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

Primary Purpose

Diabetes Type 2

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Aspirin
Aspirin
Aspirin
placebo tablet
Sponsored by
University of Portsmouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Type 2 focused on measuring diabetes, aspirin, oxidative stress, insulin resistance, endothelial function, inflammation, photoplethysmography, dysglycaemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Pharmacy and Biomedical Sciences, University of Posrtmouth
  • Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Aspirin low dose

Aspirin medium dose

aspirin high dose

placebo

Arm Description

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

Effects of using aspirin 300 mgs/day

aspirin 900mgs QID orally for 2 weeks

Outcomes

Primary Outcome Measures

Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance

Secondary Outcome Measures

Change in inflammatory markers

Full Information

First Posted
May 11, 2009
Last Updated
May 11, 2009
Sponsor
University of Portsmouth
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1. Study Identification

Unique Protocol Identification Number
NCT00898950
Brief Title
Effects of Different Doses of Aspirin on Pathophysiological Markers in Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Portsmouth

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
Keywords
diabetes, aspirin, oxidative stress, insulin resistance, endothelial function, inflammation, photoplethysmography, dysglycaemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin low dose
Arm Type
Experimental
Arm Description
Effects of using aspirin 75 mgs/day for 2 weeks.
Arm Title
Aspirin medium dose
Arm Type
Experimental
Arm Description
Effects of using aspirin 300 mgs/day
Arm Title
aspirin high dose
Arm Type
Experimental
Arm Description
aspirin 900mgs QID orally for 2 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
acetyl salicylic acid
Intervention Description
Aspirin 75mgs/day orally for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
acetyl salicylic acid
Intervention Description
300mgs/day orally for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
acetyl salicylic acid
Intervention Description
aspirin 900mgs QID orally for 2 weeks
Intervention Type
Other
Intervention Name(s)
placebo tablet
Intervention Description
placebo tablet with lactose and excipients.
Primary Outcome Measure Information:
Title
Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in inflammatory markers
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajeev P Raghavan, MBBS, MRCP
Organizational Affiliation
Portsmouth Hospitals NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael H Cummings, MD, FRCP
Organizational Affiliation
Portsmouth Hospitals NHS TRust & University of Portsmouth
Official's Role
Study Director
Facility Information:
Facility Name
School of Pharmacy and Biomedical Sciences, University of Posrtmouth
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO1 2DT
Country
United Kingdom
Facility Name
Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24372992
Citation
Raghavan RP, Laight DW, Cummings MH. Aspirin in type 2 diabetes, a randomised controlled study: effect of different doses on inflammation, oxidative stress, insulin resistance and endothelial function. Int J Clin Pract. 2014 Feb;68(2):271-7. doi: 10.1111/ijcp.12310. Epub 2013 Dec 22.
Results Reference
derived

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

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