Spinal cord area measurement using MRI in monitoring diabetic neuropathy

Not Applicable

• Conditions: Spinal cord atrophy in people with diabetic neuropathy; Nervous System Diseases

• Registration Number: ISRCTN11328492
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-08
• Last Update Posted: 9 January 2023
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

1. Aged between 18 and 75 years
2. Able to give informed consent
3. Able to speak and understand English language
4. Diagnosis consistent with one of the study groups (diabetes without diabetic peripheral neuropathy, diabetes with diabetic peripheral neuropathy, healthy volunteers, multiple sclerosis, or other peripheral neuropathies) with initial symptoms having preceded inclusion into the study by 12 months and/or condition stable for =2 months

Exclusion Criteria

1. Extensive cardiovascular and/or cerebrovascular comorbidity (treatment for angina or peripheral vascular disease constitutes a contraindication)
2. Other comorbidities, in particular neurological diseases, that in view of the researcher may interfere with the study
3. Significant spinal or spinal cord disease (other than MS in the MS control group)
4. Contraindications for MRI including but not restricted to pacemaker, orbital foreign body, certain aneurysm clips, claustrophobia, and un-removable piercings
5. Pregnancy or planning for pregnancy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pper cervical cord area measured using magnetic resonance imaging at baseline and between 12 and 24 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Lower cervical cord area measured using magnetic resonance imaging at baseline and between 12 and 24 months<br> 2. Mid-thoracic cord area measured using magnetic resonance imaging at baseline and between 12 and 24 months<br> 3. Brain volume measured using magnetic resonance imaging at baseline and between 12 and 24 months<br> 4. Clinical severity of diabetic neuropathy measured using clinical examination, vibration perception threshold, and neuropathic pain scores at baseline and between 12 and 24 months<br>