Type 2 DiabetesPhase 1/2NCT01043965
Myocardial Perfusion in Type 2 Diabetes
A Phase 1/2 study testing Metformin in people with Type 2 Diabetes, run by University of Sao Paulo General Hospital.
Trial summary
The investigators aimed to evaluate microvascular circulation with novel method: real-time myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary arteries. Myocardial blood flow reserve will be determined by quantitative contrast Stress echocardiography. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Aug 2009
- Phase
- Phase 1/2
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Normal echocardiogram
- Absence of obstructive epicardial coronary disease
Who cannot join
- Obstructive coronary disease
- Heart valve disease
- COPD
- Cardiac Arrhythmias
- Cardiomyopathy
About this study
Official title: Evaluation of Myocardial Perfusion and Microvascular Reserve in Real-time Utilizing Myocardial Contrast Echocardiography in Type 2 Diabetes.
The investigators aimed to evaluate microvascular circulation with novel method: real-time myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary arteries.
Myocardial blood flow reserve will be determined by quantitative contrast Stress echocardiography. Diabetic individuals will be evaluate in a decompensated state (Phase 1) and after optimization of medical treatment four months later (Phase 2).
Read the detailed description
Early stages of epicardial atherosclerosis in patients with type 2 diabetes are associated with an impairment in endothelium-dependent dilation of the coronary microvasculature, indicating that the pathophysiological consequences of atherosclerosis may extend into the coronary microcirculation.
The investigators will evaluate three parameters of myocardial quantification with contrast Stress echocardiography and correlate with HbA1C levels.
- Conditions
- Type 2 Diabetes
- Being tested
- Metformin
- Keywords
- Diabetes Mellitus, Myocardial perfusion imaging, Heart diseases, Echocardiography, Endothelium
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Metformin 850mg
| Study group | Role | What they receive |
|---|---|---|
| Diabetes | Active comparator | Type 2 diabetes patients without obstructive coronary disease. Interventional group: lifestyle changes and treatment with metformin. Receives: Drug: Metformin |
| Control | No intervention | Control group - normal, healthy individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial blood flow velocity, myocardial blood flow reserve
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startAug 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Wilson Mathias Jr, Md, PhD, Study director, Heart Institute - Sao Paulo - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043965
- Sponsor's protocol ID
- 0925
- Other IDs
- nata925
- Status last verified
- Aug 2005
- First submitted
- 6 Jan 2010
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Myocardial Perfusion and Microvascular Reserve in Real-time Utilizing Myocardial Contrast Echocardiography in Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT01043965
- Acronym / sponsor ID
- 0925
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Mellitus, Myocardial perfusion imaging, Heart diseases, Echocardiography, Endothelium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Jan 2010 (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 investigators aimed to evaluate microvascular circulation with novel method: real-time myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary arteries.
Myocardial blood flow reserve will be determined by quantitative contrast Stress echocardiography. Diabetic individuals will be evaluate in a decompensated state (Phase 1) and after optimization of medical treatment four months later (Phase 2).
Detailed description
Early stages of epicardial atherosclerosis in patients with type 2 diabetes are associated with an impairment in endothelium-dependent dilation of the coronary microvasculature, indicating that the pathophysiological consequences of atherosclerosis may extend into the coronary microcirculation.
The investigators will evaluate three parameters of myocardial quantification with contrast Stress echocardiography and correlate with HbA1C levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes | Active comparator | Drug: MetforminType 2 diabetes patients without obstructive coronary disease. Interventional group: lifestyle changes and treatment with metformin. |
| Control | No intervention | –Control group - normal, healthy individuals. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- Normal echocardiogram
- Absence of obstructive epicardial coronary disease
Key exclusion criteria (5 listed)
- Obstructive coronary disease
- Heart valve disease
- COPD
- Cardiac Arrhythmias
- Cardiomyopathy
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 |
|---|---|---|
| MetforminAlso: GlucophageMetformin 850mg | Drug | Diabetes |
Primary outcome
myocardial blood flow velocity, myocardial blood flow reserve
Time frame: 3 months
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 7 Jan 2010.
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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.
Wilson Mathias Jr, Md, PhD study director
Heart Institute - Sao Paulo - Brazil
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Metformin in people with Type 2 Diabetes, run by University of Sao Paulo General Hospital.
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 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 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
myocardial blood flow velocity, myocardial blood flow reserve (time frame: 3 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 7 Jan 2010.