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Clinical Trials/EUCTR2008-007875-26-GB
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

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.

Registry
who.int
Start Date
July 6, 2009
End Date
December 31, 2012
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Leeds

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 In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn.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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