabetes, monogenic ...)
• Cancer within the last 5 years (except cutaneous squamous cell carcinoma)
• History of anti-cancer chemotherapy
• Suspicion of autoimmune pathology
• Active neurological pathology
• Electromyography in favor of large fiber neuropathy
• Chronic pathology that may interfere with the neurophysiological assessment
• Patient who were given anticoagulation drug therapy, anti-cholinergic drugs, beta-blocker and impossibility to withdraw the treatment before neurophysiological tests

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hôpital Larrey

Toulouse, 31059, France

Location

Related Publications (4)

• Chung KF. Chronic 'cough hypersensitivity syndrome': a more precise label for chronic cough. Pulm Pharmacol Ther. 2011 Jun;24(3):267-71. doi: 10.1016/j.pupt.2011.01.012. Epub 2011 Feb 1.

  PMID: 21292019 BACKGROUND

• De Santi F, Zoppini G, Locatelli F, Finocchio E, Cappa V, Dauriz M, Verlato G. Type 2 diabetes is associated with an increased prevalence of respiratory symptoms as compared to the general population. BMC Pulm Med. 2017 Jul 17;17(1):101. doi: 10.1186/s12890-017-0443-1.

  PMID: 28716044 BACKGROUND

• Pavy-Le Traon A, Fontaine S, Tap G, Guidolin B, Senard JM, Hanaire H. Cardiovascular autonomic neuropathy and other complications in type 1 diabetes. Clin Auton Res. 2010 Jun;20(3):153-60. doi: 10.1007/s10286-010-0062-x. Epub 2010 Mar 31.

  PMID: 20354891 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Chronic Cough; Diabetes Mellitus, Type 2; Cough; Diabetes Mellitus; Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Laurent Guilleminault, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: June 14, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)