BIRA Study Version 1.0
Research type
Research Study
Full title
Brain Insulin Resistance Assessment (BIRA) Study
IRAS ID
322853
Contact name
Ivan Koychev
Contact email
Sponsor organisation
University of Oxford, Research Governance, Ethics and Assurance
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The risk of developing either dementia or diabetes increases as people get older. Studies have suggested that the two are linked with people with diabetes being two times more likely to receive a future diagnosis of dementia than people without diabetes. It has been suggested that the brain may have problems using the body’s own insulin and that this may explain why some people with diabetes go on to get dementia. The purpose of this study is to establish what a normal, healthy response to insulin in the brain looks like. This is important as it will allow future researchers and clinicians to identify those who are showing abnormal brain responses to insulin and study whether they are particularly at risk of developing dementia. Such individuals could then be identified for possible drug trials and earlier interventions to reduce their risk of dementia by helping insulin to work better in the brain.
To establish what a healthy response to insulin in the brain looks like, we are going to do the following over three study visits lasting around 60 minutes each:
1. Recruit healthy volunteers over the age of 40 (divided into those with normal and high body weight) and while fasted check how sensitive they are to their own insulin using a blood test and assess their memory and thinking skills
2. Give low doses of insulin on one day in a nasal spray and a placebo (here saline solution) on another day before having a 30-minute brain scan on both days
3. Take some non-invasive (painless) brain scans looking at the structure and function of the brain
4. Analyse blood tests for measures of brain sensitivity to insulin and risk of Alzheimer’s disease
To assess changes in cognitive function over time, we will also ask participants to complete follow-up cognitive testing at home 2-months after scanning and 6-months after scanning.REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0516
Date of REC Opinion
9 Jun 2023
REC opinion
Favourable Opinion