Type 1 Diabetes Mellitus
Conditions
Interventions
Trade Name: Aspirin
Product Name: not applicable
Product Code: not applicable
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: salicylic acid
CAS Number: 50782
Concentration unit: IU/mg in
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with type 1 diabetes(T1DM), treated with insulin only age 18 - 65 not taking any other medication no significant medical history(see below) using reliable contraception ie. oral contraceptive pill, intra-utering device, diaphragm + condom Healthy volunteers as above but without T1DM Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any history of cardiovascular disease. Prior treatment with aspirin, clopidogril or warfarin. Regular previous or current treatment with non-steroidal anti-inflammatory drugs, Current treatment with any medication other than insulin History of acute coronary syndrome or stroke, deep vein thrombosis, pulmonary embolism, previous or current upper gastrointestinal pathology, malignancy or coagulation disorders. Any individual found to have abnormal liver function (measured by ALT>3 fold upper limit of normal) or abnormal thyroid function will be excluded at this time and offered further investigation. Control subjects will be excluded if found to have impaired glucose tolerance or diabetes measured according to current guidelines. Not currently using contraception Pregnant women will not be included in the study. In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the prevalence of aspirin resistance in patients with diabetes;Secondary Objective: study the mechanisms involved in aspirin resistance;Primary end point(s): not applicable | — |
Countries
United Kingdom
Outcome results
None listed