Unravelling the etiology of chronic idiopathic axonal polyneuropathy

Unravelling the etiology of chronic idiopathic axonal polyneuropathy - Etiology of CIAP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32297

Enrollment

948

Registered

2008-07-29

Start date

2009-04-22

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic idiopathic axonal polyneuropathy cryptogenic axonal polyneuropathy polyneuropathy without an identifiable cause

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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: 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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results