Spinal Imaging in Neuropathy of Diabetes: Longitudinal Evaluation
Research type
Research Study
Full title
NORMALISED SPINAL CORD AREA MEASUREMENT IN MONITORING DIABETIC NEUROPATHY
IRAS ID
209300
Contact name
Cris Constantinescu
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Diabetes mellitus (DM) affects almost 400 million people worldwide and about 4.6% of the United Kingdom population. This prevalence is expected to increase significantly. Diabetes is typically irreversible. Its late complications cause decreased life expectancy and major medical, social and financial burdens.
The most frequent nervous system involvement is the diabetic distal symmetric polyneuropathy (DSP), commonly called “diabetic (peripheral) neuropathy, DPN”. DM is the most common cause of peripheral neuropathy in the western world. DSP can be complicated by foot ulcers and is the leading non-trauma cause of lower limb amputation.
There is evidence of central nervous system (CNS) involvement in DM. In addition to brain atrophy, memory deficits, and higher risk of dementia, pathological studies revealed degeneration of spinal cord dorsal columns.
Having expertise in spinal cord MRI and histopathology, we have performed one of very few longitudinal studies of cord atrophy in multiple sclerosis (MS), and monitored the effect of interferon beta therapy. We have optimised the technique for high field (3T) imaging and have dramatically reduced variance at all cord levels by correcting for height and gender.
This study proposes a longitudinal evaluation of spinal cord imaging in DM, focusing on normalised upper cervical cord area (UCCA) measurement and assessing the utility of UCCA in the monitoring of DPN.
We aim to recruit 110 participants, aged 18-70, from 5 groups: DM+DPN, DM without DPN, other neuropathies without DM, MS, and heathy volunteers.
The study will take place at Queen’s Medical Centre in Nottingham and Sir Peter Mansfield Imaging centre at the University of Nottingham.
The study will run for 4 years (18 months per participant). Participants will undergo two MRI scans at baseline and after 18 months together with questionnaires about their symptoms, blood tests, urine analysis, and nerve conduction studies.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0087
Date of REC Opinion
27 Mar 2017
REC opinion
Further Information Favourable Opinion