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

Diabetes Type 2 Clinical Trial

Official title:

The Links Between Dysglycaemia, Insulin Resistance, Endothelial Function, Inflammation and Oxidative Stress: Effect of Different Doses of Aspirin in Subjects With Type-2 Diabetes and High Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898950
• Other study ID #: 2004-001418-14
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: May 11, 2009
• Start date: August 2004
• Est. completion date: July 2006

Study information

• Verified date: May 2009
• Source: University of Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Insulin Resistance

Intervention

Drug:
• Aspirin
Aspirin 75mgs/day orally for 2 weeks.
• Aspirin
300mgs/day orally for 2 weeks
• Aspirin
aspirin 900mgs QID orally for 2 weeks

Other:
• placebo tablet
placebo tablet with lactose and excipients.

Locations

Country	Name	City	State
United Kingdom	Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust	Portsmouth	Hampshire
United Kingdom	School of Pharmacy and Biomedical Sciences, University of Posrtmouth	Portsmouth	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Portsmouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance		2 weeks	No
Secondary	Change in inflammatory markers		2 weeks	No