Type 2 DiabetesNCT00549874
Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes
A study testing Rosiglitazone and Glyburide in people with Type 2 Diabetes, run by University of Michigan at 2 sites in United States.
Trial summary
The overall hypothesis to be tested is that increased insulin resistance contributes to abnormal cardiac blood flow regulation in type 2 diabetic patients, which can be reversed by 6 months treatment with rosiglitazone. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Rosiglitazone and Glyburide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2002to Nov 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- 30-75 years of age
- less than 1% fluctuation in HbA1c over 3 months
- women must be on contraception
- HbA1c 6-9%
- willingness to sign approved consent form
Who cannot join
- Nursing mothers, pregnant women (excluded by a negative pregnancy test).
- Subjects requiring insulin therapy (>20 units/day) and can not be converted to sulfonylurea therapy without loss of diabetes control.
- Patients with a history of drug or alcohol dependence in the last 5 years
- Patients with pre-existing cardiovascular disease including coronary artery disease, heart attack, heart failure, abnormal heart rhythms, structural abnormalities and valve disease, peripheral vascular disease and uncontrolled high blood pressure.
- Patients with a history of high cholesterol requiring therapy.
- Patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy
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- Patients currently taking drugs which act on the blood vessels (for example for hypertension)
- Patients taking antidepressants, or other drugs or medications known to interfere with the uptake or metabolism of catecholamines (stress hormones)
- Patients with poor renal function or have significant liver disease
- Patients with a history of previous kidney, pancreas or cardiac transplantation.
- Patients with a history of "severe hypoglycemia" which required the assistance of a third party or ketoacidosis requiring hospital admission within the last 3 months.
- Patients with lung disease for example resulting from chronic obstructive airways disease.
- Patients with abnormal thyroid function tests.
- Patients having taken other systemic investigational drugs (especially for neuropathy) or initiating a new or experimental insulin delivery device within 3 months of starting the study.
- Patients with a history of allergic reactions to multiple drugs or biological products.
- Obese patients (BMI greater than 35).
- Patients who refuse to sign the informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Toledo - Health Campus
Toledo, Ohio, 43606
About this study
The overall hypothesis to be tested is that increased insulin resistance contributes to abnormal cardiac blood flow regulation in type 2 diabetic patients, which can be reversed by 6 months treatment with rosiglitazone. The planned experimental approach will be to utilize nuclear medicine techniques to evaluate whether the administration of rosiglitazone for 6 months can reverse regional deficits in myocardial blood flow and glucose utilization in type 2 diabetes in a randomized double blind controlled study. These studies will help elucidate the potential of rosiglitazone to correct deficits of myocardial blood flow complicating diabetes with the overall aim being the eventual prevention of sudden cardiac death.
- Conditions
- Type 2 Diabetes
- Being tested
- Rosiglitazone, Glyburide
- Keywords
- insulin resistance, type 2 diabetes, myocardial perfusion, nitrosative stress, thiazolidinediones
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
oral 8 mg/once daily for 6 months
GlyburideDrug
20 mg/ once daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Rosiglitazone |
| 2 | Experimental | Not described Receives: Drug: Glyburide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial blood flow regulation
Measured: 6 months intervention
Secondary outcomes (1)
biomarkers of oxidative/nitrosative stress
Measured: 6 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startFeb 2002
- Study completionNov 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 Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Martin Stevens, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549874
- Sponsor's protocol ID
- SKB 276
- Status last verified
- Oct 2007
- First submitted
- 24 Oct 2007
- Last updated
- 9 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pop-Busui R, Oral E, Raffel D, Byun J, Bajirovic V, Vivekanandan-Giri A, Kellogg A, Pennathur S, Stevens MJ. Impact of rosiglitazone and glyburide on nitrosative stress and myocardial blood flow regulation in type 2 diabetes mellitus. Metabolism. 2009 Jul;58(7):989-94. doi: 10.1016/j.metabol.2009.02.020.
PubMed 19394661
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00549874
- Acronym / sponsor ID
- SKB 276
- Conditions
- Type 2 Diabetes
- Keywords
- insulin resistance, type 2 diabetes, myocardial perfusion, nitrosative stress, thiazolidinediones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2002
- Study completion
- Nov 2006 (actual)
- First posted
- 26 Oct 2007 (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 overall hypothesis to be tested is that increased insulin resistance contributes to abnormal cardiac blood flow regulation in type 2 diabetic patients, which can be reversed by 6 months treatment with rosiglitazone. The planned experimental approach will be to utilize nuclear medicine techniques to evaluate whether the administration of rosiglitazone for 6 months can reverse regional deficits in myocardial blood flow and glucose utilization in type 2 diabetes in a randomized double blind controlled study. These studies will help elucidate the potential of rosiglitazone to correct deficits of myocardial blood flow complicating diabetes with the overall aim being the eventual prevention of sudden cardiac death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rosiglitazone |
| 2 | Experimental | Drug: Glyburide |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes
- 30-75 years of age
- less than 1% fluctuation in HbA1c over 3 months
- women must be on contraception
- HbA1c 6-9%
Key exclusion criteria (17 listed)
- Nursing mothers, pregnant women (excluded by a negative pregnancy test).
- Subjects requiring insulin therapy (>20 units/day) and can not be converted to sulfonylurea therapy without loss of diabetes control.
- Patients with a history of drug or alcohol dependence in the last 5 years
- Patients with pre-existing cardiovascular disease including coronary artery disease, heart attack, heart failure, abnormal heart rhythms, structural abnormalities and valve disease, peripheral vascular disease and uncontrolled high blood pressure.
- Patients with a history of high cholesterol requiring therapy.
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 |
|---|---|---|
| Rosiglitazoneoral 8 mg/once daily for 6 months | Drug | 1 |
| Glyburide20 mg/ once daily for 6 months | Drug | 2 |
Primary outcome
Myocardial blood flow regulation
Time frame: 6 months intervention
1 secondary outcome
biomarkers of oxidative/nitrosative stress
Time frame: 6 month intervention
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 Nov 2007.
- Derived from this study: PubMed 19394661Pop-Busui R, Oral E, Raffel D, Byun J, Bajirovic V, Vivekanandan-Giri A, Kellogg A, Pennathur S, Stevens MJ. Impact of rosiglitazone and glyburide on nitrosative stress and myocardial blood flow regulation in type 2 diabetes mellitus. Metabolism. 2009 Jul;58(7):989-94. doi: 10.1016/j.metabol.2009.02.020.
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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.
Martin Stevens, MD, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosiglitazone and Glyburide in people with Type 2 Diabetes, run by University of Michigan at 2 sites 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 6 inclusion and 17 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 Nov 2007. 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 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?
Myocardial blood flow regulation (time frame: 6 months intervention). 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 NCT00549874, 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 9 Nov 2007.