Sonographic and electrophysiological characterisation of peripheral nerves in patients with type 2 diabetes

• Conditions: G63.2; G61.8; Diabetic polyneuropathy; Other inflammatory polyneuropathies

• Registration Number: DRKS00023026
• Lead Sponsor: niversitätsklinik Jena, Klinik für Neurologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-07
• Results First Posted: 2022-06-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Indication/diagnosis: patients with diabetes mellitus type 2
- Age: = 40 years = 85 years
- Written consent

Exclusion Criteria

- Neuromuscular disease of other cause
- History of alcohol abuse
- Derailed diabetes (HbA1c > 9%)
- Rheumatological disease
- Arterial obstructive disease
- Active malignant disease
- Use of neurotoxic drugs (ongoing/medical history)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the value of nerve ultrasound in diabetic polyneuropathy (compared to the gold standard of electrophysiological measurement). <br>

Secondary Outcome Measures

Name	Time	Method
1. The prevalence of diabetic polyneuropathy and the prevalence of CIDP in diabetes mellitus will be determined. <br><br>2. The value of nerve ultrasound in CIDP patients with diabetes mellitus will be assessed in order to better differentiate one of the most common inflammatory and treatable neuropathies from diabetic polyneuropathy. <br><br>3. In order to be able to make prognostic statements, the progression of diabetic polyneuropathy will be estimated using nerve ultrasound. <br><br>4. Since changes in the peripheral nerves already take place before the patients become symptomatic, we want to find preclinical parameters in ultrasound and electrophysiology, which can be used as risk factors for the development of diabetic polyneuropathy.