Skip to content

Spinal cord area measurement using MRI in monitoring diabetic neuropathy

Spinal Imaging in Neuropathy of Diabetes: Longitudinal Evaluation (SpINDLE)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11328492
Enrollment
115
Registered
2021-04-08
Start date
2019-03-13
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Spinal cord atrophy in people with diabetic neuropathy Nervous System Diseases Spinal cord atrophy in people with diabetic neuropathy

Interventions

There will be 5 study groups: 1. Diabetes without diabetic peripheral neuropathy (DM-DPN) 2. Diabetes with diabetic peripheral neuropathy (DM+DPN) 3. He

Sponsors

University of Nottingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Upper cervical cord area measured using magnetic resonance imaging at baseline and between 12 and 24 months

Secondary

MeasureTime frame
1. Lower cervical cord area measured using magnetic resonance imaging at baseline and between 12 and 24 months 2. Mid-thoracic cord area measured using magnetic resonance imaging at baseline and between 12 and 24 months 3. Brain volume measured using magnetic resonance imaging at baseline and between 12 and 24 months 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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026