BEST-IN-T2D
Research type
Research Study
Full title
A proof-of-concept randomised intervention trial to establish the impact of prasugrel versus aspirin on the proinflammatory and prothrombotic effects of experimental hypoglycaemia in type 2 diabetes.
IRAS ID
1003876
Contact name
Professor Robert Storey
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2021-002906-28
ISRCTN Number
ISRCTN53525957
Research summary
Heart attacks and strokes cause more deaths in people with type-2 diabetes (T2D) than any other cause and mostly result from the formation of blood clots inside blood vessels supplying the heart and brain. A common side-effect of treating high blood sugar levels in T2D is episodes of low sugar levels, called hypoglycaemia (‘hypos’). We have discovered that hypos cause inflammation and increased clotting tendency in T2D. In this study, we will study what effects two commonly-used anti-clotting drugs, aspirin and prasugrel, have on the harmful effects of hypos in T2D. This may indicate the most promising anti-clotting medication in T2D patients, especially in those at risk of hypos. If this study shows promising results we plan to perform a larger trial. Ultimately, if this larger trial is successful, our findings may help millions of people with T2D achieve the benefits of good glucose control whilst protecting against the harmful effects of hypos on the heart.
Participants will be eligible to take part if they have T2D and meet the study entry criteria. The study will involve screening participants for any health problems and then a period of either taking aspirin, prasugrel or no medication for 12 to 16 days. Participants will also be asked to wear a continuous glucose monitoring (CGM) device to monitor your blood sugars on two occasions. The study will involve one full day visit to have drips of insulin and glucose given into the veins to control participants' blood sugar and bring it into the hypo range for 60 minutes. Participants will also have blood tests throughout the study. Overall, there will be 6 in person visits and 2 telephone calls with the study team. This study is funded by the Medical Research Council and will take place over 1 year at Sheffield Teaching Hospitals.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0276
Date of REC Opinion
21 Jan 2022
REC opinion
Further Information Favourable Opinion