Peripheral and Central Biomarkers of Painful Diabetic Neuropathy
Research type
Research Study
Full title
Peripheral and Central Biomarkers of Painful Diabetic Peripheral Neuropathy
IRAS ID
227603
Contact name
Solomon Tesfaye
Contact email
Sponsor organisation
Sheffield Teaching Hospitals
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Up to a third of people with diabetes can develop nerve damage, neuropathy, in their feet and legs. This can lead to a loss of sensation and in some, severe pain. Previous studies have found differences on skin biopsy and brain scanning in neuropathy but the underlying cause, particularly of painful symptoms, remains unknown.
The study will look into the differences found in the brain, spinal cord and skin nerves in people with diabetic neuropathy. We will compare different groups of people including: healthy volunteers, patients with type 2 diabetes without neuropathy, with established painful neuropathy, established painless neuropathy, and, as a pilot, early painful neuropathy (less than 2 years since diagnosis). Patients will undergo clinical assessment, neurophysiological assessment, skin biopsy and magnetic resonance imaging.
The study will investigate how several potential peripheral skin biopsy biomarkers of painful diabetic neuropathy interact with clinical phenotypes and central manifestations of painful diabetic neuropathy. The long-term objective is to identify biomarkers of painful neuropathy that can be used: (i) to detect early neuropathic involvement suitable for therapeutic intervention and (ii) as markers with which to monitor treatment response and outcome.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
17/EM/0430
Date of REC Opinion
18 Dec 2017
REC opinion
Further Information Favourable Opinion