Type 2 Diabetes MellitusDIADNCT00769275
Detection of Ischemia in Asymptomatic Diabetics
An observational study of Type 2 Diabetes Mellitus, run by Yale University at 1 site in United States.
Trial summary
Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction. The aims are: 1. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 1,123 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Jan 2008
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asymptomatic patients with type 2 diabetes mellitus
Who may be able to join
- Age 50-75 years
- Type 2 diabetes mellitus
Who cannot join
- Angina or anginal equivalent
- Abnormal rest ECG (Q or ST depression)
- Known CAD
- Stress testing within the last 3 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction.
The aims are:
- To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus.
- To identify on the basis of clinical and/or biochemical variables in a high-risk cohort in which screening for coronary artery disease is appropriate.
- To assess progression of (silent) myocardial ischemia after 3 years.
- To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- silent ischemia, type 2 diabetes mellitus, screening, cardiac outcome, Prevalence silent myocardial ischemia, Cardiac outcome in screened and not-screened subjects
- Medical subject headings
- Diabetes Mellitus, Type 2
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 |
|---|---|---|
| 1 | Screening at start study with Adenosine vasodilator stress Tc-99m Sestamibi SPECT imaging | |
| 2 | No screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%.
Measured: At study entry
At repeat stress imaging three years after recruitment 79% of subjects showed resolution of ischemia, whereas only 10% developed new ischemia.
Measured: 3 years after start
Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startAug 2000
- Primary completionSep 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 1,123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Astellas Pharma US, Inc.
- Investigators
- Frans J Wackers, MD, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769275
- Sponsor's protocol ID
- DIAD
- Other IDs
- HIC #11312
- Acronym
- DIAD
- Status last verified
- Oct 2008
- First submitted
- 8 Oct 2008
- Last updated
- 9 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wackers FJ, Young LH, Inzucchi SE, Chyun DA, Davey JA, Barrett EJ, Taillefer R, Wittlin SD, Heller GV, Filipchuk N, Engel S, Ratner RE, Iskandrian AE; Detection of Ischemia in Asymptomatic Diabetics Investigators. Detection of silent myocardial ischemia in asymptomatic diabetic subjects: the DIAD study. Diabetes Care. 2004 Aug;27(8):1954-61. doi: 10.2337/diacare.27.8.1954.
PubMed 15277423Wackers FJ, Chyun DA, Young LH, Heller GV, Iskandrian AE, Davey JA, Barrett EJ, Taillefer R, Wittlin SD, Filipchuk N, Ratner RE, Inzucchi SE; Detection of Ischemia in Asymptomatic Diabetics (DIAD) Investigators. Resolution of asymptomatic myocardial ischemia in patients with type 2 diabetes in the Detection of Ischemia in Asymptomatic Diabetics (DIAD) study. Diabetes Care. 2007 Nov;30(11):2892-8. doi: 10.2337/dc07-1250. Epub 2007 Aug 6.
PubMed 17682123Young LH, Wackers FJ, Chyun DA, Davey JA, Barrett EJ, Taillefer R, Heller GV, Iskandrian AE, Wittlin SD, Filipchuk N, Ratner RE, Inzucchi SE; DIAD Investigators. Cardiac outcomes after screening for asymptomatic coronary artery disease in patients with type 2 diabetes: the DIAD study: a randomized controlled trial. JAMA. 2009 Apr 15;301(15):1547-55. doi: 10.1001/jama.2009.476.
PubMed 19366774
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Ischemia in Asymptomatic Diabetics
- ClinicalTrials.gov ID
- NCT00769275
- Acronym / sponsor ID
- DIAD / DIAD
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- silent ischemia, type 2 diabetes mellitus, screening, cardiac outcome, Prevalence silent myocardial ischemia, Cardiac outcome in screened and not-screened subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,123 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Astellas Pharma US, Inc.
- Study start
- Aug 2000
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 9 Oct 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.
Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction.
The aims are:
- To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus.
- To identify on the basis of clinical and/or biochemical variables in a high-risk cohort in which screening for coronary artery disease is appropriate.
- To assess progression of (silent) myocardial ischemia after 3 years.
- To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Screening at start study with Adenosine vasodilator stress Tc-99m Sestamibi SPECT imaging |
| 2 | – | –No screening |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic patients with type 2 diabetes mellitus
Key inclusion criteria (2 listed)
- Age 50-75 years
- Type 2 diabetes mellitus
Key exclusion criteria (4 listed)
- Angina or anginal equivalent
- Abnormal rest ECG (Q or ST depression)
- Known CAD
- Stress testing within the last 3 years
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
Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%.
Time frame: At study entry
At repeat stress imaging three years after recruitment 79% of subjects showed resolution of ischemia, whereas only 10% developed new ischemia.
Time frame: 3 years after start
Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort
Time frame: 5 years
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 9 Oct 2008.
- Background: PubMed 15277423Wackers FJ, Young LH, Inzucchi SE, Chyun DA, Davey JA, Barrett EJ, Taillefer R, Wittlin SD, Heller GV, Filipchuk N, Engel S, Ratner RE, Iskandrian AE; Detection of Ischemia in Asymptomatic Diabetics Investigators. Detection of silent myocardial ischemia in asymptomatic diabetic subjects: the DIAD study. Diabetes Care. 2004 Aug;27(8):1954-61. doi: 10.2337/diacare.27.8.1954.
- Background: PubMed 17682123Wackers FJ, Chyun DA, Young LH, Heller GV, Iskandrian AE, Davey JA, Barrett EJ, Taillefer R, Wittlin SD, Filipchuk N, Ratner RE, Inzucchi SE; Detection of Ischemia in Asymptomatic Diabetics (DIAD) Investigators. Resolution of asymptomatic myocardial ischemia in patients with type 2 diabetes in the Detection of Ischemia in Asymptomatic Diabetics (DIAD) study. Diabetes Care. 2007 Nov;30(11):2892-8. doi: 10.2337/dc07-1250. Epub 2007 Aug 6.
- Derived from this study: PubMed 19366774Young LH, Wackers FJ, Chyun DA, Davey JA, Barrett EJ, Taillefer R, Heller GV, Iskandrian AE, Wittlin SD, Filipchuk N, Ratner RE, Inzucchi SE; DIAD Investigators. Cardiac outcomes after screening for asymptomatic coronary artery disease in patients with type 2 diabetes: the DIAD study: a randomized controlled trial. JAMA. 2009 Apr 15;301(15):1547-55. doi: 10.1001/jama.2009.476.
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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.
Frans J Wackers, MD study chair
Yale University
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 Type 2 Diabetes Mellitus, run by Yale University at 1 site in United States.
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 2 inclusion and 4 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 9 Oct 2008. 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 United States. 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?
Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%. (time frame: At study entry). The study lists 3 primary outcomes in all. 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 NCT00769275, which also lists 3 linked publications.
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 9 Oct 2008.