[Selection of risk and diagnosis in diabetic polyneuropathy. Validation of method of new systems].

Introduction: In a previous study we developed a specific algorithm, the polyneuropathy selection method (PSM) with 4 parameters (age, HDL-C, HbA1c, and retinopathy), to select patients at risk of diabetic polyneuropathy (DPN). We also developed a simplified method for DPN diagnosis: outpatient polyneuropathy diagnosis (OPD), with 4 variables (symptoms and 3 objective tests).

Objectives: To confirm the validity of conventional tests for DPN diagnosis; to validate the discriminatory power of the PSM and the diagnostic value of OPD by evaluating their relationship to electrodiagnosis studies and objective clinical neurological assessment; and to evaluate the correlation of DPN and pro-inflammatory status.

Design: Cross-sectional, crossed association for PSM validation. Paired samples for OPD validation.

Setting: Primary care in 3 counties.

Participants: Random sample of 75 subjects from the type-2 diabetes census for PSM evaluation. Thirty DPN patients and 30 non-DPN patients (from 2 DM2 sub-groups in our earlier study) for OPD evaluation.

Methods: The gold standard for DPN diagnosis will be studied by means of a clinical neurological study (symptoms, physical examination, and sensitivity tests) and electrodiagnosis studies (sensitivity and motor EMG). Risks of neuropathy, macroangiopathy and pro-inflammatory status (PCR, TNF soluble fraction and total TGF-beta1) will be studied in every subject.

Expected Results: Electrodiagnosis studies should confirm the validity of conventional tests for DPN diagnosis. PSM and OPD will be valid methods for selecting patients at risk and diagnosing DPN. There will be a significant relationship between DPN and pro-inflammatory tests.