Diabetes Mellitus, Type IINCT00649909
Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients
An observational study of Diabetes Mellitus, Type II, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. We will perform an observational study where we follow up patients with uncontrolled type 2 Diabetes Mellitus and low response to aspirin (Aspirin Resistance), during a period of 6 months in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type II
- How many people
- 18 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Nov 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 2 diabetic patients that take aspirin, from the diabetology clinic.
Who may be able to join
- Type 2 DM.
- Patients that take aspirin.
- Antecubital forearm veins allowing technically good sampling for platelet studies.
- Reduced Laboratory response to aspirin.
- HbA1c > 8 %
- The physician decides that there is an indication for glucose control.
Who cannot join
- Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.
- Acute kidney disease or chronic kidney disease with creatinine clearance <30.
- Acute liver disease or chronic liver disease with severe liver impairment.
- Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.
- Thrombocytopenia (platelet count <150 x 109/L)
Trial locations and contacts
1 site in 1 country.
About this study
The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes.
We will perform an observational study where we follow up patients with uncontrolled type 2 Diabetes Mellitus and low response to aspirin (Aspirin Resistance), during a period of 6 months in the diabetic clinic. Our hypothesis is that glucose control will improve the response to aspirin in those patients.
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- Diabetes Mellitus, Type II, Aspirin, Resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Type 2 diabetic patients with reduced laboratory response to aspirin.(Aspirin Resistance)and with HbA1c >8%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome measure is the laboratory Aspirin Resistance.
Measured: 3 and 6 months.
Secondary outcomes (1)
To determine the incidence of laboratory aspirin resistance in type 2 DM in stable out-patients in the diabetic clinic, and possibly related factors.
Measured: On screening visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Varon, Hadassah Medical Organization
- Investigators
- David Varon, MD, Principal investigator, Hematology Department, Hadassah Medical Organization, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649909
- Sponsor's protocol ID
- 0020-08-HMO-CTIL
- Status last verified
- Aug 2017
- First submitted
- 27 Mar 2008
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00649909
- Acronym / sponsor ID
- 0020-08-HMO-CTIL
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- Diabetes Mellitus, Type II, Aspirin, Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 1 Apr 2008 (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.
The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes.
We will perform an observational study where we follow up patients with uncontrolled type 2 Diabetes Mellitus and low response to aspirin (Aspirin Resistance), during a period of 6 months in the diabetic clinic. Our hypothesis is that glucose control will improve the response to aspirin in those patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Type 2 diabetic patients with reduced laboratory response to aspirin.(Aspirin Resistance)and with HbA1c >8%. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 2 diabetic patients that take aspirin, from the diabetology clinic.
Key inclusion criteria (6 listed)
- Type 2 DM.
- Patients that take aspirin.
- Antecubital forearm veins allowing technically good sampling for platelet studies.
- Reduced Laboratory response to aspirin.
- HbA1c > 8 %
Key exclusion criteria (5 listed)
- Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.
- Acute kidney disease or chronic kidney disease with creatinine clearance <30.
- Acute liver disease or chronic liver disease with severe liver impairment.
- Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.
- Thrombocytopenia (platelet count <150 x 109/L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The outcome measure is the laboratory Aspirin Resistance.
Time frame: 3 and 6 months.
1 secondary outcome
To determine the incidence of laboratory aspirin resistance in type 2 DM in stable out-patients in the diabetic clinic, and possibly related factors.
Time frame: On screening visit.
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 10 Aug 2017.
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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.
David Varon, MD principal investigator
Hematology Department, Hadassah Medical Organization, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type II, run by Hadassah Medical Organization at 1 site in Israel.
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 6 inclusion and 5 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 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. 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?
The outcome measure is the laboratory Aspirin Resistance. (time frame: 3 and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2017.