NCT00898950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2004

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

May 12, 2009

Status Verified

May 1, 2009

Enrollment Period

1.9 years

First QC Date

May 11, 2009

Last Update Submit

May 11, 2009

Conditions

Diabetes Type 2

Keywords

diabetesaspirinoxidative stressinsulin resistanceendothelial functioninflammationphotoplethysmographydysglycaemia

Outcome Measures

Primary Outcomes (1)

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

    2 weeks

Secondary Outcomes (1)

  • Change in inflammatory markers

    2 weeks

Study Arms (4)

Aspirin low dose

EXPERIMENTAL

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

Drug: Aspirin

Aspirin medium dose

EXPERIMENTAL

Effects of using aspirin 300 mgs/day

Drug: Aspirin

aspirin high dose

EXPERIMENTAL

aspirin 900mgs QID orally for 2 weeks

Drug: Aspirin

placebo

PLACEBO COMPARATOR
Other: placebo tablet

Interventions

AspirinDRUG

Aspirin 75mgs/day orally for 2 weeks.

Also known as: acetyl salicylic acid
Aspirin low dose
placebo tabletOTHER

placebo tablet with lactose and excipients.

placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School of Pharmacy and Biomedical Sciences, University of Posrtmouth

Portsmouth, Hampshire, PO1 2DT, United Kingdom

Location

Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24372992DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin ResistanceInflammation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Rajeev P Raghavan, MBBS, MRCP

    Portsmouth Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

  • Michael H Cummings, MD, FRCP

    Portsmouth Hospitals NHS TRust & University of Portsmouth

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 12, 2009

Study Start

August 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

May 12, 2009

Record last verified: 2009-05

Locations

GB(2)