Diabetes Type 2NCT00898950
Effects of Different Doses of Aspirin on Pathophysiological Markers in Type 2 Diabetes
A study testing Aspirin in people with Diabetes Type 2, run by University of Portsmouth at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2004to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetes type 2
- age > 18 and < 70
- high cardiovascular risk
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
School of Pharmacy and Biomedical Sciences, University of Posrtmouth
Portsmouth, Hampshire, PO1 2DT
Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
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
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.
- Conditions
- Diabetes Type 2
- Being tested
- Aspirin, placebo tablet
- Keywords
- diabetes, aspirin, oxidative stress, insulin resistance, endothelial function, inflammation, photoplethysmography, dysglycaemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called acetyl salicylic acid
Aspirin 75mgs/day orally for 2 weeks.
AspirinDrug
Also called acetyl salicylic acid
300mgs/day orally for 2 weeks
AspirinDrug
Also called acetyl salicylic acid
aspirin 900mgs QID orally for 2 weeks
placebo tabletOther
placebo tablet with lactose and excipients.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin low dose | Experimental | Effects of using aspirin 75 mgs/day for 2 weeks. Receives: Drug: Aspirin |
| Aspirin medium dose | Experimental | Effects of using aspirin 300 mgs/day Receives: Drug: Aspirin |
| aspirin high dose | Experimental | aspirin 900mgs QID orally for 2 weeks Receives: Drug: Aspirin |
| placebo | Placebo comparator | Not described Receives: Other: placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance
Measured: 2 weeks
Secondary outcomes (1)
Change in inflammatory markers
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startAug 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Investigators
- Rajeev P Raghavan, MBBS, MRCP, Principal investigator, Portsmouth Hospitals NHS TrustMichael H Cummings, MD, FRCP, Study director, Portsmouth Hospitals NHS TRust & University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898950
- Sponsor's protocol ID
- 2004-001418-14
- Other IDs
- 2004
- Status last verified
- May 2009
- First submitted
- 11 May 2009
- Last updated
- 12 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24372992
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00898950
- Acronym / sponsor ID
- 2004-001418-14
- Conditions
- Diabetes Type 2
- Keywords
- diabetes, aspirin, oxidative stress, insulin resistance, endothelial function, inflammation, photoplethysmography, dysglycaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aspirin low dose | Experimental | Drug: AspirinEffects of using aspirin 75 mgs/day for 2 weeks. |
| Aspirin medium dose | Experimental | Drug: AspirinEffects of using aspirin 300 mgs/day |
| aspirin high dose | Experimental | Drug: Aspirinaspirin 900mgs QID orally for 2 weeks |
| placebo | Placebo comparator | Other: placebo tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetes type 2
- age > 18 and < 70
- high cardiovascular risk
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: acetyl salicylic acidAspirin 75mgs/day orally for 2 weeks. | Drug | Aspirin low dose |
| AspirinAlso: acetyl salicylic acid300mgs/day orally for 2 weeks | Drug | Aspirin medium dose |
| AspirinAlso: acetyl salicylic acidaspirin 900mgs QID orally for 2 weeks | Drug | aspirin high dose |
| placebo tabletplacebo tablet with lactose and excipients. | Other | placebo |
Primary outcome
Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance
Time frame: 2 weeks
1 secondary outcome
Change in inflammatory markers
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
- Derived from this study: PubMed 24372992Raghavan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajeev P Raghavan, MBBS, MRCP principal investigator
Portsmouth Hospitals NHS Trust
Michael H Cummings, MD, FRCP study director
Portsmouth Hospitals NHS TRust & University of Portsmouth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin in people with Diabetes Type 2, run by University of Portsmouth at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00898950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2009.