ow Blood glucose & the Effects of Systemic antiThrombotics IN Type 2 Diabetes (BEST-IN-T2D)

Not Applicable

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN53525957
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-18
• Last Update Posted: 22 April 2024
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Provision of informed consent prior to any study-specific procedures
2. Male or female aged between 18 and 65 years old
3. Confirmed diagnosis of T2D taking oral hypoglycaemic agents and/or glucagon-like peptide 1 analogs/insulin: participants treated with insulin will be eligible if the duration of treatment with insulin is 2 years
4. Screening glycated haemoglobin A1c (HbA1c) 6.5-10.5% (48-91 mmol/mol), if the screening HbA1c is outside this range then participants will be ineligible

Exclusion Criteria

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 modalities
2. History of cardiac arrhythmia other than ectopic beats
3. 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 up
8. 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 screening
9. 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 screening
10. Significant symptoms suggestive of CV disease
11. Known untreated hyperthyroidism
12. Epilepsy or previous seizures
13. Participants on blockers or QT interval prolonging drugs
14. Cardiac autonomic neuropathy as measured at screening
15. Serious intercurrent illness within the last 6 weeks
16. Previous history of deep vein thrombosis or pulmonary embolism
17. 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 death
19. 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 randomisation
21. Any planned surgery or other procedure that may require suspension or discontinuation of trial medication expected to occur within 2 months of randomisation
22. 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 excipients
24. 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 screening
25. Abnormal clotting profile on screening that in the opinion of the investigator, would preclude safe involvement in the study or compromise its scientific credibility
26. Abnormal full blood count on screening that in the opinion of the investigator, would preclude safe involvement in the study or compromise its scientific credibility
27. Evidence of active pathological bleeding or peptic ulc

Study & Design

• Study Type: Interventional
• Study Design: Not specified