Endothelial Function Clinical Trial
Official title:
Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease
Cardiovascular complications account for the highest mortality in type 2 diabetic patients,
mainly due to ischeamia heart disease (IHD). Most of the attention in treating IHD in type 2
diabetes is understandably directed toward treating coronary artery conditions. However
there are other treatable culprits in these patients.
Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with IHD, even
in the absence of hypertension. It is a strong predictor of cardiovascular events and
all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality
than either multivessel coronary disease or impaired left ventricular function. Regression
of LVH has been associated with an improved prognosis, independent of change in blood
pressure (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with IHD
might will be reduced if we can find novel therapies to regress LVH.
Pioglitazone can improve atherosclerosis. Therefore, we hypothesied that pioglitazone can
regress the left ventricular mass (LVM) in type 2 diabetes with IHD.Therefore, in this
study, we will treat patients with pioglitazone, and we will also metformin as control.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - type 2 diabetes - aged 40~75 years old - with IHD Exclusion Criteria: - heart failure - renal failure - hypertension (>130/80 mmHg) - hemoglobin A1c 9% |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Xiang Guangda | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Xiang Guang-da |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The changes of LVM | The LVM will be measured at baseline, 6 momth and 9 month | Yes | |
Secondary | The changes of endothelial function | The endothelial function will be measured at baseline, 6 month and 9 month | Yes |
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