Effects of Different Doses of Aspirin on Pathophysiological Markers in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-07-31

Brief Summary

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This study was set up to assess the effects of different doses of aspirin when compared with placebo (dummy drug), used sequentially over a 2 week study period with a 2 week wash-out (rest period) in between, in people with type-2 diabetes and high cardiovascular risk. Specifically, its effects on different factors which are thought to contribute to diabetes such as insulin resistance (body's ability to effectively use insulin), dysglycaemia (excess glucose in the blood), oxidative stress (effects from accumulation of by-products of metabolism), endothelial function (function of lining of blood vessels) and inflammation were studied.

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Detailed Description

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Conditions

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Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aspirin low dose

Effects of using aspirin 75 mgs/day for 2 weeks.

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Aspirin 75mgs/day orally for 2 weeks.

Aspirin medium dose

Effects of using aspirin 300 mgs/day

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

300mgs/day orally for 2 weeks

aspirin high dose

aspirin 900mgs QID orally for 2 weeks

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

aspirin 900mgs QID orally for 2 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo tablet

Intervention Type OTHER

placebo tablet with lactose and excipients.

Interventions

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Aspirin

Aspirin 75mgs/day orally for 2 weeks.

Intervention Type DRUG

Aspirin

300mgs/day orally for 2 weeks

Intervention Type DRUG

Aspirin

aspirin 900mgs QID orally for 2 weeks

Intervention Type DRUG

placebo tablet

placebo tablet with lactose and excipients.

Intervention Type OTHER

Other Intervention Names

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acetyl salicylic acid acetyl salicylic acid acetyl salicylic acid

Eligibility Criteria

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Inclusion Criteria

* diabetes type 2
* age \> 18 and \< 70
* high cardiovascular risk

Exclusion Criteria

* presence of active/established cardiovascular disease (ischaemic heart disease, cerebrovascular disease or peripheral vascular disease)
* insulin treatment
* patients with known peptic ulcer disease or those on anti-coagulation
* significant renal impairment
* aspirin intolerance
* use of anticoagulants
* significant liver disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes