Modulation of Clot Structure and Platelet Function by Aspirin in Individuals with Diabetes: the role of aspirin dose and Glycaemic control - Aspirin in Diabetes

Phase 1

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: EUCTR2008-007875-26-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-06
• Study Completion: 2012-12-31
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

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

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 In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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