EUCTR2008-007875-26-GB
Active, not recruiting
Phase 1
Modulation of Clot Structure and Platelet Function by Aspirin in Individuals with Diabetes: the role of aspirin dose and Glycaemic control - Aspirin in Diabetes
niversity of Leeds0 sites96 target enrollmentJuly 6, 2009
ConditionsType 1 Diabetes Mellitus
DrugsAspirin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- niversity of Leeds
- Enrollment
- 96
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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 In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn.
Outcomes
Primary Outcomes
Not specified
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