Rapid detection of chronic polyneuropathy in patients with diabetes mellitus or chronic kidney failure
Recruiting
- Conditions
- (peripheral) neuropathynerve disease10034606
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 370
Inclusion Criteria
Age > 18 year and diagnosed with diagnosed with diabetes mellitus type 2 or
type 1 for more than 10 year (fasting glucose >= 7.0 mmol/l or non-fasting
glucose >= 11.0 mmol/l or use of any antidiabetics) and/or chronic kidney
failure (eGFR < 30 ml/min/1.73m2)
Exclusion Criteria
unable to fill in the symptom questionnaire (e.g. a language barrier or severe
cognitive problems)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the performance of the E-PSS expressed as area<br /><br>under the curve (AUC) and visualize this with a receiver operating<br /><br>characteristic (ROC) curve. Using the Youden*s J statistic we will determine<br /><br>the cut-off value with the best discrimination performance. We will evaluate<br /><br>the performance further with the sensitivity and specificity for this cut-off<br /><br>value.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives are:<br /><br>- the prevalence of polyneuropathy,<br /><br>- the proportion of underdiagnosed polyneuropathy<br /><br>- the prevalence of co-occurrence of risk factors<br /><br>- usage of neuropathic painkillers<br /><br>- the relationship between presence of polyneuropathy and severity, duration<br /><br>and treatment of the underlying disease </p><br>