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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Sharon Caunt
+44 (0) 114 226 5976
sharon.caunt@nhs.net


Dr Ahmed Iqbal
+44 (0)114 215 9238
ahmed.iqbal@sheffield.ac.uk


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Be Part of Research - Trial Details - Low Blood glucose & the Effects of Systemic antiThrombotics IN Type 2 Diabetes (BEST-IN-T2D)
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Low Blood glucose & the Effects of Systemic antiThrombotics IN Type 2 Diabetes (BEST-IN-T2D)

Recruiting

Open to: All Genders

Age: Adult

Sheffield

Medical Conditions

Type 2 diabetes

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 and heart disease.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Sep 2022 31 Oct 2025

The study will involve health screening and then a period of either taking aspirin, prasugrel or no medication for 12 to 16 days. Medical records will be reviewed at the screening visit to obtain medical history, medication records, laboratory results and imaging test results to ensure eligibility for the study. Specifically, we will confirm a diabetes diagnosis and assess if there is a history of medical conditions that could exclude potential participants from the study because of increased risk from hypos and/or from the use of anti-clotting medications. These include previous heart disease, stroke, peripheral vascular disease, kidney problems, cancer, and significant eye damage from diabetes. Participants will be asked to wear a continuous glucose monitoring (CGM) device to monitor their blood sugars for up to 10 days in this period. This will be followed by a full day at the Clinical Research Facility at Northern General Hospital to have drips of insulin and glucose given into their veins to control their blood sugar and bring it into the hypo range for a brief period of time. Participants will also have blood tests during this visit. Participants will then be seen the following day to do more blood tests and to be fitted with a CGM device for another week before coming back for a final set of blood tests. We will also keep in contact by telephone until 2 weeks after the full-day visit to hospital when their blood sugar was controlled. Overall, there will be 6 in-person visits which include one full-day visit and 2 telephone calls with the study team.


People with confirmed T2D who are aged between 18-65 years old and are either taking tablets or insulin for their diabetes but have not had previous heart attacks or strokes.

You can take part if:



You may not be able to take part if:


1. History of previous myocardial infarction or any other acute coronary syndrome event, ischaemic heart disease as a clinical diagnosis and/or proven through percutaneous coronary intervention (PCI) and/or cardiac imaging modalities2. History of cardiac arrhythmia other than ectopic beats3. History of heart failure (clinical diagnosis and/or based on echocardiographic findings)4. History of peripheral vascular disease (clinical diagnosis and/or based on vascular imaging studies)5. History of stroke (haemorrhagic or ischaemic)6. History of transient ischaemic attack (TIA)7. Significant visual impairment due to retinopathy in the opinion of the investigator, untreated stage 3 or above diabetic retinopathy, evidence of active retinal haemorrhage as determined by ongoing treatment and/or ophthalmology follow up8. Diabetic nephropathy defined as an album-to-creatinine ratio > 30 mg/mmol on routine clinical tests performed within the last year or an estimated glomerular filtration rate <30 ml/min/1.73m2 on bloods performed at screening9. Clinically significant abnormality on resting 12-lead ECG, including a resting heart rate outside the range of 50-100 beats per minute but excluding atrial or ventricular ectopic beats on an ECG performed at screening10. Significant symptoms suggestive of CV disease 11. Known untreated hyperthyroidism12. Epilepsy or previous seizures13. Participants on blockers or QT interval prolonging drugs14. Cardiac autonomic neuropathy as measured at screening15. Serious intercurrent illness within the last 6 weeks16. Previous history of deep vein thrombosis or pulmonary embolism17. Any active malignant disease (under active treatment and/or oncology follow-up) or a history of any malignant disease in the last 5 years 18. Family history of sudden death19. Inability to communicate in English 20. Treatment or planned treatment with antiplatelet (including aspirin, prasugrel, clopidogrel, ticagrelor, dipyridamole, cilostazol, or glycoprotein IIb/IIIa antagonists), anti-inflammatory/immunomodulatory (oral, topical or inhaled corticosteroids; disease-modifying anti-rheumatic drugs; immunosuppressants; chemotherapy drugs; oral or topical antihistamines) anticoagulant medications (warfarin, dabigatran, rivaroxaban, edoxaban, apixaban, parenteral anticoagulants) or fibrinolytic agents within 2 months of randomisation21. Any planned surgery or other procedure that may require suspension or discontinuation of trial medication expected to occur within 2 months of randomisation22. Current or planned use of a non-steroidal anti-inflammatory drug 23. Known hypersensitivity to aspirin, salicylic acid (including certain asthma patients who may suffer an asthma attack or faint), prasugrel or excipients24. Clinically significant liver disease, defined as known or suspected diagnosis of hepatic cirrhosis with current Child-Pugh class B or C; or elevation of serum alanine transferase or aspartate transferase greater than 3 times the upper limit of the normal range for the processing laboratory on bloods performed at screening25. Abnormal clotting profile on screening that in the opinion of the investigator, would preclude safe involvement in the study or compromise its scientific credibility26. Abnormal full blood count on screening that in the opinion of the investigator, would preclude safe involvement in the study or compromise its scientific credibility27. Evidence of active pathological bleeding or peptic ulceration, or history of peptic ulceration or gastrointestinal haemorrhage28. History of alcohol or drug abuse, defined as regular use of an illicit substance for recreational purposes or regular consumption of greater than 50 units (males) or 35 units (females) of alcohol per week, in the last year29. Participants with a clinically significant CV, respiratory, metabolic, renal, hepatic, gastrointestinal, haematological, dermatological, neurological, psychiatric,or other major disorder that, in the opinion of the investigator, would preclude safe involvement in the study or compromise its scientific credibility30. Any clinically significant abnormal laboratory test results at screening that, in the opinion of the investigator, would preclude safe involvement in the study31. Pregnant or breast-feeding women32. Methotrexate used at doses >15 mg/week33. Active gout34. Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia35. Any contraindication for prasugrel or aspirin treatment as detailed in the respective SmPCs36. Women of child-bearing potential (WOCBP)A unless negative pregnancy test at screening and willing to use highly-effective contraception for the duration of treatment with study medication


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Northern General Hospital
    Northern General Hospital NHS Trust C Floor, Huntsmnan Building Herries Road
    Sheffield
    S5 7AU

There are no guaranteed benefits to participants taking part in this trial.
The risks to participants of being involved in this study are minimal. The study medications, aspirin and prasugrel, are routinely used in the care of patients having, or have had, a heart attack and are usually well tolerated. However, both medications commonly increase the risk of bleeding and participants receiving these medications may notice they bleed longer if they cut themselves. All participants will have their blood sugar lowered (hypo) for 60 minutes (the lowest level is 2.5 mmol/l); the symptoms any individual experiences with a hypo can vary from person to person. It is, however, common to feel shaky, hungry, and sweaty and for them to be aware of their heartbeat more strongly during the hypo but this subsides when their blood sugars are brought up to the normal level. Putting the cannula in can sometimes cause a bruise or slight inflammation, which may be uncomfortable, but usually settles down in a few days.

Dr Ahmed Iqbal
+44 (0)114 215 9238
ahmed.iqbal@sheffield.ac.uk


Dr Sharon Caunt
+44 (0) 114 226 5976
sharon.caunt@nhs.net



The study is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and funded by Medical Research Council.




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Read full details for Trial ID: ISRCTN53525957

Or CPMS 51549

Last updated 11 March 2025

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