nravelling the etiology of chronic idiopathic axonal polyneuropathy

Completed

Conditions: Chronic idiopathic axonal polyneuropathy
cryptogenic axonal polyneuropathy
polyneuropathy without an identifiable cause
10034606

Registration Number: NL-OMON32297

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 948

Inclusion Criteria

Inclusion criteria for patients with CIAP are: (1) patient age 45 years or older; (2) presence of distal symmetrical sensory or sensorimotor symptoms and deficits. These impairments should have begun distally in the legs, and have evolved slowly over months; (3) exclusion of any recognized cause of polyneuropathy such as diabetes mellitus, renal insufficiency, liver disease, alcohol abuse, medication, thyroid disease, vitamin deficiency, malignancy, polycythaemia, paraproteinaemia, systemic autoimmune or connective tissue disease, inflammatory bowel disease, metabolic storage disease, sarcoidosis, amyloidosis; (4) no indication of hereditary polyneuropathy; (5) electrophysiological investigations in agreement with axonal polyneuropathy without demyelinating features.
Inclusion criteria for controls are: (1) age 45 years or older; (2) absence of symptoms suggestive of polyneuropathy; (3) absence of any recognized cause of polyneuropathy.

Exclusion Criteria

Exclusion criteria for patients with CIAP are: (1) age younger than 45 years; (2) presence of asymmetrical or multifocal symptoms and deficits suggestive of a multifocal neuropathy; (3) (sub)acute onset and rapid progression of the neuropathy to a nadir within 12 weeks; (4) presence of any recognized of polyneuropathy, including hereditary neuropathy; (5) electrophysiological evidence of a demyelinating neuropathy according to established electrophysiological criteria.
Exclusion criteria for controls are: (1) age younger than 45 years; (2) presence of symptoms suggestive of polyneuropathy; (3) presence of any recognized cause of polyneuropathy.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Determine the incidence of CIAP in the middle of the Netherlands (province of<br /><br>Utrecht).<br /><br>- Establish by means of odds ratios if and to what extent CIAP is associated<br /><br>with the metabolic syndrome and which of is components are the most important<br /><br>determinants.<br /><br>- Establish by means of odds ratios if other prevalent conditions such as COPD,<br /><br>cardiovascular disease, environmental and nutritional factors contribute to the<br /><br>risk of CIAP.<br /><br>- Establish by means of Cox regression analysis if there is an association<br /><br>between clinical features such as age at onset, gender, disease duration,<br /><br>neurological symptoms and identified significant risk factors.</p><br>

Secondary Outcome Measures