Efficacy of 31P-MRS as a biomarker for Painful-Diabetic Neuropathy
Research type
Research Study
Full title
Investigating the efficacy of cerebral bioenergetics as a biomarker for neuropathic pain in diabetic peripheral neuropathy
IRAS ID
341333
Contact name
Gordon Sloan
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study will examine new methods of assessing pain in people with Diabetes using objective brain scan techniques. We will recruit 50 participants to the study, 24 with Diabetes and Nerve Pain in the Feet (Painful-DPN) and 26 people without Painful-DPN (13 with Diabetes and 13 without Diabetes and without other serious health conditions). People with Diabetes will be recruited from Sheffield Teaching Hospitals outpatient clinics and people without diabetes from local advertisement.
All participants will be invited to a first study visit which will last at most 120 minutes. They will be asked about their medical history; have a physical examination; assessments of nerve function; and complete questionnaires to assess mood, cognition, quality of life. At their second visit, all participants will undergo a brain scan, a certain type of Magnetic Resonance Imaging scan (31-Phosphorus Magnetic Resonance Spectroscopy). Participants with Painful-DPN will undergo this scan whilst taking their pain medications. This visit will take around 60-minutes, with approximately 30 minutes of scan time. This will conclude the involvement for participants without Painful-DPN.
Participants with Painful-DPN will undergo a second scan (at visit 3) after discontinuing their treatments for nerve pain in their feet. These medications will be reduced and then stopped entirely, in most people this will be, for 36-48 hours. The second scan visit will be the same as the first. After participants have undergone this scan their treatments will be re-introduced.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
24/WM/0110
Date of REC Opinion
25 Jun 2024
REC opinion
Further Information Favourable Opinion